| <!DOCTYPE html> |
| <html lang="en-US"> |
| <head> |
| <meta charset="UTF-8"> |
| <title>0aec4542-8112-41df-bc16-87f7f6320bf6</title> |
| <meta name="viewport" content="width=device-width, initial-scale=1"> |
| <link rel="stylesheet" href="https://cdn.mathpix.com/fonts/cmu.css"/> |
| <style>html,body { |
| width: 100%; |
| height: 100%; |
| } |
| *, *::before,*::after { |
| box-sizing: border-box; |
| } |
| body { |
| margin: 0; |
| color: #1E2029; |
| font-size: 14px; |
| line-height: normal; |
| } |
| hr { |
| box-sizing: content-box; |
| height: 0; |
| overflow: visible; |
| } |
| h1, h2, h3, h4, h5, h6 { |
| margin-top: 0; |
| margin-bottom: 0.5em; |
| color: rgba(0, 0, 0, 0.85); |
| font-weight: 500; |
| } |
| p { |
| margin-top: 0; |
| margin-bottom: 1em; |
| } |
| ol, ul, dl { |
| margin-top: 0; |
| margin-bottom: 1em; |
| } |
| ol ol, ul ul, ol ul, ul ol { |
| margin-bottom: 0; |
| } |
| dt { |
| font-weight: 500; |
| } |
| dd { |
| margin-bottom: 0.5em; |
| margin-left: 0; |
| } |
| blockquote { |
| margin: 0 0 1em; |
| } |
| dfn { |
| font-style: italic; |
| } |
| b, strong { |
| font-weight: bolder; |
| } |
| small { |
| font-size: 80%; |
| } |
| sub, sup { |
| position: relative; |
| font-size: 75%; |
| line-height: 0; |
| vertical-align: baseline; |
| } |
| sub { |
| bottom: -0.25em; |
| } |
| sup { |
| top: -0.5em; |
| } |
| a { |
| color: #0B93ff; |
| text-decoration: none; |
| background-color: transparent; |
| outline: none; |
| cursor: pointer; |
| transition: color 0.3s; |
| } |
| a:hover { |
| color: #33aaff; |
| } |
| a:active { |
| color: #0070d9; |
| } |
| a:active, a:hover { |
| text-decoration: none; |
| outline: 0; |
| } |
| a[disabled] { |
| color: rgba(0, 0, 0, 0.25); |
| cursor: not-allowed; |
| pointer-events: none; |
| } |
| pre, code, kbd, samp { |
| font-size: 1em; |
| } |
| pre { |
| margin-top: 0; |
| margin-bottom: 1em; |
| overflow: auto; |
| } |
| figure { |
| margin: 0 0 1em; |
| } |
| img { |
| vertical-align: middle; |
| border-style: none; |
| } |
| svg:not(:root) { |
| overflow: hidden; |
| } |
| table { |
| border-collapse: collapse; |
| } |
| caption { |
| padding-top: 0.75em; |
| padding-bottom: 0.3em; |
| color: rgba(0, 0, 0, 0.45); |
| text-align: left; |
| caption-side: bottom; |
| } |
| th { |
| text-align: inherit; |
| } |
| mjx-container[jax="SVG"] { |
| direction: ltr; |
| } |
| |
| mjx-container[jax="SVG"] > svg { |
| overflow: visible; |
| min-height: 1px; |
| min-width: 1px; |
| } |
| |
| mjx-container[jax="SVG"] > svg a { |
| fill: blue; |
| stroke: blue; |
| } |
| |
| mjx-container[jax="SVG"][display="true"] { |
| display: block; |
| text-align: center; |
| margin: 1em 0; |
| } |
| |
| mjx-container[jax="SVG"][display="true"][width="full"] { |
| display: flex; |
| } |
| |
| mjx-container[jax="SVG"][justify="left"] { |
| text-align: left; |
| } |
| |
| mjx-container[jax="SVG"][justify="right"] { |
| text-align: right; |
| } |
| |
| g[data-mml-node="merror"] > g { |
| fill: red; |
| stroke: red; |
| } |
| |
| g[data-mml-node="merror"] > rect[data-background] { |
| fill: yellow; |
| stroke: none; |
| } |
| |
| g[data-mml-node="mtable"] > line[data-line], svg[data-table] > g > line[data-line] { |
| stroke-width: 70px; |
| fill: none; |
| } |
| |
| g[data-mml-node="mtable"] > rect[data-frame], svg[data-table] > g > rect[data-frame] { |
| stroke-width: 70px; |
| fill: none; |
| } |
| |
| g[data-mml-node="mtable"] > .mjx-dashed, svg[data-table] > g > .mjx-dashed { |
| stroke-dasharray: 140; |
| } |
| |
| g[data-mml-node="mtable"] > .mjx-dotted, svg[data-table] > g > .mjx-dotted { |
| stroke-linecap: round; |
| stroke-dasharray: 0,140; |
| } |
| |
| g[data-mml-node="mtable"] > g > svg { |
| overflow: visible; |
| } |
| |
| [jax="SVG"] mjx-tool { |
| display: inline-block; |
| position: relative; |
| width: 0; |
| height: 0; |
| } |
| |
| [jax="SVG"] mjx-tool > mjx-tip { |
| position: absolute; |
| top: 0; |
| left: 0; |
| } |
| |
| mjx-tool > mjx-tip { |
| display: inline-block; |
| padding: .2em; |
| border: 1px solid #888; |
| font-size: 70%; |
| background-color: #F8F8F8; |
| color: black; |
| box-shadow: 2px 2px 5px #AAAAAA; |
| } |
| |
| g[data-mml-node="maction"][data-toggle] { |
| cursor: pointer; |
| } |
| |
| mjx-status { |
| display: block; |
| position: fixed; |
| left: 1em; |
| bottom: 1em; |
| min-width: 25%; |
| padding: .2em .4em; |
| border: 1px solid #888; |
| font-size: 90%; |
| background-color: #F8F8F8; |
| color: black; |
| } |
| |
| foreignObject[data-mjx-xml] { |
| font-family: initial; |
| line-height: normal; |
| overflow: visible; |
| } |
| |
| mjx-container[jax="SVG"] path[data-c], mjx-container[jax="SVG"] use[data-c] { |
| stroke-width: 3; |
| } |
| #setText > div { |
| justify-content: inherit; |
| margin-top: 0; |
| margin-bottom: 1em; |
| |
| |
| } |
| #setText div:last-child { |
| margin-bottom: 0 !important; |
| } |
| #setText > br, #preview-content br { |
| line-height: 1.2; |
| } |
| #preview-content > div { |
| margin-top: 0; |
| margin-bottom: 1em; |
| |
| } |
| .proof > div, |
| #preview-content .proof > div, #setText .proof > div, |
| .theorem > div, |
| #preview-content .theorem > div, #setText .theorem > div { |
| margin-top: 1rem; |
| } |
| mjx-container { |
| text-indent: 0; |
| overflow-y: hidden; |
| overflow-x: auto; |
| padding-top: 1px; |
| padding-bottom: 1px; |
| |
| } |
| .math-inline mjx-container { |
| display: inline-block !important; |
| page-break-inside: avoid; |
| max-width: 100%; |
| padding: 0; |
| line-height: 0; |
| } |
| .math-inline[data-overflow="visible"] mjx-container { |
| overflow: visible; |
| } |
| .math-inline mjx-container mjx-assistive-mml { |
| max-width: 100%; |
| } |
| .math-block { |
| align-items: center; |
| page-break-after: auto; |
| page-break-inside: avoid; |
| margin: 0; |
| display: block; |
| } |
| .math-inline { |
| display: inline-flex; |
| max-width: 100%; |
| } |
| .math-block[data-width="full"] { |
| overflow-x: auto; |
| display: flex; |
| } |
| .math-block[data-width="full"] mjx-container[jax=SVG][display=true] { |
| display: flex; |
| flex: 1 1; |
| justify-content: center; |
| } |
| svg .math-inline { |
| display: initial; |
| max-width: initial; |
| } |
| svg .math-inline mjx-container { |
| max-width: initial; |
| } |
| svg mjx-container { |
| overflow: visible; |
| padding: 0; |
| } |
| svg .math-block[data-width="full"] { |
| overflow: visible; |
| } |
| .math-block, .math-inline { |
| --mmd-highlight-color: rgba(0, 147, 255, 0.25); |
| --mmd-highlight-text-color: #1e2029; |
| } |
| .math-block[data-highlight-color] mjx-container[jax="SVG"] > svg { |
| background-color: var(--mmd-highlight-color); |
| } |
| .math-block[data-highlight-text-color] mjx-container[jax="SVG"] > svg { |
| color: var(--mmd-highlight-text-color); |
| } |
| .math-inline[data-highlight-color] mjx-container[jax="SVG"] { |
| background-color: var(--mmd-highlight-color); |
| } |
| .math-inline[data-highlight-text-color] mjx-container[jax="SVG"] { |
| color: var(--mmd-highlight-text-color); |
| } |
| .math-block p { |
| flex-shrink: 1; |
| } |
| .math-block mjx-container { |
| margin: 0 !important; |
| } |
| .math-error { |
| background-color: yellow; |
| color: red; |
| } |
| #preview-content img, #setText img { |
| max-width: 100%; |
| } |
| #preview-content blockquote, #setText blockquote { |
| page-break-inside: avoid; |
| color: #666; |
| margin: 0 0 1em 0; |
| padding-left: 3em; |
| border-left: .5em solid #eee; |
| } |
| #preview-content pre, #setText pre { |
| border: none; |
| padding: 0; |
| overflow: auto; |
| font-size: 85%; |
| line-height: 1.45; |
| border-radius: 6px; |
| box-sizing: border-box; |
| background: #f8f8fa; |
| } |
| #preview-content pre code, #setText pre code { |
| padding: 1rem; |
| display: block; |
| overflow-x: auto; |
| line-height: 24px; |
| } |
| #preview-content table, #setText table { |
| display: table; |
| overflow: auto; |
| max-width: 100%; |
| border-collapse: collapse; |
| page-break-inside: avoid; |
| margin-bottom: 1em; |
| } |
| #preview-content table th, #setText table th { |
| text-align: center; |
| font-weight: bold; |
| } |
| #preview-content table td, #setText table td, |
| #preview-content table th, #setText table th { |
| border: 1px solid #dfe2e5; |
| padding: 6px 13px; |
| } |
| #preview-content table tr, #setText table tr { |
| background-color: #fff; |
| border-top: 1px solid #c6cbd1; |
| } |
| #preview-content table tr:nth-child(2n), #setText table tr:nth-child(2n) { |
| background-color: #f6f8fa; |
| } |
| .main-title, |
| #preview-content .main-title, #setText .main-title { |
| text-align: center; |
| line-height: 1.2; |
| margin: 0 auto 1em auto; |
| } |
| .author, |
| #preview-content .author, #setText .author { |
| text-align: center; |
| margin: 0 auto; |
| display: flex; |
| justify-content: center; |
| flex-wrap: wrap; |
| } |
| .author p, |
| #preview-content .author p, #setText .author p { |
| min-width: 30%; |
| max-width: 50%; |
| padding: 0 7px; |
| } |
| .author > p > span, |
| #preview-content .author > p > span, #setText .author > p > span { |
| display: block; |
| text-align: center; |
| } |
| .section-title, |
| #preview-content .section-title, #setText .section-title { |
| margin-top: 1.5em; |
| } |
| .abstract, |
| #preview-content .abstract, #setText .abstract { |
| text-align: justify; |
| margin-bottom: 1em; |
| } |
| .abstract p, |
| #preview-content .abstract p, #setText .abstract p { |
| margin-bottom: 0; |
| } |
| #preview-content sup, #setText sup { |
| top: -.5em; |
| position: relative; |
| font-size: 75%; |
| line-height: 0; |
| vertical-align: baseline; |
| } |
| .text-url, |
| #preview-content .text-url, #setText .text-url { |
| color: #0B93ff; |
| cursor: text; |
| pointer-events: none; |
| } |
| .text-url a:hover, |
| #preview-content .text-url a:hover, #setText .text-url a:hover { |
| color: #0B93ff; |
| } |
| mark, |
| #preview-content mark, #setText mark { |
| background-color: #feffe6; |
| } |
| span[data-underline-type] mark, |
| #preview-content span[data-underline-type] mark, |
| #setText span[data-underline-type] mark { |
| background: inherit; |
| background-color: #feffe6; |
| padding-top: 0; |
| padding-bottom: 0; |
| } |
| *[data-has-dotfill] { |
| position: relative; |
| overflow: hidden; |
| } |
| *[data-has-dotfill] .dotfill::after { |
| position: absolute; |
| padding-left: .25ch; |
| content: " . . . . . . . . . . . . . . . . . . . " |
| ". . . . . . . . . . . . . . . . . . . . . . . " |
| ". . . . . . . . . . . . . . . . . . . . . . . " |
| ". . . . . . . . . . . . . . . . . . . . . . . " |
| ". . . . . . . . . . . . . . . . . . . . . . . " |
| ". . . . . . . . . . . . . . . . . . . . . . . " |
| ". . . . . . . . . . . . . . . . . . . . . . . "; |
| text-align: right; |
| } |
| .smiles, |
| #preview-content .smiles, #setText .smiles { |
| text-align: center; |
| } |
| div.svg-container, |
| #preview-content > div.svg-container, |
| #setText > div.svg-container { |
| display: flex; |
| justify-content: center; |
| } |
| @media print { |
| #preview { |
| font-size: 10pt !important; |
| } |
| .math-block svg, .math-inline svg { |
| shape-rendering: crispEdges; |
| margin-top: 1px; |
| } |
| #preview-content img, #setText img { |
| display: block; |
| } |
| #preview-content .figure_img img, #setText .figure_img img { |
| display: inline; |
| } |
| #preview-content h1, #preview-content h2, #preview-content h3, |
| #preview-content h4, #preview-content h5, #preview-content h6, |
| #setText h1, #setText h2, #setText h3, |
| #setText h4, #setText h5, #setText h6 { |
| page-break-inside: avoid; |
| position: relative; |
| border: 2px solid transparent; |
| } |
| #preview-content h1::after, #preview-content h2::after, #preview-content h3::after, |
| #preview-content h4::after, #preview-content h5::after, #preview-content h6::after, |
| #setText h1::after, #setText h2::after, #setText h3::after, |
| #setText h4::after, #setText h5::after, #setText h6::after { |
| content: ""; |
| display: block; |
| height: 100px; |
| margin-bottom: -100px; |
| position: relative; |
| } |
| } |
| #preview-content code, #setText code { |
| font-family: Inconsolata; |
| font-size: inherit; |
| display: initial; |
| background: #f8f8fa; |
| } |
| #preview-content .mmd-highlight code, #setText .mmd-highlight code, |
| #preview-content pre.mmd-highlight code, #setText pre.mmd-highlight code { |
| background-color: transparent; |
| } |
| #preview-content pre code, #setText pre code { |
| font-family: 'DM Mono', Inconsolata, monospace; |
| color: #333; |
| font-size: 15px; |
| } |
| .hljs-comment, .hljs-quote, |
| #preview-content .hljs-comment, #setText .hljs-comment, |
| #preview-content .hljs-quote, #setText .hljs-quote { |
| color: #998; |
| font-style: italic; |
| } |
| .hljs-command, |
| #preview-content .hljs-command, #setText .hljs-command { |
| color: #005cc5; |
| } |
| .hljs-keyword, .hljs-selector-tag, .hljs-subst, |
| #preview-content .hljs-keyword, #setText .hljs-keyword, |
| #preview-content .hljs-selector-tag, #setText .hljs-selector-tag, |
| #preview-content .hljs-subst, #setText .hljs-subst { |
| color: #d73a49; |
| font-weight: bold; |
| } |
| .hljs-number, .hljs-literal, .hljs-variable, |
| .hljs-template-variable, .hljs-tag .hljs-attr, |
| #preview-content .hljs-number, #setText .hljs-number, |
| #preview-content .hljs-literal, #setText .hljs-literal, |
| #preview-content .hljs-variable, #setText .hljs-variable, |
| #preview-content .hljs-template-variable, #setText .hljs-template-variable, |
| #preview-content .hljs-tag .hljs-attr, #setText .hljs-tag .hljs-attr { |
| color: #005cc5; |
| } |
| .hljs-string, .hljs-doctag, |
| #preview-content .hljs-string, #setText .hljs-string, |
| #preview-content .hljs-doctag, #setText .hljs-doctag { |
| color: #24292e; |
| } |
| .hljs-title, .hljs-section, .hljs-selector-id, |
| #preview-content .hljs-title, #setText .hljs-title, |
| #preview-content .hljs-section, #setText .hljs-section, |
| #preview-content .hljs-selector-id, #setText .hljs-selector-id { |
| color: #6f42c1; |
| font-weight: bold; |
| } |
| .hljs-subst, |
| #preview-content .hljs-subst, #setText .hljs-subst { |
| font-weight: normal; |
| } |
| .hljs-type, .hljs-class .hljs-title, |
| #preview-content .hljs-type, #setText .hljs-type, |
| #preview-content .hljs-class .hljs-title, #setText .hljs-class .hljs-title { |
| color: #458; |
| font-weight: bold; |
| } |
| .hljs-tag, .hljs-name, .hljs-attribute, |
| #preview-content .hljs-tag, #setText .hljs-tag, |
| #preview-content .hljs-name, #setText .hljs-name, |
| #preview-content .hljs-attribute, #setText .hljs-attribute { |
| color: #000080; |
| font-weight: normal; |
| } |
| .hljs-regexp, .hljs-link, |
| #preview-content .hljs-regexp, #setText .hljs-regexp, |
| #preview-content .hljs-link, #setText .hljs-link { |
| color: #009926; |
| } |
| .hljs-symbol, .hljs-bullet, |
| #preview-content .hljs-symbol, #setText .hljs-symbol, |
| #preview-content .hljs-bullet, #setText .hljs-bullet { |
| color: #990073; |
| } |
| .hljs-built_in, .hljs-builtin-name, |
| #preview-content .hljs-built_in, #setText .hljs-built_in, |
| #preview-content .hljs-builtin-name, #setText .hljs-builtin-name { |
| color: #24292e; |
| } |
| .hljs-meta, |
| #preview-content .hljs-meta, #setText .hljs-meta { |
| color: #999; |
| font-weight: bold; |
| } |
| .hljs-meta-keyword, |
| #preview-content .hljs-meta-keyword, #setText .hljs-meta-keyword { |
| color: #d73a49; |
| } |
| .hljs-meta-string, |
| #preview-content .hljs-meta-string, #setText .hljs-meta-string { |
| color: #032f62; |
| } |
| .hljs-deletion, |
| #preview-content .hljs-deletion, #setText .hljs-deletion { |
| background: #fdd; |
| } |
| .hljs-addition, |
| #preview-content .hljs-addition, #setText .hljs-addition { |
| background: #dfd; |
| } |
| .hljs-emphasis, |
| #preview-content .hljs-emphasis, #setText .hljs-emphasis { |
| font-style: italic; |
| } |
| .hljs-strong, |
| #preview-content .hljs-strong, #setText .hljs-strong { |
| font-weight: bold; |
| } |
| .table_tabular, |
| #preview-content .table_tabular, #setText .table_tabular { |
| overflow-x: auto; |
| padding: 0 2px 0.5em 2px; |
| } |
| .tabular, |
| #preview-content .tabular, #setText .tabular { |
| display: inline-table !important; |
| width: auto; |
| table-layout: auto; |
| border-collapse: collapse; |
| border-spacing: 0; |
| margin: 0 0 1em; |
| font-size: inherit; |
| height: fit-content; |
| } |
| .tabular th, |
| #preview-content .tabular th, #setText .tabular th { |
| border: none !important; |
| padding: 6px 13px; |
| background-color: transparent; |
| font-weight: bold; |
| } |
| .tabular tr, |
| #preview-content .tabular tr, #setText .tabular tr { |
| border-top: none !important; |
| border-bottom: none !important; |
| background-color: transparent; |
| } |
| .tabular td, |
| #preview-content .tabular td, #setText .tabular td { |
| border-style: none !important; |
| background-color: #fff; |
| border-color: #000 !important; |
| word-break: keep-all; |
| padding: 0.1em 0.5em !important; |
| } |
| .tabular td > p, |
| #preview-content .tabular td > p, #setText .tabular td > p { |
| margin-bottom: 0; |
| margin-top: 0; |
| } |
| .tabular td._empty, |
| #preview-content .tabular td._empty, #setText .tabular td._empty { |
| height: 1.3em; |
| } |
| .tabular td .f, |
| #preview-content .tabular td .f, #setText .tabular td .f { |
| opacity: 0; |
| } |
| #preview-content .sub-table table, #setText .sub-table table { |
| margin-bottom: 0; |
| } |
| html[data-theme="dark"] .tabular tr, |
| html[data-theme="dark"] #preview-content .tabular tr, html[data-theme="dark"] #setText .tabular tr, |
| html[data-theme="dark"] .tabular td, |
| html[data-theme="dark"] #preview-content .tabular td, html[data-theme="dark"] #setText .tabular td { |
| background-color: #202226; |
| border-color: #fff !important; |
| } |
| .figure_img, |
| #preview-content .figure_img, #setText .figure_img { |
| margin-bottom: 0.5em; |
| overflow-x: auto; |
| } |
| div.figure_img img, |
| #preview-content div.figure_img img, #setText div.figure_img img { |
| display: inline; |
| margin: 0; |
| } |
| ol.enumerate, ul.itemize, |
| #preview-content ol.enumerate, #setText ol.enumerate, |
| #preview-content ul.itemize, #setText ul.itemize { |
| padding-inline-start: 40px; |
| margin: 0 0 1em 0; |
| } |
| li > ol.enumerate, li > ul.itemize, |
| #preview-content li > ol.enumerate, #setText li > ol.enumerate, |
| #preview-content li > ul.itemize, #setText li > ul.itemize { |
| margin: 0; |
| } |
| ul.itemize > li, |
| #preview-content ul.itemize > li, #setText ul.itemize > li { |
| position: relative; |
| min-height: 1.4em; |
| margin-bottom: 0; |
| } |
| .enumerate > .li_enumerate, |
| #preview-content .enumerate > .li_enumerate, #setText .enumerate > .li_enumerate { |
| margin-bottom: 0; |
| } |
| .itemize > li > span.li_level, .li_enumerate.not_number > span.li_level, |
| #preview-content .itemize > li > span.li_level, #setText .itemize > li > span.li_level, |
| #preview-content .li_enumerate.not_number > span.li_level, #setText .li_enumerate.not_number > span.li_level { |
| position: absolute; |
| right: 100%; |
| white-space: nowrap; |
| width: max-content; |
| display: flex; |
| justify-content: flex-end; |
| padding-right: 10px; |
| box-sizing: border-box; |
| } |
| .li_enumerate.not_number, |
| #preview-content .li_enumerate.not_number, #setText .li_enumerate.not_number { |
| position: relative; |
| display: inline-block; |
| list-style-type: none; |
| min-height: 1.4em; |
| } |
| .itemize > li > span.li_level .math-inline, |
| .enumerate > li > span.li_level .math-inline, |
| #preview-content .itemize > li > span.li_level .math-inline, |
| #setText .itemize > li > span.li_level .math-inline, |
| #preview-content .enumerate > li > span.li_level .math-inline, |
| #setText .enumerate > li > span.li_level .math-inline { |
| display: inline-block; |
| } |
| #preview { |
| font-family: 'CMU Serif', 'Georgia', Helvetica, Arial, sans-serif; |
| font-size: 17px; |
| visibility: visible; |
| word-break: break-word; |
| padding: 2.5em; |
| max-width: 800px; |
| margin: auto; |
| box-sizing: content-box; |
| } |
| #preview h1, #preview h2, #preview h3, #preview h4, #preview h5, #preview strong { |
| font-family: 'CMU Serif Bold', 'Georgia', Helvetica, Arial, sans-serif; |
| } |
| #preview i, #preview em { |
| font-family: 'CMU Serif Italic', 'Georgia', Helvetica, Arial, sans-serif; |
| } |
| .mmd-menu { |
| max-width: 320px; |
| position: absolute; |
| background-color: white; |
| color: black; |
| width: auto; |
| padding: 5px 0; |
| border: 1px solid #E5E6EB; |
| margin: 0; |
| cursor: default; |
| font: menu; |
| text-align: left; |
| text-indent: 0; |
| text-transform: none; |
| line-height: normal; |
| letter-spacing: normal; |
| word-spacing: normal; |
| word-wrap: normal; |
| white-space: nowrap; |
| float: none; |
| z-index: 201; |
| border-radius: 5px; |
| -webkit-border-radius: 5px; |
| -moz-border-radius: 5px; |
| -khtml-border-radius: 5px; |
| box-shadow: 0 10px 20px #808080; |
| -webkit-box-shadow: 0 10px 20px #808080; |
| -moz-box-shadow: 0 10px 20px #808080; |
| -khtml-box-shadow: 0 10px 20px #808080; |
| } |
| .mmd-menu:focus { outline: none; } |
| .mmd-menu.mmd-menu-sm { |
| max-width: 100vw; |
| padding-bottom: 34px; |
| border-radius: 0; |
| -webkit-border-radius: 0; |
| -moz-border-radius: 0; |
| -khtml-border-radius: 0; |
| } |
| .mmd-menu-item-icon { |
| color: #1E2029; |
| margin-left: auto; |
| align-items: center; |
| display: none; |
| flex-shrink: 0; |
| } |
| .mmd-menu-item { |
| padding: 8px 1.25rem; |
| display: flex; |
| background: transparent; |
| height: 52px; |
| max-height: 52px; |
| } |
| .mmd-menu-item:focus { outline: none; } |
| .mmd-menu-item.active { |
| background-color: #e1e0e5; |
| } |
| .mmd-menu-item.active .mmd-menu-item-icon { |
| display: flex; |
| } |
| .mmd-menu-item-container { |
| overflow: hidden; |
| } |
| .mmd-menu-item-title { |
| color: #1E2029; |
| white-space: nowrap; |
| text-overflow: ellipsis; |
| overflow: hidden; |
| font-size: 14px; |
| line-height: 20px; |
| } |
| .mmd-menu-item-value { |
| color: #7d829c; |
| white-space: nowrap; |
| text-overflow: ellipsis; |
| overflow: hidden; |
| font-size: 12px; |
| line-height: 16px; |
| } |
| html[data-theme="dark"] .mmd-menu-item-title { |
| color: #ebefe7; |
| } |
| html[data-theme="dark"] .mmd-menu-item.active .mmd-menu-item-title { |
| color: #1E2029; |
| } |
| html[data-theme="dark"] .mmd-menu { |
| background-color: #33363a; |
| } |
| .mmd-context-menu-overlay { |
| background: rgba(0, 0, 0, 0.56); |
| } |
| .ClipboardButton { |
| padding: 0; |
| margin: 0.5rem; |
| display: inline-block; |
| cursor: pointer; |
| color: rgb(36, 41, 47); |
| background: rgb(246, 248, 250); |
| border-radius: 6px; |
| border: 1px solid rgba(31, 35, 40, 0.15); |
| box-shadow: rgba(31, 35, 40, 0.04) 0 1px 0 0, rgba(255, 255, 255, 0.25) 0 1px 0 0 inset; |
| position: relative; |
| } |
| .ClipboardButton:hover { |
| background-color: rgb(243, 244, 246); |
| border-color: rgba(31, 35, 40, 0.15); |
| transition-duration: .1s; |
| } |
| td .mmd-clipboard-copy-container { |
| line-height: 0; |
| } |
| td .ClipboardButton { |
| margin: 1px; |
| line-height: 0; |
| } |
| td .ClipboardButton .mmd-clipboard-icon { |
| margin: 1px !important; |
| transform: scale(0.6); |
| } |
| .mmd-clipboard-icon { |
| fill: currentColor; |
| vertical-align: text-bottom; |
| } |
| .mmd-clipboard-copy-icon { |
| color: rgb(101, 109, 118); |
| } |
| .mmd-clipboard-check-icon { |
| color: rgb(26, 127, 55); |
| } |
| .mmd-tooltipped-no-delay:hover::before, |
| .mmd-tooltipped-no-delay:hover::after { |
| animation-delay: 0s; |
| } |
| .mmd-tooltipped:hover::before, |
| .mmd-tooltipped:hover::after { |
| display: inline-block; |
| text-decoration: none; |
| animation-name: tooltip-appear; |
| animation-duration: .1s; |
| animation-fill-mode: forwards; |
| animation-timing-function: ease-in; |
| animation-delay: .4s; |
| } |
| .mmd-tooltipped-w::before { |
| top: 50%; |
| bottom: 50%; |
| left: -7px; |
| margin-top: -6px; |
| border-left-color: rgb(36, 41, 47); |
| } |
| .mmd-tooltipped::before { |
| position: absolute; |
| z-index: 1000001; |
| display: none; |
| width: 0; |
| height: 0; |
| color: rgb(36, 41, 47); |
| pointer-events: none; |
| content: ""; |
| border: 6px solid transparent; |
| opacity: 0; |
| } |
| .mmd-tooltipped-w::after { |
| right: 100%; |
| bottom: 50%; |
| margin-right: 6px; |
| transform: translateY(50%); |
| } |
| .mmd-tooltipped::after { |
| position: absolute; |
| z-index: 1000000; |
| display: none; |
| padding: 0.5em 0.75em; |
| font: normal normal 11px/1.5 'CMU Serif', 'Georgia', Helvetica, Arial, sans-serif; |
| -webkit-font-smoothing: subpixel-antialiased; |
| color: white; |
| text-align: center; |
| text-decoration: none; |
| text-shadow: none; |
| text-transform: none; |
| letter-spacing: normal; |
| word-wrap: break-word; |
| white-space: pre; |
| pointer-events: none; |
| content: attr(aria-label); |
| background: rgb(36, 41, 47); |
| border-radius: 6px; |
| opacity: 0; |
| }</style> |
| </head> |
| <body> |
| <div id="preview" class="preview scrollEditor"> |
| <div id="container-ruller" /> |
| <div id="preview-content"> |
| <h1 type="title" class="main-title" id="compare-the-efficacy-of-different-antiplatelet-therapy-strategy-after-coronary-artery-bypass-graft-surgery"> |
| Compare the efficacy of different antiplatelet therapy strategy after Coronary Artery Bypass Graft Surgery </h1> |
| <div><div class="author"> |
| <p><span>(Study Number ISSBRIL0211)</span></p> |
| </div></div> |
| <div><div class="author"> |
| <p><span>Statistical Analysis Plan</span></p> |
| </div></div> |
| <div>(Version: 4.0)</div> |
| <div><div class="author"> |
| <p><span>Shanghai Bestudy Medical Technology Co.,Ltd</span></p> |
| </div></div> |
| <div>28Aug2017</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="contents"> |
| Contents</h2> |
| <div>Contents ..... 2<br> |
| ABBREVIATIONS ..... 4<br> |
| 0、Introduction ..... 5<br> |
| 0.1 Background ..... 5<br> |
| 0.2 Research Hypothesis ..... 5<br> |
| 0.3 Rationale for Conducting this Study ..... 5<br> |
| 0.4 Benefit/risk and Ethical Assessment ..... 5<br> |
| 1、Introduction to Study ..... 6<br> |
| 1.1 Types of this Study ..... 6<br> |
| 1.2 Objective ..... 6<br> |
| 1.3 Treatment Products in the Study ..... 6<br> |
| 1.3.1 Recommendation for the Dosage of Ticargrelor and Aspirin ..... 6<br> |
| 1.3.2 Doses and Treatment Regimens ..... 6<br> |
| 2. STUDY OBJECTIVES ..... 6<br> |
| 2.1 Primary Objective ..... 6<br> |
| 2.2 Secondary Objectives ..... 7<br> |
| 2.3 Safety Objective ..... 7<br> |
| 3. Study Design ..... 7<br> |
| 3.1 Overall Study Design and Flow Chart ..... 7<br> |
| 3.2 Schematic Overview of the Study ..... 8<br> |
| 3.3 Sample Size Justification ..... 8<br> |
| 3.4 Randomization and Blinding ..... 8<br> |
| 3.4.1 Randomization after Subjects Enrolled ..... 8<br> |
| 3.4.2 Blinding ..... 8<br> |
| 4. Study Endpoints ..... 9<br> |
| 4.1 Evaluation Methods for Study Endpoints ..... 9<br> |
| 4.2 Efficacy Endpoints ..... 9<br> |
| 4.2.1 Primary Efficacy Endpoint ..... 9<br> |
| 4.2.2 Secondary Efficacy Endpoints ..... 9<br> |
| 4.3 Safety Endpoints ..... 9<br> |
| 4.4 Other Endpoints ..... 9<br> |
| 5, Data Management ..... 10<br> |
| 6. Analysis Specifications ..... 10<br> |
| 6.1 Adverse Events ..... 10<br> |
| 6.1.1 AE Duration ..... 10<br> |
| 6.1.2 Imputation of Missing AE Data ..... 10<br> |
| 6.2 Concomitant Medication ..... 10<br> |
| 6.3 Age Calculation ..... 10<br> |
| 7. Analysis Sets ..... 10<br> |
| 7.1 Intent to Treat (ITT) ..... 10<br> |
| 7.2 Modified Full Analysis Set (mFAS) ..... 10<br> |
| 7.3 Per Protocol Set (PPS) ..... 10<br> |
| 7.4 Safety Analysis Set (SS) ..... 11<br> |
| 8. Statistical Analysis Methods ..... 11<br> |
| 8.1 Statistical Analysis Software ..... 11<br> |
| 8.2 General Statistical Analysis Methods Applied ..... 11<br> |
| 8.2.1 Continuous Variables ..... 11<br> |
| 8.2.2 Discrete Variables ..... 11<br> |
| 8.2.3 Ordinal Variables ..... 11<br> |
| 8.3 Statistical Test for Primary Endpoint ..... 11<br> |
| 8.3.1 Handling in Missing Values for Primary Endpoint ..... 11<br> |
| 8.3.2 Statistical Test for Primary Endpoint ..... 12<br> |
| 8.3.3 Statistical Descriptive of Patency of Grafts ..... 12<br> |
| 8.4 Secondary Endpoints ..... 12<br> |
| 8.4.1 Handling in Missing Values for Secondary Endpoint ..... 12<br> |
| 8.4.2 Statistical Descriptive and Statistical Test for Secondary Endpoints ..... 12<br> |
| 8.5 Safety Endpoints ..... 12<br> |
| 8.5.1 Adverse Events ..... 12<br> |
| 8.5.2 Smoking ..... 12<br> |
| 8.5.3 Bleeding Events ..... 12<br> |
| 8.5.4 Comparison in the Chemistry and Vital Sign Endpoints among 3 Treatment Groups ..... 13<br> |
| 8.6 Other Variables ..... 13<br> |
| 8.6.1 Demographic and Baseline Data ..... 13<br> |
| 8.6.2 Baseline and Medical History ..... 13<br> |
| 8.6.3 Operation Information Data ..... 13<br> |
| 8.6.4 Concomitant Medication ..... 13<br> |
| 8.7 Interim Analysis ..... 13<br> |
| References ..... 14<br> |
| Appendix: Time and Events Schedule ..... 15</div> |
| <div class="table" number="1"> |
| <div class="caption_table">ABBREVIATIONS</div><div class="table_tabular" style="text-align: center"> |
| <div class="inline-tabular"><table class="tabular"> |
| <tbody> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top-style: solid !important; border-top-width: 1px !important; width: auto; vertical-align: middle; ">ACS</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top-style: solid !important; border-top-width: 1px !important; width: auto; vertical-align: middle; ">Acute Coronary Syndrome</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">AE</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Adverse Event</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">ALT</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Alanine Aminotransferase</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">AST</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Aspartate Aminotransferase</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">BMI</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Body Mass Index</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">CABG</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Coronary Artery Bypass Grafting</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">CCS</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Canadian Cardiovascular Society</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">CFDA</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">China Food and Drug Administration</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">CMH X2</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Cochran-Mantel-Haenszel Chi-Squared Test</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">CRA</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Clinical Research Associate</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">CRF</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Case Report Form</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">CTA</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Clinical Trial Agreement</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">DM</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Data Management</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">EAP</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Effective Analysis Population</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">EC</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Ethics Committee</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">EDC</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Electronic Data Capture</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">FDA</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Food and Drug Administration</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">ICF</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Informed Consent Form</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">IEC</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Independent Ethics Committee</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">ITT</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Intent to Treat</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Max</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Max</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Mean</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Mean</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Median</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Median</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">MedDRA</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Medical Dictionary for Regulatory Activities</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Min</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Min</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Missing</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Missing</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">MSCTA</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Multi-slice Spiral Computed Tomography Angiography</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">N</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Number of Subjects (Number of Analysis Records)</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">OPCAB</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Off pump Coronary Artery Bypass</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">PI</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Principal Investigator</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">PLATO</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Platelet Inhibition and Patient Outcomes</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">PP</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Per-Protocol Set</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">SAE</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Serious Adverse Event</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">SS</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Safety Analysis Set</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">TIMI</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Thrombolysis and Thrombin Inhibition in Myocardial Infarction</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">UCG</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Ultrasonic Cardiogram</td> |
| </tr> |
| </tbody> |
| </table> |
| </div></div> |
| </div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="0%E3%80%81introduction"> |
| 0、Introduction</h2> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="0.1-background"> |
| 0.1 Background</h3> |
| <div>For 30 years, antiplatelet therapy has been the gold standard for preventing saphenous vein graft closure after CABG. Aspirin is recognized as the standard of care and is generally continued indefinitely given its benefit in preventing subsequent clinical events. But 2010 Canadian guideline4 and 2012 Society of Thoracic Surgeons guideline 5 recommended that in patients undergoing CABG after ACS, dual antiplatelet drugs should be restarted and that may have secondary benefit of increasing early vein graft patency. Hence, different antiplatelet therapy strategy after CABG is still in controversy.</div> |
| <div>However, as many as <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="4.147ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 1833 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> of patients do not have adequate response to aspirin on the first postoperative day after cardiac procedures, and this percentage increases in the first week after operation, especially for off-pump procedures. Interestingly, the addition of clopidogrel did not seem to alter this nonresponse to aspirin. The clinical consequences of this lack of response remain uncertain, but evidence suggests lack of response to aspirin correlates with early vein graft closure after CABG and with recurrent cardiac events.</div> |
| <div>In patients with high residual platelet reactivity after the usual doses of clopidogrel, the novel antiplatelet agents are more effective at reducing platelet reactivity compared with increasing dose of clopidogrel. In the PLATO trial, ticagrelor, a novel reversible inhibitor of the P2Y12 receptor, in addition to aspirin significantly reduced cardiovascular events in patients with ACS as compared to aspirin plus clopidogrel. The CABG substudy of the PLATO trial showed ticagrelor compared with clopidogrel was associated with a substantial reduction in total and CV mortality without excess risk of CABG-related bleeding.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="0.2-research-hypothesis"> |
| 0.2 Research Hypothesis</h3> |
| <div>This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of vein graft patency.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="0.3-rationale-for-conducting-this-study"> |
| 0.3 Rationale for Conducting this Study</h3> |
| <div>For the study rationale, four recent published guidelines on CABG stated different antiplatelet therapy strategy for post-CABG is still in controversy. As 2010 ESC guideline on myocardial revascularization and 2011 ACCF/AHA Guideline for CABG recommended, aspirin monotherapy should be given to reduce the occurrence of vein graft closure and adverse cardiovascular events (Class I recommendation), but dual antiplatelet therapy is recommended (Class I) in 2010 Canadian guideline and 2012 society of thoracic surgeons guideline.</div> |
| <div>PLATO-CABG subgroup analysis showed that combination ticagrelor with aspirin is effective in this population, but it is still not clear which one will be more benefit for from dual antiplatelet or monotherapy as current controversy in patients receiving clopidogrel.</div> |
| <div>A systematically review showed that clopidogrel treatment alone demonstrate inferior with combination clopidogrel with aspirin in CABG patients.</div> |
| <div>Arterial graft patency rates are high even in the absence of antiplatelet therapy, the administration of antiplatelet therapy has not shown an improvement. 15 In previous published literatures and datas in our center , compared with artery graft, vein graft patency rate is lower. Meanwhile, short-term(one year) stenosis or closure of vein graft is the main factor for thrombosis. So vein graft patency is an objective index for evaluating the effect of CABG postoperative.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="0.4-benefit%2Frisk-and-ethical-assessment"> |
| 0.4 Benefit/risk and Ethical Assessment</h3> |
| <div>The Prescription Information for ticagrelor contains the information supporting the overall<br> |
| risk/benefit assessment of the investigational agent and is available as a reference for investigators. It contains a summary of all the relevant pharmaceutical, nonclinical and clinical findings with ticagrelor.</div> |
| <div>Patients enrolled in this study will be treated with ticagrelor. Participation will entail recording of medical information about the patient in a confidential manner. Patient care will not be altered by participation. Ticagrelor will be provided to the subjects for free. The risks to patients include bleeding and dyspnoea, which are believed to be adequately handled in the clinical situation. The study will be approved by the local research ethics committee.</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="1%E3%80%81introduction-to-study"> |
| 1、Introduction to Study</h2> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="1.1-types-of-this-study"> |
| 1.1 Types of this Study</h3> |
| <div>This is a phase IV, multi-center, open-label, active-controlled, randomized, parallel-group study.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="1.2-objective"> |
| 1.2 Objective</h3> |
| <div>The primary objective of this study will be to evaluate whether, as compared with aspirin monotherapy, ticagrelor plus aspirin and ticagrelor monotherapy could increase saphenous vein graft patency at 12 months after surgery in the patients undergoing elective CABG, as assessed by multislice computed tomography angiography (MSCTA) or coronary angiography (CAG).</div> |
| <div>Secondary objectives including:</div> |
| <ol> |
| <li>Saphenous vein graft patency at <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.05ex;" xmlns="http://www.w3.org/2000/svg" width="3.231ex" height="1.981ex" role="img" focusable="false" viewBox="0 -853.7 1428 875.7"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="mn"><path data-c="37" d="M55 458Q56 460 72 567L88 674Q88 676 108 676H128V672Q128 662 143 655T195 646T364 644H485V605L417 512Q408 500 387 472T360 435T339 403T319 367T305 330T292 284T284 230T278 162T275 80Q275 66 275 52T274 28V19Q270 2 255 -10T221 -22Q210 -22 200 -19T179 0T168 40Q168 198 265 368Q285 400 349 489L395 552H302Q128 552 119 546Q113 543 108 522T98 479L95 458V455H55V458Z"></path></g><g data-mml-node="TeXAtom" transform="translate(533,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mtext"><path data-c="74" d="M27 422Q80 426 109 478T141 600V615H181V431H316V385H181V241Q182 116 182 100T189 68Q203 29 238 29Q282 29 292 100Q293 108 293 146V181H333V146V134Q333 57 291 17Q264 -10 221 -10Q187 -10 162 2T124 33T105 68T98 100Q97 107 97 248V385H18V422H27Z"></path><path data-c="68" d="M41 46H55Q94 46 102 60V68Q102 77 102 91T102 124T102 167T103 217T103 272T103 329Q103 366 103 407T103 482T102 542T102 586T102 603Q99 622 88 628T43 637H25V660Q25 683 27 683L37 684Q47 685 66 686T103 688Q120 689 140 690T170 693T181 694H184V367Q244 442 328 442Q451 442 463 329Q464 322 464 190V104Q464 66 466 59T477 49Q498 46 526 46H542V0H534L510 1Q487 2 460 2T422 3Q319 3 310 0H302V46H318Q379 46 379 62Q380 64 380 200Q379 335 378 343Q372 371 358 385T334 402T308 404Q263 404 229 370Q202 343 195 315T187 232V168V108Q187 78 188 68T191 55T200 49Q221 46 249 46H265V0H257L234 1Q210 2 183 2T145 3Q42 3 33 0H25V46H41Z" transform="translate(389,0)"></path><path data-c="A0" d="" transform="translate(945,0)"></path></g></g></g></g></g></svg></mjx-container></span> day after surgery in the patients undergoing elective CABG , as assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG).</li> |
| <li>Time to first event of major adverse cardiovascular event (MACE), composite of CV death, non-fatal myocardial infarction or non-fatal stroke (ischaemic or unknown etiology).</li> |
| <li>Rate of freedom from angina by questionnaire according to CCS classification at 12 months. Rate of atrial fibrillation within 7 days post CABG.</li> |
| </ol> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="1.3-treatment-products-in-the-study"> |
| 1.3 Treatment Products in the Study</h3> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="1.3.1-recommendation-for-the-dosage-of-ticargrelor-and-aspirin"> |
| 1.3.1 Recommendation for the Dosage of Ticargrelor and Aspirin</h3> |
| <div>Ticargrelor: 90 mg bid for 12 months<br> |
| Aspirin: 100 mg qd for 12 months</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="1.3.2-doses-and-treatment-regimens"> |
| 1.3.2 Doses and Treatment Regimens</h3> |
| <div>Arm A: Aspirin 100 mg qd for 12 months<br> |
| Arm B: Ticargrelor 90 mg bid plus Aspirin 100 mg qd for 12 months<br> |
| Arm C: Ticargrelor 90 mg bid for 12 months</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="2.-study-objectives"> |
| 2. STUDY OBJECTIVES</h2> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="2.1-primary-objective"> |
| 2.1 Primary Objective</h3> |
| <div>The primary objective of this study will be to evaluate whether, as compared with aspirin monotherapy, ticagrelor plus aspirin and ticagrelor monotherapy could increase saphenous vein graft patency at 12 months after surgery in the patients undergoing elective CABG, as assessed by multislice computed tomography angiography (MSCTA) or coronary angiography (CAG).</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="2.2-secondary-objectives"> |
| 2.2 Secondary Objectives</h3> |
| <ol> |
| <li>Saphenous vein graft patency at <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.05ex;" xmlns="http://www.w3.org/2000/svg" width="3.231ex" height="1.981ex" role="img" focusable="false" viewBox="0 -853.7 1428 875.7"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="mn"><path data-c="37" d="M55 458Q56 460 72 567L88 674Q88 676 108 676H128V672Q128 662 143 655T195 646T364 644H485V605L417 512Q408 500 387 472T360 435T339 403T319 367T305 330T292 284T284 230T278 162T275 80Q275 66 275 52T274 28V19Q270 2 255 -10T221 -22Q210 -22 200 -19T179 0T168 40Q168 198 265 368Q285 400 349 489L395 552H302Q128 552 119 546Q113 543 108 522T98 479L95 458V455H55V458Z"></path></g><g data-mml-node="TeXAtom" transform="translate(533,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mtext"><path data-c="74" d="M27 422Q80 426 109 478T141 600V615H181V431H316V385H181V241Q182 116 182 100T189 68Q203 29 238 29Q282 29 292 100Q293 108 293 146V181H333V146V134Q333 57 291 17Q264 -10 221 -10Q187 -10 162 2T124 33T105 68T98 100Q97 107 97 248V385H18V422H27Z"></path><path data-c="68" d="M41 46H55Q94 46 102 60V68Q102 77 102 91T102 124T102 167T103 217T103 272T103 329Q103 366 103 407T103 482T102 542T102 586T102 603Q99 622 88 628T43 637H25V660Q25 683 27 683L37 684Q47 685 66 686T103 688Q120 689 140 690T170 693T181 694H184V367Q244 442 328 442Q451 442 463 329Q464 322 464 190V104Q464 66 466 59T477 49Q498 46 526 46H542V0H534L510 1Q487 2 460 2T422 3Q319 3 310 0H302V46H318Q379 46 379 62Q380 64 380 200Q379 335 378 343Q372 371 358 385T334 402T308 404Q263 404 229 370Q202 343 195 315T187 232V168V108Q187 78 188 68T191 55T200 49Q221 46 249 46H265V0H257L234 1Q210 2 183 2T145 3Q42 3 33 0H25V46H41Z" transform="translate(389,0)"></path><path data-c="A0" d="" transform="translate(945,0)"></path></g></g></g></g></g></svg></mjx-container></span> day after surgery in the patients undergoing elective CABG , as assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG).</li> |
| <li>Time to first event of major adverse cardiovascular event (MACE), composite of CV death, non-fatal myocardial infarction or non-fatal stroke (ischaemic or unknown etiology).</li> |
| <li>Rate of freedom from angina by questionnaire according to CCS classification at 12 months. Rate of atrial fibrillation within 7 days post CABG.</li> |
| </ol> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="2.3-safety-objective"> |
| 2.3 Safety Objective</h3> |
| <ol> |
| <li>To compared with aspirin monotherapy, the major bleeding risk of ticagrelor plus aspirin and ticagrelor monotherapy according to Thrombolysis in Myocardial Infarction (TIMI) criteria.</li> |
| <li>Other advers events (AEs) during the study</li> |
| </ol> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="3.-study-design"> |
| 3. Study Design</h2> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="3.1-overall-study-design-and-flow-chart"> |
| 3.1 Overall Study Design and Flow Chart</h3> |
| <div>The study population will include all patients undergoing elective CABG. Consent and randomization will occur before surgery. Total 500 patients undergoing elective CABG will be randomly assigned into three groups with <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="7.165ex" height="1.507ex" role="img" focusable="false" viewBox="0 -666 3167.1 666"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g><g data-mml-node="mo" transform="translate(777.8,0)"><path data-c="3A" d="M78 370Q78 394 95 412T138 430Q162 430 180 414T199 371Q199 346 182 328T139 310T96 327T78 370ZM78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z"></path></g><g data-mml-node="mn" transform="translate(1333.6,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g><g data-mml-node="mo" transform="translate(2111.3,0)"><path data-c="3A" d="M78 370Q78 394 95 412T138 430Q162 430 180 414T199 371Q199 346 182 328T139 310T96 327T78 370ZM78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z"></path></g><g data-mml-node="mn" transform="translate(2667.1,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g></g></g></svg></mjx-container></span> ratio( 167 patients per group) in this open-label study. All the enrolled patients will stop oral antiplatlet drugs according to local protocol before the surgery. Within the first 24 hours after surgery, study medication should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs by giving aspirin 100 mg qd, Arm B will also restart oral antiplatelet drugs by giving ticagrelor 90 mg bid plus aspirin 100 mg qd and Arm C will also restart oral antiplatelet drugs by giving ticagrelor 90 mg bid. Treatment will continue for 12 months, at which time patients will undergo a multislice computed tomography angiography to assess vein graft patency.</div> |
| <div class="table" number="1"> |
| <div class="caption_figure">Schematic Overview of the Study</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/0aec4542-8112-41df-bc16-87f7f6320bf6-08.jpg?height=622&width=1432&top_left_y=440&top_left_x=298" alt="" style="max-width: 100%;"/></div></div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="3.3-sample-size-justification"> |
| 3.3 Sample Size Justification</h3> |
| <div>The trial was designed to compare rates of SV graft patency 1 year post CABG in patients randomized to ticagrelor plus aspirin combination therapy versus aspirin monotherapy, and in patients randomized to ticagrelor monotherapy versus aspirin monotherapy. The 1-year vein graft patency rate in the aspirin monotherapy group was assumed to be <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="4.147ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 1833 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> in the ticagrelor plus aspirin group, <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="4.147ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 1833 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="38" d="M70 417T70 494T124 618T248 666Q319 666 374 624T429 515Q429 485 418 459T392 417T361 389T335 371T324 363L338 354Q352 344 366 334T382 323Q457 264 457 174Q457 95 399 37T249 -22Q159 -22 101 29T43 155Q43 263 172 335L154 348Q133 361 127 368Q70 417 70 494ZM286 386L292 390Q298 394 301 396T311 403T323 413T334 425T345 438T355 454T364 471T369 491T371 513Q371 556 342 586T275 624Q268 625 242 625Q201 625 165 599T128 534Q128 511 141 492T167 463T217 431Q224 426 228 424L286 386ZM250 21Q308 21 350 55T392 137Q392 154 387 169T375 194T353 216T330 234T301 253T274 270Q260 279 244 289T218 306L210 311Q204 311 181 294T133 239T107 157Q107 98 150 60T250 21Z"></path><path data-c="37" d="M55 458Q56 460 72 567L88 674Q88 676 108 676H128V672Q128 662 143 655T195 646T364 644H485V605L417 512Q408 500 387 472T360 435T339 403T319 367T305 330T292 284T284 230T278 162T275 80Q275 66 275 52T274 28V19Q270 2 255 -10T221 -22Q210 -22 200 -19T179 0T168 40Q168 198 265 368Q285 400 349 489L395 552H302Q128 552 119 546Q113 543 108 522T98 479L95 458V455H55V458Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> in the ticagrelor group and <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="4.147ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 1833 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="38" d="M70 417T70 494T124 618T248 666Q319 666 374 624T429 515Q429 485 418 459T392 417T361 389T335 371T324 363L338 354Q352 344 366 334T382 323Q457 264 457 174Q457 95 399 37T249 -22Q159 -22 101 29T43 155Q43 263 172 335L154 348Q133 361 127 368Q70 417 70 494ZM286 386L292 390Q298 394 301 396T311 403T323 413T334 425T345 438T355 454T364 471T369 491T371 513Q371 556 342 586T275 624Q268 625 242 625Q201 625 165 599T128 534Q128 511 141 492T167 463T217 431Q224 426 228 424L286 386ZM250 21Q308 21 350 55T392 137Q392 154 387 169T375 194T353 216T330 234T301 253T274 270Q260 279 244 289T218 306L210 311Q204 311 181 294T133 239T107 157Q107 98 150 60T250 21Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> in the aspirin group. The sample size calculations were performed with a 2 -sided alpha level of 0.05 and <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="4.147ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 1833 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="38" d="M70 417T70 494T124 618T248 666Q319 666 374 624T429 515Q429 485 418 459T392 417T361 389T335 371T324 363L338 354Q352 344 366 334T382 323Q457 264 457 174Q457 95 399 37T249 -22Q159 -22 101 29T43 155Q43 263 172 335L154 348Q133 361 127 368Q70 417 70 494ZM286 386L292 390Q298 394 301 396T311 403T323 413T334 425T345 438T355 454T364 471T369 491T371 513Q371 556 342 586T275 624Q268 625 242 625Q201 625 165 599T128 534Q128 511 141 492T167 463T217 431Q224 426 228 424L286 386ZM250 21Q308 21 350 55T392 137Q392 154 387 169T375 194T353 216T330 234T301 253T274 270Q260 279 244 289T218 306L210 311Q204 311 181 294T133 239T107 157Q107 98 150 60T250 21Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> power. On the basis of these assumptions, a total of 199 SV grafts would be required in each group for the comparison of combination therapy versus aspirin monotherapy; and 441 grafts would be required in each group for the comparison of the 2 monotherapy groups. A total of 500 patients would be required to provide a total of 1350 to 1500 SV grafts, assuming that each patient would receive an average of 2.7 to 3.0 SV grafts.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="3.4-randomization-and-blinding"> |
| 3.4 Randomization and Blinding</h3> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="3.4.1-randomization-after-subjects-enrolled"> |
| 3.4.1 Randomization after Subjects Enrolled</h3> |
| <div>Patient eligibility will be established before treatment randomization. Patients will be enrolled/randomized strictly sequentially, as patients become eligible for enrolment/randomization. If a patient discontinues from the study, the patient number will not be reused, and the patient will not be allowed to re-enter the study.</div> |
| <div>After providing informed consent, patients who are consistent with the inclusion and exclusion criteria will be randomly assigned to one of the three treatment groups. The randomization will be performed by a computer equally for the three treatment regimens. Each centre will be provided with sealed treatment code envelopes corresponding to a list of patient randomization numbers. Randomization numbers will be assigned strictly sequentially as subjects become eligible for randomization. When a subject is allocated to a specified randomization number, the corresponding code envelope will be opened to identify the allocated treatment regimen.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="3.4.2-blinding"> |
| 3.4.2 Blinding</h3> |
| <div>This is an open-label study, so blinding is not applicable.</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="4.-study-endpoints"> |
| 4. Study Endpoints</h2> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.1-evaluation-methods-for-study-endpoints"> |
| 4.1 Evaluation Methods for Study Endpoints</h3> |
| <ol> |
| <li>The patency of vein grafts: assessed by multi-slice computed tomography angiography (MSCTA) or coronary angiography (CAG) according to Fitzgibbon Class</li> |
| <li>Recurrent angina: based on CCS Angina Class</li> |
| </ol> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.2-efficacy-endpoints"> |
| 4.2 Efficacy Endpoints</h3> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.2.1-primary-efficacy-endpoint"> |
| 4.2.1 Primary Efficacy Endpoint</h3> |
| <div>Angiographic vein graft patency by MSCTA or CAG at 12 months after CABG.<br> |
| There 3 levels of patency examination in vein grafts according to the Fitzgibbon Standards, that's level A, level B, and level O. The percentage of level A is the rate of vein graft patency.</div> |
| <div>Primary endpoint will analyzed based on mFAS and PP.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.2.2-secondary-efficacy-endpoints"> |
| 4.2.2 Secondary Efficacy Endpoints</h3> |
| <ol> |
| <li>Angiographic vein graft patency assessed by MSCTA or CAG at 7th day post CABG.</li> |
| <li>In this study, MACE is defined as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (ischemic or unexplained). The rate of MACE and time to first MACE will be compared among 3 treatment groups.</li> |
| <li>Rate of recurrent angina will be compared among 3 treatment groups.</li> |
| <li>Rate of atrial fibrillation within 7 days post CABG . This rate is the percentage of subjects who had at least one PAF detected on electrocardiogram within 7 days post CABG. This rate will be compared among 3 treatment groups.</li> |
| </ol> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.3-safety-endpoints"> |
| 4.3 Safety Endpoints</h3> |
| <ol> |
| <li>Rate of adverse events</li> |
| <li>Rate of serious adverse events</li> |
| <li>Rate of adverse events leading to study agent interruption or withdrawal</li> |
| <li>Bleeding events will be defined according to TIMI standards (There are 2 types of bleeding events, CABG related bleeding and non-CABG related bleeding).<br> |
| In this study, bleeding will also be compared among 3 treatment groups.</li> |
| </ol> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.4-other"> |
| 4.4 Other</h3> |
| <ol> |
| <li>Summary of the operation information, include the type of grafts, off-pump or on-pump CABG technique, etc.</li> |
| <li>Interested concomitant medication used, such as beta- receptor blockers, ACEI / ARBs, statins, and proton pump inhibitors</li> |
| <li>Rate of smoking at visit 9 (1 year after CABG)</li> |
| <li>Comparison in the chemistry and vital sign endpoints among 3 treatment groups</li> |
| </ol> |
| <div>Rate of Glycated hemoglobin ( HbA 1 c <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="8.673ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 3833.6 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="29" d="M60 749L64 750Q69 750 74 750H86L114 726Q208 641 251 514T294 250Q294 182 284 119T261 12T224 -76T186 -143T145 -194T113 -227T90 -246Q87 -249 86 -250H74Q66 -250 63 -250T58 -247T55 -238Q56 -237 66 -225Q221 -64 221 250T66 725Q56 737 55 738Q55 746 60 749Z"></path></g><g data-mml-node="mo" transform="translate(666.8,0)"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1722.6,0)"><path data-c="36" d="M42 313Q42 476 123 571T303 666Q372 666 402 630T432 550Q432 525 418 510T379 495Q356 495 341 509T326 548Q326 592 373 601Q351 623 311 626Q240 626 194 566Q147 500 147 364L148 360Q153 366 156 373Q197 433 263 433H267Q313 433 348 414Q372 400 396 374T435 317Q456 268 456 210V192Q456 169 451 149Q440 90 387 34T253 -22Q225 -22 199 -14T143 16T92 75T56 172T42 313ZM257 397Q227 397 205 380T171 335T154 278T148 216Q148 133 160 97T198 39Q222 21 251 21Q302 21 329 59Q342 77 347 104T352 209Q352 289 347 316T329 361Q302 397 257 397Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(3000.6,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9;<br> |
| Rate of Glycated hemoglobin ( HbA 1 c ) <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.312ex;" xmlns="http://www.w3.org/2000/svg" width="7.165ex" height="2.009ex" role="img" focusable="false" viewBox="0 -750 3166.8 888"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="37" d="M55 458Q56 460 72 567L88 674Q88 676 108 676H128V672Q128 662 143 655T195 646T364 644H485V605L417 512Q408 500 387 472T360 435T339 403T319 367T305 330T292 284T284 230T278 162T275 80Q275 66 275 52T274 28V19Q270 2 255 -10T221 -22Q210 -22 200 -19T179 0T168 40Q168 198 265 368Q285 400 349 489L395 552H302Q128 552 119 546Q113 543 108 522T98 479L95 458V455H55V458Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(2333.8,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9;<br> |
| Rate of Low-density lipoprotein <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="13.696ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 6053.8 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="38" d="M70 417T70 494T124 618T248 666Q319 666 374 624T429 515Q429 485 418 459T392 417T361 389T335 371T324 363L338 354Q352 344 366 334T382 323Q457 264 457 174Q457 95 399 37T249 -22Q159 -22 101 29T43 155Q43 263 172 335L154 348Q133 361 127 368Q70 417 70 494ZM286 386L292 390Q298 394 301 396T311 403T323 413T334 425T345 438T355 454T364 471T369 491T371 513Q371 556 342 586T275 624Q268 625 242 625Q201 625 165 599T128 534Q128 511 141 492T167 463T217 431Q224 426 228 424L286 386ZM250 21Q308 21 350 55T392 137Q392 154 387 169T375 194T353 216T330 234T301 253T274 270Q260 279 244 289T218 306L210 311Q204 311 181 294T133 239T107 157Q107 98 150 60T250 21Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(2333.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(3211.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(4089.8,0)"><path data-c="1D45C" d="M201 -11Q126 -11 80 38T34 156Q34 221 64 279T146 380Q222 441 301 441Q333 441 341 440Q354 437 367 433T402 417T438 387T464 338T476 268Q476 161 390 75T201 -11ZM121 120Q121 70 147 48T206 26Q250 26 289 58T351 142Q360 163 374 216T388 308Q388 352 370 375Q346 405 306 405Q243 405 195 347Q158 303 140 230T121 120Z"></path></g><g data-mml-node="mi" transform="translate(4574.8,0)"><path data-c="1D459" d="M117 59Q117 26 142 26Q179 26 205 131Q211 151 215 152Q217 153 225 153H229Q238 153 241 153T246 151T248 144Q247 138 245 128T234 90T214 43T183 6T137 -11Q101 -11 70 11T38 85Q38 97 39 102L104 360Q167 615 167 623Q167 626 166 628T162 632T157 634T149 635T141 636T132 637T122 637Q112 637 109 637T101 638T95 641T94 647Q94 649 96 661Q101 680 107 682T179 688Q194 689 213 690T243 693T254 694Q266 694 266 686Q266 675 193 386T118 83Q118 81 118 75T117 65V59Z"></path></g><g data-mml-node="TeXAtom" data-mjx-texclass="ORD" transform="translate(4872.8,0)"><g data-mml-node="mo"><path data-c="2F" d="M423 750Q432 750 438 744T444 730Q444 725 271 248T92 -240Q85 -250 75 -250Q68 -250 62 -245T56 -231Q56 -221 230 257T407 740Q411 750 423 750Z"></path></g></g><g data-mml-node="mi" transform="translate(5372.8,0)"><path data-c="1D43F" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 217 683Q271 680 344 680Q485 680 506 683H518Q524 677 524 674T522 656Q517 641 513 637H475Q406 636 394 628Q387 624 380 600T313 336Q297 271 279 198T252 88L243 52Q243 48 252 48T311 46H328Q360 46 379 47T428 54T478 72T522 106T564 161Q580 191 594 228T611 270Q616 273 628 273H641Q647 264 647 262T627 203T583 83T557 9Q555 4 553 3T537 0T494 -1Q483 -1 418 -1T294 0H116Q32 0 32 10Q32 17 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9;<br> |
| Rate of Low-density lipoprotein <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="13.696ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 6053.8 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="32" d="M109 429Q82 429 66 447T50 491Q50 562 103 614T235 666Q326 666 387 610T449 465Q449 422 429 383T381 315T301 241Q265 210 201 149L142 93L218 92Q375 92 385 97Q392 99 409 186V189H449V186Q448 183 436 95T421 3V0H50V19V31Q50 38 56 46T86 81Q115 113 136 137Q145 147 170 174T204 211T233 244T261 278T284 308T305 340T320 369T333 401T340 431T343 464Q343 527 309 573T212 619Q179 619 154 602T119 569T109 550Q109 549 114 549Q132 549 151 535T170 489Q170 464 154 447T109 429Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="36" d="M42 313Q42 476 123 571T303 666Q372 666 402 630T432 550Q432 525 418 510T379 495Q356 495 341 509T326 548Q326 592 373 601Q351 623 311 626Q240 626 194 566Q147 500 147 364L148 360Q153 366 156 373Q197 433 263 433H267Q313 433 348 414Q372 400 396 374T435 317Q456 268 456 210V192Q456 169 451 149Q440 90 387 34T253 -22Q225 -22 199 -14T143 16T92 75T56 172T42 313ZM257 397Q227 397 205 380T171 335T154 278T148 216Q148 133 160 97T198 39Q222 21 251 21Q302 21 329 59Q342 77 347 104T352 209Q352 289 347 316T329 361Q302 397 257 397Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(2333.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(3211.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(4089.8,0)"><path data-c="1D45C" d="M201 -11Q126 -11 80 38T34 156Q34 221 64 279T146 380Q222 441 301 441Q333 441 341 440Q354 437 367 433T402 417T438 387T464 338T476 268Q476 161 390 75T201 -11ZM121 120Q121 70 147 48T206 26Q250 26 289 58T351 142Q360 163 374 216T388 308Q388 352 370 375Q346 405 306 405Q243 405 195 347Q158 303 140 230T121 120Z"></path></g><g data-mml-node="mi" transform="translate(4574.8,0)"><path data-c="1D459" d="M117 59Q117 26 142 26Q179 26 205 131Q211 151 215 152Q217 153 225 153H229Q238 153 241 153T246 151T248 144Q247 138 245 128T234 90T214 43T183 6T137 -11Q101 -11 70 11T38 85Q38 97 39 102L104 360Q167 615 167 623Q167 626 166 628T162 632T157 634T149 635T141 636T132 637T122 637Q112 637 109 637T101 638T95 641T94 647Q94 649 96 661Q101 680 107 682T179 688Q194 689 213 690T243 693T254 694Q266 694 266 686Q266 675 193 386T118 83Q118 81 118 75T117 65V59Z"></path></g><g data-mml-node="TeXAtom" data-mjx-texclass="ORD" transform="translate(4872.8,0)"><g data-mml-node="mo"><path data-c="2F" d="M423 750Q432 750 438 744T444 730Q444 725 271 248T92 -240Q85 -250 75 -250Q68 -250 62 -245T56 -231Q56 -221 230 257T407 740Q411 750 423 750Z"></path></g></g><g data-mml-node="mi" transform="translate(5372.8,0)"><path data-c="1D43F" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 217 683Q271 680 344 680Q485 680 506 683H518Q524 677 524 674T522 656Q517 641 513 637H475Q406 636 394 628Q387 624 380 600T313 336Q297 271 279 198T252 88L243 52Q243 48 252 48T311 46H328Q360 46 379 47T428 54T478 72T522 106T564 161Q580 191 594 228T611 270Q616 273 628 273H641Q647 264 647 262T627 203T583 83T557 9Q555 4 553 3T537 0T494 -1Q483 -1 418 -1T294 0H116Q32 0 32 10Q32 17 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9;<br> |
| Rate of Systolic blood pressure <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.312ex;" xmlns="http://www.w3.org/2000/svg" width="5.782ex" height="1.844ex" role="img" focusable="false" viewBox="0 -677 2555.8 815"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path><path data-c="34" d="M462 0Q444 3 333 3Q217 3 199 0H190V46H221Q241 46 248 46T265 48T279 53T286 61Q287 63 287 115V165H28V211L179 442Q332 674 334 675Q336 677 355 677H373L379 671V211H471V165H379V114Q379 73 379 66T385 54Q393 47 442 46H471V0H462ZM293 211V545L74 212L183 211H293Z" transform="translate(500,0)"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(1000,0)"></path></g></g></g></svg></mjx-container></span> or Diastolic blood pressure <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.464ex;" xmlns="http://www.w3.org/2000/svg" width="11.712ex" height="2.009ex" role="img" focusable="false" viewBox="0 -683 5176.8 888"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(2055.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(2933.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(3811.8,0)"><path data-c="1D43B" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 219 683Q260 681 355 681Q389 681 418 681T463 682T483 682Q499 682 499 672Q499 670 497 658Q492 641 487 638H485Q483 638 480 638T473 638T464 637T455 637Q416 636 405 634T387 623Q384 619 355 500Q348 474 340 442T328 395L324 380Q324 378 469 378H614L615 381Q615 384 646 504Q674 619 674 627T617 637Q594 637 587 639T580 648Q580 650 582 660Q586 677 588 679T604 682Q609 682 646 681T740 680Q802 680 835 681T871 682Q888 682 888 672Q888 645 876 638H874Q872 638 869 638T862 638T853 637T844 637Q805 636 794 634T776 623Q773 618 704 340T634 58Q634 51 638 51Q646 48 692 46H723Q729 38 729 37T726 19Q722 6 716 0H701Q664 2 567 2Q533 2 504 2T458 2T437 1Q420 1 420 10Q420 15 423 24Q428 43 433 45Q437 46 448 46H454Q481 46 514 49Q520 50 522 50T528 55T534 64T540 82T547 110T558 153Q565 181 569 198Q602 330 602 331T457 332H312L279 197Q245 63 245 58Q245 51 253 49T303 46H334Q340 38 340 37T337 19Q333 6 327 0H312Q275 2 178 2Q144 2 115 2T69 2T48 1Q31 1 31 10Q31 12 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g><g data-mml-node="mi" transform="translate(4699.8,0)"><path data-c="1D454" d="M311 43Q296 30 267 15T206 0Q143 0 105 45T66 160Q66 265 143 353T314 442Q361 442 401 394L404 398Q406 401 409 404T418 412T431 419T447 422Q461 422 470 413T480 394Q480 379 423 152T363 -80Q345 -134 286 -169T151 -205Q10 -205 10 -137Q10 -111 28 -91T74 -71Q89 -71 102 -80T116 -111Q116 -121 114 -130T107 -144T99 -154T92 -162L90 -164H91Q101 -167 151 -167Q189 -167 211 -155Q234 -144 254 -122T282 -75Q288 -56 298 -13Q311 35 311 43ZM384 328L380 339Q377 350 375 354T369 368T359 382T346 393T328 402T306 405Q262 405 221 352Q191 313 171 233T151 117Q151 38 213 38Q269 38 323 108L331 118L384 328Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9.</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="5%2C-data-management"> |
| 5, Data Management</h2> |
| <div>A quality assurance audit/inspection of this trial may be conducted by AstraZeneca or sponsor's designees or by IRBs/IECs or by regulatory authorities. The quality assurance auditor will have access to all medical records, the investigator's trial-related files and correspondence, and the informed consent documentation of this clinical trial.</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="6.-analysis-specifications"> |
| 6. Analysis Specifications</h2> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="6.1-adverse-events"> |
| 6.1 Adverse Events</h3> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="6.1.1-ae-duration"> |
| 6.1.1 AE Duration</h3> |
| <div>AE duration is in days:<br> |
| Duration <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="1.76ex" height="1.505ex" role="img" focusable="false" viewBox="0 -583 778 665"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g></g></g></svg></mjx-container></span> end date - start date <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="6.034ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 2667 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2B" d="M56 237T56 250T70 270H369V420L370 570Q380 583 389 583Q402 583 409 568V270H707Q722 262 722 250T707 230H409V-68Q401 -82 391 -82H389H387Q375 -82 369 -68V230H70Q56 237 56 250Z"></path></g><g data-mml-node="mn" transform="translate(778,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g><g data-mml-node="mstyle" transform="translate(1278,0)"><g data-mml-node="mspace"></g></g><g data-mml-node="mo" transform="translate(2278,0)"><path data-c="28" d="M94 250Q94 319 104 381T127 488T164 576T202 643T244 695T277 729T302 750H315H319Q333 750 333 741Q333 738 316 720T275 667T226 581T184 443T167 250T184 58T225 -81T274 -167T316 -220T333 -241Q333 -250 318 -250H315H302L274 -226Q180 -141 137 -14T94 250Z"></path></g></g></g></svg></mjx-container></span> days <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="0.88ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 389 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="29" d="M60 749L64 750Q69 750 74 750H86L114 726Q208 641 251 514T294 250Q294 182 284 119T261 12T224 -76T186 -143T145 -194T113 -227T90 -246Q87 -249 86 -250H74Q66 -250 63 -250T58 -247T55 -238Q56 -237 66 -225Q221 -64 221 250T66 725Q56 737 55 738Q55 746 60 749Z"></path></g></g></g></svg></mjx-container></span></div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="6.1.2-imputation-of-missing-ae-data"> |
| 6.1.2 Imputation of Missing AE Data</h3> |
| <ol> |
| <li>Severity</li> |
| </ol> |
| <div>If the severity is missing, then "severe" will be imputed.<br> |
| 2. Relationship</div> |
| <div>If the relationship is missing, then "very likely" will be imputed.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="6.2-concomitant-medication"> |
| 6.2 Concomitant Medication</h3> |
| <div>Imputation won't be applied to concomitant medication data.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="6.3-age-calculation"> |
| 6.3 Age Calculation</h3> |
| <div>Age of subjects will be calculated based on the date of visit 1 , and in years, the formula is:<br> |
| (date of visit <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="2.891ex" height="1.692ex" role="img" focusable="false" viewBox="0 -666 1278 748"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g><g data-mml-node="mo" transform="translate(500,0)"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g></g></g></svg></mjx-container></span> birthday +1 ) <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.081ex;" xmlns="http://www.w3.org/2000/svg" width="8.045ex" height="1.588ex" role="img" focusable="false" viewBox="0 -666 3556 702"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="F7" d="M318 466Q318 500 339 518T386 537Q418 537 438 517T458 466Q458 438 440 417T388 396Q355 396 337 417T318 466ZM56 237T56 250T70 270H706Q721 262 721 250T706 230H70Q56 237 56 250ZM318 34Q318 68 339 86T386 105Q418 105 438 85T458 34Q458 6 440 -15T388 -36Q355 -36 337 -15T318 34Z"></path></g><g data-mml-node="mn" transform="translate(778,0)"><path data-c="33" d="M127 463Q100 463 85 480T69 524Q69 579 117 622T233 665Q268 665 277 664Q351 652 390 611T430 522Q430 470 396 421T302 350L299 348Q299 347 308 345T337 336T375 315Q457 262 457 175Q457 96 395 37T238 -22Q158 -22 100 21T42 130Q42 158 60 175T105 193Q133 193 151 175T169 130Q169 119 166 110T159 94T148 82T136 74T126 70T118 67L114 66Q165 21 238 21Q293 21 321 74Q338 107 338 175V195Q338 290 274 322Q259 328 213 329L171 330L168 332Q166 335 166 348Q166 366 174 366Q202 366 232 371Q266 376 294 413T322 525V533Q322 590 287 612Q265 626 240 626Q208 626 181 615T143 592T132 580H135Q138 579 143 578T153 573T165 566T175 555T183 540T186 520Q186 498 172 481T127 463Z"></path><path data-c="36" d="M42 313Q42 476 123 571T303 666Q372 666 402 630T432 550Q432 525 418 510T379 495Q356 495 341 509T326 548Q326 592 373 601Q351 623 311 626Q240 626 194 566Q147 500 147 364L148 360Q153 366 156 373Q197 433 263 433H267Q313 433 348 414Q372 400 396 374T435 317Q456 268 456 210V192Q456 169 451 149Q440 90 387 34T253 -22Q225 -22 199 -14T143 16T92 75T56 172T42 313ZM257 397Q227 397 205 380T171 335T154 278T148 216Q148 133 160 97T198 39Q222 21 251 21Q302 21 329 59Q342 77 347 104T352 209Q352 289 347 316T329 361Q302 397 257 397Z" transform="translate(500,0)"></path><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z" transform="translate(1000,0)"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(1500,0)"></path><path data-c="32" d="M109 429Q82 429 66 447T50 491Q50 562 103 614T235 666Q326 666 387 610T449 465Q449 422 429 383T381 315T301 241Q265 210 201 149L142 93L218 92Q375 92 385 97Q392 99 409 186V189H449V186Q448 183 436 95T421 3V0H50V19V31Q50 38 56 46T86 81Q115 113 136 137Q145 147 170 174T204 211T233 244T261 278T284 308T305 340T320 369T333 401T340 431T343 464Q343 527 309 573T212 619Q179 619 154 602T119 569T109 550Q109 549 114 549Q132 549 151 535T170 489Q170 464 154 447T109 429Z" transform="translate(1778,0)"></path><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z" transform="translate(2278,0)"></path></g></g></g></svg></mjx-container></span></div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="7.-analysis-sets"> |
| 7. Analysis Sets</h2> |
| <div>This study will be analyzed by the planned treatment, regardless the actual treatment this subject received.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="7.1-intent-to-treat-(itt)"> |
| 7.1 Intent to Treat (ITT)</h3> |
| <div>ITT will include all the subjects who were randomized.<br> |
| Demographic and baseline data will be analyzed on ITT.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="7.2-modified-full-analysis-set-(mfas)"> |
| 7.2 Modified Full Analysis Set (mFAS)</h3> |
| <div>All the subjects in ITT will be included in mFAS, except those subjects who didn't take any study agent or withdraw ICF before the first dose of study agent.</div> |
| <div>All the efficacy analysis will be based on mFAS .</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="7.3-per-protocol-set-(pps)"> |
| 7.3 Per Protocol Set (PPS)</h3> |
| <div>The subjects in mFAS who have no drug discontinuation or drug discontinuation <=60 days, have<br> |
| no other major protocol deviation, didn't take any forbidden concomitant medication, have the primary endpoints assessment at 1 year post-CABG will be included in PPS.</div> |
| <div>PPS will only be used in primary endpoint sensitive analysis.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="7.4-safety-analysis-set-(ss)"> |
| 7.4 Safety Analysis Set (SS)</h3> |
| <div>All the subjects who took at least one study agent will be included in safety analysis set.<br> |
| Safety endpoints, such as adverse events, bleeding events, laboratory test, vital sign, will be analyzed based on safety analysis set.</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8.-statistical-analysis-methods"> |
| 8. Statistical Analysis Methods</h2> |
| <div>This part contains general and specific definitions of statistical methods for the analysis of collected data in this study, however, any post-hoc analyses performed that are different from this part, will be documented in the analyses section of the CSR.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.1-statistical-analysis-software"> |
| 8.1 Statistical Analysis Software</h3> |
| <div>All the statistical analyses are done on SAS 9.3 (SAS Institute Inc.).</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.2-general-statistical-analysis-methods-applied"> |
| 8.2 General Statistical Analysis Methods Applied</h3> |
| <div>Unless otherwise stated, statistical significance level is set to 0.05 (2-sided).</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.2.1-continuous-variables"> |
| 8.2.1 Continuous Variables</h3> |
| <div>Descriptive summary statistics, such as number of subjects, mean, standard deviation (SD), median, interquartile range (IQR), minimum, and maximum will be used for continuous variable.</div> |
| <div>ANOVA or Kruskal-Wallis test will be applied to the statistical test in the homogeneity of distribution among these 3 treatment group, whether ANOVA or Kruskal-Wallis test is determined by the tests of normality distribution and homogeneity of variance with the alpha level 0.05 for this variable。</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.2.2-discrete-variables"> |
| 8.2.2 Discrete Variables</h3> |
| <div>Counts and percentages will be used to summarize the discrete variables. Fisher exact test, Continuity Adjusted Chi-Squared test, or Pearson Chi-Squared test will be applied to test homogeneity of the rates among 3 treatment groups, the choice on the method will be based on the actual counts in the frequency cells.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.2.3-ordinal-variables"> |
| 8.2.3 Ordinal Variables</h3> |
| <div>Counts and percentages will be used to summarize the ordinal variables. Kruskal-Wallis test will be used in the comparison of ordinal variables.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.3-statistical-test-for-primary-endpoint"> |
| 8.3 Statistical Test for Primary Endpoint</h3> |
| <div>The primary endpoint is the patency rate of vein grafts at visit 9 ( 1 year after CABG). Generally, there will be 1 to 4 grafts be examined per a subject, this is a typical repeated measures data, since those grafts within a subjects are definitely correlated, the conventional statistical methods like Pearson Chi-Squared test isn't appropriate to test primary endpoint in this study. GEE (Generalized Estimating Equation) [1] is used to test the hypothesis of this study, <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="4.147ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 1833 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> CIs and 2 -sided p values will be provided.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.3.1-handling-in-missing-values-for-primary-endpoint"> |
| 8.3.1 Handling in Missing Values for Primary Endpoint</h3> |
| <div>If the patency examination for a graft at the visit 9 ( 1 year after CABG ) is missing, then level O will be imputed, then this graft is deemed as occlusion in primary analysis.</div> |
| <div>8．3．2 Statistical Test for Primary Endpoint</div> |
| <div><span class="math-block "> |
| <mjx-container class="MathJax" jax="SVG" display="true"><svg style="vertical-align: -0.486ex;" xmlns="http://www.w3.org/2000/svg" width="84.167ex" height="2.183ex" role="img" focusable="false" viewBox="0 -750 37201.9 965"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msub"><g data-mml-node="mi"><path data-c="1D43B" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 219 683Q260 681 355 681Q389 681 418 681T463 682T483 682Q499 682 499 672Q499 670 497 658Q492 641 487 638H485Q483 638 480 638T473 638T464 637T455 637Q416 636 405 634T387 623Q384 619 355 500Q348 474 340 442T328 395L324 380Q324 378 469 378H614L615 381Q615 384 646 504Q674 619 674 627T617 637Q594 637 587 639T580 648Q580 650 582 660Q586 677 588 679T604 682Q609 682 646 681T740 680Q802 680 835 681T871 682Q888 682 888 672Q888 645 876 638H874Q872 638 869 638T862 638T853 637T844 637Q805 636 794 634T776 623Q773 618 704 340T634 58Q634 51 638 51Q646 48 692 46H723Q729 38 729 37T726 19Q722 6 716 0H701Q664 2 567 2Q533 2 504 2T458 2T437 1Q420 1 420 10Q420 15 423 24Q428 43 433 45Q437 46 448 46H454Q481 46 514 49Q520 50 522 50T528 55T534 64T540 82T547 110T558 153Q565 181 569 198Q602 330 602 331T457 332H312L279 197Q245 63 245 58Q245 51 253 49T303 46H334Q340 38 340 37T337 19Q333 6 327 0H312Q275 2 178 2Q144 2 115 2T69 2T48 1Q31 1 31 10Q31 12 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g><g data-mml-node="TeXAtom" transform="translate(864,-150) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g></g></g><g data-mml-node="mo" transform="translate(1545.3,0)"><path data-c="3A" d="M78 370Q78 394 95 412T138 430Q162 430 180 414T199 371Q199 346 182 328T139 310T96 327T78 370ZM78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z"></path></g><g data-mml-node="msub" transform="translate(2101.1,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-150) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D447" d="M40 437Q21 437 21 445Q21 450 37 501T71 602L88 651Q93 669 101 677H569H659Q691 677 697 676T704 667Q704 661 687 553T668 444Q668 437 649 437Q640 437 637 437T631 442L629 445Q629 451 635 490T641 551Q641 586 628 604T573 629Q568 630 515 631Q469 631 457 630T439 622Q438 621 368 343T298 60Q298 48 386 46Q418 46 427 45T436 36Q436 31 433 22Q429 4 424 1L422 0Q419 0 415 0Q410 0 363 1T228 2Q99 2 64 0H49Q43 6 43 9T45 27Q49 40 55 46H83H94Q174 46 189 55Q190 56 191 56Q196 59 201 76T241 233Q258 301 269 344Q339 619 339 625Q339 630 310 630H279Q212 630 191 624Q146 614 121 583T67 467Q60 445 57 441T43 437H40Z"></path></g></g></g><g data-mml-node="mo" transform="translate(3546.1,0)"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g><g data-mml-node="msub" transform="translate(4546.4,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-152.7) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g></g></g><g data-mml-node="mo" transform="translate(6079.5,0)"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g><g data-mml-node="mn" transform="translate(7135.2,0)"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g><g data-mml-node="mstyle" transform="translate(7635.2,0)"><g data-mml-node="mspace"></g></g><g data-mml-node="msub" transform="translate(8635.2,0)"><g data-mml-node="mi"><path data-c="1D43B" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 219 683Q260 681 355 681Q389 681 418 681T463 682T483 682Q499 682 499 672Q499 670 497 658Q492 641 487 638H485Q483 638 480 638T473 638T464 637T455 637Q416 636 405 634T387 623Q384 619 355 500Q348 474 340 442T328 395L324 380Q324 378 469 378H614L615 381Q615 384 646 504Q674 619 674 627T617 637Q594 637 587 639T580 648Q580 650 582 660Q586 677 588 679T604 682Q609 682 646 681T740 680Q802 680 835 681T871 682Q888 682 888 672Q888 645 876 638H874Q872 638 869 638T862 638T853 637T844 637Q805 636 794 634T776 623Q773 618 704 340T634 58Q634 51 638 51Q646 48 692 46H723Q729 38 729 37T726 19Q722 6 716 0H701Q664 2 567 2Q533 2 504 2T458 2T437 1Q420 1 420 10Q420 15 423 24Q428 43 433 45Q437 46 448 46H454Q481 46 514 49Q520 50 522 50T528 55T534 64T540 82T547 110T558 153Q565 181 569 198Q602 330 602 331T457 332H312L279 197Q245 63 245 58Q245 51 253 49T303 46H334Q340 38 340 37T337 19Q333 6 327 0H312Q275 2 178 2Q144 2 115 2T69 2T48 1Q31 1 31 10Q31 12 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g><g data-mml-node="TeXAtom" transform="translate(864,-150) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g></g></g><g data-mml-node="mo" transform="translate(10180.6,0)"><path data-c="3A" d="M78 370Q78 394 95 412T138 430Q162 430 180 414T199 371Q199 346 182 328T139 310T96 327T78 370ZM78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z"></path></g><g data-mml-node="msub" transform="translate(10736.4,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-150) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D447" d="M40 437Q21 437 21 445Q21 450 37 501T71 602L88 651Q93 669 101 677H569H659Q691 677 697 676T704 667Q704 661 687 553T668 444Q668 437 649 437Q640 437 637 437T631 442L629 445Q629 451 635 490T641 551Q641 586 628 604T573 629Q568 630 515 631Q469 631 457 630T439 622Q438 621 368 343T298 60Q298 48 386 46Q418 46 427 45T436 36Q436 31 433 22Q429 4 424 1L422 0Q419 0 415 0Q410 0 363 1T228 2Q99 2 64 0H49Q43 6 43 9T45 27Q49 40 55 46H83H94Q174 46 189 55Q190 56 191 56Q196 59 201 76T241 233Q258 301 269 344Q339 619 339 625Q339 630 310 630H279Q212 630 191 624Q146 614 121 583T67 467Q60 445 57 441T43 437H40Z"></path></g></g></g><g data-mml-node="mo" transform="translate(12181.4,0)"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g><g data-mml-node="msub" transform="translate(13181.6,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-152.7) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g></g></g><g data-mml-node="mo" transform="translate(14714.7,0)"><path data-c="2260" d="M166 -215T159 -215T147 -212T141 -204T139 -197Q139 -190 144 -183L306 133H70Q56 140 56 153Q56 168 72 173H327L406 327H72Q56 332 56 347Q56 360 70 367H426Q597 702 602 707Q605 716 618 716Q625 716 630 712T636 703T638 696Q638 692 471 367H707Q722 359 722 347Q722 336 708 328L451 327L371 173H708Q722 163 722 153Q722 140 707 133H351Q175 -210 170 -212Q166 -215 159 -215Z"></path></g><g data-mml-node="mn" transform="translate(15770.5,0)"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g><g data-mml-node="mstyle" transform="translate(16270.5,0)"><g data-mml-node="mspace"></g></g><g data-mml-node="mtext" transform="translate(17270.5,0)"><path data-c="A0" d=""></path><text data-variant="normal" transform="translate(250,0) scale(1,-1)" font-size="884px" font-family="serif">与</text><path data-c="A0" d="" transform="translate(1250,0)"></path></g><g data-mml-node="msub" transform="translate(18770.5,0)"><g data-mml-node="mi"><path data-c="1D43B" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 219 683Q260 681 355 681Q389 681 418 681T463 682T483 682Q499 682 499 672Q499 670 497 658Q492 641 487 638H485Q483 638 480 638T473 638T464 637T455 637Q416 636 405 634T387 623Q384 619 355 500Q348 474 340 442T328 395L324 380Q324 378 469 378H614L615 381Q615 384 646 504Q674 619 674 627T617 637Q594 637 587 639T580 648Q580 650 582 660Q586 677 588 679T604 682Q609 682 646 681T740 680Q802 680 835 681T871 682Q888 682 888 672Q888 645 876 638H874Q872 638 869 638T862 638T853 637T844 637Q805 636 794 634T776 623Q773 618 704 340T634 58Q634 51 638 51Q646 48 692 46H723Q729 38 729 37T726 19Q722 6 716 0H701Q664 2 567 2Q533 2 504 2T458 2T437 1Q420 1 420 10Q420 15 423 24Q428 43 433 45Q437 46 448 46H454Q481 46 514 49Q520 50 522 50T528 55T534 64T540 82T547 110T558 153Q565 181 569 198Q602 330 602 331T457 332H312L279 197Q245 63 245 58Q245 51 253 49T303 46H334Q340 38 340 37T337 19Q333 6 327 0H312Q275 2 178 2Q144 2 115 2T69 2T48 1Q31 1 31 10Q31 12 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g><g data-mml-node="TeXAtom" transform="translate(864,-150) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g></g></g><g data-mml-node="mo" transform="translate(20315.8,0)"><path data-c="3A" d="M78 370Q78 394 95 412T138 430Q162 430 180 414T199 371Q199 346 182 328T139 310T96 327T78 370ZM78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z"></path></g><g data-mml-node="msub" transform="translate(20871.6,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-152.7) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D447" d="M40 437Q21 437 21 445Q21 450 37 501T71 602L88 651Q93 669 101 677H569H659Q691 677 697 676T704 667Q704 661 687 553T668 444Q668 437 649 437Q640 437 637 437T631 442L629 445Q629 451 635 490T641 551Q641 586 628 604T573 629Q568 630 515 631Q469 631 457 630T439 622Q438 621 368 343T298 60Q298 48 386 46Q418 46 427 45T436 36Q436 31 433 22Q429 4 424 1L422 0Q419 0 415 0Q410 0 363 1T228 2Q99 2 64 0H49Q43 6 43 9T45 27Q49 40 55 46H83H94Q174 46 189 55Q190 56 191 56Q196 59 201 76T241 233Q258 301 269 344Q339 619 339 625Q339 630 310 630H279Q212 630 191 624Q146 614 121 583T67 467Q60 445 57 441T43 437H40Z"></path></g><g data-mml-node="mo" transform="translate(704,0)"><path data-c="2B" d="M56 237T56 250T70 270H369V420L370 570Q380 583 389 583Q402 583 409 568V270H707Q722 262 722 250T707 230H409V-68Q401 -82 391 -82H389H387Q375 -82 369 -68V230H70Q56 237 56 250Z"></path></g><g data-mml-node="mi" transform="translate(1482,0)"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g></g></g><g data-mml-node="mo" transform="translate(23397.1,0)"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g><g data-mml-node="msub" transform="translate(24397.3,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-152.7) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g></g></g><g data-mml-node="mo" transform="translate(25930.4,0)"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g><g data-mml-node="mn" transform="translate(26986.2,0)"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g><g data-mml-node="mstyle" transform="translate(27486.2,0)"><g data-mml-node="mspace"></g></g><g data-mml-node="msub" transform="translate(28486.2,0)"><g data-mml-node="mi"><path data-c="1D43B" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 219 683Q260 681 355 681Q389 681 418 681T463 682T483 682Q499 682 499 672Q499 670 497 658Q492 641 487 638H485Q483 638 480 638T473 638T464 637T455 637Q416 636 405 634T387 623Q384 619 355 500Q348 474 340 442T328 395L324 380Q324 378 469 378H614L615 381Q615 384 646 504Q674 619 674 627T617 637Q594 637 587 639T580 648Q580 650 582 660Q586 677 588 679T604 682Q609 682 646 681T740 680Q802 680 835 681T871 682Q888 682 888 672Q888 645 876 638H874Q872 638 869 638T862 638T853 637T844 637Q805 636 794 634T776 623Q773 618 704 340T634 58Q634 51 638 51Q646 48 692 46H723Q729 38 729 37T726 19Q722 6 716 0H701Q664 2 567 2Q533 2 504 2T458 2T437 1Q420 1 420 10Q420 15 423 24Q428 43 433 45Q437 46 448 46H454Q481 46 514 49Q520 50 522 50T528 55T534 64T540 82T547 110T558 153Q565 181 569 198Q602 330 602 331T457 332H312L279 197Q245 63 245 58Q245 51 253 49T303 46H334Q340 38 340 37T337 19Q333 6 327 0H312Q275 2 178 2Q144 2 115 2T69 2T48 1Q31 1 31 10Q31 12 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g><g data-mml-node="TeXAtom" transform="translate(864,-150) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g></g></g><g data-mml-node="mo" transform="translate(30031.5,0)"><path data-c="3A" d="M78 370Q78 394 95 412T138 430Q162 430 180 414T199 371Q199 346 182 328T139 310T96 327T78 370ZM78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z"></path></g><g data-mml-node="msub" transform="translate(30587.3,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-152.7) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D447" d="M40 437Q21 437 21 445Q21 450 37 501T71 602L88 651Q93 669 101 677H569H659Q691 677 697 676T704 667Q704 661 687 553T668 444Q668 437 649 437Q640 437 637 437T631 442L629 445Q629 451 635 490T641 551Q641 586 628 604T573 629Q568 630 515 631Q469 631 457 630T439 622Q438 621 368 343T298 60Q298 48 386 46Q418 46 427 45T436 36Q436 31 433 22Q429 4 424 1L422 0Q419 0 415 0Q410 0 363 1T228 2Q99 2 64 0H49Q43 6 43 9T45 27Q49 40 55 46H83H94Q174 46 189 55Q190 56 191 56Q196 59 201 76T241 233Q258 301 269 344Q339 619 339 625Q339 630 310 630H279Q212 630 191 624Q146 614 121 583T67 467Q60 445 57 441T43 437H40Z"></path></g><g data-mml-node="mo" transform="translate(704,0)"><path data-c="2B" d="M56 237T56 250T70 270H369V420L370 570Q380 583 389 583Q402 583 409 568V270H707Q722 262 722 250T707 230H409V-68Q401 -82 391 -82H389H387Q375 -82 369 -68V230H70Q56 237 56 250Z"></path></g><g data-mml-node="mi" transform="translate(1482,0)"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g></g></g><g data-mml-node="mo" transform="translate(33112.8,0)"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g><g data-mml-node="msub" transform="translate(34113,0)"><g data-mml-node="mi"><path data-c="1D443" d="M287 628Q287 635 230 637Q206 637 199 638T192 648Q192 649 194 659Q200 679 203 681T397 683Q587 682 600 680Q664 669 707 631T751 530Q751 453 685 389Q616 321 507 303Q500 302 402 301H307L277 182Q247 66 247 59Q247 55 248 54T255 50T272 48T305 46H336Q342 37 342 35Q342 19 335 5Q330 0 319 0Q316 0 282 1T182 2Q120 2 87 2T51 1Q33 1 33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM645 554Q645 567 643 575T634 597T609 619T560 635Q553 636 480 637Q463 637 445 637T416 636T404 636Q391 635 386 627Q384 621 367 550T332 412T314 344Q314 342 395 342H407H430Q542 342 590 392Q617 419 631 471T645 554Z"></path></g><g data-mml-node="TeXAtom" transform="translate(675,-152.7) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mi"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g></g></g><g data-mml-node="mo" transform="translate(35646.1,0)"><path data-c="2260" d="M166 -215T159 -215T147 -212T141 -204T139 -197Q139 -190 144 -183L306 133H70Q56 140 56 153Q56 168 72 173H327L406 327H72Q56 332 56 347Q56 360 70 367H426Q597 702 602 707Q605 716 618 716Q625 716 630 712T636 703T638 696Q638 692 471 367H707Q722 359 722 347Q722 336 708 328L451 327L371 173H708Q722 163 722 153Q722 140 707 133H351Q175 -210 170 -212Q166 -215 159 -215Z"></path></g><g data-mml-node="mn" transform="translate(36701.9,0)"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g></g></g></svg></mjx-container></span></div> |
| <div>A－Aspirin、T－ticagrelor、T＋A－Aspirin＋ticagrelor<br> |
| Patency results from all the 3 treatment groups will be modeled in a same Generalized Estimating Equation，the rate difference and its <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="7.007ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 3097 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g><g data-mml-node="mi" transform="translate(1833,0)"><path data-c="1D436" d="M50 252Q50 367 117 473T286 641T490 704Q580 704 633 653Q642 643 648 636T656 626L657 623Q660 623 684 649Q691 655 699 663T715 679T725 690L740 705H746Q760 705 760 698Q760 694 728 561Q692 422 692 421Q690 416 687 415T669 413H653Q647 419 647 422Q647 423 648 429T650 449T651 481Q651 552 619 605T510 659Q484 659 454 652T382 628T299 572T226 479Q194 422 175 346T156 222Q156 108 232 58Q280 24 350 24Q441 24 512 92T606 240Q610 253 612 255T628 257Q648 257 648 248Q648 243 647 239Q618 132 523 55T319 -22Q206 -22 128 53T50 252Z"></path></g><g data-mml-node="mi" transform="translate(2593,0)"><path data-c="1D43C" d="M43 1Q26 1 26 10Q26 12 29 24Q34 43 39 45Q42 46 54 46H60Q120 46 136 53Q137 53 138 54Q143 56 149 77T198 273Q210 318 216 344Q286 624 286 626Q284 630 284 631Q274 637 213 637H193Q184 643 189 662Q193 677 195 680T209 683H213Q285 681 359 681Q481 681 487 683H497Q504 676 504 672T501 655T494 639Q491 637 471 637Q440 637 407 634Q393 631 388 623Q381 609 337 432Q326 385 315 341Q245 65 245 59Q245 52 255 50T307 46H339Q345 38 345 37T342 19Q338 6 332 0H316Q279 2 179 2Q143 2 113 2T65 2T43 1Z"></path></g></g></g></svg></mjx-container></span> will be derived for the comparisons of A vs <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="6.055ex" height="1.805ex" role="img" focusable="false" viewBox="0 -716 2676.4 798"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mi"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g><g data-mml-node="mo" transform="translate(972.2,0)"><path data-c="2B" d="M56 237T56 250T70 270H369V420L370 570Q380 583 389 583Q402 583 409 568V270H707Q722 262 722 250T707 230H409V-68Q401 -82 391 -82H389H387Q375 -82 369 -68V230H70Q56 237 56 250Z"></path></g><g data-mml-node="mi" transform="translate(1972.4,0)"><path data-c="1D447" d="M40 437Q21 437 21 445Q21 450 37 501T71 602L88 651Q93 669 101 677H569H659Q691 677 697 676T704 667Q704 661 687 553T668 444Q668 437 649 437Q640 437 637 437T631 442L629 445Q629 451 635 490T641 551Q641 586 628 604T573 629Q568 630 515 631Q469 631 457 630T439 622Q438 621 368 343T298 60Q298 48 386 46Q418 46 427 45T436 36Q436 31 433 22Q429 4 424 1L422 0Q419 0 415 0Q410 0 363 1T228 2Q99 2 64 0H49Q43 6 43 9T45 27Q49 40 55 46H83H94Q174 46 189 55Q190 56 191 56Q196 59 201 76T241 233Q258 301 269 344Q339 619 339 625Q339 630 310 630H279Q212 630 191 624Q146 614 121 583T67 467Q60 445 57 441T43 437H40Z"></path></g></g></g></svg></mjx-container></span>（or A vs T ）．If the lower of <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.127ex;" xmlns="http://www.w3.org/2000/svg" width="7.007ex" height="1.824ex" role="img" focusable="false" viewBox="0 -750 3097 806"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g><g data-mml-node="mi" transform="translate(1833,0)"><path data-c="1D436" d="M50 252Q50 367 117 473T286 641T490 704Q580 704 633 653Q642 643 648 636T656 626L657 623Q660 623 684 649Q691 655 699 663T715 679T725 690L740 705H746Q760 705 760 698Q760 694 728 561Q692 422 692 421Q690 416 687 415T669 413H653Q647 419 647 422Q647 423 648 429T650 449T651 481Q651 552 619 605T510 659Q484 659 454 652T382 628T299 572T226 479Q194 422 175 346T156 222Q156 108 232 58Q280 24 350 24Q441 24 512 92T606 240Q610 253 612 255T628 257Q648 257 648 248Q648 243 647 239Q618 132 523 55T319 -22Q206 -22 128 53T50 252Z"></path></g><g data-mml-node="mi" transform="translate(2593,0)"><path data-c="1D43C" d="M43 1Q26 1 26 10Q26 12 29 24Q34 43 39 45Q42 46 54 46H60Q120 46 136 53Q137 53 138 54Q143 56 149 77T198 273Q210 318 216 344Q286 624 286 626Q284 630 284 631Q274 637 213 637H193Q184 643 189 662Q193 677 195 680T209 683H213Q285 681 359 681Q481 681 487 683H497Q504 676 504 672T501 655T494 639Q491 637 471 637Q440 637 407 634Q393 631 388 623Q381 609 337 432Q326 385 315 341Q245 65 245 59Q245 52 255 50T307 46H339Q345 38 345 37T342 19Q338 6 332 0H316Q279 2 179 2Q143 2 113 2T65 2T43 1Z"></path></g></g></g></svg></mjx-container></span> is greater than 0 ，then <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="6.055ex" height="1.805ex" role="img" focusable="false" viewBox="0 -716 2676.4 798"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mi"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g><g data-mml-node="mo" transform="translate(972.2,0)"><path data-c="2B" d="M56 237T56 250T70 270H369V420L370 570Q380 583 389 583Q402 583 409 568V270H707Q722 262 722 250T707 230H409V-68Q401 -82 391 -82H389H387Q375 -82 369 -68V230H70Q56 237 56 250Z"></path></g><g data-mml-node="mi" transform="translate(1972.4,0)"><path data-c="1D447" d="M40 437Q21 437 21 445Q21 450 37 501T71 602L88 651Q93 669 101 677H569H659Q691 677 697 676T704 667Q704 661 687 553T668 444Q668 437 649 437Q640 437 637 437T631 442L629 445Q629 451 635 490T641 551Q641 586 628 604T573 629Q568 630 515 631Q469 631 457 630T439 622Q438 621 368 343T298 60Q298 48 386 46Q418 46 427 45T436 36Q436 31 433 22Q429 4 424 1L422 0Q419 0 415 0Q410 0 363 1T228 2Q99 2 64 0H49Q43 6 43 9T45 27Q49 40 55 46H83H94Q174 46 189 55Q190 56 191 56Q196 59 201 76T241 233Q258 301 269 344Q339 619 339 625Q339 630 310 630H279Q212 630 191 624Q146 614 121 583T67 467Q60 445 57 441T43 437H40Z"></path></g></g></g></svg></mjx-container></span>（or T ）is statistical significantly higher in the patency rate than A ，the superiority of <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="6.055ex" height="1.805ex" role="img" focusable="false" viewBox="0 -716 2676.4 798"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mi"><path data-c="1D434" d="M208 74Q208 50 254 46Q272 46 272 35Q272 34 270 22Q267 8 264 4T251 0Q249 0 239 0T205 1T141 2Q70 2 50 0H42Q35 7 35 11Q37 38 48 46H62Q132 49 164 96Q170 102 345 401T523 704Q530 716 547 716H555H572Q578 707 578 706L606 383Q634 60 636 57Q641 46 701 46Q726 46 726 36Q726 34 723 22Q720 7 718 4T704 0Q701 0 690 0T651 1T578 2Q484 2 455 0H443Q437 6 437 9T439 27Q443 40 445 43L449 46H469Q523 49 533 63L521 213H283L249 155Q208 86 208 74ZM516 260Q516 271 504 416T490 562L463 519Q447 492 400 412L310 260L413 259Q516 259 516 260Z"></path></g><g data-mml-node="mo" transform="translate(972.2,0)"><path data-c="2B" d="M56 237T56 250T70 270H369V420L370 570Q380 583 389 583Q402 583 409 568V270H707Q722 262 722 250T707 230H409V-68Q401 -82 391 -82H389H387Q375 -82 369 -68V230H70Q56 237 56 250Z"></path></g><g data-mml-node="mi" transform="translate(1972.4,0)"><path data-c="1D447" d="M40 437Q21 437 21 445Q21 450 37 501T71 602L88 651Q93 669 101 677H569H659Q691 677 697 676T704 667Q704 661 687 553T668 444Q668 437 649 437Q640 437 637 437T631 442L629 445Q629 451 635 490T641 551Q641 586 628 604T573 629Q568 630 515 631Q469 631 457 630T439 622Q438 621 368 343T298 60Q298 48 386 46Q418 46 427 45T436 36Q436 31 433 22Q429 4 424 1L422 0Q419 0 415 0Q410 0 363 1T228 2Q99 2 64 0H49Q43 6 43 9T45 27Q49 40 55 46H83H94Q174 46 189 55Q190 56 191 56Q196 59 201 76T241 233Q258 301 269 344Q339 619 339 625Q339 630 310 630H279Q212 630 191 624Q146 614 121 583T67 467Q60 445 57 441T43 437H40Z"></path></g></g></g></svg></mjx-container></span>（or T ）proved．</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E3%EF%BC%8E3-statistical-descriptive-of-patency-of-grafts"> |
| 8．3．3 Statistical Descriptive of Patency of Grafts</h2> |
| <div>There levels of patency examination in grafts according to the Fitzgibbon Standards，that＇s level A，level B，and level O，and it＇s ordinal variable．The patency of grafts at the visit 5 （ 7 days after CABG）and visit 9 （ 1 year after CABG）will be summarized by using the statistical method for the ordinal variable．</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E4-secondary-endpoints"> |
| 8．4 Secondary Endpoints</h2> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E4%EF%BC%8E1-handling-in-missing-values-for-secondary-endpoint"> |
| 8．4．1 Handling in Missing Values for Secondary Endpoint</h2> |
| <div>For the missing values in the patency examination for any graft in any visit will be imputed by the worst level in Fitzgibbon Standards．</div> |
| <div>For the other secondary endpoints，missing value won＇t be imputed．</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E4%EF%BC%8E2-statistical-descriptive-and-statistical-test-for-secondary-endpoints"> |
| 8．4．2 Statistical Descriptive and Statistical Test for Secondary Endpoints</h2> |
| <div>GEE will be applied to the rate of patency and non－occlusion of grafts，the other secondary endpoints will be analyzed by using the statistical methods defined in chapter 8．2，depends on the property of the variables．</div> |
| <div>For MACE，statistical methods for the discrete variables will be applied to compare the rates of MACE event among these 3 treatment groups，Time to MACE（measured in days）will be analyzed using a log－rank test．Subjects who had not experienced MACE will be right－censored．The survival curves will be estimated using Kaplan－Meier estimates．</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E5-safety-endpoints"> |
| 8．5 Safety Endpoints</h2> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E5%EF%BC%8E1-adverse-events"> |
| 8．5．1 Adverse Events</h2> |
| <div>AEs that occurred any time over the study will be reported and coded using Medical Dictionary for Regulatory Activities（MedDRA）．All the adverse events will be listed．AEs will be summarized by treatment group，system organ class and preferred term．<br> |
| The following AE summary tables will be provided for this study：<br> |
| －Adverse event<br> |
| －Serious adverse event（SAEs）<br> |
| －AEs leading to study agent interruption or withdrawal</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E5%EF%BC%8E2-smoking"> |
| 8．5．2 Smoking</h2> |
| <div>The comparison of smoking status in these 3 treatment groups will be analyzed by using the statistical methods for the discrete variable</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="8%EF%BC%8E5%EF%BC%8E3-bleeding-events"> |
| 8．5．3 Bleeding Events</h2> |
| <div>The rate of bleeding events（Major bleeding，CABG related bleeding，non CABG related bleeding）among these 3 treatment groups will be summarized by using the statistical method for discrete variable．</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.5.4-comparison-in-the-chemistry-and-vital-sign-endpoints-among-3-treatment-groups"> |
| 8.5.4 Comparison in the Chemistry and Vital Sign Endpoints among 3 Treatment Groups</h3> |
| <div>Rate of Glycated hemoglobin ( HbA 1 c <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="8.673ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 3833.6 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="29" d="M60 749L64 750Q69 750 74 750H86L114 726Q208 641 251 514T294 250Q294 182 284 119T261 12T224 -76T186 -143T145 -194T113 -227T90 -246Q87 -249 86 -250H74Q66 -250 63 -250T58 -247T55 -238Q56 -237 66 -225Q221 -64 221 250T66 725Q56 737 55 738Q55 746 60 749Z"></path></g><g data-mml-node="mo" transform="translate(666.8,0)"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1722.6,0)"><path data-c="36" d="M42 313Q42 476 123 571T303 666Q372 666 402 630T432 550Q432 525 418 510T379 495Q356 495 341 509T326 548Q326 592 373 601Q351 623 311 626Q240 626 194 566Q147 500 147 364L148 360Q153 366 156 373Q197 433 263 433H267Q313 433 348 414Q372 400 396 374T435 317Q456 268 456 210V192Q456 169 451 149Q440 90 387 34T253 -22Q225 -22 199 -14T143 16T92 75T56 172T42 313ZM257 397Q227 397 205 380T171 335T154 278T148 216Q148 133 160 97T198 39Q222 21 251 21Q302 21 329 59Q342 77 347 104T352 209Q352 289 347 316T329 361Q302 397 257 397Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(3000.6,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9<br> |
| Rate of Glycated hemoglobin ( HbA1c) <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.312ex;" xmlns="http://www.w3.org/2000/svg" width="7.165ex" height="2.009ex" role="img" focusable="false" viewBox="0 -750 3166.8 888"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="37" d="M55 458Q56 460 72 567L88 674Q88 676 108 676H128V672Q128 662 143 655T195 646T364 644H485V605L417 512Q408 500 387 472T360 435T339 403T319 367T305 330T292 284T284 230T278 162T275 80Q275 66 275 52T274 28V19Q270 2 255 -10T221 -22Q210 -22 200 -19T179 0T168 40Q168 198 265 368Q285 400 349 489L395 552H302Q128 552 119 546Q113 543 108 522T98 479L95 458V455H55V458Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(2333.8,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9<br> |
| Rate of Low-density lipoprotein <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="13.696ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 6053.8 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="38" d="M70 417T70 494T124 618T248 666Q319 666 374 624T429 515Q429 485 418 459T392 417T361 389T335 371T324 363L338 354Q352 344 366 334T382 323Q457 264 457 174Q457 95 399 37T249 -22Q159 -22 101 29T43 155Q43 263 172 335L154 348Q133 361 127 368Q70 417 70 494ZM286 386L292 390Q298 394 301 396T311 403T323 413T334 425T345 438T355 454T364 471T369 491T371 513Q371 556 342 586T275 624Q268 625 242 625Q201 625 165 599T128 534Q128 511 141 492T167 463T217 431Q224 426 228 424L286 386ZM250 21Q308 21 350 55T392 137Q392 154 387 169T375 194T353 216T330 234T301 253T274 270Q260 279 244 289T218 306L210 311Q204 311 181 294T133 239T107 157Q107 98 150 60T250 21Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(2333.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(3211.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(4089.8,0)"><path data-c="1D45C" d="M201 -11Q126 -11 80 38T34 156Q34 221 64 279T146 380Q222 441 301 441Q333 441 341 440Q354 437 367 433T402 417T438 387T464 338T476 268Q476 161 390 75T201 -11ZM121 120Q121 70 147 48T206 26Q250 26 289 58T351 142Q360 163 374 216T388 308Q388 352 370 375Q346 405 306 405Q243 405 195 347Q158 303 140 230T121 120Z"></path></g><g data-mml-node="mi" transform="translate(4574.8,0)"><path data-c="1D459" d="M117 59Q117 26 142 26Q179 26 205 131Q211 151 215 152Q217 153 225 153H229Q238 153 241 153T246 151T248 144Q247 138 245 128T234 90T214 43T183 6T137 -11Q101 -11 70 11T38 85Q38 97 39 102L104 360Q167 615 167 623Q167 626 166 628T162 632T157 634T149 635T141 636T132 637T122 637Q112 637 109 637T101 638T95 641T94 647Q94 649 96 661Q101 680 107 682T179 688Q194 689 213 690T243 693T254 694Q266 694 266 686Q266 675 193 386T118 83Q118 81 118 75T117 65V59Z"></path></g><g data-mml-node="TeXAtom" data-mjx-texclass="ORD" transform="translate(4872.8,0)"><g data-mml-node="mo"><path data-c="2F" d="M423 750Q432 750 438 744T444 730Q444 725 271 248T92 -240Q85 -250 75 -250Q68 -250 62 -245T56 -231Q56 -221 230 257T407 740Q411 750 423 750Z"></path></g></g><g data-mml-node="mi" transform="translate(5372.8,0)"><path data-c="1D43F" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 217 683Q271 680 344 680Q485 680 506 683H518Q524 677 524 674T522 656Q517 641 513 637H475Q406 636 394 628Q387 624 380 600T313 336Q297 271 279 198T252 88L243 52Q243 48 252 48T311 46H328Q360 46 379 47T428 54T478 72T522 106T564 161Q580 191 594 228T611 270Q616 273 628 273H641Q647 264 647 262T627 203T583 83T557 9Q555 4 553 3T537 0T494 -1Q483 -1 418 -1T294 0H116Q32 0 32 10Q32 17 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9<br> |
| Rate of Low-density lipoprotein <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="13.696ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 6053.8 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="32" d="M109 429Q82 429 66 447T50 491Q50 562 103 614T235 666Q326 666 387 610T449 465Q449 422 429 383T381 315T301 241Q265 210 201 149L142 93L218 92Q375 92 385 97Q392 99 409 186V189H449V186Q448 183 436 95T421 3V0H50V19V31Q50 38 56 46T86 81Q115 113 136 137Q145 147 170 174T204 211T233 244T261 278T284 308T305 340T320 369T333 401T340 431T343 464Q343 527 309 573T212 619Q179 619 154 602T119 569T109 550Q109 549 114 549Q132 549 151 535T170 489Q170 464 154 447T109 429Z"></path><path data-c="2E" d="M78 60Q78 84 95 102T138 120Q162 120 180 104T199 61Q199 36 182 18T139 0T96 17T78 60Z" transform="translate(500,0)"></path><path data-c="36" d="M42 313Q42 476 123 571T303 666Q372 666 402 630T432 550Q432 525 418 510T379 495Q356 495 341 509T326 548Q326 592 373 601Q351 623 311 626Q240 626 194 566Q147 500 147 364L148 360Q153 366 156 373Q197 433 263 433H267Q313 433 348 414Q372 400 396 374T435 317Q456 268 456 210V192Q456 169 451 149Q440 90 387 34T253 -22Q225 -22 199 -14T143 16T92 75T56 172T42 313ZM257 397Q227 397 205 380T171 335T154 278T148 216Q148 133 160 97T198 39Q222 21 251 21Q302 21 329 59Q342 77 347 104T352 209Q352 289 347 316T329 361Q302 397 257 397Z" transform="translate(778,0)"></path></g><g data-mml-node="mi" transform="translate(2333.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(3211.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(4089.8,0)"><path data-c="1D45C" d="M201 -11Q126 -11 80 38T34 156Q34 221 64 279T146 380Q222 441 301 441Q333 441 341 440Q354 437 367 433T402 417T438 387T464 338T476 268Q476 161 390 75T201 -11ZM121 120Q121 70 147 48T206 26Q250 26 289 58T351 142Q360 163 374 216T388 308Q388 352 370 375Q346 405 306 405Q243 405 195 347Q158 303 140 230T121 120Z"></path></g><g data-mml-node="mi" transform="translate(4574.8,0)"><path data-c="1D459" d="M117 59Q117 26 142 26Q179 26 205 131Q211 151 215 152Q217 153 225 153H229Q238 153 241 153T246 151T248 144Q247 138 245 128T234 90T214 43T183 6T137 -11Q101 -11 70 11T38 85Q38 97 39 102L104 360Q167 615 167 623Q167 626 166 628T162 632T157 634T149 635T141 636T132 637T122 637Q112 637 109 637T101 638T95 641T94 647Q94 649 96 661Q101 680 107 682T179 688Q194 689 213 690T243 693T254 694Q266 694 266 686Q266 675 193 386T118 83Q118 81 118 75T117 65V59Z"></path></g><g data-mml-node="TeXAtom" data-mjx-texclass="ORD" transform="translate(4872.8,0)"><g data-mml-node="mo"><path data-c="2F" d="M423 750Q432 750 438 744T444 730Q444 725 271 248T92 -240Q85 -250 75 -250Q68 -250 62 -245T56 -231Q56 -221 230 257T407 740Q411 750 423 750Z"></path></g></g><g data-mml-node="mi" transform="translate(5372.8,0)"><path data-c="1D43F" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 217 683Q271 680 344 680Q485 680 506 683H518Q524 677 524 674T522 656Q517 641 513 637H475Q406 636 394 628Q387 624 380 600T313 336Q297 271 279 198T252 88L243 52Q243 48 252 48T311 46H328Q360 46 379 47T428 54T478 72T522 106T564 161Q580 191 594 228T611 270Q616 273 628 273H641Q647 264 647 262T627 203T583 83T557 9Q555 4 553 3T537 0T494 -1Q483 -1 418 -1T294 0H116Q32 0 32 10Q32 17 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9<br> |
| Rate of Systolic blood pressure <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.312ex;" xmlns="http://www.w3.org/2000/svg" width="5.782ex" height="1.844ex" role="img" focusable="false" viewBox="0 -677 2555.8 815"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path><path data-c="34" d="M462 0Q444 3 333 3Q217 3 199 0H190V46H221Q241 46 248 46T265 48T279 53T286 61Q287 63 287 115V165H28V211L179 442Q332 674 334 675Q336 677 355 677H373L379 671V211H471V165H379V114Q379 73 379 66T385 54Q393 47 442 46H471V0H462ZM293 211V545L74 212L183 211H293Z" transform="translate(500,0)"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(1000,0)"></path></g></g></g></svg></mjx-container></span> or Diastolic blood pressure <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.464ex;" xmlns="http://www.w3.org/2000/svg" width="11.712ex" height="2.009ex" role="img" focusable="false" viewBox="0 -683 5176.8 888"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(2055.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(2933.8,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(3811.8,0)"><path data-c="1D43B" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 219 683Q260 681 355 681Q389 681 418 681T463 682T483 682Q499 682 499 672Q499 670 497 658Q492 641 487 638H485Q483 638 480 638T473 638T464 637T455 637Q416 636 405 634T387 623Q384 619 355 500Q348 474 340 442T328 395L324 380Q324 378 469 378H614L615 381Q615 384 646 504Q674 619 674 627T617 637Q594 637 587 639T580 648Q580 650 582 660Q586 677 588 679T604 682Q609 682 646 681T740 680Q802 680 835 681T871 682Q888 682 888 672Q888 645 876 638H874Q872 638 869 638T862 638T853 637T844 637Q805 636 794 634T776 623Q773 618 704 340T634 58Q634 51 638 51Q646 48 692 46H723Q729 38 729 37T726 19Q722 6 716 0H701Q664 2 567 2Q533 2 504 2T458 2T437 1Q420 1 420 10Q420 15 423 24Q428 43 433 45Q437 46 448 46H454Q481 46 514 49Q520 50 522 50T528 55T534 64T540 82T547 110T558 153Q565 181 569 198Q602 330 602 331T457 332H312L279 197Q245 63 245 58Q245 51 253 49T303 46H334Q340 38 340 37T337 19Q333 6 327 0H312Q275 2 178 2Q144 2 115 2T69 2T48 1Q31 1 31 10Q31 12 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g><g data-mml-node="mi" transform="translate(4699.8,0)"><path data-c="1D454" d="M311 43Q296 30 267 15T206 0Q143 0 105 45T66 160Q66 265 143 353T314 442Q361 442 401 394L404 398Q406 401 409 404T418 412T431 419T447 422Q461 422 470 413T480 394Q480 379 423 152T363 -80Q345 -134 286 -169T151 -205Q10 -205 10 -137Q10 -111 28 -91T74 -71Q89 -71 102 -80T116 -111Q116 -121 114 -130T107 -144T99 -154T92 -162L90 -164H91Q101 -167 151 -167Q189 -167 211 -155Q234 -144 254 -122T282 -75Q288 -56 298 -13Q311 35 311 43ZM384 328L380 339Q377 350 375 354T369 368T359 382T346 393T328 402T306 405Q262 405 221 352Q191 313 171 233T151 117Q151 38 213 38Q269 38 323 108L331 118L384 328Z"></path></g></g></g></svg></mjx-container></span> from visit 6 to visit 9<br> |
| The above comparisons will be analyzed by using the statistical methods for the discrete variable.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.6-other-variables"> |
| 8.6 Other Variables</h3> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.6.1-demographic-and-baseline-data"> |
| 8.6.1 Demographic and Baseline Data</h3> |
| <div>Demographic and baseline characteristic variables will be descriptively summarized in ITT, no formal statistical comparison is planned.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.6.2-baseline-and-medical-history"> |
| 8.6.2 Baseline and Medical History</h3> |
| <div>The collected daseline data and medical history included angina, (CCS angina grade) , history of myocardial infarction, New York Heart Association (NYHA) functional classification, history of cerebrovascular accident; history of hypertension, history of diabetes mellitus, history of hyperlipidemia, history of chronic obstructive pulmonary disease (COPD), history of peptic ulcer or digestive hemorrhage, history of chronic kidney disease (CKD) (defined as baseline creatinine > <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.566ex;" xmlns="http://www.w3.org/2000/svg" width="11.118ex" height="2.262ex" role="img" focusable="false" viewBox="0 -750 4914 1000"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="32" d="M109 429Q82 429 66 447T50 491Q50 562 103 614T235 666Q326 666 387 610T449 465Q449 422 429 383T381 315T301 241Q265 210 201 149L142 93L218 92Q375 92 385 97Q392 99 409 186V189H449V186Q448 183 436 95T421 3V0H50V19V31Q50 38 56 46T86 81Q115 113 136 137Q145 147 170 174T204 211T233 244T261 278T284 308T305 340T320 369T333 401T340 431T343 464Q343 527 309 573T212 619Q179 619 154 602T119 569T109 550Q109 549 114 549Q132 549 151 535T170 489Q170 464 154 447T109 429Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(1000,0)"></path></g><g data-mml-node="mi" transform="translate(1500,0)"><path data-c="1D462" d="M21 287Q21 295 30 318T55 370T99 420T158 442Q204 442 227 417T250 358Q250 340 216 246T182 105Q182 62 196 45T238 27T291 44T328 78L339 95Q341 99 377 247Q407 367 413 387T427 416Q444 431 463 431Q480 431 488 421T496 402L420 84Q419 79 419 68Q419 43 426 35T447 26Q469 29 482 57T512 145Q514 153 532 153Q551 153 551 144Q550 139 549 130T540 98T523 55T498 17T462 -8Q454 -10 438 -10Q372 -10 347 46Q345 45 336 36T318 21T296 6T267 -6T233 -11Q189 -11 155 7Q103 38 103 113Q103 170 138 262T173 379Q173 380 173 381Q173 390 173 393T169 400T158 404H154Q131 404 112 385T82 344T65 302T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(2072,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(2950,0)"><path data-c="1D45C" d="M201 -11Q126 -11 80 38T34 156Q34 221 64 279T146 380Q222 441 301 441Q333 441 341 440Q354 437 367 433T402 417T438 387T464 338T476 268Q476 161 390 75T201 -11ZM121 120Q121 70 147 48T206 26Q250 26 289 58T351 142Q360 163 374 216T388 308Q388 352 370 375Q346 405 306 405Q243 405 195 347Q158 303 140 230T121 120Z"></path></g><g data-mml-node="mi" transform="translate(3435,0)"><path data-c="1D459" d="M117 59Q117 26 142 26Q179 26 205 131Q211 151 215 152Q217 153 225 153H229Q238 153 241 153T246 151T248 144Q247 138 245 128T234 90T214 43T183 6T137 -11Q101 -11 70 11T38 85Q38 97 39 102L104 360Q167 615 167 623Q167 626 166 628T162 632T157 634T149 635T141 636T132 637T122 637Q112 637 109 637T101 638T95 641T94 647Q94 649 96 661Q101 680 107 682T179 688Q194 689 213 690T243 693T254 694Q266 694 266 686Q266 675 193 386T118 83Q118 81 118 75T117 65V59Z"></path></g><g data-mml-node="TeXAtom" data-mjx-texclass="ORD" transform="translate(3733,0)"><g data-mml-node="mo"><path data-c="2F" d="M423 750Q432 750 438 744T444 730Q444 725 271 248T92 -240Q85 -250 75 -250Q68 -250 62 -245T56 -231Q56 -221 230 257T407 740Q411 750 423 750Z"></path></g></g><g data-mml-node="mi" transform="translate(4233,0)"><path data-c="1D43F" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 217 683Q271 680 344 680Q485 680 506 683H518Q524 677 524 674T522 656Q517 641 513 637H475Q406 636 394 628Q387 624 380 600T313 336Q297 271 279 198T252 88L243 52Q243 48 252 48T311 46H328Q360 46 379 47T428 54T478 72T522 106T564 161Q580 191 594 228T611 270Q616 273 628 273H641Q647 264 647 262T627 203T583 83T557 9Q555 4 553 3T537 0T494 -1Q483 -1 418 -1T294 0H116Q32 0 32 10Q32 17 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g></g></g></svg></mjx-container></span> ), history of peripheral arterial disease (PAD) (defined as a stenosis <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.312ex;" xmlns="http://www.w3.org/2000/svg" width="6.536ex" height="2.009ex" role="img" focusable="false" viewBox="0 -750 2888.8 888"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2A7E" d="M83 616Q83 624 89 630T99 636Q107 636 253 568T543 431T687 361Q694 356 694 346T687 331Q685 329 395 192L107 56H101Q83 58 83 76Q83 77 83 79Q82 86 98 95Q117 105 248 167Q326 204 378 228L626 346L360 472Q291 505 200 548Q112 589 98 597T83 616ZM674 172Q692 172 694 154Q694 142 687 137Q685 135 395 -2L107 -138H101Q83 -136 83 -118Q83 -106 96 -100Q100 -98 380 35T665 170T674 172Z"></path></g><g data-mml-node="mn" transform="translate(1055.8,0)"><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path></g><g data-mml-node="mi" transform="translate(2055.8,0)"><path data-c="25" d="M465 605Q428 605 394 614T340 632T319 641Q332 608 332 548Q332 458 293 403T202 347Q145 347 101 402T56 548Q56 637 101 693T202 750Q241 750 272 719Q359 642 464 642Q580 642 650 732Q662 748 668 749Q670 750 673 750Q682 750 688 743T693 726Q178 -47 170 -52Q166 -56 160 -56Q147 -56 142 -45Q137 -36 142 -27Q143 -24 363 304Q469 462 525 546T581 630Q528 605 465 605ZM207 385Q235 385 263 427T292 548Q292 617 267 664T200 712Q193 712 186 709T167 698T147 668T134 615Q132 595 132 548V527Q132 436 165 403Q183 385 203 385H207ZM500 146Q500 234 544 290T647 347Q699 347 737 292T776 146T737 0T646 -56Q590 -56 545 0T500 146ZM651 -18Q679 -18 707 24T736 146Q736 215 711 262T644 309Q637 309 630 306T611 295T591 265T578 212Q577 200 577 146V124Q577 -18 647 -18H651Z"></path></g></g></g></svg></mjx-container></span> detected in any carotid or femoral artery by Doppler ultrasonography), history of smoking, results of ultrasonic cardiogram (LVED, LVEF), SYNTAX score, EuroScore, and preoperative concomitant medication (including aspirin, IIb/IIa antagonist, low molecular weight heparin, beta blocker, ACEI / ARB, statin and proton pump inhibitor).</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.6.3-operation-information-data"> |
| 8.6.3 Operation Information Data</h3> |
| <div>Operation information data including type of total grafts, number of IMA grafts RA grafts and SV grafts; off-pump or on-pump were collected as categorical variables.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.6.4-concomitant-medication"> |
| 8.6.4 Concomitant Medication</h3> |
| <div>The proportion of patients using concomitant medication was collected at each follow-up point and was compared among the three groups. Main concomitant medications included beta blocker, ACEI / ARB, statin and proton pump inhibitor, comparative statistical analysis was carried out in each medication.</div> |
| <h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="8.7-interim-analysis"> |
| 8.7 Interim Analysis</h3> |
| <div>No interim analysis for this study.</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="references"> |
| References</h2> |
| <div>[1]. Liang, K. Y. and Zeger, S. L. (1986), "Longitudinal Data Analysis Using Generalized Linear Models," Biometrika, 73, 13-22.</div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="appendix%3A-time-and-events-schedule"> |
| Appendix: Time and Events Schedule</h2> |
| <div class="table_tabular" style="text-align: center"> |
| <div class="inline-tabular"><table class="tabular"> |
| <tbody> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top-style: solid !important; border-top-width: 1px !important; width: auto; vertical-align: middle; ">Phase</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top-style: solid !important; border-top-width: 1px !important; width: auto; vertical-align: middle; ">Base line/ Scre enin <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.464ex;" xmlns="http://www.w3.org/2000/svg" width="2.067ex" height="2.368ex" role="img" focusable="false" viewBox="0 -841.7 913.6 1046.7"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="mi"><path data-c="1D454" d="M311 43Q296 30 267 15T206 0Q143 0 105 45T66 160Q66 265 143 353T314 442Q361 442 401 394L404 398Q406 401 409 404T418 412T431 419T447 422Q461 422 470 413T480 394Q480 379 423 152T363 -80Q345 -134 286 -169T151 -205Q10 -205 10 -137Q10 -111 28 -91T74 -71Q89 -71 102 -80T116 -111Q116 -121 114 -130T107 -144T99 -154T92 -162L90 -164H91Q101 -167 151 -167Q189 -167 211 -155Q234 -144 254 -122T282 -75Q288 -56 298 -13Q311 35 311 43ZM384 328L380 339Q377 350 375 354T369 368T359 382T346 393T328 402T306 405Q262 405 221 352Q191 313 171 233T151 117Q151 38 213 38Q269 38 323 108L331 118L384 328Z"></path></g><g data-mml-node="TeXAtom" transform="translate(510,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="34" d="M462 0Q444 3 333 3Q217 3 199 0H190V46H221Q241 46 248 46T265 48T279 53T286 61Q287 63 287 115V165H28V211L179 442Q332 674 334 675Q336 677 355 677H373L379 671V211H471V165H379V114Q379 73 379 66T385 54Q393 47 442 46H471V0H462ZM293 211V545L74 212L183 211H293Z"></path></g></g></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: center; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom: none !important; border-top: none !important; border-top-style: solid !important; border-top-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; " colspan="9">Treatment (Day 1-Day 360)</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Disch arge <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="0.988ex" height="1.887ex" role="img" focusable="false" viewBox="0 -833.9 436.6 833.9"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="TeXAtom" data-mjx-texclass="ORD"></g><g data-mml-node="TeXAtom" transform="translate(33,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="32" d="M109 429Q82 429 66 447T50 491Q50 562 103 614T235 666Q326 666 387 610T449 465Q449 422 429 383T381 315T301 241Q265 210 201 149L142 93L218 92Q375 92 385 97Q392 99 409 186V189H449V186Q448 183 436 95T421 3V0H50V19V31Q50 38 56 46T86 81Q115 113 136 137Q145 147 170 174T204 211T233 244T261 278T284 308T305 340T320 369T333 401T340 431T343 464Q343 527 309 573T212 619Q179 619 154 602T119 569T109 550Q109 549 114 549Q132 549 151 535T170 489Q170 464 154 447T109 429Z"></path></g></g></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Endp oint <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="0.988ex" height="1.885ex" role="img" focusable="false" viewBox="0 -833.2 436.6 833.2"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="TeXAtom" data-mjx-texclass="ORD"></g><g data-mml-node="TeXAtom" transform="translate(33,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="33" d="M127 463Q100 463 85 480T69 524Q69 579 117 622T233 665Q268 665 277 664Q351 652 390 611T430 522Q430 470 396 421T302 350L299 348Q299 347 308 345T337 336T375 315Q457 262 457 175Q457 96 395 37T238 -22Q158 -22 100 21T42 130Q42 158 60 175T105 193Q133 193 151 175T169 130Q169 119 166 110T159 94T148 82T136 74T126 70T118 67L114 66Q165 21 238 21Q293 21 321 74Q338 107 338 175V195Q338 290 274 322Q259 328 213 329L171 330L168 332Q166 335 166 348Q166 366 174 366Q202 366 232 371Q266 376 294 413T322 525V533Q322 590 287 612Q265 626 240 626Q208 626 181 615T143 592T132 580H135Q138 579 143 578T153 573T165 566T175 555T183 540T186 520Q186 498 172 481T127 463Z"></path></g></g></g></g></g></svg></mjx-container></span></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Treatment Day <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="0.988ex" height="1.887ex" role="img" focusable="false" viewBox="0 -833.9 436.6 833.9"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="TeXAtom" data-mjx-texclass="ORD"></g><g data-mml-node="TeXAtom" transform="translate(33,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g></g></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D1</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D2</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D3</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D5 <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="2.891ex" height="1.507ex" role="img" focusable="false" viewBox="0 -666 1278 666"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="B1" d="M56 320T56 333T70 353H369V502Q369 651 371 655Q376 666 388 666Q402 666 405 654T409 596V500V353H707Q722 345 722 333Q722 320 707 313H409V40H707Q722 32 722 20T707 0H70Q56 7 56 20T70 40H369V313H70Q56 320 56 333Z"></path></g><g data-mml-node="mn" transform="translate(778,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D9 <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="2.891ex" height="1.507ex" role="img" focusable="false" viewBox="0 -666 1278 666"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="B1" d="M56 320T56 333T70 353H369V502Q369 651 371 655Q376 666 388 666Q402 666 405 654T409 596V500V353H707Q722 345 722 333Q722 320 707 313H409V40H707Q722 32 722 20T707 0H70Q56 7 56 20T70 40H369V313H70Q56 320 56 333Z"></path></g><g data-mml-node="mn" transform="translate(778,0)"><path data-c="32" d="M109 429Q82 429 66 447T50 491Q50 562 103 614T235 666Q326 666 387 610T449 465Q449 422 429 383T381 315T301 241Q265 210 201 149L142 93L218 92Q375 92 385 97Q392 99 409 186V189H449V186Q448 183 436 95T421 3V0H50V19V31Q50 38 56 46T86 81Q115 113 136 137Q145 147 170 174T204 211T233 244T261 278T284 308T305 340T320 369T333 401T340 431T343 464Q343 527 309 573T212 619Q179 619 154 602T119 569T109 550Q109 549 114 549Q132 549 151 535T170 489Q170 464 154 447T109 429Z"></path></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D30 +7</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D90 <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.05ex;" xmlns="http://www.w3.org/2000/svg" width="2.891ex" height="1.579ex" role="img" focusable="false" viewBox="0 -676 1278 698"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="B1" d="M56 320T56 333T70 353H369V502Q369 651 371 655Q376 666 388 666Q402 666 405 654T409 596V500V353H707Q722 345 722 333Q722 320 707 313H409V40H707Q722 32 722 20T707 0H70Q56 7 56 20T70 40H369V313H70Q56 320 56 333Z"></path></g><g data-mml-node="mn" transform="translate(778,0)"><path data-c="37" d="M55 458Q56 460 72 567L88 674Q88 676 108 676H128V672Q128 662 143 655T195 646T364 644H485V605L417 512Q408 500 387 472T360 435T339 403T319 367T305 330T292 284T284 230T278 162T275 80Q275 66 275 52T274 28V19Q270 2 255 -10T221 -22Q210 -22 200 -19T179 0T168 40Q168 198 265 368Q285 400 349 489L395 552H302Q128 552 119 546Q113 543 108 522T98 479L95 458V455H55V458Z"></path></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D180 +14</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">D360 <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="4.023ex" height="1.532ex" role="img" focusable="false" viewBox="0 -677 1778 677"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="B1" d="M56 320T56 333T70 353H369V502Q369 651 371 655Q376 666 388 666Q402 666 405 654T409 596V500V353H707Q722 345 722 333Q722 320 707 313H409V40H707Q722 32 722 20T707 0H70Q56 7 56 20T70 40H369V313H70Q56 320 56 333Z"></path></g><g data-mml-node="mn" transform="translate(778,0)"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path><path data-c="34" d="M462 0Q444 3 333 3Q217 3 199 0H190V46H221Q241 46 248 46T265 48T279 53T286 61Q287 63 287 115V165H28V211L179 442Q332 674 334 675Q336 677 355 677H373L379 671V211H471V165H379V114Q379 73 379 66T385 54Q393 47 442 46H471V0H462ZM293 211V545L74 212L183 211H293Z" transform="translate(500,0)"></path></g></g></g></svg></mjx-container></span></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Visit</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V1</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V2</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V3</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V4</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V5</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V6</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V7</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V8</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">V9</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Informed Consent Form <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="0.988ex" height="1.887ex" role="img" focusable="false" viewBox="0 -833.9 436.6 833.9"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="TeXAtom" data-mjx-texclass="ORD"></g><g data-mml-node="TeXAtom" transform="translate(33,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z"></path></g></g></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Medical History</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Vital Signs</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Physical Examination</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Concomitant medications</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Hematology</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Coagulation</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Biochemistry</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Inclusion/Exclusion Criteria</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Randomization</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Ticagrelor <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.464ex;" xmlns="http://www.w3.org/2000/svg" width="5.328ex" height="1.971ex" role="img" focusable="false" viewBox="0 -666 2355 871"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path></g><g data-mml-node="mn" transform="translate(500,0)"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g><g data-mml-node="mi" transform="translate(1000,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(1878,0)"><path data-c="1D454" d="M311 43Q296 30 267 15T206 0Q143 0 105 45T66 160Q66 265 143 353T314 442Q361 442 401 394L404 398Q406 401 409 404T418 412T431 419T447 422Q461 422 470 413T480 394Q480 379 423 152T363 -80Q345 -134 286 -169T151 -205Q10 -205 10 -137Q10 -111 28 -91T74 -71Q89 -71 102 -80T116 -111Q116 -121 114 -130T107 -144T99 -154T92 -162L90 -164H91Q101 -167 151 -167Q189 -167 211 -155Q234 -144 254 -122T282 -75Q288 -56 298 -13Q311 35 311 43ZM384 328L380 339Q377 350 375 354T369 368T359 382T346 393T328 402T306 405Q262 405 221 352Q191 313 171 233T151 117Q151 38 213 38Q269 38 323 108L331 118L384 328Z"></path></g></g></g></svg></mjx-container></span> bid</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Aspirin <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.464ex;" xmlns="http://www.w3.org/2000/svg" width="6.459ex" height="1.971ex" role="img" focusable="false" viewBox="0 -666 2855 871"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="31" d="M213 578L200 573Q186 568 160 563T102 556H83V602H102Q149 604 189 617T245 641T273 663Q275 666 285 666Q294 666 302 660V361L303 61Q310 54 315 52T339 48T401 46H427V0H416Q395 3 257 3Q121 3 100 0H88V46H114Q136 46 152 46T177 47T193 50T201 52T207 57T213 61V578Z"></path></g><g data-mml-node="mn" transform="translate(500,0)"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g><g data-mml-node="mn" transform="translate(1000,0)"><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z"></path></g><g data-mml-node="mi" transform="translate(1500,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(2378,0)"><path data-c="1D454" d="M311 43Q296 30 267 15T206 0Q143 0 105 45T66 160Q66 265 143 353T314 442Q361 442 401 394L404 398Q406 401 409 404T418 412T431 419T447 422Q461 422 470 413T480 394Q480 379 423 152T363 -80Q345 -134 286 -169T151 -205Q10 -205 10 -137Q10 -111 28 -91T74 -71Q89 -71 102 -80T116 -111Q116 -121 114 -130T107 -144T99 -154T92 -162L90 -164H91Q101 -167 151 -167Q189 -167 211 -155Q234 -144 254 -122T282 -75Q288 -56 298 -13Q311 35 311 43ZM384 328L380 339Q377 350 375 354T369 368T359 382T346 393T328 402T306 405Q262 405 221 352Q191 313 171 233T151 117Q151 38 213 38Q269 38 323 108L331 118L384 328Z"></path></g></g></g></svg></mjx-container></span> qd</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">ECG</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">UCG</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">MSCTA <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="0.988ex" height="1.887ex" role="img" focusable="false" viewBox="0 -833.9 436.6 833.9"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="TeXAtom" data-mjx-texclass="ORD"></g><g data-mml-node="TeXAtom" transform="translate(33,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="36" d="M42 313Q42 476 123 571T303 666Q372 666 402 630T432 550Q432 525 418 510T379 495Q356 495 341 509T326 548Q326 592 373 601Q351 623 311 626Q240 626 194 566Q147 500 147 364L148 360Q153 366 156 373Q197 433 263 433H267Q313 433 348 414Q372 400 396 374T435 317Q456 268 456 210V192Q456 169 451 149Q440 90 387 34T253 -22Q225 -22 199 -14T143 16T92 75T56 172T42 313ZM257 397Q227 397 205 380T171 335T154 278T148 216Q148 133 160 97T198 39Q222 21 251 21Q302 21 329 59Q342 77 347 104T352 209Q352 289 347 316T329 361Q302 397 257 397Z"></path></g></g></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Pregnancy Test</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Bleeding Events</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| </tr> |
| <tr style="border-top: none !important; border-bottom: none !important;"> |
| <td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">AEs <span class="math-inline " data-overflow="visible"> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: 0;" xmlns="http://www.w3.org/2000/svg" width="0.988ex" height="1.903ex" role="img" focusable="false" viewBox="0 -841 436.6 841"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="msup"><g data-mml-node="TeXAtom" data-mjx-texclass="ORD"></g><g data-mml-node="TeXAtom" transform="translate(33,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mn"><path data-c="37" d="M55 458Q56 460 72 567L88 674Q88 676 108 676H128V672Q128 662 143 655T195 646T364 644H485V605L417 512Q408 500 387 472T360 435T339 403T319 367T305 330T292 284T284 230T278 162T275 80Q275 66 275 52T274 28V19Q270 2 255 -10T221 -22Q210 -22 200 -19T179 0T168 40Q168 198 265 368Q285 400 349 489L395 552H302Q128 552 119 546Q113 543 108 522T98 479L95 458V455H55V458Z"></path></g></g></g></g></g></svg></mjx-container></span></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; " class="_empty"></td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">X</td> |
| </tr> |
| </tbody> |
| </table> |
| </div></div> |
| <h2 type="section" data-unnumbered="true" class="section-title" id="note%3A"> |
| NOTE:</h2> |
| <ol> |
| <li>CAGB procedure will be operated on Day 0</li> |
| <li>Discharge examination on Day <span class="math-inline "> |
| <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.05ex;" xmlns="http://www.w3.org/2000/svg" width="5.028ex" height="1.557ex" role="img" focusable="false" viewBox="0 -666 2222.4 688"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="39" d="M352 287Q304 211 232 211Q154 211 104 270T44 396Q42 412 42 436V444Q42 537 111 606Q171 666 243 666Q245 666 249 666T257 665H261Q273 665 286 663T323 651T370 619T413 560Q456 472 456 334Q456 194 396 97Q361 41 312 10T208 -22Q147 -22 108 7T68 93T121 149Q143 149 158 135T173 96Q173 78 164 65T148 49T135 44L131 43Q131 41 138 37T164 27T206 22H212Q272 22 313 86Q352 142 352 280V287ZM244 248Q292 248 321 297T351 430Q351 508 343 542Q341 552 337 562T323 588T293 615T246 625Q208 625 181 598Q160 576 154 546T147 441Q147 358 152 329T172 282Q197 248 244 248Z"></path></g><g data-mml-node="mo" transform="translate(722.2,0)"><path data-c="B1" d="M56 320T56 333T70 353H369V502Q369 651 371 655Q376 666 388 666Q402 666 405 654T409 596V500V353H707Q722 345 722 333Q722 320 707 313H409V40H707Q722 32 722 20T707 0H70Q56 7 56 20T70 40H369V313H70Q56 320 56 333Z"></path></g><g data-mml-node="mn" transform="translate(1722.4,0)"><path data-c="32" d="M109 429Q82 429 66 447T50 491Q50 562 103 614T235 666Q326 666 387 610T449 465Q449 422 429 383T381 315T301 241Q265 210 201 149L142 93L218 92Q375 92 385 97Q392 99 409 186V189H449V186Q448 183 436 95T421 3V0H50V19V31Q50 38 56 46T86 81Q115 113 136 137Q145 147 170 174T204 211T233 244T261 278T284 308T305 340T320 369T333 401T340 431T343 464Q343 527 309 573T212 619Q179 619 154 602T119 569T109 550Q109 549 114 549Q132 549 151 535T170 489Q170 464 154 447T109 429Z"></path></g></g></g></svg></mjx-container></span> may be optional according to each center's routine care.</li> |
| <li>Subject who prematurely terminate treatment for any reason have to complete all the tests listed in the endpoint column. Follow-up duration can be 12 months</li> |
| <li>Investigators must test all the screening results before study drug administration.</li> |
| <li>Informed consent form must be obtained before any study -related procedure.</li> |
| <li>MSCTA: Multislice Computed Tomography Angiography</li> |
| <li>AEs recording began from the signing of informed consent throughout the study until and including the last visit</li> |
| </ol> |
|
|
| </div> |
| </div> |
| </body> |
| </html> |
