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The analysis of this secondary endpoint is a one-group test","text_display":"\nused as a secondary measure of safety. The analysis of this secondary endpoint is a one-group test","confidence":1,"confidence_rate":1},{"cnt":[[168,481],[1886,481],[1886,526],[168,526]],"region":{"top_left_x":167,"top_left_y":481,"width":1720,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db72bccea7a641569cd77806247a7bf5","type":"text","conversion_output":true,"text":"against a performance goal (PG) for the proportion of subjects in the Attempted Procedure population","text_display":" against a performance goal (PG) for the proportion of subjects in the Attempted Procedure population","confidence":0.9936654447860739,"confidence_rate":0.9999394808442968},{"cnt":[[168,541],[1613,541],[1613,587],[168,587]],"region":{"top_left_x":167,"top_left_y":541,"width":1447,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f22d3f6516d498eb664a91551c66d40","type":"text","conversion_output":true,"text":"free from the composite of this secondary 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the mean change in 6 MWT distance at 12 months from baseline.","confidence":0.964251185623245,"confidence_rate":0.9996629877984686},{"cnt":[[168,1173],[1757,1173],[1757,1222],[168,1222]],"region":{"top_left_x":167,"top_left_y":1173,"width":1591,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abac9c16192f40aeb8f5de864947f8a4","type":"text","conversion_output":true,"text":"The analysis will be performed in subjects with paired 6 MWT data at baseline and 12 months.","text_display":"\nThe analysis will be performed in subjects with paired 6 MWT data at baseline and 12 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S., \"The Use of the Confidence or Fiducial Limits Illustrated in the Case of the","confidence":0.9931781210470945,"confidence_rate":0.9999399557120361},{"cnt":[[296,563],[939,563],[939,604],[296,604]],"region":{"top_left_x":296,"top_left_y":562,"width":643,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02b13517298f4e8ea0f2ed36e1cd019c","type":"text","conversion_output":true,"text":"Binomial.\" Biometrika, 1934, 26, 404-413.","text_display":" Binomial.\" Biometrika, 1934, 26, 404-413.","confidence":1,"confidence_rate":1},{"cnt":[[234,666],[1925,666],[1925,707],[234,707]],"region":{"top_left_x":234,"top_left_y":666,"width":1691,"height":41},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27f054d6296146c1bbdc342e154ca21f","type":"text","conversion_output":true,"text":"2. Newcombe, R. G., \"Interval estimation for the difference between independent proportions: comparison of","text_display":"\n2. 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SAS/STAT® 9.3 User's Guide, SAS Institute Inc., Cary, NC, 2011.","text_display":"\n13. SAS/STAT® 9.3 User's Guide, SAS Institute Inc., Cary, NC, 2011.","confidence":0.99609375,"confidence_rate":0.9999448761768226},{"cnt":[[236,524],[1876,524],[1876,569],[236,569]],"region":{"top_left_x":236,"top_left_y":524,"width":1640,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5367b84b1239464d9d977179696e7996","type":"text","conversion_output":true,"text":"14. Dmitrienko, A. et. al., Analysis of Clinical Trials Using SAS: A Practical Guide, SAS Institute, Cary, NC,","text_display":"\n14. 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