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These will determined by","text_display":" pneumopericardium within the first 10 days of life. 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Head ultrasound findings will be","text_display":"\n- Grade 3 or 4 IVH within the first 10 days of life. Head ultrasound findings will be","confidence":1,"confidence_rate":1},{"cnt":[[455,2389],[1072,2389],[1072,2434],[455,2434]],"region":{"top_left_x":455,"top_left_y":2389,"width":618,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd41b61262854396ae949c8b780811a9","type":"text","conversion_output":true,"text":"used to determine incidence of IVH.","text_display":" used to determine incidence of IVH.","confidence":1,"confidence_rate":1},{"cnt":[[954,2580],[1171,2580],[1171,2628],[954,2628]],"region":{"top_left_x":953,"top_left_y":2580,"width":218,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf1696f33a5c46ac8ad339370913cbe7","type":"page_info","conversion_output":false,"text":"Page 6 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-07","page":7,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1b2d95cf0e5441394ad089d54552a0b","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1880,129],[1880,174],[1689,174]],"region":{"top_left_x":1688,"top_left_y":128,"width":192,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f23bc92aa0248a69da0109b889d2286","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[395,258],[1841,258],[1841,305],[395,305]],"region":{"top_left_x":395,"top_left_y":257,"width":1447,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b96a5f863b74b72814909c740e078b7","type":"text","conversion_output":true,"text":"- Any other serious adverse events that have been adjudicated as potentially relating","text_display":"\n- Any other serious adverse events that have been adjudicated as potentially relating","confidence":1,"confidence_rate":1},{"cnt":[[458,305],[1253,305],[1253,354],[458,354]],"region":{"top_left_x":457,"top_left_y":305,"width":796,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f59c44dfd0f4bc0893d0b386313dae2","type":"text","conversion_output":true,"text":"to the intervention. (See Protocol section 9.2.2)","text_display":" to the intervention. (See Protocol section 9.2.2)","confidence":1,"confidence_rate":1},{"cnt":[[322,374],[1867,374],[1867,421],[322,421]],"region":{"top_left_x":322,"top_left_y":373,"width":1545,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16b74faa13384e28b861f8613cfc869e","type":"text","conversion_output":true,"text":"Adverse events will be compared between intervention arms. Adverse event data, including","text_display":"\n\nAdverse events will be compared between intervention arms. 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The DSMC will ultimately adjudicate whether the reported adverse event is in fact an","confidence":1,"confidence_rate":1},{"cnt":[[954,2580],[1171,2580],[1171,2632],[954,2632]],"region":{"top_left_x":953,"top_left_y":2580,"width":218,"height":52},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"338e61e96418444c8630605e57bfd512","type":"page_info","conversion_output":false,"text":"Page 8 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-09","page":9,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a60ac8ba6de47a8b0c71243f2115650","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1880,129],[1880,174],[1689,174]],"region":{"top_left_x":1688,"top_left_y":128,"width":192,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f55e1ff982f4c349b066b8e1c0c7200","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1841,254],[1841,301],[245,301]],"region":{"top_left_x":244,"top_left_y":253,"width":1598,"height":48},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6af2541551f44774b9df4a7fd17f9fc8","type":"text","conversion_output":true,"text":"adverse event, and a serious AE, if the SAE could be attributed to the intervention, and unblind","text_display":"\nadverse event, and a serious AE, if the SAE could be attributed to the intervention, and unblind","confidence":0.9990236759185791,"confidence_rate":0.9999903287497746},{"cnt":[[245,301],[1128,301],[1128,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":884,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a999f371b124da287c3825a1eae2b9a","type":"text","conversion_output":true,"text":"the intervention identifiers if they deem it necessary.","text_display":" the intervention identifiers if they deem it necessary.","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[243,365],[748,365],[748,423],[243,423]],"region":{"top_left_x":242,"top_left_y":365,"width":506,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"776998e48a0f462b99756114c6681e46","type":"section_header","conversion_output":false,"children_ids":["f498901d47ef4a0dbb35efed820e561e"],"text":"","text_display":""},{"cnt":[[245,370],[743,370],[743,419],[245,419]],"region":{"top_left_x":244,"top_left_y":369,"width":500,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f498901d47ef4a0dbb35efed820e561e","type":"text","conversion_output":true,"parent_id":"776998e48a0f462b99756114c6681e46","text":"3.4.2 Other Adverse Events","text_display":"\n\n\\subsection*{3.4.2 Other Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[318,438],[1738,438],[1738,488],[318,488]],"region":{"top_left_x":317,"top_left_y":438,"width":1422,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"218069b9ae6941749ce483ed4a25cd71","type":"text","conversion_output":true,"text":"For Steering Committee Meetings, two types of summaries of adverse events will be","text_display":"\n\nFor Steering Committee Meetings, two types of summaries of adverse events will be","confidence":1,"confidence_rate":1},{"cnt":[[245,486],[1222,486],[1222,535],[245,535]],"region":{"top_left_x":244,"top_left_y":485,"width":979,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07a7e75a614c4b8ca3069ab8f086aac1","type":"text","conversion_output":true,"text":"produced. These data will also be provided to the DSMC.","text_display":" produced. These data will also be provided to the DSMC.","confidence":1,"confidence_rate":1},{"cnt":[[247,554],[1824,554],[1824,604],[247,604]],"region":{"top_left_x":247,"top_left_y":554,"width":1578,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9a897a5f13145b9beec95665a427d6f","type":"text","conversion_output":true,"text":"1. A listing of all adverse events will be produced by the CDM staff in the DCC directly from","text_display":"\n1. A listing of all adverse events will be produced by the CDM staff in the DCC directly from","confidence":1,"confidence_rate":1},{"cnt":[[294,604],[1815,604],[1815,651],[294,651]],"region":{"top_left_x":294,"top_left_y":603,"width":1522,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5173d10ac2d448f0b924ea13d61b2cd0","type":"text","conversion_output":true,"text":"the AE/SAE form in the REDCap database. This listing will include a description, date of","text_display":" the AE/SAE form in the REDCap database. This listing will include a description, date of","confidence":0.99609375,"confidence_rate":0.9999579159466216},{"cnt":[[294,649],[1858,649],[1858,700],[294,700]],"region":{"top_left_x":294,"top_left_y":648,"width":1565,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a3c9a0ef4f94e83800687a72edff43a","type":"text","conversion_output":true,"text":"onset, grade, and relationship to study intervention, and whether or not the event was serious.","text_display":" onset, grade, and relationship to study intervention, and whether or not the event was serious.","confidence":1,"confidence_rate":1},{"cnt":[[245,718],[1820,718],[1820,769],[245,769]],"region":{"top_left_x":244,"top_left_y":717,"width":1576,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b3986c758af46d1bded4ef30619f4b7","type":"text","conversion_output":true,"text":"2. The study biostatistician will produce summaries of the observed adverse events combined","text_display":"\n2. The study biostatistician will produce summaries of the observed adverse events combined","confidence":1,"confidence_rate":1},{"cnt":[[296,767],[1755,767],[1755,816],[296,816]],"region":{"top_left_x":296,"top_left_y":766,"width":1460,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55a436fd409a4be29c031b4154b4cc80","type":"text","conversion_output":true,"text":"into categories, as needed, using SAS or another similar statistical tool. All the events,","text_display":" into categories, as needed, using SAS or another similar statistical tool. All the events,","confidence":1,"confidence_rate":1},{"cnt":[[294,816],[1766,816],[1766,866],[294,866]],"region":{"top_left_x":294,"top_left_y":816,"width":1473,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ecd8771dbbd42db930567022e9345da","type":"text","conversion_output":true,"text":"regardless of the relationship to the study intervention, will be included in these reports.","text_display":" regardless of the relationship to the study intervention, will be included in these reports.","confidence":1,"confidence_rate":1},{"cnt":[[294,864],[1863,864],[1863,913],[294,913]],"region":{"top_left_x":294,"top_left_y":863,"width":1569,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24c0e1d4733c4d86a9e4b1f2423cbad1","type":"text","conversion_output":true,"text":"These reports will combine data across all interventions and clinical sites. An example of the","text_display":" These reports will combine data across all interventions and clinical sites. An example of the","confidence":1,"confidence_rate":1},{"cnt":[[294,911],[1652,911],[1652,960],[294,960]],"region":{"top_left_x":294,"top_left_y":910,"width":1359,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87e9c5b11e39472dbf6b29817329d28c","type":"text","conversion_output":true,"text":"type of table which will be produced for safety analysis is shown in Appendix B.","text_display":" type of table which will be produced for safety analysis is shown in Appendix B.","confidence":1,"confidence_rate":1},{"cnt":[[241,1044],[668,1044],[668,1096],[241,1096]],"region":{"top_left_x":240,"top_left_y":1044,"width":429,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86f8f71ffb0741f5ad0bfa5be72b0a4b","type":"section_header","conversion_output":false,"children_ids":["8f14aa05c49441d4a291ca776eabaf8f"],"text":"","text_display":""},{"cnt":[[245,1048],[662,1048],[662,1089],[245,1089]],"region":{"top_left_x":244,"top_left_y":1048,"width":418,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f14aa05c49441d4a291ca776eabaf8f","type":"text","conversion_output":true,"parent_id":"86f8f71ffb0741f5ad0bfa5be72b0a4b","text":"4. Interim Analysis","text_display":"\n\n\\section*{4. Interim Analysis}","confidence":0.99951171875,"confidence_rate":0.9999796501863057},{"cnt":[[322,1117],[1729,1117],[1729,1167],[322,1167]],"region":{"top_left_x":322,"top_left_y":1117,"width":1408,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e5e85b5082a4c4c9abb4b948908f26e","type":"text","conversion_output":true,"text":"Since neonatal safety is a consideration in this study, we have chosen to use a group","text_display":"\n\nSince neonatal safety is a consideration in this study, we have chosen to use a group","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[245,1164],[1783,1164],[1783,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1540,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07bfb8bc45584413a1c23f69c0775902","type":"text","conversion_output":true,"text":"sequential design. Thus, in addition to the final analysis, there will be two interim statistical","text_display":" sequential design. Thus, in addition to the final analysis, there will be two interim statistical","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1876,1212],[1876,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1632,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29b5a02d860c4685896a0b48c8f01e34","type":"text","conversion_output":true,"text":"analyses during the course of this study. The purpose of the interim analyses will be to determine","text_display":" analyses during the course of this study. The purpose of the interim analyses will be to determine","confidence":0.9990234375,"confidence_rate":0.9999905142231666},{"cnt":[[245,1259],[1785,1259],[1785,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1542,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14e13661a8264b6083c900e9fbcaa315","type":"text","conversion_output":true,"text":"whether or not there is sufficient evidence of a difference between the treatment arms in the","text_display":" whether or not there is sufficient evidence of a difference between the treatment arms in the","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[245,1308],[1824,1308],[1824,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1308,"width":1581,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21c46832af73475d9a1fe2a3985c4304","type":"text","conversion_output":true,"text":"primary endpoint such that the trial should be discontinued prior to reaching the target accrual","text_display":" primary endpoint such that the trial should be discontinued prior to reaching the target accrual","confidence":1,"confidence_rate":1},{"cnt":[[245,1358],[333,1358],[333,1407],[245,1407]],"region":{"top_left_x":244,"top_left_y":1357,"width":90,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7ec79ee3252447a902338be2e4e5b86","type":"text","conversion_output":true,"text":"goal.","text_display":" goal.","confidence":1,"confidence_rate":1},{"cnt":[[322,1427],[1781,1427],[1781,1476],[322,1476]],"region":{"top_left_x":322,"top_left_y":1426,"width":1460,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0565939d7bd04034b3ed26fa78b5e869","type":"text","conversion_output":true,"text":"Interim analyses will be performed after approximately \\(1 / 3\\) ( 200 subjects) and \\(2 / 3\\) ( 400","text_display":"\n\nInterim analyses will be performed after approximately \\(1 / 3\\) ( 200 subjects) and \\(2 / 3\\) ( 400","confidence":0.5420769138993364,"confidence_rate":0.993955496612974},{"cnt":[[245,1474],[1790,1474],[1790,1523],[245,1523]],"region":{"top_left_x":244,"top_left_y":1473,"width":1546,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49da83cba8ed4621a64caf5e8230399e","type":"text","conversion_output":true,"text":"subjects) of the total required patients have completed their primary outcome. An additional","text_display":" subjects) of the total required patients have completed their primary outcome. An additional","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[1858,1521],[1858,1571],[245,1571]],"region":{"top_left_x":244,"top_left_y":1521,"width":1615,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fef272859344ec7801a66e925712e3f","type":"text","conversion_output":true,"text":"safety review will be undertaken after 1/6 (100 subjects) have completed their primary outcome.","text_display":" safety review will be undertaken after 1/6 (100 subjects) have completed their primary outcome.","confidence":0.6912543426733464,"confidence_rate":0.9963143343625502},{"cnt":[[245,1568],[1809,1568],[1809,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1568,"width":1565,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b608a8b1ee944741aac914852ca0b568","type":"text","conversion_output":true,"text":"The results of the interim analyses will be presented to the SAIL Data Safety and Monitoring","text_display":" The results of the interim analyses will be presented to the SAIL Data Safety and Monitoring","confidence":0.9931640625,"confidence_rate":0.9999292869379061},{"cnt":[[245,1616],[1833,1616],[1833,1669],[245,1669]],"region":{"top_left_x":244,"top_left_y":1615,"width":1589,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d66af007b7af4c64967f66c66afec527","type":"text","conversion_output":true,"text":"Committee (DSMC). The primary outcome for the interim analyses will be the comparison of","text_display":" Committee (DSMC). The primary outcome for the interim analyses will be the comparison of","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[245,1663],[1815,1663],[1815,1714],[245,1714]],"region":{"top_left_x":244,"top_left_y":1662,"width":1572,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3be22a19de134b84a4445e1a6e2608cf","type":"text","conversion_output":true,"text":"death/BPD between the treatment arms. This comparison will be accomplished by means of a","text_display":" death/BPD between the treatment arms. This comparison will be accomplished by means of a","confidence":1,"confidence_rate":1},{"cnt":[[245,1712],[1790,1712],[1790,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1712,"width":1546,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fdc0eb6b5bd40f083166dc077e3182b","type":"text","conversion_output":true,"text":"simple generalized estimating equation (GEE) model for death/BPD versus treatment (since","text_display":" simple generalized estimating equation (GEE) model for death/BPD versus treatment (since","confidence":1,"confidence_rate":1},{"cnt":[[245,1762],[1880,1762],[1880,1811],[245,1811]],"region":{"top_left_x":244,"top_left_y":1761,"width":1636,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b333831501a14fcea3213d1b772c159f","type":"text","conversion_output":true,"text":"adjustment for deliveries with multiple babies will be needed). An approximate O'Brien-Fleming","text_display":" adjustment for deliveries with multiple babies will be needed). An approximate O'Brien-Fleming","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,1809],[1835,1809],[1835,1858],[245,1858]],"region":{"top_left_x":244,"top_left_y":1808,"width":1591,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc3927381d6c4f5d96576e581c94d7e4","type":"text","conversion_output":true,"text":"boundary will be used at each interim look to calculate the nominal significance level to which","text_display":" boundary will be used at each interim look to calculate the nominal significance level to which","confidence":1,"confidence_rate":1},{"cnt":[[245,1856],[1745,1856],[1745,1906],[245,1906]],"region":{"top_left_x":244,"top_left_y":1856,"width":1501,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b206e059de304727a834bf44b2f14f82","type":"text","conversion_output":true,"text":"interim p-values are compared (O'Brien PC, 1979). Using the O'Brien Fleming spending","text_display":" interim p-values are compared (O'Brien PC, 1979). Using the O'Brien Fleming spending","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[245,1904],[1798,1904],[1798,1953],[245,1953]],"region":{"top_left_x":244,"top_left_y":1903,"width":1555,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"886436c908524af99cf7824d6f93be87","type":"text","conversion_output":true,"text":"function, the three analyses (2 interim + final) should use the following incremental \\(\\alpha\\) values","text_display":" function, the three analyses (2 interim + final) should use the following incremental \\(\\alpha\\) values","confidence":0.3927954916679255,"confidence_rate":0.9908804049283618},{"cnt":[[245,1951],[1334,1951],[1334,2002],[245,2002]],"region":{"top_left_x":244,"top_left_y":1950,"width":1091,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"625ebca9065c4144a285ee8aa807d6ac","type":"text","conversion_output":true,"text":"( \\(0.0002,0.012\\), and 0.038 ) in order to achieve an overall \\(\\alpha=0.05\\).","text_display":" ( \\(0.0002,0.012\\), and 0.038 ) in order to achieve an overall \\(\\alpha=0.05\\).","confidence":0.6468629425799008,"confidence_rate":0.9947016368087872},{"cnt":[[320,2020],[1841,2020],[1841,2071],[320,2071]],"region":{"top_left_x":320,"top_left_y":2019,"width":1522,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad365b32b8d14befb07d3416db9fa034","type":"text","conversion_output":true,"text":"There are four comparisons to warrant early stopping: (1) Clear superiority: Superiority of","text_display":"\n\nThere are four comparisons to warrant early stopping: (1) Clear superiority: Superiority of","confidence":1,"confidence_rate":1},{"cnt":[[245,2067],[1833,2067],[1833,2118],[245,2118]],"region":{"top_left_x":244,"top_left_y":2066,"width":1589,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c48858de6aa4e228dea33ec95063e0e","type":"text","conversion_output":true,"text":"the intervention is sufficiently large that the study should be discontinued because equipoise is","text_display":" the intervention is sufficiently large that the study should be discontinued because equipoise is","confidence":1,"confidence_rate":1},{"cnt":[[245,2116],[1777,2116],[1777,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2116,"width":1533,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f50bba1da0704652b018f6e2ebb210e8","type":"text","conversion_output":true,"text":"lost and randomization should no longer proceed. (2) Futility: The evidence in favor of the","text_display":" lost and randomization should no longer proceed. (2) Futility: The evidence in favor of the","confidence":1,"confidence_rate":1},{"cnt":[[245,2166],[1811,2166],[1811,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2165,"width":1568,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"717976bacb6043b59817537a73457dda","type":"text","conversion_output":true,"text":"intervention is such that at the completion of the study, there is inadequate power to detect an","text_display":" intervention is such that at the completion of the study, there is inadequate power to detect an","confidence":1,"confidence_rate":1},{"cnt":[[245,2213],[1785,2213],[1785,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":1542,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be86160ed6e4405f9efc6079e9d94ff1","type":"text","conversion_output":true,"text":"improvement and the study should be dropped. (3) Inferiority: The evidence shows that the","text_display":" improvement and the study should be dropped. (3) Inferiority: The evidence shows that the","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1841,2260],[1841,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1598,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41ecc3da7b814985be37e5d2bdff1871","type":"text","conversion_output":true,"text":"intervention is worse than the control and the study needs to be stopped. (4) Safety: Secondary","text_display":" intervention is worse than the control and the study needs to be stopped. (4) Safety: Secondary","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[245,2307],[1772,2307],[1772,2359],[245,2359]],"region":{"top_left_x":244,"top_left_y":2307,"width":1529,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5acba113cb8941bdbe168b841928f8e6","type":"text","conversion_output":true,"text":"safety outcomes that are considered serious adverse events possible related to the study are","text_display":" safety outcomes that are considered serious adverse events possible related to the study are","confidence":1,"confidence_rate":1},{"cnt":[[245,2357],[1852,2357],[1852,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2356,"width":1608,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"866199602ea2426c9b366b5959b9abdf","type":"text","conversion_output":true,"text":"clinically higher in the intervention group. (See also section 4.4 for additional safety outcomes).","text_display":" clinically higher in the intervention group. (See also section 4.4 for additional safety outcomes).","confidence":1,"confidence_rate":1},{"cnt":[[954,2582],[1171,2582],[1171,2628],[954,2628]],"region":{"top_left_x":953,"top_left_y":2582,"width":218,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8eb30844da1541bd8c98951174f7ed41","type":"page_info","conversion_output":false,"text":"Page 9 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-10","page":10,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5bdf613efc94e1db275890822626efe","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1878,129],[1878,174],[1689,174]],"region":{"top_left_x":1688,"top_left_y":128,"width":190,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0819a707d796442fb7f36535b88e804f","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,254],[1828,254],[1828,303],[322,303]],"region":{"top_left_x":322,"top_left_y":253,"width":1507,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df17ec3ed2e4454dbc82d8b194818837","type":"text","conversion_output":true,"text":"(1) Clear superiority -- whether the experimental treatment is clearly inferior to standard","text_display":"\n(1) Clear superiority -- whether the experimental treatment is clearly inferior to standard","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1848,301],[1848,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1604,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c267794842c4288868a95dc2809e33a","type":"text","conversion_output":true,"text":"therapy. For these calculations, we trade off the power to detect a difference and the size of that","text_display":" therapy. For these calculations, we trade off the power to detect a difference and the size of that","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[245,348],[1858,348],[1858,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1615,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f40e998a4da34217840e177465a20412","type":"text","conversion_output":true,"text":"difference. Assuming \\(\\alpha=0.0002\\) for boundaries for the initial interim analysis when 200 children","text_display":" difference. Assuming \\(\\alpha=0.0002\\) for boundaries for the initial interim analysis when 200 children","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1876,397],[1876,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1632,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf9327c02a4341c9b87dd9d340cbd884","type":"text","conversion_output":true,"text":"have been followed to completion, power is limited except to detect large reductions in outcomes","text_display":" have been followed to completion, power is limited except to detect large reductions in outcomes","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1850,447],[1850,494],[245,494]],"region":{"top_left_x":244,"top_left_y":446,"width":1606,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57f28057acaa4b7eafeeddeacaba0952","type":"text","conversion_output":true,"text":"of death and BPD. For example, power is approximately 0.81 to detect a reduction from \\(65 \\%\\) in","text_display":" of death and BPD. For example, power is approximately 0.81 to detect a reduction from \\(65 \\%\\) in","confidence":0.994631290435791,"confidence_rate":0.9999477375514105},{"cnt":[[245,492],[1865,492],[1865,541],[245,541]],"region":{"top_left_x":244,"top_left_y":491,"width":1621,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78ed680e213f4ca5bd6356b6be49a81c","type":"text","conversion_output":true,"text":"the conventional therapy to \\(32.5 \\%\\) in the experimental therapy, a \\(50 \\%\\) relative reduction. For the","text_display":" the conventional therapy to \\(32.5 \\%\\) in the experimental therapy, a \\(50 \\%\\) relative reduction. For the","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[245,541],[1871,541],[1871,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1628,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ebe65ad543442f1aa8ccf5b4a8e795e","type":"text","conversion_output":true,"text":"second interim analysis, using \\(\\alpha=0.012\\), power with 400 children followed is about 0.85 to detect","text_display":" second interim analysis, using \\(\\alpha=0.012\\), power with 400 children followed is about 0.85 to detect","confidence":0.9990234375,"confidence_rate":0.9999911978797494},{"cnt":[[245,589],[1846,589],[1846,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1602,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f11a35e9d8de4f32be0a12c0e298d6b2","type":"text","conversion_output":true,"text":"an absolute reduction from \\(65 \\%\\) to \\(40 \\%\\) in the risk of death plus BPD. Thus, early or premature","text_display":" an absolute reduction from \\(65 \\%\\) to \\(40 \\%\\) in the risk of death plus BPD. Thus, early or premature","confidence":0.9931640625,"confidence_rate":0.9999340463139736},{"cnt":[[245,636],[1865,636],[1865,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1621,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb7bc1af885d4542b840123f03c4093a","type":"text","conversion_output":true,"text":"stopping for superiority is unlikely, without dramatic improvement from experimental treatment.","text_display":" stopping for superiority is unlikely, without dramatic improvement from experimental treatment.","confidence":1,"confidence_rate":1},{"cnt":[[322,705],[1850,705],[1850,754],[322,754]],"region":{"top_left_x":322,"top_left_y":704,"width":1528,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66f1f3f82d0b452f90cea37422c8dee5","type":"text","conversion_output":true,"text":"(2) Futility. Early stopping based on futility of the primary outcome will not be considered","text_display":"\n(2) Futility. Early stopping based on futility of the primary outcome will not be considered","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[1824,752],[1824,801],[245,801]],"region":{"top_left_x":244,"top_left_y":751,"width":1581,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"453e0c8e52a2489bb2f8555f41b89950","type":"text","conversion_output":true,"text":"independently of the secondary clinical and safety outcomes. In the event that the intervention","text_display":" independently of the secondary clinical and safety outcomes. In the event that the intervention","confidence":1,"confidence_rate":1},{"cnt":[[245,801],[1863,801],[1863,851],[245,851]],"region":{"top_left_x":244,"top_left_y":801,"width":1619,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8896d9908d1148ff9ab904da57129460","type":"text","conversion_output":true,"text":"arm has equivalent BPD/death rates to the standard care arm, it would still be clinically useful to","text_display":" arm has equivalent BPD/death rates to the standard care arm, it would still be clinically useful to","confidence":0.9970703125,"confidence_rate":0.9999717889802962},{"cnt":[[245,849],[1846,849],[1846,898],[245,898]],"region":{"top_left_x":244,"top_left_y":848,"width":1602,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e14932988d374534babcf1e9dc32ab28","type":"text","conversion_output":true,"text":"know if the intervention improves any of the secondary outcomes (that are closer to the time of","text_display":" know if the intervention improves any of the secondary outcomes (that are closer to the time of","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1257,898],[1257,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":1013,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7986566e39e1421c96f3d2e0309f7500","type":"text","conversion_output":true,"text":"the intervention) or decreases the serious adverse event rate.","text_display":" the intervention) or decreases the serious adverse event rate.","confidence":1,"confidence_rate":1},{"cnt":[[331,965],[1841,965],[1841,1016],[331,1016]],"region":{"top_left_x":330,"top_left_y":964,"width":1512,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d25dc74473c4e96bb818c6142318dbd","type":"text","conversion_output":true,"text":"(3) Inferiority. Power is limited to identify inferiority of the experimental treatment, with","text_display":"\n(3) Inferiority. Power is limited to identify inferiority of the experimental treatment, with","confidence":1,"confidence_rate":1},{"cnt":[[245,1014],[1846,1014],[1846,1063],[245,1063]],"region":{"top_left_x":244,"top_left_y":1014,"width":1602,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cefd32c4e7594e90a1937a416df233ad","type":"text","conversion_output":true,"text":"0.8 power to demonstrate a \\(15 \\%\\) point increase in the risk of outcome from \\(65 \\%\\) in the standard","text_display":" 0.8 power to demonstrate a \\(15 \\%\\) point increase in the risk of outcome from \\(65 \\%\\) in the standard","confidence":0.9907486144362541,"confidence_rate":0.9999097667371644},{"cnt":[[245,1061],[834,1061],[834,1111],[245,1111]],"region":{"top_left_x":244,"top_left_y":1061,"width":590,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08eed26b65fb4f4fbc889de046532b62","type":"text","conversion_output":true,"text":"therapy to \\(80 \\%\\) in the intervention.","text_display":" therapy to \\(80 \\%\\) in the intervention.","confidence":1,"confidence_rate":1},{"cnt":[[329,1130],[522,1130],[522,1182],[329,1182]],"region":{"top_left_x":328,"top_left_y":1130,"width":195,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffba8080108440a6bfeed8bee5ed1b28","type":"section_header","conversion_output":false,"children_ids":["02b8ac74e1e4471fa7a759f4dc8c18f1"],"text":"","text_display":""},{"cnt":[[331,1130],[518,1130],[518,1179],[331,1179]],"region":{"top_left_x":330,"top_left_y":1130,"width":188,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02b8ac74e1e4471fa7a759f4dc8c18f1","type":"text","conversion_output":true,"parent_id":"ffba8080108440a6bfeed8bee5ed1b28","text":"(4) Safety.","text_display":"\n\n\\section*{(4) Safety.}","confidence":1,"confidence_rate":1},{"cnt":[[320,1199],[1833,1199],[1833,1248],[320,1248]],"region":{"top_left_x":320,"top_left_y":1198,"width":1513,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"673544f801574ea7b120828c47fac3e2","type":"text","conversion_output":true,"text":"(a) Early stopping based on inferior safety and non-inferior efficacy must be based largely","text_display":"\n(a) Early stopping based on inferior safety and non-inferior efficacy must be based largely","confidence":1,"confidence_rate":1},{"cnt":[[245,1246],[1815,1246],[1815,1296],[245,1296]],"region":{"top_left_x":244,"top_left_y":1246,"width":1572,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f76a1f8cf173460f92c1cfc3cf4a94f3","type":"text","conversion_output":true,"text":"on descriptive data and close examination of adverse events. With 200 subjects per group at a","text_display":" on descriptive data and close examination of adverse events. With 200 subjects per group at a","confidence":1,"confidence_rate":1},{"cnt":[[245,1293],[1830,1293],[1830,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1293,"width":1587,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6647df771c5d46539143c628d0a7ff75","type":"text","conversion_output":true,"text":"second early stopping review, and assuming that the experimental therapy is actually no worse","text_display":" second early stopping review, and assuming that the experimental therapy is actually no worse","confidence":1,"confidence_rate":1},{"cnt":[[245,1341],[1807,1341],[1807,1390],[245,1390]],"region":{"top_left_x":244,"top_left_y":1340,"width":1563,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b60115342ae4294a3bcae86da546f42","type":"text","conversion_output":true,"text":"than conventional care, observed risk in the experimental group would have to be at most 0.5","text_display":" than conventional care, observed risk in the experimental group would have to be at most 0.5","confidence":1,"confidence_rate":1},{"cnt":[[245,1388],[1841,1388],[1841,1439],[245,1439]],"region":{"top_left_x":244,"top_left_y":1387,"width":1598,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f333df75d47b4d71a4f9e091bd3cd33f","type":"text","conversion_output":true,"text":"(risk of death and BPD) to have \\(80 \\%\\) power to show non-inferior efficacy (with alpha \\(=0.012\\) ).","text_display":" (risk of death and BPD) to have \\(80 \\%\\) power to show non-inferior efficacy (with alpha \\(=0.012\\) ).","confidence":1,"confidence_rate":1},{"cnt":[[320,1457],[1781,1457],[1781,1508],[320,1508]],"region":{"top_left_x":320,"top_left_y":1456,"width":1462,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c61ac2f188b4a43891f47a0a3c2ed73","type":"text","conversion_output":true,"text":"(b) To justify stopping for non-inferior efficacy and superior safety again will require a","text_display":"\n(b) To justify stopping for non-inferior efficacy and superior safety again will require a","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[1800,1508],[1800,1558],[245,1558]],"region":{"top_left_x":244,"top_left_y":1508,"width":1557,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72e4c02f0d984fed8447b7d4d829a8da","type":"text","conversion_output":true,"text":"substantial observed improvement in the experimental arm at the second early stopping time.","text_display":" substantial observed improvement in the experimental arm at the second early stopping time.","confidence":1,"confidence_rate":1},{"cnt":[[318,1577],[1815,1577],[1815,1626],[318,1626]],"region":{"top_left_x":317,"top_left_y":1576,"width":1499,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9662ffb3f964fbda8f81b70c2ffe33f","type":"text","conversion_output":true,"text":"In summary, given the projected number of patients to be enrolled, early stopping will be","text_display":"\n\nIn summary, given the projected number of patients to be enrolled, early stopping will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1624],[1841,1624],[1841,1674],[245,1674]],"region":{"top_left_x":244,"top_left_y":1624,"width":1598,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a37af2f9f7aa402b991f3be42b56f2ca","type":"text","conversion_output":true,"text":"unlikely unless the observed effect of experimental care is clearly better or worse than standard","text_display":" unlikely unless the observed effect of experimental care is clearly better or worse than standard","confidence":1,"confidence_rate":1},{"cnt":[[245,1671],[1119,1671],[1119,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1671,"width":876,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1978b6c6aed4ab8a77afec134c555a2","type":"text","conversion_output":true,"text":"care at the planned early stopping assessment times.","text_display":" care at the planned early stopping assessment times.","confidence":1,"confidence_rate":1},{"cnt":[[318,1740],[1841,1740],[1841,1790],[318,1790]],"region":{"top_left_x":317,"top_left_y":1740,"width":1525,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b543d1c363244e32813f5b391fea43a8","type":"text","conversion_output":true,"text":"All of the standard reports described in the previous section will be provided to the DSMC","text_display":"\n\nAll of the standard reports described in the previous section will be provided to the DSMC","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[1858,1788],[1858,1837],[245,1837]],"region":{"top_left_x":244,"top_left_y":1787,"width":1615,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd844dfe0dba4045898b6fde069fc632","type":"text","conversion_output":true,"text":"with this analysis. Additional measures to be considered at the interim analysis include baseline","text_display":" with this analysis. Additional measures to be considered at the interim analysis include baseline","confidence":0.99853515625,"confidence_rate":0.9999856283612877},{"cnt":[[245,1835],[1846,1835],[1846,1884],[245,1884]],"region":{"top_left_x":244,"top_left_y":1834,"width":1602,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9c5f6407394441180c47f1c497af469","type":"text","conversion_output":true,"text":"clinical factors and adverse events. The study population for all of the analyses provided to the","text_display":" clinical factors and adverse events. The study population for all of the analyses provided to the","confidence":1,"confidence_rate":1},{"cnt":[[245,1884],[1854,1882],[1854,1933],[245,1935]],"region":{"top_left_x":244,"top_left_y":1882,"width":1611,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1a17959a6a8456992d22e0d76974a7c","type":"text","conversion_output":true,"text":"DSMC is the intent-to-treat population, including all participants and time points for which data","text_display":" DSMC is the intent-to-treat population, including all participants and time points for which data","confidence":1,"confidence_rate":1},{"cnt":[[245,1929],[1858,1929],[1858,1981],[245,1981]],"region":{"top_left_x":244,"top_left_y":1929,"width":1615,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f6480b3ce804f6f8ece29419848870b","type":"text","conversion_output":true,"text":"have been entered and verified in the study database. A summary of the analyses to be included","text_display":" have been entered and verified in the study database. A summary of the analyses to be included","confidence":1,"confidence_rate":1},{"cnt":[[245,1979],[1824,1979],[1824,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1978,"width":1581,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"809a6bcfdeaf409c94248bfd126b3ed1","type":"text","conversion_output":true,"text":"in the interim report is outlined below. Additional details of the statistical methods to be used","text_display":" in the interim report is outlined below. Additional details of the statistical methods to be used","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1195,2028],[1195,2078],[245,2078]],"region":{"top_left_x":244,"top_left_y":2028,"width":951,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"317272ca5c9e4708821da25d673ff04e","type":"text","conversion_output":true,"text":"are given in the next section regarding the final analysis.","text_display":" are given in the next section regarding the final analysis.","confidence":1,"confidence_rate":1},{"cnt":[[241,2093],[513,2093],[513,2151],[241,2151]],"region":{"top_left_x":240,"top_left_y":2092,"width":274,"height":59},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e26fb6aab134cd0a22d7a4c4deeefcf","type":"section_header","conversion_output":false,"children_ids":["f2d42058fd0542a696039d917e7a9060"],"text":"","text_display":""},{"cnt":[[245,2097],[509,2097],[509,2146],[245,2146]],"region":{"top_left_x":244,"top_left_y":2096,"width":266,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2d42058fd0542a696039d917e7a9060","type":"text","conversion_output":true,"parent_id":"3e26fb6aab134cd0a22d7a4c4deeefcf","text":"4.1 Blinding","text_display":"\n\n\\subsection*{4.1 Blinding}","confidence":1,"confidence_rate":1},{"cnt":[[320,2166],[1798,2166],[1798,2215],[320,2215]],"region":{"top_left_x":320,"top_left_y":2165,"width":1479,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb8dd9d5b0b84614893eb216c57cc384","type":"text","conversion_output":true,"text":"The study will be blinded in treatment allocation; patients, parents and clinicians will be","text_display":"\n\nThe study will be blinded in treatment allocation; patients, parents and clinicians will be","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,2213],[1811,2213],[1811,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":1568,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"915b9ba691fc4ca98355aac8036ac1e8","type":"text","conversion_output":true,"text":"unblinded once treatment is assigned; and then blinded analyses. All analyses provided to the","text_display":" unblinded once treatment is assigned; and then blinded analyses. All analyses provided to the","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1848,2260],[1848,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1604,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"726ac7b4f878410da25e245b48988bd5","type":"text","conversion_output":true,"text":"DSMC will be provided by intervention, but with the individual interventions identified only as","text_display":" DSMC will be provided by intervention, but with the individual interventions identified only as","confidence":1,"confidence_rate":1},{"cnt":[[245,2307],[1785,2307],[1785,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2307,"width":1542,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f32ae44f53e4551999b330f87080b07","type":"text","conversion_output":true,"text":"A and B. The same code will be used for each intervention throughout the report. A sealed","text_display":" A and B. The same code will be used for each intervention throughout the report. A sealed","confidence":0.99609375,"confidence_rate":0.9999583636399967},{"cnt":[[245,2357],[1807,2357],[1807,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2356,"width":1563,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a755d575e0dc418fa7fd57ba90b6c356","type":"text","conversion_output":true,"text":"envelope with the codes for these interventions will be provided to the chair of the DSMC, to","text_display":" envelope with the codes for these interventions will be provided to the chair of the DSMC, to","confidence":1,"confidence_rate":1},{"cnt":[[245,2406],[1777,2406],[1777,2454],[245,2454]],"region":{"top_left_x":244,"top_left_y":2406,"width":1533,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7957e29e9bd2410f926a21b31aa23f01","type":"text","conversion_output":true,"text":"allow the DSMC to unblind these results if needed for safety reasons. These codes are also","text_display":" allow the DSMC to unblind these results if needed for safety reasons. These codes are also","confidence":0.9990236759185791,"confidence_rate":0.9999897179371111},{"cnt":[[245,2454],[1811,2454],[1811,2503],[245,2503]],"region":{"top_left_x":244,"top_left_y":2453,"width":1568,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a2f7d3798a34fd3b4f849eebc2e1ec4","type":"text","conversion_output":true,"text":"maintained by a member of the DCC who is not involved in the group trials and are not made","text_display":" maintained by a member of the DCC who is not involved in the group trials and are not made","confidence":1,"confidence_rate":1},{"cnt":[[941,2582],[1179,2582],[1179,2632],[941,2632]],"region":{"top_left_x":941,"top_left_y":2582,"width":239,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b71e39310f944d9f8b117d58d94c1cf1","type":"page_info","conversion_output":false,"text":"Page 10 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-11","page":11,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bf284dbca1341ad924bbe7ebb6e2467","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1880,129],[1880,174],[1689,174]],"region":{"top_left_x":1688,"top_left_y":128,"width":192,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f18d6609ab948d69193e621b5b6f651","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1824,254],[1824,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1581,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f3db72010fc4ff3a68fc28b1397c9cc","type":"text","conversion_output":true,"text":"available to any other DCC members, including the statisticians. None of the personnel in the","text_display":"\navailable to any other DCC members, including the statisticians. None of the personnel in the","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1725,301],[1725,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1482,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a02dd7818f34c299ca8755b0b996ce5","type":"text","conversion_output":true,"text":"DCC, including the statisticians, will have access to these codes until the study has been","text_display":" DCC, including the statisticians, will have access to these codes until the study has been","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1734,348],[1734,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1490,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cfba91ce84840c6b82d0765349b567a","type":"text","conversion_output":true,"text":"completed, all data are entered and verified in the database, and the DSMC has approved","text_display":" completed, all data are entered and verified in the database, and the DSMC has approved","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[879,397],[879,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":635,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c3fce9918524aa7bfc6fdd0f0875b41","type":"text","conversion_output":true,"text":"unblinding of the intervention results.","text_display":" unblinding of the intervention results.","confidence":1,"confidence_rate":1},{"cnt":[[241,460],[767,460],[767,518],[241,518]],"region":{"top_left_x":240,"top_left_y":459,"width":527,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab0bdbc145fe4774b6e18b21d15d8952","type":"section_header","conversion_output":false,"children_ids":["c918844c6c42459fb7ccc375d3e5de6e"],"text":"","text_display":""},{"cnt":[[245,466],[761,466],[761,513],[245,513]],"region":{"top_left_x":244,"top_left_y":466,"width":517,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c918844c6c42459fb7ccc375d3e5de6e","type":"text","conversion_output":true,"parent_id":"ab0bdbc145fe4774b6e18b21d15d8952","text":"4.2 Baseline/Delivery Data","text_display":"\n\n\\subsection*{4.2 Baseline/Delivery Data}","confidence":1,"confidence_rate":1},{"cnt":[[320,533],[1852,533],[1852,584],[320,584]],"region":{"top_left_x":320,"top_left_y":532,"width":1532,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbedbd8020a64bdebda4d5b125c6e581","type":"text","conversion_output":true,"text":"Selected baseline factors will be summarized and compared between intervention groups to","text_display":"\n\nSelected baseline factors will be summarized and compared between intervention groups to","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[245,580],[1828,580],[1828,632],[245,632]],"region":{"top_left_x":244,"top_left_y":580,"width":1585,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddcf44b43c9041fda1d46c16b122738e","type":"text","conversion_output":true,"text":"evaluate the adequacy of randomization, the impact of any post-randomization dropout, and to","text_display":" evaluate the adequacy of randomization, the impact of any post-randomization dropout, and to","confidence":1,"confidence_rate":1},{"cnt":[[245,627],[1792,627],[1792,681],[245,681]],"region":{"top_left_x":244,"top_left_y":627,"width":1548,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54644483c06f421cb01e3940a9b7d3b1","type":"text","conversion_output":true,"text":"identify any imbalances that may affect intervention comparisons (Appendix B, Table 1 and","text_display":" identify any imbalances that may affect intervention comparisons (Appendix B, Table 1 and","confidence":1,"confidence_rate":1},{"cnt":[[245,677],[1815,677],[1815,728],[245,728]],"region":{"top_left_x":244,"top_left_y":676,"width":1572,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1379060b3e58475ea0304270d7c06a8c","type":"text","conversion_output":true,"text":"Table 2). Standard descriptive statistics will be used to describe baseline characteristics, both","text_display":" Table 2). Standard descriptive statistics will be used to describe baseline characteristics, both","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1768,726],[1768,776],[245,776]],"region":{"top_left_x":244,"top_left_y":726,"width":1525,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5601ac26b8eb4279959e1821396ca197","type":"text","conversion_output":true,"text":"overall and within each intervention group. Baseline characteristics examined will include","text_display":" overall and within each intervention group. Baseline characteristics examined will include","confidence":1,"confidence_rate":1},{"cnt":[[245,773],[1815,773],[1815,823],[245,823]],"region":{"top_left_x":244,"top_left_y":773,"width":1572,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e0100feb7984daea034c2a8dd22260d","type":"text","conversion_output":true,"text":"maternal and gestational age, race/ethnicity, Clinical Site, consenting procedure (antenatal vs.","text_display":" maternal and gestational age, race/ethnicity, Clinical Site, consenting procedure (antenatal vs.","confidence":1,"confidence_rate":1},{"cnt":[[245,821],[1824,821],[1824,872],[245,872]],"region":{"top_left_x":244,"top_left_y":820,"width":1581,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e2cd10991ad4eb8b7dc6314883e9f97","type":"text","conversion_output":true,"text":"deferred consent), route of treatment (facemask vs. nasopharyngeal tube), and enrollment date","text_display":" deferred consent), route of treatment (facemask vs. nasopharyngeal tube), and enrollment date","confidence":1,"confidence_rate":1},{"cnt":[[245,868],[1811,868],[1811,920],[245,920]],"region":{"top_left_x":244,"top_left_y":867,"width":1568,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"020624d34c0344479737237e95d15601","type":"text","conversion_output":true,"text":"(in 3 month increments). Baseline values of selected secondary outcomes will be included as","text_display":" (in 3 month increments). Baseline values of selected secondary outcomes will be included as","confidence":1,"confidence_rate":1},{"cnt":[[245,915],[793,915],[793,969],[245,969]],"region":{"top_left_x":244,"top_left_y":915,"width":549,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9339e04d90c4891bb22eccbf14a8d80","type":"text","conversion_output":true,"text":"part of that analysis (see below).","text_display":" part of that analysis (see below).","confidence":1,"confidence_rate":1},{"cnt":[[318,984],[1833,984],[1833,1036],[318,1036]],"region":{"top_left_x":317,"top_left_y":983,"width":1516,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c921a13c41fa4685880f3f8c25f9edf1","type":"text","conversion_output":true,"text":"Summary statistics such as medians, ranges, minima and maxima, and percentages will be","text_display":"\n\nSummary statistics such as medians, ranges, minima and maxima, and percentages will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1033],[1760,1033],[1760,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1033,"width":1516,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acfc56d84b19481bb7d9765428d77f71","type":"text","conversion_output":true,"text":"produced for all measured variables. Frequencies will be computed for all categorical and","text_display":" produced for all measured variables. Frequencies will be computed for all categorical and","confidence":1,"confidence_rate":1},{"cnt":[[245,1079],[1867,1079],[1867,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1078,"width":1623,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce93100aa3e042eba8c9ac015e397f3a","type":"text","conversion_output":true,"text":"ordinal variables. Graphical methods including stem and leaf plots, histograms, scatterplots, and","text_display":" ordinal variables. Graphical methods including stem and leaf plots, histograms, scatterplots, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1130],[1858,1130],[1858,1179],[245,1179]],"region":{"top_left_x":244,"top_left_y":1130,"width":1615,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2ced6df51aa47438c31febb445e2477","type":"text","conversion_output":true,"text":"boxplots, will be used in order to understand aspects of data quality, examine assumptions (such","text_display":" boxplots, will be used in order to understand aspects of data quality, examine assumptions (such","confidence":1,"confidence_rate":1},{"cnt":[[245,1177],[1854,1177],[1854,1227],[245,1227]],"region":{"top_left_x":244,"top_left_y":1177,"width":1611,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1104d74bdbec40d5a2331e4c2b954013","type":"text","conversion_output":true,"text":"as normality) underlying statistical models, identify potential influential points, and guide in the","text_display":" as normality) underlying statistical models, identify potential influential points, and guide in the","confidence":1,"confidence_rate":1},{"cnt":[[245,1225],[1871,1225],[1871,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1224,"width":1628,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51ba3950945d4760a59e295f26a519bd","type":"text","conversion_output":true,"text":"choice of transformations if warranted. The balance of baseline measures across the intervention","text_display":" choice of transformations if warranted. The balance of baseline measures across the intervention","confidence":1,"confidence_rate":1},{"cnt":[[245,1272],[1768,1272],[1768,1326],[245,1326]],"region":{"top_left_x":244,"top_left_y":1271,"width":1525,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"606f7bd7121c40eeb510fab2aa408b2b","type":"text","conversion_output":true,"text":"groups will be compared by inspection and by standardized differences. Overall imbalance","text_display":" groups will be compared by inspection and by standardized differences. Overall imbalance","confidence":1,"confidence_rate":1},{"cnt":[[245,1319],[1794,1319],[1794,1373],[245,1373]],"region":{"top_left_x":244,"top_left_y":1319,"width":1550,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5aaf3e84125c40edb162471f4a2845de","type":"text","conversion_output":true,"text":"across several or all covariates will be examined using multivariable logistic regression with","text_display":" across several or all covariates will be examined using multivariable logistic regression with","confidence":1,"confidence_rate":1},{"cnt":[[245,1371],[913,1371],[913,1420],[245,1420]],"region":{"top_left_x":244,"top_left_y":1370,"width":670,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4190e02762334546b4d1ee888f382a59","type":"text","conversion_output":true,"text":"treatment assignment as the outcome. .","text_display":" treatment assignment as the outcome. .","confidence":1,"confidence_rate":1},{"cnt":[[241,1435],[1027,1435],[1027,1493],[241,1493]],"region":{"top_left_x":240,"top_left_y":1435,"width":787,"height":59},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0cfed60ece64cc1a6bd74d4f3f98026","type":"section_header","conversion_output":false,"children_ids":["c20e30451fe54964a987eff63df722f2"],"text":"","text_display":""},{"cnt":[[245,1439],[1021,1439],[1021,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1439,"width":777,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c20e30451fe54964a987eff63df722f2","type":"text","conversion_output":true,"parent_id":"f0cfed60ece64cc1a6bd74d4f3f98026","text":"4.3 Subject Accounting and Withdrawals","text_display":"\n\n\\subsection*{4.3 Subject Accounting and Withdrawals}","confidence":1,"confidence_rate":1},{"cnt":[[318,1508],[1846,1508],[1846,1558],[318,1558]],"region":{"top_left_x":317,"top_left_y":1508,"width":1529,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ea182e2b5714f389543397de8902b2c","type":"text","conversion_output":true,"text":"A detailed summary of subject accounting over the course of the study will be prepared for","text_display":"\n\nA detailed summary of subject accounting over the course of the study will be prepared for","confidence":1,"confidence_rate":1},{"cnt":[[245,1555],[1835,1555],[1835,1605],[245,1605]],"region":{"top_left_x":244,"top_left_y":1555,"width":1591,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8bd9ed390da47ce88e6c9e7e454f6ec","type":"text","conversion_output":true,"text":"each treatment group (Appendix B, Table 3 \\& 4). A study flow diagram, derived from the one","text_display":" each treatment group (Appendix B, Table 3 \\& 4). A study flow diagram, derived from the one","confidence":1,"confidence_rate":1},{"cnt":[[245,1603],[1837,1603],[1837,1652],[245,1652]],"region":{"top_left_x":244,"top_left_y":1602,"width":1593,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"862c0bc728de4b6ab245cb552688991f","type":"text","conversion_output":true,"text":"recommended by CONSORT, will also be provided (Appendix B, Figure 1). Withdrawal rates","text_display":" recommended by CONSORT, will also be provided (Appendix B, Figure 1). Withdrawal rates","confidence":1,"confidence_rate":1},{"cnt":[[245,1650],[1871,1650],[1871,1699],[245,1699]],"region":{"top_left_x":244,"top_left_y":1650,"width":1628,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cb73f9e2f9b40938e99904fdb7f5946","type":"text","conversion_output":true,"text":"over time and reasons for withdrawal will be summarized. For the follow-up evaluation at 22-26","text_display":" over time and reasons for withdrawal will be summarized. For the follow-up evaluation at 22-26","confidence":0.9302096366882324,"confidence_rate":0.9992695063097815},{"cnt":[[245,1697],[1837,1697],[1837,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1697,"width":1593,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd26edb247ec47f38ecc68269f47d51c","type":"text","conversion_output":true,"text":"month corrected GA, withdrawal rates will be compared between arms using standard methods","text_display":" month corrected GA, withdrawal rates will be compared between arms using standard methods","confidence":1,"confidence_rate":1},{"cnt":[[245,1745],[703,1745],[703,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1744,"width":459,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22d51f7ace00406faef3be0fbe0d75d0","type":"text","conversion_output":true,"text":"for dichotomous measures.","text_display":" for dichotomous measures.","confidence":1,"confidence_rate":1},{"cnt":[[241,1811],[718,1811],[718,1871],[241,1871]],"region":{"top_left_x":240,"top_left_y":1811,"width":478,"height":61},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b6fbf1b475349c1964d40a9e0d80196","type":"section_header","conversion_output":false,"children_ids":["02ac6338bae44f788a24bd6522bd35c8"],"text":"","text_display":""},{"cnt":[[245,1815],[715,1815],[715,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1815,"width":472,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02ac6338bae44f788a24bd6522bd35c8","type":"text","conversion_output":true,"parent_id":"9b6fbf1b475349c1964d40a9e0d80196","text":"4.4 Evaluation of Safety","text_display":"\n\n\\subsection*{4.4 Evaluation of Safety}","confidence":0.99951171875,"confidence_rate":0.999983158745329},{"cnt":[[318,1884],[1867,1884],[1867,1936],[318,1936]],"region":{"top_left_x":317,"top_left_y":1884,"width":1550,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7129b74897a0416fab54c0e784582238","type":"text","conversion_output":true,"text":"In addition to the standard reports, statistical analyses will be performed to compare adverse","text_display":"\n\nIn addition to the standard reports, statistical analyses will be performed to compare adverse","confidence":1,"confidence_rate":1},{"cnt":[[245,1934],[1824,1934],[1824,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1933,"width":1581,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d21b457689c546beb8262ec1a040a499","type":"text","conversion_output":true,"text":"event rates between treatments. In particular, the rate of pneumothorax, pulmonary interstitial","text_display":" event rates between treatments. In particular, the rate of pneumothorax, pulmonary interstitial","confidence":1,"confidence_rate":1},{"cnt":[[245,1979],[1863,1979],[1863,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1978,"width":1619,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7913189625b74738b2143b5bf92a9097","type":"text","conversion_output":true,"text":"emphysema (PIE), and/or other serious adverse events (that have been adjudicated as potentially","text_display":" emphysema (PIE), and/or other serious adverse events (that have been adjudicated as potentially","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1852,2028],[1852,2078],[245,2078]],"region":{"top_left_x":244,"top_left_y":2028,"width":1608,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e3de651fd714de3a01c77134a046de9","type":"text","conversion_output":true,"text":"relating to the intervention; see Protocol section 8.2.2). In order to minimize the risk, this safety","text_display":" relating to the intervention; see Protocol section 8.2.2). In order to minimize the risk, this safety","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1837,2075],[1837,2125],[245,2125]],"region":{"top_left_x":244,"top_left_y":2075,"width":1593,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c5cfa0a8b964c3cb4bf143521ac27ee","type":"text","conversion_output":true,"text":"outcome will be compared between treatment arms after \\(1 / 6\\) ( 100 subjects) have completed the","text_display":" outcome will be compared between treatment arms after \\(1 / 6\\) ( 100 subjects) have completed the","confidence":0.9164825070183724,"confidence_rate":0.9991536370216616},{"cnt":[[245,2123],[1815,2123],[1815,2172],[245,2172]],"region":{"top_left_x":244,"top_left_y":2122,"width":1572,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68e71eb77a8b4a5da7e35a200cd04e3a","type":"text","conversion_output":true,"text":"primary outcome, as well as at the two planned interim analyses for the primary outcome ( \\(1 / 3\\)","text_display":" primary outcome, as well as at the two planned interim analyses for the primary outcome ( \\(1 / 3\\)","confidence":0.9965834617614746,"confidence_rate":0.9999647182725911},{"cnt":[[245,2170],[1843,2170],[1843,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1600,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fed9f9b06a146a3b2fda2b6bd601b8e","type":"text","conversion_output":true,"text":"and \\(2 / 3\\) ), since we would not expect any statistically significant differences in the rate after 100","text_display":" and \\(2 / 3\\) ), since we would not expect any statistically significant differences in the rate after 100","confidence":0.5536581407068297,"confidence_rate":0.9944899293572285},{"cnt":[[245,2217],[1691,2217],[1691,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2217,"width":1447,"height":54},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88f3340364804089818bf73f85b73feb","type":"text","conversion_output":true,"text":"subjects (with O'Brien-Fleming alpha 0.000002). Instead, we will look for a clinically","text_display":" subjects (with O'Brien-Fleming alpha 0.000002). Instead, we will look for a clinically","confidence":0.6222546100616455,"confidence_rate":0.994800313446747},{"cnt":[[245,2264],[1854,2264],[1854,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2264,"width":1611,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7faf33fc46f44465ae83da59c6d07fa8","type":"text","conversion_output":true,"text":"meaningful double the risk in the intervention versus standard care arms. (Appendix B, Table 5)","text_display":" meaningful double the risk in the intervention versus standard care arms. (Appendix B, Table 5)","confidence":1,"confidence_rate":1},{"cnt":[[318,2333],[1772,2333],[1772,2387],[318,2387]],"region":{"top_left_x":317,"top_left_y":2333,"width":1456,"height":54},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecf4700990344a6c91900134f2ec9e51","type":"text","conversion_output":true,"text":"All other adverse events not explicitly mentioned in the Protocol will also be included,","text_display":"\n\nAll other adverse events not explicitly mentioned in the Protocol will also be included,","confidence":1,"confidence_rate":1},{"cnt":[[243,2385],[1764,2385],[1764,2434],[243,2434]],"region":{"top_left_x":242,"top_left_y":2384,"width":1522,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ec16a04574b45c399e66a05db63da0b","type":"text","conversion_output":true,"text":"regardless of their presumed relationship to the study intervention. Adverse events will be","text_display":" regardless of their presumed relationship to the study intervention. Adverse events will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2432],[1871,2432],[1871,2484],[245,2484]],"region":{"top_left_x":244,"top_left_y":2432,"width":1628,"height":52},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfe7fbcb13884bc6ad69fa7bee6a7e7f","type":"text","conversion_output":true,"text":"collapsed into groups based on body part depending on numbers seen. The proportion of subjects","text_display":" collapsed into groups based on body part depending on numbers seen. The proportion of subjects","confidence":1,"confidence_rate":1},{"cnt":[[941,2580],[1179,2580],[1179,2632],[941,2632]],"region":{"top_left_x":941,"top_left_y":2580,"width":239,"height":52},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71840b59350e40a2b01569b3d5b759f8","type":"page_info","conversion_output":false,"text":"Page 11 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-12","page":12,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50816bc971ab48d4aae629e987607fc2","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1880,129],[1880,176],[1689,176]],"region":{"top_left_x":1688,"top_left_y":128,"width":192,"height":49},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48c3ecf778a44591a9eb7caaa03c6c92","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1830,254],[1830,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1587,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53eb64ee52704e5b95b96b54474ad936","type":"text","conversion_output":true,"text":"with any adverse event will be compared between groups using an exact Mantel-Haenszel test.","text_display":"\nwith any adverse event will be compared between groups using an exact Mantel-Haenszel test.","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1334,301],[1334,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1091,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60542a36cf014ed3a4612f336bc40864","type":"text","conversion_output":true,"text":"Comparisons between interventions will be primarily descriptive","text_display":" Comparisons between interventions will be primarily descriptive","confidence":1,"confidence_rate":1},{"cnt":[[241,434],[1248,434],[1248,488],[241,488]],"region":{"top_left_x":240,"top_left_y":433,"width":1009,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"151be6475acc4e1d83295b88ac037773","type":"section_header","conversion_output":false,"children_ids":["cc999c2137aa4714966d22d967f55250"],"text":"","text_display":""},{"cnt":[[245,438],[1244,438],[1244,483],[245,483]],"region":{"top_left_x":244,"top_left_y":438,"width":1000,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc999c2137aa4714966d22d967f55250","type":"text","conversion_output":true,"parent_id":"151be6475acc4e1d83295b88ac037773","text":"5. Final Data Analysis upon Completion of Trial","text_display":"\n\n\\section*{5. Final Data Analysis upon Completion of Trial}","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[322,507],[1848,507],[1848,556],[322,556]],"region":{"top_left_x":322,"top_left_y":507,"width":1526,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef7f305acdd64e52b137234bd140a339","type":"text","conversion_output":true,"text":"Upon completion of the primary outcome at 36 weeks PMA, after all data has been entered","text_display":"\n\nUpon completion of the primary outcome at 36 weeks PMA, after all data has been entered","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,554],[1850,554],[1850,604],[245,604]],"region":{"top_left_x":244,"top_left_y":554,"width":1606,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f9a400a20dd411997923cf671f0d5b2","type":"text","conversion_output":true,"text":"in the database and query resolution is complete, the primary statistical analysis and description","text_display":" in the database and query resolution is complete, the primary statistical analysis and description","confidence":1,"confidence_rate":1},{"cnt":[[245,604],[1850,602],[1850,653],[245,655]],"region":{"top_left_x":244,"top_left_y":601,"width":1606,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45566b6aed9848439bb805b0e2bc2ec0","type":"text","conversion_output":true,"text":"of the data will be performed. The final analysis for the \\(22-26\\) month cGA secondary outcomes","text_display":" of the data will be performed. The final analysis for the \\(22-26\\) month cGA secondary outcomes","confidence":0.5263137817382812,"confidence_rate":0.9936019780550397},{"cnt":[[245,649],[1824,649],[1824,700],[245,700]],"region":{"top_left_x":244,"top_left_y":648,"width":1581,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86d6f298f2ef4bd790a9a33ba8f13078","type":"text","conversion_output":true,"text":"will be completed separately, after that data has been entered in the database and cleaned. The","text_display":" will be completed separately, after that data has been entered in the database and cleaned. The","confidence":1,"confidence_rate":1},{"cnt":[[245,698],[1833,698],[1833,750],[245,750]],"region":{"top_left_x":244,"top_left_y":698,"width":1589,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6911d7adb9b94334b638bbcc6e16e991","type":"text","conversion_output":true,"text":"staff biostatistician under the direction of the faculty biostatisticians will produce a final report","text_display":" staff biostatistician under the direction of the faculty biostatisticians will produce a final report","confidence":1,"confidence_rate":1},{"cnt":[[245,748],[1876,748],[1876,797],[245,797]],"region":{"top_left_x":244,"top_left_y":747,"width":1632,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70aaf40502024ac9ad24f99a2399ca3c","type":"text","conversion_output":true,"text":"outlining all analyses and interpretation of the results. This report will be used as the basis of the","text_display":" outlining all analyses and interpretation of the results. This report will be used as the basis of the","confidence":1,"confidence_rate":1},{"cnt":[[245,795],[1734,795],[1734,844],[245,844]],"region":{"top_left_x":244,"top_left_y":794,"width":1490,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e9558f88dcb45b48903f691973ef214","type":"text","conversion_output":true,"text":"primary manuscript to be prepared for publication. Details of the analyses and statistical","text_display":" primary manuscript to be prepared for publication. Details of the analyses and statistical","confidence":1,"confidence_rate":1},{"cnt":[[245,842],[1772,842],[1772,892],[245,892]],"region":{"top_left_x":244,"top_left_y":842,"width":1529,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2ab80c57fc548a6969ee0bf53fa224e","type":"text","conversion_output":true,"text":"methods to be included in the final report are outlined below. All statistical tests described","text_display":" methods to be included in the final report are outlined below. All statistical tests described","confidence":1,"confidence_rate":1},{"cnt":[[245,889],[1326,889],[1326,939],[245,939]],"region":{"top_left_x":244,"top_left_y":889,"width":1082,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82622a726bfa47bbb34b814eb9d4d4d1","type":"text","conversion_output":true,"text":"below will be conducted using a two-sided level of significance.","text_display":" below will be conducted using a two-sided level of 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These adjusted analyses of the primary","text_display":" primary endpoint (death/BPD rate) may be performed. These adjusted analyses of the primary","confidence":1,"confidence_rate":1},{"cnt":[[245,1603],[1876,1603],[1876,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1602,"width":1632,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"997766115c2c468d85ed11cd0b68d9c2","type":"text","conversion_output":true,"text":"endpoint will rely on logistic regression and generalized estimating equation (GEE, to control for","text_display":" endpoint will rely on logistic regression and generalized estimating equation (GEE, to control for","confidence":1,"confidence_rate":1},{"cnt":[[245,1652],[1841,1652],[1841,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1652,"width":1598,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"830ecc108edd44098acef29d40a61ce7","type":"text","conversion_output":true,"text":"clustering within multiple births) methods to evaluate whether observed differences, if any, are","text_display":" clustering within multiple births) methods to evaluate whether observed differences, if any, are","confidence":1,"confidence_rate":1},{"cnt":[[245,1697],[1858,1697],[1858,1751],[245,1751]],"region":{"top_left_x":244,"top_left_y":1697,"width":1615,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54f113c6b91143109e93ca20b6164ce5","type":"text","conversion_output":true,"text":"attributable to imbalances in prognostic factors such as gender, gestational age, initial heart rate,","text_display":" attributable to imbalances in prognostic factors such as gender, gestational age, initial heart rate,","confidence":1,"confidence_rate":1},{"cnt":[[245,1749],[1708,1749],[1708,1798],[245,1798]],"region":{"top_left_x":244,"top_left_y":1748,"width":1465,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8d5f604a9144212806eeaf35a394916","type":"text","conversion_output":true,"text":"maternal corticosteriods use, and small for gestational age (SGA). 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If there are clinical or demographic characteristic imbalances","text_display":" data points for these analyses. If there are clinical or demographic characteristic imbalances","confidence":1,"confidence_rate":1},{"cnt":[[245,1891],[1850,1891],[1850,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1890,"width":1606,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aab340bca9f74eeab5bc563605a62afb","type":"text","conversion_output":true,"text":"between the two treatment arms, a propensity score analysis (via stratification into 5 subgroups,","text_display":" between the two treatment arms, a propensity score analysis (via stratification into 5 subgroups,","confidence":1,"confidence_rate":1},{"cnt":[[245,1938],[1850,1938],[1850,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1937,"width":1606,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aea72b56376d4feca15bd0e66bfd76a6","type":"text","conversion_output":true,"text":"and via inverse propensity treatment weights) will be used to assess the sensitivity of the results","text_display":" and via inverse propensity treatment weights) will be used to assess the sensitivity of the results","confidence":1,"confidence_rate":1},{"cnt":[[245,1989],[821,1989],[821,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1989,"width":577,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aebe6460a200432a8221e45d448d41af","type":"text","conversion_output":true,"text":"to any treatment allocation biases.","text_display":" to any treatment allocation biases.","confidence":1,"confidence_rate":1},{"cnt":[[318,2056],[1820,2056],[1820,2108],[318,2108]],"region":{"top_left_x":317,"top_left_y":2056,"width":1503,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a64c386d37b84066a08ef406657c1057","type":"text","conversion_output":true,"text":"Prior studies offer no basis for assuming a priori interactions between treatment arms and","text_display":"\n\nPrior studies offer no basis for assuming a priori interactions between treatment arms and","confidence":1,"confidence_rate":1},{"cnt":[[245,2105],[1843,2105],[1843,2155],[245,2155]],"region":{"top_left_x":244,"top_left_y":2105,"width":1600,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4ea72029bb74de3a48308692ceff390","type":"text","conversion_output":true,"text":"subgroups defined by sex, race/ethnicity, gestational age, site or a combination of these groups,","text_display":" subgroups defined by sex, race/ethnicity, gestational age, site or a combination of these groups,","confidence":0.9970703125,"confidence_rate":0.9999712358310027},{"cnt":[[245,2153],[1798,2153],[1798,2202],[245,2202]],"region":{"top_left_x":244,"top_left_y":2152,"width":1555,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aa0a3ff48224648b91b128ce46cc14c","type":"text","conversion_output":true,"text":"beyond that already controlled for in the randomization. For that reason, preplanned tests for","text_display":" beyond that already controlled for in the randomization. For that reason, preplanned tests for","confidence":1,"confidence_rate":1},{"cnt":[[245,2200],[1790,2200],[1790,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2200,"width":1546,"height":54},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bfb8cbe664a48388ebb9ab205b25c1d","type":"text","conversion_output":true,"text":"interactions with treatment assignment are not warranted, and not powered for. We propose,","text_display":" interactions with treatment assignment are not warranted, and not powered for. We propose,","confidence":1,"confidence_rate":1},{"cnt":[[245,2247],[1833,2247],[1833,2299],[245,2299]],"region":{"top_left_x":244,"top_left_y":2247,"width":1589,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1143081fe07148268d620985f317b370","type":"text","conversion_output":true,"text":"however, to table all results by subgroups for descriptive purposes and to explore in secondary","text_display":" however, to table all results by subgroups for descriptive purposes and to explore in secondary","confidence":1,"confidence_rate":1},{"cnt":[[245,2295],[1803,2295],[1803,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2294,"width":1559,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fe341973c4e4bf187ab620965c2d161","type":"text","conversion_output":true,"text":"analyses possible subgroup differences by treatment group, solely for purposes of generating","text_display":" analyses possible subgroup differences by treatment group, solely for purposes of generating","confidence":1,"confidence_rate":1},{"cnt":[[245,2342],[1828,2342],[1828,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2341,"width":1585,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4a3cf25732c4786a79ffd82c565798e","type":"text","conversion_output":true,"text":"hypotheses for future studies. In particular, there is interest in exploring subgroups defined by:","text_display":" hypotheses for future studies. In particular, there is interest in exploring subgroups defined by:","confidence":1,"confidence_rate":1},{"cnt":[[941,2580],[1179,2580],[1179,2632],[941,2632]],"region":{"top_left_x":941,"top_left_y":2580,"width":239,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77a3422640194d4b8cc86c050391f07c","type":"page_info","conversion_output":false,"text":"Page 12 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-13","page":13,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faca86a8ec3d4e00bc1549a16d702c73","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1880,129],[1880,176],[1689,176]],"region":{"top_left_x":1688,"top_left_y":128,"width":192,"height":49},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"905496451aa04f14a205e831824e735a","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,254],[1803,254],[1803,305],[305,305]],"region":{"top_left_x":305,"top_left_y":253,"width":1498,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28c85d2a98ca49069d65812a633153cd","type":"text","conversion_output":true,"text":"- Consenting procedure which may vary by site (antenatal vs. deferred consent). While","text_display":"\n- Consenting procedure which may vary by site (antenatal vs. deferred consent). While","confidence":1,"confidence_rate":1},{"cnt":[[370,305],[1863,305],[1863,354],[370,354]],"region":{"top_left_x":369,"top_left_y":305,"width":1494,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d2af209462b4280a40c3b852a3a3580","type":"text","conversion_output":true,"text":"consenting procedure differences may result in some selection bias, this will be implicity","text_display":" consenting procedure differences may result in some selection bias, this will be implicity","confidence":1,"confidence_rate":1},{"cnt":[[370,352],[1833,352],[1833,402],[370,402]],"region":{"top_left_x":369,"top_left_y":352,"width":1464,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76d292ee4dd24d6db159f0cd14d7750d","type":"text","conversion_output":true,"text":"adjusted for with the already planned clinical site stratification factor. Additionally, the","text_display":" adjusted for with the already planned clinical site stratification factor. Additionally, the","confidence":1,"confidence_rate":1},{"cnt":[[370,400],[1803,400],[1803,449],[370,449]],"region":{"top_left_x":369,"top_left_y":399,"width":1434,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a40c9a08bebe47afbff6d485421b0f37","type":"text","conversion_output":true,"text":"sample size still results in \\(80 \\%\\) power at \\(\\alpha=0.038\\) for the primary outcome even if the","text_display":" sample size still results in \\(80 \\%\\) power at \\(\\alpha=0.038\\) for the primary outcome even if the","confidence":1,"confidence_rate":1},{"cnt":[[370,447],[1222,447],[1222,492],[370,492]],"region":{"top_left_x":369,"top_left_y":446,"width":854,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"875c9644af3d433e83bfcd75de364ac1","type":"text","conversion_output":true,"text":"selection bias results in a reduced control arm rate.","text_display":" selection bias results in a reduced control arm rate.","confidence":1,"confidence_rate":1},{"cnt":[[305,518],[1880,518],[1880,569],[305,569]],"region":{"top_left_x":305,"top_left_y":517,"width":1575,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c9cf43f65a541a9b8842d694293ecfd","type":"text","conversion_output":true,"text":"- Route of treatment (facemask vs. nasopharyngeal tube). While not expected to modify the","text_display":"\n- Route of treatment (facemask vs. nasopharyngeal tube). While not expected to modify the","confidence":1,"confidence_rate":1},{"cnt":[[370,567],[1807,567],[1807,617],[370,617]],"region":{"top_left_x":369,"top_left_y":567,"width":1438,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77c8a67e733e4c859e1c384c159b1e8c","type":"text","conversion_output":true,"text":"intervention effectiveness, exploring this difference will be important for future study","text_display":" intervention effectiveness, exploring this difference will be important for future study","confidence":1,"confidence_rate":1},{"cnt":[[370,614],[844,614],[844,664],[370,664]],"region":{"top_left_x":369,"top_left_y":614,"width":476,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a453a87e998e4482bb352891cc31918f","type":"text","conversion_output":true,"text":"design and clinical practice.","text_display":" design and clinical practice.","confidence":1,"confidence_rate":1},{"cnt":[[305,683],[1800,683],[1800,737],[305,737]],"region":{"top_left_x":305,"top_left_y":683,"width":1496,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca241dd9ba134463ad78e7ea957268b0","type":"text","conversion_output":true,"text":"- Enrollment date. Clinical practices unrelated to this intervention, as well as increased","text_display":"\n- Enrollment date. Clinical practices unrelated to this intervention, as well as increased","confidence":1,"confidence_rate":1},{"cnt":[[370,735],[1747,735],[1747,784],[370,784]],"region":{"top_left_x":369,"top_left_y":734,"width":1378,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d98980a1dc04270a0c3c2548f0698d9","type":"text","conversion_output":true,"text":"intervention experience, could result in changes in the clinical effectiveness of the","text_display":" intervention experience, could result in changes in the clinical effectiveness of the","confidence":1,"confidence_rate":1},{"cnt":[[370,782],[1742,782],[1742,831],[370,831]],"region":{"top_left_x":369,"top_left_y":782,"width":1374,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6eff23acf3bc46709d5c53c7a42bbf79","type":"text","conversion_output":true,"text":"intervention over time (positively or negatively). We will explore graphically any","text_display":" intervention over time (positively or negatively). We will explore graphically any","confidence":1,"confidence_rate":1},{"cnt":[[370,829],[1871,829],[1871,879],[370,879]],"region":{"top_left_x":369,"top_left_y":829,"width":1503,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18f5af7e5f1e4418b0f1dbaae6b10a8f","type":"text","conversion_output":true,"text":"temporal trends in the intervention effect, and will allow/test for a time-varying treatment","text_display":" temporal trends in the intervention effect, and will allow/test for a time-varying treatment","confidence":1,"confidence_rate":1},{"cnt":[[370,879],[1850,879],[1850,930],[370,930]],"region":{"top_left_x":369,"top_left_y":878,"width":1481,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"765a48573eae4e57ab4eaa6c4c12cee9","type":"text","conversion_output":true,"text":"effect via a functional logistic regression model, if needed (for which the original power","text_display":" effect via a functional logistic regression model, if needed (for which the original power","confidence":1,"confidence_rate":1},{"cnt":[[370,924],[1326,924],[1326,973],[370,973]],"region":{"top_left_x":369,"top_left_y":923,"width":957,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e188a9d2d86649b0914649af2d421b2e","type":"text","conversion_output":true,"text":"calculations are conservative) (Ratcliffe SJ, et al., 2002).","text_display":" calculations are conservative) (Ratcliffe SJ, et al., 2002).","confidence":0.99951171875,"confidence_rate":0.9999924861744118},{"cnt":[[241,988],[741,988],[741,1051],[241,1051]],"region":{"top_left_x":240,"top_left_y":988,"width":502,"height":63},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfc035931d624f249ff214de156f438e","type":"section_header","conversion_output":false,"children_ids":["bdc0bf74407e42feb6ddfc298049393f"],"text":"","text_display":""},{"cnt":[[245,993],[737,993],[737,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":992,"width":493,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdc0bf74407e42feb6ddfc298049393f","type":"text","conversion_output":true,"parent_id":"cfc035931d624f249ff214de156f438e","text":"5.4.2 Secondary Endpoints","text_display":"\n\n\\subsection*{5.4.2 Secondary Endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[320,1061],[1790,1061],[1790,1113],[320,1113]],"region":{"top_left_x":320,"top_left_y":1061,"width":1470,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab05af3c649f4edb8a05776e4a88c454","type":"text","conversion_output":true,"text":"Secondary outcomes will be analyzed using similar procedures to the primary outcome.","text_display":"\n\nSecondary outcomes will be analyzed using similar procedures to the primary outcome.","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1790,1113],[1790,1162],[245,1162]],"region":{"top_left_x":244,"top_left_y":1112,"width":1546,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46b074dd7c9f446e893c927bb8808da7","type":"text","conversion_output":true,"text":"Descriptive statistics for secondary outcome measures will be calculated. Outcomes will be","text_display":" Descriptive statistics for secondary outcome measures will be calculated. Outcomes will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1160],[1813,1160],[1813,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1160,"width":1570,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4510276dfaff403093beabc2e4e97b71","type":"text","conversion_output":true,"text":"compared between treatment groups using GEE methods (where needed to account for twins)","text_display":" compared between treatment groups using GEE methods (where needed to account for twins)","confidence":1,"confidence_rate":1},{"cnt":[[245,1207],[1811,1207],[1811,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1207,"width":1568,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ead4ebcc145490f93f52809470f85d0","type":"text","conversion_output":true,"text":"with logistic regression (dichotomous outcomes), linear regression (continuous outcomes), or","text_display":" with logistic regression (dichotomous outcomes), linear regression (continuous outcomes), or","confidence":1,"confidence_rate":1},{"cnt":[[245,1255],[1792,1255],[1792,1304],[245,1304]],"region":{"top_left_x":244,"top_left_y":1254,"width":1548,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f38bb24a8b854a78ad1c0822444d8078","type":"text","conversion_output":true,"text":"survival analysis (survival time outcomes), as appropriate. If indicated, these models will be","text_display":" survival analysis (survival time outcomes), as appropriate. If indicated, these models will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1302],[1841,1302],[1841,1351],[245,1351]],"region":{"top_left_x":244,"top_left_y":1301,"width":1598,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a5b602eeb34492492727862099417fe","type":"text","conversion_output":true,"text":"expanded to include baseline covariates and potential interactions between baseline factors and","text_display":" expanded to include baseline covariates and potential interactions between baseline factors and","confidence":1,"confidence_rate":1},{"cnt":[[245,1349],[466,1349],[466,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1349,"width":223,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f464f66312ea40a0981815e5cbbcb481","type":"text","conversion_output":true,"text":"intervention.","text_display":" intervention.","confidence":1,"confidence_rate":1},{"cnt":[[318,1418],[1880,1418],[1880,1472],[318,1472]],"region":{"top_left_x":317,"top_left_y":1417,"width":1563,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f1b0f2731d9493da71bcd7d46941b65","type":"text","conversion_output":true,"text":"Standard data and regression diagnostics will be used to assess model adequacy and examine","text_display":"\n\nStandard data and regression diagnostics will be used to assess model adequacy and examine","confidence":1,"confidence_rate":1},{"cnt":[[245,1470],[1755,1470],[1755,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1469,"width":1512,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25819f34870d4d2bafdf3706b496cd1a","type":"text","conversion_output":true,"text":"potential outlying or influential data points for all of the above analyses. If these analyses","text_display":" potential outlying or influential data points for all of the above analyses. If these analyses","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,1517],[1687,1517],[1687,1566],[245,1566]],"region":{"top_left_x":244,"top_left_y":1516,"width":1443,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"486e85599a72440caa791e31b965cdf0","type":"text","conversion_output":true,"text":"suggest significant skewness or other violations of parametric model assumptions, the","text_display":" suggest significant skewness or other violations of parametric model assumptions, the","confidence":1,"confidence_rate":1},{"cnt":[[245,1564],[1807,1564],[1807,1613],[245,1613]],"region":{"top_left_x":244,"top_left_y":1564,"width":1563,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d8df7144f384b1999ca1a256214f206","type":"text","conversion_output":true,"text":"comparisons above may be supplemented with non-parametric methods based on rank scores","text_display":" comparisons above may be supplemented with non-parametric methods based on rank scores","confidence":1,"confidence_rate":1},{"cnt":[[245,1611],[1837,1611],[1837,1661],[245,1661]],"region":{"top_left_x":244,"top_left_y":1611,"width":1593,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e99294231cbe457eac82465d594fec74","type":"text","conversion_output":true,"text":"within the generalized Mantel-Haenszel testing framework, adjusting for clustering of multiple","text_display":" within the generalized Mantel-Haenszel testing framework, adjusting for clustering of multiple","confidence":1,"confidence_rate":1},{"cnt":[[245,1659],[359,1659],[359,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1658,"width":115,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0199a61faf6d488bacddc2b168462c3e","type":"text","conversion_output":true,"text":"births.","text_display":" births.","confidence":1,"confidence_rate":1},{"cnt":[[241,1723],[1229,1723],[1229,1783],[241,1783]],"region":{"top_left_x":240,"top_left_y":1723,"width":989,"height":61},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a42c2ac2da8146ae963573aab4c37f65","type":"section_header","conversion_output":false,"children_ids":["ce128d526edf445a94d022f167675dfa"],"text":"","text_display":""},{"cnt":[[245,1727],[1222,1727],[1222,1779],[245,1779]],"region":{"top_left_x":244,"top_left_y":1727,"width":979,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce128d526edf445a94d022f167675dfa","type":"text","conversion_output":true,"parent_id":"a42c2ac2da8146ae963573aab4c37f65","text":"5.4.3 Group Sequential Boundary for Primary Endpoint","text_display":"\n\n\\subsection*{5.4.3 Group Sequential Boundary for Primary Endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[318,1796],[1762,1796],[1762,1846],[318,1846]],"region":{"top_left_x":317,"top_left_y":1796,"width":1445,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71d09547edb741008e6ae2600ee0c5c7","type":"text","conversion_output":true,"text":"To avoid inflating the overall Type I error rate for the primary analysis of efficacy, an","text_display":"\n\nTo avoid inflating the overall Type I error rate for the primary analysis of efficacy, an","confidence":1,"confidence_rate":1},{"cnt":[[245,1843],[1852,1843],[1852,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1843,"width":1608,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7a3c6936cad443e99c949d22dd40733","type":"text","conversion_output":true,"text":"O'Brien-Fleming boundary will be used to calculate the nominal significance level to which the","text_display":" O'Brien-Fleming boundary will be used to calculate the nominal significance level to which the","confidence":1,"confidence_rate":1},{"cnt":[[245,1893],[1796,1893],[1796,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1892,"width":1553,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29f3c18d694e4ab493f6f9b4eb2a4fb9","type":"text","conversion_output":true,"text":"interim p-value for the primary endpoint is compared. The efficacy boundary is 0.038 at the","text_display":" interim p-value for the primary endpoint is compared. The efficacy boundary is 0.038 at the","confidence":0.95703125,"confidence_rate":0.9995564697630245},{"cnt":[[245,1938],[483,1938],[483,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1937,"width":240,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4602c2356e8a4bcd9f8a704b2762f5c9","type":"text","conversion_output":true,"text":"final analysis.","text_display":" final analysis.","confidence":1,"confidence_rate":1},{"cnt":[[236,2071],[1190,2071],[1190,2129],[236,2129]],"region":{"top_left_x":236,"top_left_y":2071,"width":955,"height":59},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bf4df98e3bd4fc7888622602db38d52","type":"section_header","conversion_output":false,"children_ids":["8fd7b5f803a841b1b6a3a3e4fa1eb852"],"text":"","text_display":""},{"cnt":[[243,2075],[1184,2075],[1184,2125],[243,2125]],"region":{"top_left_x":242,"top_left_y":2075,"width":942,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fd7b5f803a841b1b6a3a3e4fa1eb852","type":"text","conversion_output":true,"parent_id":"9bf4df98e3bd4fc7888622602db38d52","text":"6. Intent-to-Treat Analysis and Missing Data","text_display":"\n\n\\section*{6. Intent-to-Treat Analysis and Missing Data}","confidence":1,"confidence_rate":1},{"cnt":[[236,2140],[960,2140],[960,2202],[236,2202]],"region":{"top_left_x":236,"top_left_y":2139,"width":725,"height":64},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b571308b977e49d9ae27238e4dd36b3a","type":"section_header","conversion_output":false,"children_ids":["5593d354ce4145308c081beb9ab515a7"],"text":"","text_display":""},{"cnt":[[245,2144],[954,2144],[954,2198],[245,2198]],"region":{"top_left_x":244,"top_left_y":2144,"width":710,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5593d354ce4145308c081beb9ab515a7","type":"text","conversion_output":true,"parent_id":"b571308b977e49d9ae27238e4dd36b3a","text":"6.1 Treatment and Study Withdrawals","text_display":"\n\n\\subsection*{6.1 Treatment and Study Withdrawals}","confidence":1,"confidence_rate":1},{"cnt":[[318,2213],[1828,2213],[1828,2264],[318,2264]],"region":{"top_left_x":317,"top_left_y":2212,"width":1512,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"763af021dc574407840470cc44e101c9","type":"text","conversion_output":true,"text":"It is anticipated that there will be a small number of infants who, because of acute clinical","text_display":"\n\nIt is anticipated that there will be a small number of infants who, because of acute clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,2262],[1828,2262],[1828,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2262,"width":1585,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e06e738f94484450b7092be631d67a0d","type":"text","conversion_output":true,"text":"deterioration are treated according to the preference of their medical team rather than by study","text_display":" deterioration are treated according to the preference of their medical team rather than by study","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,2312],[1717,2312],[1717,2363],[245,2363]],"region":{"top_left_x":244,"top_left_y":2311,"width":1473,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abd9d3f4b4a04c84a439c52b2888d7c4","type":"text","conversion_output":true,"text":"protocol. However, their outcomes will be measured and analyzed according to original","text_display":" protocol. However, their outcomes will be measured and analyzed according to original","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[947,2359],[947,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2358,"width":704,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aebbd188dbaa4be0a22364fb9f75830e","type":"text","conversion_output":true,"text":"allocation by intention-to-treat principles.","text_display":" allocation by intention-to-treat principles.","confidence":1,"confidence_rate":1},{"cnt":[[941,2578],[1179,2578],[1179,2632],[941,2632]],"region":{"top_left_x":941,"top_left_y":2578,"width":239,"height":54},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aef2b4d9dd7f4ef5b6752574105162e6","type":"page_info","conversion_output":false,"text":"Page 13 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-14","page":14,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff87061c167f458c88ec8b66c78bbc7a","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1880,129],[1880,174],[1689,174]],"region":{"top_left_x":1688,"top_left_y":128,"width":192,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc8a880fff2c4cf8b12d8b90047ade88","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,254],[1785,254],[1785,303],[322,303]],"region":{"top_left_x":322,"top_left_y":253,"width":1464,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8e4d074c389441b959a26be1fd9575a","type":"text","conversion_output":true,"text":"It should be noted that infants who discontinue in the trial, particularly in the case of an","text_display":"\n\nIt should be noted that infants who discontinue in the trial, particularly in the case of an","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1841,301],[1841,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1598,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03407a1c1b1348e581a6289b94d7ce02","type":"text","conversion_output":true,"text":"adverse event, will not be considered withdrawals from the study unless their parent withdraws","text_display":" adverse event, will not be considered withdrawals from the study unless their parent withdraws","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1850,348],[1850,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1606,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6375354d36c44a44985f241769297c0b","type":"text","conversion_output":true,"text":"consent for further follow-up. The parents of such infants will be encouraged to continue in the","text_display":" consent for further follow-up. The parents of such infants will be encouraged to continue in the","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,397],[1732,397],[1732,445],[245,445]],"region":{"top_left_x":244,"top_left_y":397,"width":1488,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41cf39429fb941abbfb8933e583b1f09","type":"text","conversion_output":true,"text":"study in order to provide complete follow-up information. The characteristics at time of","text_display":" study in order to provide complete follow-up information. The characteristics at time of","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1807,443],[1807,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1563,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7e820de94b74f4cb8c3dbc6806124e6","type":"text","conversion_output":true,"text":"randomization for those participants without complete follow-up will be examined; however,","text_display":" randomization for those participants without complete follow-up will be examined; however,","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[1833,492],[1833,541],[245,541]],"region":{"top_left_x":244,"top_left_y":491,"width":1589,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48f9a70fa67545fbbacd9f9c22f65641","type":"text","conversion_output":true,"text":"there will be limited statistical power to detect any but major differences between these infants","text_display":" there will be limited statistical power to detect any but major differences between these infants","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1846,541],[1846,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1602,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c3233222936409c8f719c438387c0d1","type":"text","conversion_output":true,"text":"and those with complete follow-up. As mentioned above, in order to assess the potential biases","text_display":" and those with complete follow-up. As mentioned above, in order to assess the potential biases","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1794,589],[1794,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1550,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea8477ef6d50412daf727eb770379028","type":"text","conversion_output":true,"text":"introduced by differential withdrawal among intervention arms, a comparison of withdrawal","text_display":" introduced by differential withdrawal among intervention arms, a comparison of withdrawal","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1764,636],[1764,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1520,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82e069c8dbfe424e80e0b6906dd99e9c","type":"text","conversion_output":true,"text":"rates will be carried out using the exact conditional test (ECT) version of Mantel-Haenszel","text_display":" rates will be carried out using the exact conditional test (ECT) version of Mantel-Haenszel","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1025,683],[1025,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":781,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"017151875c9b40f79f75ebe3bdfe2315","type":"text","conversion_output":true,"text":"methods to adjust for within-center clustering.","text_display":" methods to adjust for within-center clustering.","confidence":1,"confidence_rate":1},{"cnt":[[318,752],[1850,752],[1850,801],[318,801]],"region":{"top_left_x":317,"top_left_y":751,"width":1533,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95d8defdb0c94227ba158fc5239dc1a1","type":"text","conversion_output":true,"text":"Potential effects of withdrawals and other sources of missing data on the statistical analysis","text_display":"\n\nPotential effects of withdrawals and other sources of missing data on the statistical analysis","confidence":0.9985356330871582,"confidence_rate":0.9999851976838389},{"cnt":[[245,799],[1188,799],[1188,851],[245,851]],"region":{"top_left_x":244,"top_left_y":799,"width":945,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"290a4cd72deb45ecb347831544329af8","type":"text","conversion_output":true,"text":"and interpretation of results are discussed further below.","text_display":" and interpretation of results are discussed further below.","confidence":1,"confidence_rate":1},{"cnt":[[241,866],[965,866],[965,922],[241,922]],"region":{"top_left_x":240,"top_left_y":865,"width":725,"height":57},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07ea7e9dc16849cea49c297180b8f274","type":"section_header","conversion_output":false,"children_ids":["958929822d844448841838cc50dffdbd"],"text":"","text_display":""},{"cnt":[[245,872],[960,872],[960,917],[245,917]],"region":{"top_left_x":244,"top_left_y":872,"width":717,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"958929822d844448841838cc50dffdbd","type":"text","conversion_output":true,"parent_id":"07ea7e9dc16849cea49c297180b8f274","text":"6.2 Other Missing Data Considerations","text_display":"\n\n\\subsection*{6.2 Other Missing Data Considerations}","confidence":1,"confidence_rate":1},{"cnt":[[318,937],[1863,937],[1863,986],[318,986]],"region":{"top_left_x":317,"top_left_y":936,"width":1546,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de0eaaca6c004275b0dd98f12a64e03a","type":"text","conversion_output":true,"text":"In addition to data that is naturally missing from participants who withdraw from study, it is","text_display":"\n\nIn addition to data that is naturally missing from participants who withdraw from study, it is","confidence":1,"confidence_rate":1},{"cnt":[[245,986],[1807,986],[1807,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":986,"width":1563,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff45bb34f4e646d5afc2c07032e07a12","type":"text","conversion_output":true,"text":"expected that there may be occasional missing values for other subjects. All attempts will be","text_display":" expected that there may be occasional missing values for other subjects. All attempts will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1033],[1880,1033],[1880,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1033,"width":1636,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30431c15802e42d3bf00521bc282268e","type":"text","conversion_output":true,"text":"made to keep missing data to a minimum. Extensive procedures to minimize missing data during","text_display":" made to keep missing data to a minimum. Extensive procedures to minimize missing data during","confidence":1,"confidence_rate":1},{"cnt":[[245,1083],[1695,1083],[1695,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1082,"width":1452,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f29a85693a1403ab9e2160bad4dcd89","type":"text","conversion_output":true,"text":"the data collection and entry process will be put in place, following standard operating","text_display":" the data collection and entry process will be put in place, following standard operating","confidence":1,"confidence_rate":1},{"cnt":[[245,1130],[1869,1130],[1869,1179],[245,1179]],"region":{"top_left_x":244,"top_left_y":1130,"width":1626,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87c41a4274cf4047a10e6734817bc155","type":"text","conversion_output":true,"text":"procedures at the DCC. These procedures will be described further in the Manual of Procedures.","text_display":" procedures at the DCC. These procedures will be described further in the Manual of Procedures.","confidence":1,"confidence_rate":1},{"cnt":[[245,1177],[1807,1177],[1807,1227],[245,1227]],"region":{"top_left_x":244,"top_left_y":1177,"width":1563,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ae21880d2bd4852805b4b5a0eec3b8f","type":"text","conversion_output":true,"text":"In addition, since the infants are still hospitalized at 36 weeks PMA as part of routine clinical","text_display":" In addition, since the infants are still hospitalized at 36 weeks PMA as part of routine clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,1227],[1742,1227],[1742,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1226,"width":1499,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce16ff7441a34aed80b63864f5beea68","type":"text","conversion_output":true,"text":"care, it has been our experience that this type of missing data is minimal. The number of","text_display":" care, it has been our experience that this type of missing data is minimal. The number of","confidence":1,"confidence_rate":1},{"cnt":[[245,1274],[1871,1274],[1871,1326],[245,1326]],"region":{"top_left_x":244,"top_left_y":1274,"width":1628,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3814b5f39caf40fbb3ef29e7e7428fae","type":"text","conversion_output":true,"text":"subjects included with each individual analysis will be given with the results. In general, missing","text_display":" subjects included with each individual analysis will be given with the results. In general, missing","confidence":1,"confidence_rate":1},{"cnt":[[245,1323],[999,1323],[999,1373],[245,1373]],"region":{"top_left_x":244,"top_left_y":1323,"width":756,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0b2e259537a4a78832f3d30559e3307","type":"text","conversion_output":true,"text":"data will not be directly imputed in any way.","text_display":" data will not be directly imputed in any way.","confidence":1,"confidence_rate":1},{"cnt":[[241,1388],[1233,1388],[1233,1446],[241,1446]],"region":{"top_left_x":240,"top_left_y":1387,"width":994,"height":59},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0eb222a6375d4a358f82355cf62e3fd4","type":"section_header","conversion_output":false,"children_ids":["a69eb01940534a019dc878d8a5ba5c28"],"text":"","text_display":""},{"cnt":[[245,1392],[1229,1392],[1229,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1392,"width":985,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a69eb01940534a019dc878d8a5ba5c28","type":"text","conversion_output":true,"parent_id":"0eb222a6375d4a358f82355cf62e3fd4","text":"6.3 Intent-to-Treat Analysis for the Primary Endpoint","text_display":"\n\n\\subsection*{6.3 Intent-to-Treat Analysis for the Primary Endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[318,1457],[1858,1457],[1858,1508],[318,1508]],"region":{"top_left_x":317,"top_left_y":1456,"width":1542,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d25e96f92f364bda8dc66ebde02151b7","type":"text","conversion_output":true,"text":"An as randomized (formerly called \"intent-to-treat\") analysis, in which all available data on","text_display":"\n\nAn as randomized (formerly called \"intent-to-treat\") analysis, in which all available data on","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[1768,1508],[1768,1558],[245,1558]],"region":{"top_left_x":244,"top_left_y":1508,"width":1525,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b942f14ff0b84ca4a21f5bb55fa8cc1f","type":"text","conversion_output":true,"text":"all randomized participants are included, will be used for the primary endpoint comparison","text_display":" all randomized participants are included, will be used for the primary endpoint comparison","confidence":1,"confidence_rate":1},{"cnt":[[245,1555],[629,1555],[629,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1555,"width":386,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0af5775a52524696912df1aa050b4e44","type":"text","conversion_output":true,"text":"between interventions.","text_display":" between interventions.","confidence":1,"confidence_rate":1},{"cnt":[[241,1620],[1360,1620],[1360,1678],[241,1678]],"region":{"top_left_x":240,"top_left_y":1619,"width":1120,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be5091e890e240b7acc6ec57408d70f4","type":"section_header","conversion_output":false,"children_ids":["b1795bb8ea414cb79d4197f776c70388"],"text":"","text_display":""},{"cnt":[[245,1624],[1356,1624],[1356,1674],[245,1674]],"region":{"top_left_x":244,"top_left_y":1624,"width":1112,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1795bb8ea414cb79d4197f776c70388","type":"text","conversion_output":true,"parent_id":"be5091e890e240b7acc6ec57408d70f4","text":"6.4 Potential Effects of Missing Data on Secondary Endpoints","text_display":"\n\n\\subsection*{6.4 Potential Effects of Missing Data on Secondary Endpoints}","confidence":0.9873106479644775,"confidence_rate":0.9998035493068148},{"cnt":[[318,1693],[1772,1693],[1772,1742],[318,1742]],"region":{"top_left_x":317,"top_left_y":1692,"width":1456,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f665644f9225460d92253448c8d99da1","type":"text","conversion_output":true,"text":"The possibility of missing data can have serious consequences for the interpretation of","text_display":"\n\nThe possibility of missing data can have serious consequences for the interpretation of","confidence":1,"confidence_rate":1},{"cnt":[[245,1740],[1880,1740],[1880,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1636,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78878d8cb7324f5393c63ef0ede2346d","type":"text","conversion_output":true,"text":"statistical analyses. This is particularly problematic if the probability of missing data is related to","text_display":" statistical analyses. This is particularly problematic if the probability of missing data is related to","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[1768,1788],[1768,1837],[245,1837]],"region":{"top_left_x":244,"top_left_y":1787,"width":1525,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"271d7b17017446acaa43b51cc5b5c208","type":"text","conversion_output":true,"text":"the intervention, the outcome, or both. There is a large statistical literature on the potential","text_display":" the intervention, the outcome, or both. There is a large statistical literature on the potential","confidence":1,"confidence_rate":1},{"cnt":[[245,1835],[1809,1835],[1809,1884],[245,1884]],"region":{"top_left_x":244,"top_left_y":1834,"width":1565,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56e6fe4c889c4e82ae7b8f225ac56cd3","type":"text","conversion_output":true,"text":"effects of missing data and also some proposed methods for analysis, although these methods","text_display":" effects of missing data and also some proposed methods for analysis, although these methods","confidence":1,"confidence_rate":1},{"cnt":[[245,1884],[1854,1884],[1854,1934],[245,1934]],"region":{"top_left_x":244,"top_left_y":1884,"width":1611,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"319ce62d12bc40b6adfb4c2fde3a21e4","type":"text","conversion_output":true,"text":"often require assumptions that cannot be tested within the trial dataset itself. Some of the issues","text_display":" often require assumptions that cannot be tested within the trial dataset itself. Some of the issues","confidence":1,"confidence_rate":1},{"cnt":[[245,1929],[1824,1929],[1824,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1929,"width":1581,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb6dfb46e8f247cca51c55d3b1b3c6ca","type":"text","conversion_output":true,"text":"regarding the potential effects of missing data on the evaluation of secondary endpoints in this","text_display":" regarding the potential effects of missing data on the evaluation of secondary endpoints in this","confidence":1,"confidence_rate":1},{"cnt":[[245,1981],[799,1981],[799,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1980,"width":556,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5aea14c3144844598ea8f63fa31a593c","type":"text","conversion_output":true,"text":"trial are briefly addressed below.","text_display":" trial are briefly addressed below.","confidence":1,"confidence_rate":1},{"cnt":[[318,2050],[1803,2050],[1803,2099],[318,2099]],"region":{"top_left_x":317,"top_left_y":2049,"width":1486,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46060da7ac914b3eaccdd6e5ca22f026","type":"text","conversion_output":true,"text":"For measures recorded at 22-26 months corrected GA, some missing data due to loss-to-","text_display":"\n\nFor measures recorded at 22-26 months corrected GA, some missing data due to loss-to-","confidence":0.9970703125,"confidence_rate":0.9999674006709831},{"cnt":[[245,2097],[1854,2097],[1854,2146],[245,2146]],"region":{"top_left_x":244,"top_left_y":2096,"width":1611,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2c4107fb3ec41c19b770dd7c1431fb5","type":"text","conversion_output":true,"text":"follow-up is to be expected, though minimal. Data for those subjects without 22-26 months data","text_display":"follow-up is to be expected, though minimal. Data for those subjects without 22-26 months data","confidence":0.9980475902557373,"confidence_rate":0.9999802596071612},{"cnt":[[245,2144],[1846,2144],[1846,2194],[245,2194]],"region":{"top_left_x":244,"top_left_y":2144,"width":1602,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26356f6f6adb4e48a35e15903fd3c690","type":"text","conversion_output":true,"text":"will be omitted from these analyses. Although these analyses will be conducted, it is important","text_display":" will be omitted from these analyses. Although these analyses will be conducted, it is important","confidence":1,"confidence_rate":1},{"cnt":[[245,2191],[1796,2191],[1796,2241],[245,2241]],"region":{"top_left_x":244,"top_left_y":2191,"width":1553,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43e6552423df4ebf96e0168b0b3d55ce","type":"text","conversion_output":true,"text":"that the results be interpreted in light of the fact that they will only include a subgroup of the","text_display":" that the results be interpreted in light of the fact that they will only include a subgroup of the","confidence":1,"confidence_rate":1},{"cnt":[[245,2239],[1835,2239],[1835,2288],[245,2288]],"region":{"top_left_x":244,"top_left_y":2238,"width":1591,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b215a59c5a445ea91cb844234ee063d","type":"text","conversion_output":true,"text":"population (\"completers\"), and that the subgroup is based on outcomes such that the benefit of","text_display":" population (\"completers\"), and that the subgroup is based on outcomes such that the benefit of","confidence":1,"confidence_rate":1},{"cnt":[[245,2288],[1813,2288],[1813,2340],[245,2340]],"region":{"top_left_x":244,"top_left_y":2288,"width":1570,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3cb7a38d0304986b5a1408787eb600c","type":"text","conversion_output":true,"text":"the original randomization may no longer hold. In the event that the analysis of the secondary","text_display":" the original randomization may no longer hold. In the event that the analysis of the secondary","confidence":1,"confidence_rate":1},{"cnt":[[245,2338],[1811,2338],[1811,2385],[245,2385]],"region":{"top_left_x":244,"top_left_y":2337,"width":1568,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4068ca7a511e4e0b99c57032ffd70e99","type":"text","conversion_output":true,"text":"endpoints at 22-26 months becomes an important issue for clinical decision-making, methods","text_display":" endpoints at 22-26 months becomes an important issue for clinical decision-making, methods","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,2385],[1635,2385],[1635,2434],[245,2434]],"region":{"top_left_x":244,"top_left_y":2384,"width":1391,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c75d27a2ad0410fa615ead8a6bcdd01","type":"text","conversion_output":true,"text":"which directly model the outcomes and the withdrawal process may be considered.","text_display":" which directly model the outcomes and the withdrawal process may be considered.","confidence":1,"confidence_rate":1},{"cnt":[[941,2582],[1179,2582],[1179,2632],[941,2632]],"region":{"top_left_x":941,"top_left_y":2582,"width":239,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"252ed4ab03744cb4b0f0c2c17e14bb45","type":"page_info","conversion_output":false,"text":"Page 14 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7661986c-6b35-485b-b687-3694b03da10f-15","page":15,"lines":[{"cnt":[[245,129],[1115,129],[1115,178],[245,178]],"region":{"top_left_x":244,"top_left_y":128,"width":872,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe8e6eabc28c4a7eaef8775562690685","type":"page_info","conversion_output":false,"text":"SAIL, Data Analysis and Monitoring Plan (DAMP)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1689,129],[1880,129],[1880,178],[1689,178]],"region":{"top_left_x":1688,"top_left_y":128,"width":192,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd7d1dc8500e4259bc62d3ee723bfd16","type":"page_info","conversion_output":false,"text":"April 2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,249],[1057,249],[1057,299],[243,299]],"region":{"top_left_x":242,"top_left_y":249,"width":816,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6508f79498d74d99b27e2e64837eaa70","type":"section_header","conversion_output":false,"children_ids":["f24df05bf1c344d1979da525b9c40d64"],"text":"","text_display":""},{"cnt":[[245,254],[1053,254],[1053,294],[245,294]],"region":{"top_left_x":244,"top_left_y":253,"width":809,"height":42},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f24df05bf1c344d1979da525b9c40d64","type":"text","conversion_output":true,"parent_id":"6508f79498d74d99b27e2e64837eaa70","text":"7. Presentation and Format of Results","text_display":"\n\n\\section*{7. Presentation and Format of Results}","confidence":1,"confidence_rate":1},{"cnt":[[320,322],[1835,322],[1835,372],[320,372]],"region":{"top_left_x":320,"top_left_y":322,"width":1515,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba13949de3fe46458f676b6223196bfe","type":"text","conversion_output":true,"text":"Examples of some of the tables described in the previous section are given in Appendix B.","text_display":"\n\nExamples of some of the tables described in the previous section are given in Appendix B.","confidence":1,"confidence_rate":1},{"cnt":[[245,370],[1867,370],[1867,419],[245,419]],"region":{"top_left_x":244,"top_left_y":369,"width":1623,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb476d450e9b416e954c0e3ca94bb020","type":"text","conversion_output":true,"text":"Additional tables and appropriate figures will be produced as needed. For general reporting, one","text_display":" Additional tables and appropriate figures will be produced as needed. For general reporting, one","confidence":1,"confidence_rate":1},{"cnt":[[245,417],[1867,417],[1867,466],[245,466]],"region":{"top_left_x":244,"top_left_y":416,"width":1623,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d3660448ab546e69e112301d7cc356b","type":"text","conversion_output":true,"text":"decimal point for most efficacy and safety endpoints, p -values will be reported to two significant","text_display":" decimal point for most efficacy and safety endpoints, p -values will be reported to two significant","confidence":0.9980475902557373,"confidence_rate":0.9999822336289093},{"cnt":[[245,464],[1846,464],[1846,518],[245,518]],"region":{"top_left_x":244,"top_left_y":464,"width":1602,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72f00ed241884292a6b2dbea515082b0","type":"text","conversion_output":true,"text":"digits (following the ICJME conventions of \\(x . xx\\) for most, \\(p >0.2\\), or \\(p <0.001\\) ), and no rounding","text_display":" digits (following the ICJME conventions of \\(x . xx\\) for most, \\(p >0.2\\), or \\(p <0.001\\) ), and no rounding","confidence":0.9877986907958984,"confidence_rate":0.9998985476569664},{"cnt":[[245,511],[1158,511],[1158,563],[245,563]],"region":{"top_left_x":244,"top_left_y":511,"width":915,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaaa873c1c3e480ba6883d99acb7ce04","type":"text","conversion_output":true,"text":"in any intermediate data or analysis steps will be used.","text_display":" in any intermediate data or analysis steps will be used.","confidence":1,"confidence_rate":1},{"cnt":[[320,580],[1691,580],[1691,632],[320,632]],"region":{"top_left_x":320,"top_left_y":580,"width":1371,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"425b3ed4a895477da9949638e1c3855b","type":"text","conversion_output":true,"text":"Data will be primarily managed in REDCap. SAS will be used for secondary data","text_display":"\n\nData will be primarily managed in REDCap. SAS will be used for secondary data","confidence":1,"confidence_rate":1},{"cnt":[[245,629],[1876,629],[1876,681],[245,681]],"region":{"top_left_x":244,"top_left_y":629,"width":1632,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9d4102b32294994a07006daffd7e314","type":"text","conversion_output":true,"text":"management and descriptive statistics. SAS datasets will be downloaded at least weekly from the","text_display":" management and descriptive statistics. SAS datasets will be downloaded at least weekly from the","confidence":1,"confidence_rate":1},{"cnt":[[245,679],[1865,679],[1865,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":1621,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a1353c4bc3e405089e50441d1394f3f","type":"text","conversion_output":true,"text":"study database for analysis. Graphics will be prepared using Stata v13 (or later) (Stata Corp, San","text_display":" study database for analysis. Graphics will be prepared using Stata v13 (or later) (Stata Corp, San","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1740,726],[1740,776],[245,776]],"region":{"top_left_x":244,"top_left_y":726,"width":1497,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38ccd46f7192417e8279eeab5c97f0ff","type":"text","conversion_output":true,"text":"Antonio TX, 2009) and the R programming package v 3.0 or later (The R Foundation for","text_display":" Antonio TX, 2009) and the R programming package v 3.0 or later (The R Foundation for","confidence":0.9951210021972656,"confidence_rate":0.9999468390329969},{"cnt":[[245,773],[1876,773],[1876,823],[245,823]],"region":{"top_left_x":244,"top_left_y":773,"width":1632,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19fcda585aeb4e8e81dce810d3aad232","type":"text","conversion_output":true,"text":"Statistical Computing, Vienna, Austria, 2011). Analyses will be implemented in SAS, Stata, or R","text_display":" Statistical Computing, Vienna, Austria, 2011). Analyses will be implemented in SAS, Stata, or R","confidence":1,"confidence_rate":1},{"cnt":[[245,821],[1852,821],[1852,872],[245,872]],"region":{"top_left_x":244,"top_left_y":820,"width":1608,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb7be5e6caa74ab58c6cbfa311e277e8","type":"text","conversion_output":true,"text":"as needed. These programs will be documented according to the Standard Operating Procedures","text_display":" as needed. 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2014","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,271],[1111,271],[1111,320],[243,320]],"region":{"top_left_x":242,"top_left_y":270,"width":869,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a010d07c80cc4293958f6d1f7e0e0159","type":"section_header","conversion_output":false,"children_ids":["6bf72b9364834402bf94e7ef03d5c350"],"text":"","text_display":""},{"cnt":[[249,275],[1106,275],[1106,316],[249,316]],"region":{"top_left_x":249,"top_left_y":275,"width":858,"height":41},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bf72b9364834402bf94e7ef03d5c350","type":"text","conversion_output":true,"parent_id":"a010d07c80cc4293958f6d1f7e0e0159","text":"10. Appendix B: Draft Study Report Tables","text_display":"\n\n\\section*{10. Appendix B: Draft Study Report Tables}","confidence":1,"confidence_rate":1},{"cnt":[[318,339],[1811,339],[1811,391],[318,391]],"region":{"top_left_x":317,"top_left_y":339,"width":1495,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be2c69b7ecde4b7e8588fe2298bf643c","type":"text","conversion_output":true,"text":"The following are examples of some of the tables that may be included in final report for","text_display":"\n\nThe following are examples of some of the tables that may be included in final report for","confidence":1,"confidence_rate":1},{"cnt":[[245,391],[1742,391],[1742,440],[245,440]],"region":{"top_left_x":244,"top_left_y":391,"width":1499,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e04a9b0708c34a63ab8023bf5488f8d4","type":"text","conversion_output":true,"text":"this clinical trial. Selected tables may also be used for reporting the results of the interim","text_display":" this clinical trial. Selected tables may also be used for reporting the results of the interim","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,438],[1772,438],[1772,488],[245,488]],"region":{"top_left_x":244,"top_left_y":438,"width":1529,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce113e6a38dc4577a8a880c6a9a90839","type":"text","conversion_output":true,"text":"analyses. Although the exact content and format may change, an attempt has been made to","text_display":" analyses. Although the exact content and format may change, an attempt has been made to","confidence":1,"confidence_rate":1},{"cnt":[[245,486],[1386,486],[1386,535],[245,535]],"region":{"top_left_x":244,"top_left_y":485,"width":1142,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c771b21ea8142edacb1ff089583f846","type":"text","conversion_output":true,"text":"summarize the most important population, safety, and efficacy data.","text_display":" summarize the most important population, safety, and efficacy data.","confidence":1,"confidence_rate":1},{"cnt":[[312,580],[1811,580],[1811,632],[312,632]],"region":{"top_left_x":311,"top_left_y":580,"width":1501,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"113c4f0e76514a4ab048385f652188aa","type":"figure_label","conversion_output":false,"text":"Table 1. 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Summary of Baseline Demographic Characteristics by Intervention Group}\n\\begin{tabular}{|l|l|l|l|l|}\n\\hline & A & B & Total & \\(p\\)-value \\\\\n\\hline Number of Subjects & \\(\\sim n\\) & \\(\\sim n\\) & \\(\\sim\\) n & \\\\\n\\hline \\multicolumn{5}{|l|}{Clinical Site} \\\\\n\\hline University of Pennsylvania & n (\\%) & n (\\%) & n (\\%) & n/a \\\\\n\\hline University of Melbourne & n (\\%) & n (\\%) & n (\\%) & \\\\\n\\hline etc. & n (\\%) & n (\\%) & n (\\%) & \\\\\n\\hline \\multicolumn{5}{|l|}{Consenting Procedure Used} \\\\\n\\hline Antenatal & n (\\%) & n (\\%) & n (\\%) & 0.xx \\\\\n\\hline Deferred & n (\\%) & n (\\%) & n (\\%) & \\\\\n\\hline \\multicolumn{5}{|l|}{Sex} \\\\\n\\hline Male & n (\\%) & n (\\%) & n (\\%) & 0.xx \\\\\n\\hline Female & n (\\%) & n (\\%) & n (\\%) & \\\\\n\\hline \\multicolumn{5}{|l|}{Race} \\\\\n\\hline White/Caucasian & n (\\%) & n (\\%) & n (\\%) & \\\\\n\\hline Black/African-American & n (\\%) & n (\\%) & n (\\%) & \\\\\n\\hline etc. & n 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& \\multicolumn{2}{|c|}{A} & \\multicolumn{2}{|c|}{B} & \\multicolumn{2}{|c|}{Total} & p-value \\\\\n\\hline Number of Subjects & & \\(\\sim\\) n & & \\(\\sim n\\) & & ~n & \\\\\n\\hline \\multicolumn{8}{|l|}{Exposure to Antenatal Steroids} \\\\\n\\hline No & n & (\\%) & n & (\\%) & n & (\\%) & 0.xx \\\\\n\\hline Yes & n & (\\%) & n & (\\%) & n & (\\%) & \\\\\n\\hline \\multirow[t]{3}{*}{Type of Antenatal Steroids (only in subset with exposure)} & & & & & & & \\\\\n\\hline & n & (\\%) & n & (\\%) & n & (\\%) & 0.xx \\\\\n\\hline & n & (\\%) & n & (\\%) & n & (\\%) & \\\\\n\\hline \\multicolumn{8}{|l|}{Exposure to Medications to Prolong Pregnancy} \\\\\n\\hline No & n & (\\%) & n & (\\%) & n & (\\%) & 0.xx \\\\\n\\hline Yes & n & (\\%) & n & (\\%) & n & (\\%) & \\\\\n\\hline \\multicolumn{8}{|l|}{Placental Abruption} \\\\\n\\hline No & n & (\\%) & n & (\\%) & n & (\\%) & 0.xx \\\\\n\\hline Yes & n & (\\%) & n & (\\%) & n & (\\%) & \\\\\n\\hline \\multicolumn{8}{|l|}{Chorioamnionitis} 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Therefore, it may not include all patients who have data at","confidence":1,"confidence_rate":1},{"cnt":[[432,1403],[831,1403],[831,1450],[432,1450]],"region":{"top_left_x":431,"top_left_y":1402,"width":401,"height":49},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99997341da514fe187fa812bc8526e8f","type":"text","conversion_output":true,"text":"the stated gestational age.","text_display":" the stated gestational age.","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,1470],[1592,1470],[1592,1515],[245,1515]],"region":{"top_left_x":244,"top_left_y":1469,"width":1348,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f96128c1818e48d0bc4043a1e82bd6a2","type":"text","conversion_output":true,"text":"Table 4: Completion Rates Among Active Study Participants by Clinical Center","text_display":"\n\nTable 4: Completion Rates Among Active Study Participants by Clinical Center","confidence":1,"confidence_rate":1},{"cnt":[[245,1543],[1162,1543],[1162,1590],[245,1590]],"region":{"top_left_x":244,"top_left_y":1542,"width":919,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8beb6465f2d54a51a08a1dae49fd6eef","type":"text","conversion_output":true,"text":"Table 5: Age Distribution - Gestational and Maternal","text_display":"\nTable 5: Age Distribution - Gestational and Maternal","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[245,1607],[724,1607],[724,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1607,"width":481,"height":41},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f88037537a334e8ba947bda13579b415","type":"text","conversion_output":true,"text":"Table 6: Race Distribution","text_display":"\nTable 6: Race Distribution","confidence":1,"confidence_rate":1},{"cnt":[[245,1671],[767,1671],[767,1712],[245,1712]],"region":{"top_left_x":244,"top_left_y":1671,"width":523,"height":42},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37ceab9bdcab42ef9121b9a41daee4dd","type":"text","conversion_output":true,"text":"Table 7: Gender Distribution","text_display":"\nTable 7: Gender Distribution","confidence":1,"confidence_rate":1},{"cnt":[[245,1736],[1437,1736],[1437,1785],[245,1785]],"region":{"top_left_x":244,"top_left_y":1735,"width":1194,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc0bca2aef8b412bad8b69c1065279a8","type":"text","conversion_output":true,"text":"Table 8: Missing Forms (Number of Missing Forms, by Type of Form)","text_display":"\nTable 8: Missing Forms (Number of Missing Forms, by Type of Form)","confidence":0.99951171875,"confidence_rate":0.9999930228743673},{"cnt":[[245,1800],[1551,1800],[1551,1850],[245,1850]],"region":{"top_left_x":244,"top_left_y":1800,"width":1308,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d5726af6d2640aa95494226ec278679","type":"text","conversion_output":true,"text":"Table 9: Timely Entry and Verification (Mean Number of Days from Date of","text_display":"\nTable 9: Timely Entry and Verification (Mean Number of Days from Date of","confidence":1,"confidence_rate":1},{"cnt":[[432,1848],[1240,1848],[1240,1893],[432,1893]],"region":{"top_left_x":431,"top_left_y":1847,"width":809,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1b97b7f99264e95b0488385d5a297c2","type":"text","conversion_output":true,"text":"Birth/Randomization to First Entry in Database)","text_display":" Birth/Randomization to First Entry in Database)","confidence":1,"confidence_rate":1},{"cnt":[[245,1929],[1631,1929],[1631,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1929,"width":1387,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb3a82168bfc4a618bcfcdc4ca2f699f","type":"text","conversion_output":true,"text":"Table 10: Missing Values (Missing Fields Per Completed Forms, by Type of Form)","text_display":"\n\nTable 10: Missing Values (Missing Fields Per Completed Forms, by Type of Form)","confidence":0.9990234375,"confidence_rate":0.9999882285072625},{"cnt":[[245,1996],[1590,1996],[1590,2043],[245,2043]],"region":{"top_left_x":244,"top_left_y":1995,"width":1346,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c835a8affc84cf58b0a038b81bf8c2b","type":"text","conversion_output":true,"text":"Table 11: Query Rates (Fields Queried Per Completed Forms, by Type of Form)","text_display":"\nTable 11: Query Rates (Fields Queried Per Completed Forms, by Type of Form)","confidence":1,"confidence_rate":1},{"cnt":[[245,2084],[862,2084],[862,2133],[245,2133]],"region":{"top_left_x":244,"top_left_y":2083,"width":618,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ecc025c9a1f46488d0482c3c230d1a0","type":"text","conversion_output":true,"text":"Table 12: Adverse Event Reporting","text_display":"\nTable 12: Adverse Event Reporting","confidence":0.99853515625,"confidence_rate":0.9999614239629561},{"cnt":[[941,2580],[1179,2580],[1179,2628],[941,2628]],"region":{"top_left_x":941,"top_left_y":2580,"width":239,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f7f63c7666146eeaf9e38b09a4c8ba4","type":"page_info","conversion_output":false,"text":"Page 23 of 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}