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The minimum","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1846,975],[1846,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1602,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4280993617e84cd1aca484242ef82383","type":"text","conversion_output":true,"text":"length of follow-up will be slightly less than 2 years, and the median duration of follow-up will","text_display":" length of follow-up will be slightly less than 2 years, and the median duration of follow-up will","confidence":0.9926819801330566,"confidence_rate":0.9999300507519863},{"cnt":[[245,1023],[1811,1023],[1811,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":1568,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b62641a11984751946ab89c0d2afcad","type":"text","conversion_output":true,"text":"be approximately 4 years. At study entry and during the follow-up period, extensive clinical,","text_display":" be approximately 4 years. At study entry and during the follow-up period, extensive clinical,","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1055,1070],[1055,1121],[245,1121]],"region":{"top_left_x":244,"top_left_y":1069,"width":811,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21f013bd4174447e8c13e42fc83e6901","type":"text","conversion_output":true,"text":"quality-of-life, and economic data are collected.","text_display":" quality-of-life, and economic data are collected.","confidence":1,"confidence_rate":1},{"cnt":[[236,1203],[522,1203],[522,1274],[236,1274]],"region":{"top_left_x":236,"top_left_y":1203,"width":287,"height":72},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72d4da3ebe70402ca249fa9ec7ae9a23","type":"section_header","conversion_output":false,"children_ids":["a4a92bb27d2d4ad58fb9694ebd8fc30c"],"text":"","text_display":""},{"cnt":[[245,1212],[518,1212],[518,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1211,"width":274,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4a92bb27d2d4ad58fb9694ebd8fc30c","type":"text","conversion_output":true,"parent_id":"72d4da3ebe70402ca249fa9ec7ae9a23","text":"3. 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Objective}","confidence":1,"confidence_rate":1},{"cnt":[[245,1405],[1682,1405],[1682,1457],[245,1457]],"region":{"top_left_x":244,"top_left_y":1405,"width":1439,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d23c34837d3e431da35c779dfd0e471a","type":"text","conversion_output":true,"text":"The primary objective of CABANA is to determine whether the treatment strategy of","text_display":"\n\nThe primary objective of CABANA is to determine whether the treatment strategy of","confidence":1,"confidence_rate":1},{"cnt":[[245,1454],[1794,1454],[1794,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1454,"width":1550,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3cb524eb0f6450d99a0f54e3a9987e3","type":"text","conversion_output":true,"text":"percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation will","text_display":" percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation will","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,1502],[1867,1502],[1867,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1501,"width":1623,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e389b0066ff4c9099b5b87cd9c801fd","type":"text","conversion_output":true,"text":"improve clinical outcomes compared to treating the arrhythmia with current state-of-the-art drug","text_display":" improve clinical outcomes compared to treating the arrhythmia with current state-of-the-art drug","confidence":1,"confidence_rate":1},{"cnt":[[245,1551],[1330,1551],[1330,1603],[245,1603]],"region":{"top_left_x":244,"top_left_y":1551,"width":1086,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ce3048c20f6403ea83d467406ae6ddc","type":"text","conversion_output":true,"text":"therapy consisting of either rate control or rhythm control drugs.","text_display":" therapy consisting of either rate control or rhythm control drugs.","confidence":1,"confidence_rate":1},{"cnt":[[245,1646],[1734,1646],[1734,1697],[245,1697]],"region":{"top_left_x":244,"top_left_y":1645,"width":1490,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4da789393bd14f27915de1559650c040","type":"text","conversion_output":true,"text":"The primary endpoint is the time to the first event among a composite of major clinical","text_display":"\n\nThe primary endpoint is the time to the first event among a composite of major clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,1693],[647,1693],[647,1745],[245,1745]],"region":{"top_left_x":244,"top_left_y":1692,"width":403,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f696a118679d4fa0a548bf7b386805ca","type":"text","conversion_output":true,"text":"outcomes consisting 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ablation will reduce the incidence of this composite endpoint in patients with untreated","confidence":1,"confidence_rate":1},{"cnt":[[245,2088],[1760,2088],[1760,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2088,"width":1516,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d03122b26fa48b3a9bb490d7920b95e","type":"text","conversion_output":true,"text":"or under-treated AF warranting therapy, compared to current state-of-the-art drug therapy.","text_display":" or under-treated AF warranting therapy, compared to current state-of-the-art drug 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Left atrial size, morphology, and function","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1824,1212],[1824,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1581,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52d0f8d33f6c4e39aadf2b3aef09580f","type":"text","conversion_output":true,"text":"To aid in the interpretation of the primary and several of the secondary endpoint comparisons,","text_display":"\n\nTo aid in the interpretation of the primary and several of the secondary endpoint comparisons,","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1880,1259],[1880,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1636,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f668b3763e2488e87bb8f7d5c2b2629","type":"text","conversion_output":true,"text":"the individual components of the primary endpoint (in addition to death) will also be summarized","text_display":" the individual components of the primary endpoint (in addition to death) will also be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[947,1306],[947,1351],[245,1351]],"region":{"top_left_x":244,"top_left_y":1306,"width":704,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"967f0910df244704860af605eb71f05c","type":"text","conversion_output":true,"text":"between the randomized arms of the trial.","text_display":" between the randomized arms of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[241,1448],[806,1448],[806,1515],[241,1515]],"region":{"top_left_x":240,"top_left_y":1448,"width":566,"height":67},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7a2f0dee01447a08508592f82c6492c","type":"section_header","conversion_output":false,"children_ids":["e209c74622604914a0188b7d55e040f5"],"text":"","text_display":""},{"cnt":[[245,1452],[801,1452],[801,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1452,"width":558,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e209c74622604914a0188b7d55e040f5","type":"text","conversion_output":true,"parent_id":"f7a2f0dee01447a08508592f82c6492c","text":"4. 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No experimental drug or","text_display":" strategies that are used routinely across the U.S. and around the world. No experimental drug or","confidence":1,"confidence_rate":1},{"cnt":[[245,1659],[1835,1659],[1835,1708],[245,1708]],"region":{"top_left_x":244,"top_left_y":1658,"width":1591,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51e0e3f5438d4c7eaf82c8aa1b6f4f4e","type":"text","conversion_output":true,"text":"treatment is involved. The trial intervention is simply the random assignment of the subjects to","text_display":" treatment is involved. The trial intervention is simply the random assignment of the subjects to","confidence":1,"confidence_rate":1},{"cnt":[[245,1706],[1042,1706],[1042,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1705,"width":798,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ae113f5db4947fc88d6d76420bd1845","type":"text","conversion_output":true,"text":"one or the other of the two treatment strategies.","text_display":" one or the other of the two treatment strategies.","confidence":1,"confidence_rate":1},{"cnt":[[245,1800],[1854,1800],[1854,1852],[245,1852]],"region":{"top_left_x":244,"top_left_y":1800,"width":1611,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a01da68d0a864a4282b77c6fbb92bdc8","type":"text","conversion_output":true,"text":"Eligible subjects who provided written informed consent and met all inclusion and no exclusion","text_display":"\n\nEligible subjects who provided written informed consent and met all inclusion and no exclusion","confidence":1,"confidence_rate":1},{"cnt":[[245,1850],[1846,1850],[1846,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1849,"width":1602,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d8b78da5e5f4eedad56bea196ecdf71","type":"text","conversion_output":true,"text":"criteria were randomly assigned in equal proportions ( \\(1: 1\\) ) to either the catheter ablation arm or","text_display":" criteria were randomly assigned in equal proportions ( \\(1: 1\\) ) to either the catheter ablation arm or","confidence":0.6143220076337457,"confidence_rate":0.9954567440479367},{"cnt":[[245,1899],[1760,1899],[1760,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1899,"width":1516,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"926b8de54b564ef99db1e6c9940b0cd1","type":"text","conversion_output":true,"text":"the drug arm using permuted blocks, stratified by clinical site. Subject randomization was","text_display":" the drug arm using permuted blocks, stratified by clinical site. 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Primary Analysis Population","text_display":"\n\n\\section*{5. Primary Analysis Population}","confidence":1,"confidence_rate":1},{"cnt":[[245,2247],[1699,2247],[1699,2299],[245,2299]],"region":{"top_left_x":244,"top_left_y":2247,"width":1456,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41aec3ceb92e499ca9809dd48f0abb84","type":"text","conversion_output":true,"text":"Except where otherwise noted, all randomized subjects will be included in the analysis","text_display":"\n\nExcept where otherwise noted, all randomized subjects will be included in the analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1865,2299],[1865,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2298,"width":1621,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5372d16ce6c64875abe2fa1ed7c4f8ea","type":"text","conversion_output":true,"text":"population for assessing the primary and secondary endpoints. All major treatment comparisons","text_display":" population for assessing the primary and secondary endpoints. All major treatment comparisons","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1766,2346],[1766,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2346,"width":1523,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"320cebf6c2744b77a5f0ba3127878839","type":"text","conversion_output":true,"text":"between the randomized groups in the trial will be performed according to the principle of","text_display":" between the randomized groups in the trial will be performed according to the principle of","confidence":1,"confidence_rate":1},{"cnt":[[245,2393],[1865,2393],[1865,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2393,"width":1621,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4af31659130d4f3fb47bc16066201de6","type":"text","conversion_output":true,"text":"\"intention-to-treat\" (ITT); that is, subjects will be analyzed and endpoints attributed according to","text_display":" \"intention-to-treat\" (ITT); that is, subjects will be analyzed and endpoints attributed according to","confidence":1,"confidence_rate":1},{"cnt":[[245,2441],[1852,2441],[1852,2492],[245,2492]],"region":{"top_left_x":244,"top_left_y":2440,"width":1608,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53b662ce808747bea2bd6b1bd536c17f","type":"text","conversion_output":true,"text":"the treatment arm to which the patients were randomized, regardless of subsequent crossover or","text_display":" the treatment arm to which the patients were randomized, regardless of subsequent crossover or","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"875cb82470ca47b2bb685cb6ec7127d2","type":"page_info","conversion_output":false,"text":"4","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-06","page":6,"lines":[{"cnt":[[245,254],[1742,254],[1742,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1499,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a07eb3418354c80a0d799f271e4c91d","type":"text","conversion_output":true,"text":"post-randomization medical care. As explained later in this document (section 10), some","text_display":"\npost-randomization medical care. As explained later in this document (section 10), some","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1332,301],[1332,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1089,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b2be1378adf4a0d80c8a0da5c7974ac","type":"text","conversion_output":true,"text":"additional analyses will be conducted using \"on-treatment\" data.","text_display":" additional analyses will be conducted using \"on-treatment\" data.","confidence":1,"confidence_rate":1},{"cnt":[[236,451],[587,451],[587,518],[236,518]],"region":{"top_left_x":236,"top_left_y":451,"width":351,"height":67},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ba1f0f779aa450abc05cc576d9a04b9","type":"section_header","conversion_output":false,"children_ids":["77da9a9d4632494fb0e56bb0d762a79b"],"text":"","text_display":""},{"cnt":[[245,460],[578,460],[578,511],[245,511]],"region":{"top_left_x":244,"top_left_y":459,"width":334,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77da9a9d4632494fb0e56bb0d762a79b","type":"text","conversion_output":true,"parent_id":"9ba1f0f779aa450abc05cc576d9a04b9","text":"6. Data Sources","text_display":"\n\n\\section*{6. Data Sources}","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1830,563],[1830,612],[245,612]],"region":{"top_left_x":244,"top_left_y":562,"width":1587,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e22eaafab6f241e2833b7b818ba0de31","type":"text","conversion_output":true,"text":"The enrolling clinical sites complete a series of electronic Case Report Forms (eCRF) for each","text_display":"\n\nThe enrolling clinical sites complete a series of electronic Case Report Forms (eCRF) for each","confidence":1,"confidence_rate":1},{"cnt":[[245,610],[1858,610],[1858,660],[245,660]],"region":{"top_left_x":244,"top_left_y":610,"width":1615,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3c92a4752a043c1903bde97b6418a70","type":"text","conversion_output":true,"text":"subject randomized, including demographic, clinical, and quality of life forms at enrollment and","text_display":" subject randomized, including demographic, clinical, and quality of life forms at enrollment and","confidence":1,"confidence_rate":1},{"cnt":[[245,657],[1863,657],[1863,707],[245,707]],"region":{"top_left_x":244,"top_left_y":657,"width":1619,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0554fe2ae2b148b790d73786bef030e6","type":"text","conversion_output":true,"text":"at specified follow-up intervals (the follow-up intervals are detailed in the study protocol), event","text_display":" at specified follow-up intervals (the follow-up intervals are detailed in the study protocol), event","confidence":1,"confidence_rate":1},{"cnt":[[245,705],[1755,705],[1755,758],[245,758]],"region":{"top_left_x":244,"top_left_y":704,"width":1512,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60570549642a461bafa9912e6e259f8d","type":"text","conversion_output":true,"text":"forms for death, neurological events, bleeding, cardiac arrest, and other ancillary forms as","text_display":" forms for death, neurological events, bleeding, cardiac arrest, and other ancillary forms as","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[402,752],[402,806],[245,806]],"region":{"top_left_x":244,"top_left_y":751,"width":158,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27d050d64745453c949792b956cdae24","type":"text","conversion_output":true,"text":"required.","text_display":" required.","confidence":1,"confidence_rate":1},{"cnt":[[245,849],[1815,849],[1815,900],[245,900]],"region":{"top_left_x":244,"top_left_y":848,"width":1572,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1427329f45a49a0890613db7f52abd3","type":"text","conversion_output":true,"text":"Clinical data are collected using the InForm electronic data capture (EDC) system. Except as","text_display":"\n\nClinical data are collected using the InForm electronic data capture (EDC) system. Except as","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1772,898],[1772,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":1529,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7665e72f580c4c11bda59ad2842543f1","type":"text","conversion_output":true,"text":"noted below in section 9.8, rhythm data are collected using the \"CABANA Box,\" a rhythm","text_display":" noted below in section 9.8, rhythm data are collected using the \"CABANA Box,\" a rhythm","confidence":1,"confidence_rate":1},{"cnt":[[245,945],[1880,945],[1880,995],[245,995]],"region":{"top_left_x":244,"top_left_y":945,"width":1636,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d5ea56c4afc4b0d9e65c3295b2abc12","type":"text","conversion_output":true,"text":"monitoring system provided for each patient by Medicomp. The rhythm monitoring data are sent","text_display":" monitoring system provided for each patient by Medicomp. The rhythm monitoring data are sent","confidence":1,"confidence_rate":1},{"cnt":[[245,993],[1854,993],[1854,1042],[245,1042]],"region":{"top_left_x":244,"top_left_y":992,"width":1611,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1f6b42cbcf646f6b1265370b27337b1","type":"text","conversion_output":true,"text":"from Medicomp to the Duke Clinical Research Institute (DCRI), where a determination is made","text_display":" from Medicomp to the Duke Clinical Research Institute (DCRI), where a determination is made","confidence":1,"confidence_rate":1},{"cnt":[[245,1040],[1828,1040],[1828,1089],[245,1089]],"region":{"top_left_x":244,"top_left_y":1039,"width":1585,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34c9e72ee94c4e1aa5235e0bb42c4bad","type":"text","conversion_output":true,"text":"as to which rhythms should be sent to the ECG core lab in Seattle for review and adjudication.","text_display":" as to which rhythms should be sent to the ECG core lab in Seattle for review and adjudication.","confidence":1,"confidence_rate":1},{"cnt":[[245,1087],[1828,1087],[1828,1139],[245,1139]],"region":{"top_left_x":244,"top_left_y":1087,"width":1585,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"411e6865be3d4ac2ae72c41810c03567","type":"text","conversion_output":true,"text":"The core lab sends adjudicated results back to the DCRI. Sites with any subjects not using the","text_display":" The core lab sends adjudicated results back to the DCRI. Sites with any subjects not using the","confidence":1,"confidence_rate":1},{"cnt":[[245,1134],[1734,1134],[1734,1188],[245,1188]],"region":{"top_left_x":244,"top_left_y":1134,"width":1490,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53e7644b62af4affbf0fa90939dff277","type":"text","conversion_output":true,"text":"\"CABANA Box\" submit rhythm data on those subjects through a secure portal using the","text_display":" \"CABANA Box\" submit rhythm data on those subjects through a secure portal using the","confidence":1,"confidence_rate":1},{"cnt":[[245,1182],[1818,1182],[1818,1233],[245,1233]],"region":{"top_left_x":244,"top_left_y":1181,"width":1574,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e846b207152c4e0a80c3ea88cf7259ae","type":"text","conversion_output":true,"text":"CABANA sharepoint website, which is then processed and submitted to the ECG core lab for","text_display":" CABANA sharepoint website, which is then processed and submitted to the ECG core lab for","confidence":1,"confidence_rate":1},{"cnt":[[245,1231],[1781,1231],[1781,1283],[245,1283]],"region":{"top_left_x":244,"top_left_y":1231,"width":1538,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5854a9b5381d48d4a3026e4d24133667","type":"text","conversion_output":true,"text":"adjudication. CT/MRI data are received and processed by Mayo Clinic's Imaging Analysis","text_display":" adjudication. CT/MRI data are received and processed by Mayo Clinic's Imaging Analysis","confidence":0.99853515625,"confidence_rate":0.999983891144227},{"cnt":[[245,1280],[1326,1280],[1326,1330],[245,1330]],"region":{"top_left_x":244,"top_left_y":1280,"width":1082,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f323f1c521d4c70b0df080ae7b18391","type":"text","conversion_output":true,"text":"Laboratory, and the information is then transferred to the DCRI.","text_display":" Laboratory, and the information is then transferred to the DCRI.","confidence":1,"confidence_rate":1},{"cnt":[[245,1377],[1828,1377],[1828,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1377,"width":1585,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99bf0c06242a46f2ac1a3fac3a0860a1","type":"text","conversion_output":true,"text":"All data collected in the study are managed and analyzed at the CABANA Statistical and Data","text_display":"\n\nAll data collected in the study are managed and analyzed at the CABANA Statistical and Data","confidence":1,"confidence_rate":1},{"cnt":[[245,1422],[1800,1422],[1800,1474],[245,1474]],"region":{"top_left_x":244,"top_left_y":1422,"width":1557,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3be7bb3f3ac84facb26720d30a8c9e75","type":"text","conversion_output":true,"text":"Coordinating Center at the DCRI. The InForm eCRF data are carefully reviewed, queried as","text_display":" Coordinating Center at the DCRI. The InForm eCRF data are carefully reviewed, queried as","confidence":1,"confidence_rate":1},{"cnt":[[245,1472],[1863,1472],[1863,1523],[245,1523]],"region":{"top_left_x":244,"top_left_y":1471,"width":1619,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f177cbee2894ea0acd55370c95ca728","type":"text","conversion_output":true,"text":"needed, and then downloaded as raw SAS data files, and further review and checking of the data","text_display":" needed, and then downloaded as raw SAS data files, and further review and checking of the data","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[1779,1521],[1779,1571],[245,1571]],"region":{"top_left_x":244,"top_left_y":1521,"width":1535,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62ac1e337ebe41168e6bc0702a47b322","type":"text","conversion_output":true,"text":"occur. The raw SAS data, analysis datasets, and analysis programs are stored on the secure","text_display":" occur. The raw SAS data, analysis datasets, and analysis programs are stored on the secure","confidence":1,"confidence_rate":1},{"cnt":[[245,1568],[1852,1568],[1852,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1568,"width":1608,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"338cb58d4e524760ae06655f37a40d21","type":"text","conversion_output":true,"text":"DCRI statistical server. Final analyses will be performed at the DCRI using SAS version 9.4 or","text_display":" DCRI statistical server. Final analyses will be performed at the DCRI using SAS version 9.4 or","confidence":1,"confidence_rate":1},{"cnt":[[245,1616],[1768,1616],[1768,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1615,"width":1525,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97e59ef109c54eafbb95010a5bb2bcff","type":"text","conversion_output":true,"text":"higher (SAS Institute Inc., Cary, NC). All programs written to create analysis datasets and","text_display":" higher (SAS Institute Inc., Cary, NC). All programs written to create analysis datasets and","confidence":1,"confidence_rate":1},{"cnt":[[245,1663],[1742,1663],[1742,1714],[245,1714]],"region":{"top_left_x":244,"top_left_y":1662,"width":1499,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60c594021db847e9b0ae0c387dd8afe8","type":"text","conversion_output":true,"text":"perform analyses will be validated according to SOPs established by the DCRI Statistical","text_display":" perform analyses will be validated according to SOPs established by the DCRI Statistical","confidence":1,"confidence_rate":1},{"cnt":[[245,1712],[599,1712],[599,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1712,"width":356,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61ccbcc5e093401494ce73e68558810c","type":"text","conversion_output":true,"text":"Programming group.","text_display":" Programming group.","confidence":1,"confidence_rate":1},{"cnt":[[236,1850],[952,1850],[952,1923],[236,1923]],"region":{"top_left_x":236,"top_left_y":1849,"width":716,"height":74},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86f7c3a0b3c941468f35a382398b1b2e","type":"section_header","conversion_output":false,"children_ids":["82c0573fde5d4c90a0b22f949dc2f9eb"],"text":"","text_display":""},{"cnt":[[245,1858],[943,1858],[943,1914],[245,1914]],"region":{"top_left_x":244,"top_left_y":1858,"width":700,"height":57},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82c0573fde5d4c90a0b22f949dc2f9eb","type":"text","conversion_output":true,"parent_id":"86f7c3a0b3c941468f35a382398b1b2e","text":"7. General Analysis Methodology","text_display":"\n\n\\section*{7. General Analysis Methodology}","confidence":1,"confidence_rate":1},{"cnt":[[245,1972],[1858,1972],[1858,2024],[245,2024]],"region":{"top_left_x":244,"top_left_y":1972,"width":1615,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3e211fcd65e479487c2b4a59aa19bea","type":"text","conversion_output":true,"text":"As stated previously and except where otherwise noted, all major treatment comparisons will be","text_display":"\n\nAs stated previously and except where otherwise noted, all major treatment comparisons will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1766,2020],[1766,2073],[245,2073]],"region":{"top_left_x":244,"top_left_y":2019,"width":1523,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbe4a518afc647d1b486c71977f81258","type":"text","conversion_output":true,"text":"performed according to the principle of \"intention-to-treat.\" Subjects will be analyzed and","text_display":" performed according to the principle of \"intention-to-treat.\" Subjects will be analyzed and","confidence":1,"confidence_rate":1},{"cnt":[[245,2069],[1712,2069],[1712,2121],[245,2121]],"region":{"top_left_x":244,"top_left_y":2068,"width":1469,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2dcfde7dbae4b4c9de0c95c8c416d8e","type":"text","conversion_output":true,"text":"endpoints attributed according to the treatment arm to which patients were randomized,","text_display":" endpoints attributed according to the treatment arm to which patients were randomized,","confidence":1,"confidence_rate":1},{"cnt":[[245,2116],[1446,2116],[1446,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2116,"width":1202,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5b652937bd0479aa66445e8541ab458","type":"text","conversion_output":true,"text":"regardless of subsequent crossover or post-randomization medical care.","text_display":" regardless of subsequent crossover or post-randomization medical care.","confidence":1,"confidence_rate":1},{"cnt":[[245,2213],[1757,2213],[1757,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":1514,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22766963c72c4d2a96890182d16c8cea","type":"text","conversion_output":true,"text":"Appropriate statistical models and tests will be used to examine the effect of the treatment","text_display":"\n\nAppropriate statistical models and tests will be used to examine the effect of the treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1815,2260],[1815,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1572,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c4f4e6aeda64f1c94296fd6927fd56c","type":"text","conversion_output":true,"text":"strategies on the primary and secondary endpoints. For time-to-first-event endpoints, the log-","text_display":" strategies on the primary and secondary endpoints. For time-to-first-event endpoints, the log","confidence":1,"confidence_rate":1},{"cnt":[[245,2303],[1766,2303],[1766,2359],[245,2359]],"region":{"top_left_x":244,"top_left_y":2303,"width":1523,"height":56},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"075ca25253364eb68f8aee9c74739d5e","type":"text","conversion_output":true,"text":"rank test \\({ }^{1}\\) and Cox proportional hazards model \\({ }^{2}\\) will be used for statistically comparing the","text_display":"rank test \\({ }^{1}\\) and Cox proportional hazards model \\({ }^{2}\\) will be used for statistically comparing the","confidence":1,"confidence_rate":1},{"cnt":[[245,2357],[1861,2357],[1861,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2356,"width":1617,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27a59e9427e24443ae27c544ac5d4fe8","type":"text","conversion_output":true,"text":"treatment groups unless otherwise specified. Additional perspective regarding the interpretation","text_display":" treatment groups unless otherwise specified. Additional perspective regarding the interpretation","confidence":1,"confidence_rate":1},{"cnt":[[245,2402],[1876,2402],[1876,2454],[245,2454]],"region":{"top_left_x":244,"top_left_y":2401,"width":1632,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"753a431c4572499fb39dde27f08b1d4c","type":"text","conversion_output":true,"text":"of the data will be provided through extensive use of confidence intervals and graphical displays,","text_display":" of the data will be provided through extensive use of confidence intervals and graphical displays,","confidence":1,"confidence_rate":1},{"cnt":[[245,2445],[1749,2445],[1749,2503],[245,2503]],"region":{"top_left_x":244,"top_left_y":2444,"width":1505,"height":59},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82c0a3dbaa174122831cb062b17bd779","type":"text","conversion_output":true,"text":"including plots of Kaplan-Meier \\({ }^{3}\\) event-rate estimates. All statistical comparisons will be","text_display":" including plots of Kaplan-Meier \\({ }^{3}\\) event-rate estimates. All statistical comparisons will be","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b60668efe30a4bd6a76ec82abe617bb3","type":"page_info","conversion_output":false,"text":"5","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-07","page":7,"lines":[{"cnt":[[245,251],[1768,251],[1768,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1525,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8214758f7c0a46dbbf2f59691115af52","type":"text","conversion_output":true,"text":"performed using two-sided significance tests and a nominal level of significance of \\(\\alpha=0.05\\)","text_display":"\nperformed using two-sided significance tests and a nominal level of significance of \\(\\alpha=0.05\\)","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[245,301],[703,301],[703,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":459,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9e0f912120b47bcb5b6d5a1ef96e2ed","type":"text","conversion_output":true,"text":"unless otherwise specified.","text_display":" unless otherwise specified.","confidence":1,"confidence_rate":1},{"cnt":[[243,387],[975,387],[975,443],[243,443]],"region":{"top_left_x":242,"top_left_y":386,"width":734,"height":57},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ba48f7bb56c4bebb4e529359ad8662f","type":"section_header","conversion_output":false,"children_ids":["6247784d20e04e06ba68e01b1dd72a22"],"text":"","text_display":""},{"cnt":[[245,391],[971,391],[971,436],[245,436]],"region":{"top_left_x":244,"top_left_y":391,"width":728,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6247784d20e04e06ba68e01b1dd72a22","type":"text","conversion_output":true,"parent_id":"0ba48f7bb56c4bebb4e529359ad8662f","text":"7.1. Demographic and Baseline Analyses","text_display":"\n\n\\subsection*{7.1. Demographic and Baseline Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[245,498],[1833,498],[1833,546],[245,546]],"region":{"top_left_x":244,"top_left_y":498,"width":1589,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eace553f43d144b78f10218f79f09eee","type":"text","conversion_output":true,"text":"Descriptive summaries of the distribution of continuous baseline variables will be presented in","text_display":"\n\nDescriptive summaries of the distribution of continuous baseline variables will be presented in","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[245,541],[1704,541],[1704,595],[245,595]],"region":{"top_left_x":244,"top_left_y":541,"width":1460,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96640e0422b846848dbc231ae964fe65","type":"text","conversion_output":true,"text":"terms of percentiles (median, \\(25^{\\text {th }}\\) and \\(75^{\\text {th }}\\) percentiles), while discrete variables will be","text_display":" terms of percentiles (median, \\(25^{\\text {th }}\\) and \\(75^{\\text {th }}\\) percentiles), while discrete variables will be","confidence":0.9136991095729172,"confidence_rate":0.9992782288941132},{"cnt":[[245,593],[1760,593],[1760,642],[245,642]],"region":{"top_left_x":244,"top_left_y":592,"width":1516,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38d9c40c06f04fd180f3c045f07df532","type":"text","conversion_output":true,"text":"summarized in terms of frequencies and percentages. Statistical comparisons of treatment","text_display":" summarized in terms of frequencies and percentages. Statistical comparisons of treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,642],[1824,642],[1824,690],[245,690]],"region":{"top_left_x":244,"top_left_y":642,"width":1581,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b5e107f88964befb461ffa829b74adb","type":"text","conversion_output":true,"text":"groups with respect to baseline characteristics will be limited to selected variables and disease","text_display":" groups with respect to baseline characteristics will be limited to selected variables and disease","confidence":1,"confidence_rate":1},{"cnt":[[245,690],[1876,690],[1876,741],[245,741]],"region":{"top_left_x":244,"top_left_y":689,"width":1632,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f2e77ab8c774682a25fe290f86927f2","type":"text","conversion_output":true,"text":"factors known to influence prognosis. These variables will include: age, sex, race, descriptors of","text_display":" factors known to influence prognosis. These variables will include: age, sex, race, descriptors of","confidence":1,"confidence_rate":1},{"cnt":[[245,739],[1824,739],[1824,788],[245,788]],"region":{"top_left_x":244,"top_left_y":739,"width":1581,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bccf8e8fed5b4ac6a842cc566228d236","type":"text","conversion_output":true,"text":"comorbidity, heart failure class, type of AF (paroxysmal, persistent or permanent), years since","text_display":" comorbidity, heart failure class, type of AF (paroxysmal, persistent or permanent), years since","confidence":0.978515625,"confidence_rate":0.9997828383434604},{"cnt":[[245,786],[1738,786],[1738,836],[245,836]],"region":{"top_left_x":244,"top_left_y":786,"width":1495,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b87a6a794fc84436a722ec825b3ca2bc","type":"text","conversion_output":true,"text":"onset of AF, days from most recent qualifying episode of atrial fibrillation to enrollment,","text_display":" onset of AF, days from most recent qualifying episode of atrial fibrillation to enrollment,","confidence":0.7548828125,"confidence_rate":0.997075194383481},{"cnt":[[245,834],[1818,834],[1818,883],[245,883]],"region":{"top_left_x":244,"top_left_y":833,"width":1574,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dac834b13fb24e96bb7b2efb44bac658","type":"text","conversion_output":true,"text":"presence/absence of structural heart disease, and \\(CHA _{2} DS _{2}\\)-VASc score. For comparisons of","text_display":" presence/absence of structural heart disease, and \\(CHA _{2} DS _{2}\\)-VASc score. For comparisons of","confidence":0.9951221942901611,"confidence_rate":0.9999582082149074},{"cnt":[[245,883],[1790,883],[1790,930],[245,930]],"region":{"top_left_x":244,"top_left_y":883,"width":1546,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d35ccfa1497c4c65963a8e0025ddf1e9","type":"text","conversion_output":true,"text":"treatment groups with respect to continuous or ordinal baseline variables, the nonparametric","text_display":" treatment groups with respect to continuous or ordinal baseline variables, the nonparametric","confidence":1,"confidence_rate":1},{"cnt":[[245,928],[1768,928],[1768,978],[245,978]],"region":{"top_left_x":244,"top_left_y":928,"width":1525,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7f13ba941e54636b8b6b682236bad80","type":"text","conversion_output":true,"text":"Wilcoxon rank-sum test will be used. Group comparisons with respect to discrete baseline","text_display":" Wilcoxon rank-sum test will be used. Group comparisons with respect to discrete baseline","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1644,975],[1644,1027],[245,1027]],"region":{"top_left_x":244,"top_left_y":975,"width":1400,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5ec4cbeeeeb4d9e89e7f855da3d2ca1","type":"text","conversion_output":true,"text":"variables will use the Pearson's chi-square test or Fisher's exact test as appropriate.","text_display":" variables will use the Pearson's chi-square test or Fisher's exact test as appropriate.","confidence":0.9936552047729492,"confidence_rate":0.9999308175129241},{"cnt":[[245,1085],[746,1085],[746,1141],[245,1141]],"region":{"top_left_x":244,"top_left_y":1084,"width":502,"height":57},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e402e8f164d4a3a90125e4a39f498c7","type":"section_header","conversion_output":false,"children_ids":["093c94154172403db9545940290f8295"],"text":"","text_display":""},{"cnt":[[249,1087],[741,1087],[741,1137],[249,1137]],"region":{"top_left_x":249,"top_left_y":1087,"width":493,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"093c94154172403db9545940290f8295","type":"text","conversion_output":true,"parent_id":"6e402e8f164d4a3a90125e4a39f498c7","text":"7.2 Disposition of Subjects","text_display":"\n\n\\subsection*{7.2 Disposition of Subjects}","confidence":0.9990234375,"confidence_rate":0.999969467977117},{"cnt":[[245,1173],[1828,1173],[1828,1225],[245,1225]],"region":{"top_left_x":244,"top_left_y":1173,"width":1585,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b96e4bc45bc7464d9d918c69766e17b3","type":"text","conversion_output":true,"text":"The disposition of subjects (number randomized, number who received the randomly assigned","text_display":"\n\nThe disposition of subjects (number randomized, number who received the randomly assigned","confidence":1,"confidence_rate":1},{"cnt":[[245,1222],[1764,1220],[1764,1272],[245,1274]],"region":{"top_left_x":244,"top_left_y":1220,"width":1520,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8dda653a75840b8a26fc1e5142a539f","type":"text","conversion_output":true,"text":"treatment, number of treatment crossovers, number of patients who withdrew consent, and","text_display":" treatment, number of treatment crossovers, number of patients who withdrew consent, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1272],[1828,1272],[1828,1321],[245,1321]],"region":{"top_left_x":244,"top_left_y":1271,"width":1585,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2040b74fb1a84392924ec2b7b8ff2f51","type":"text","conversion_output":true,"text":"number lost to follow-up) will be summarized overall and by treatment arm. The summary of","text_display":" number lost to follow-up) will be summarized overall and by treatment arm. The summary of","confidence":1,"confidence_rate":1},{"cnt":[[245,1319],[1854,1319],[1854,1369],[245,1369]],"region":{"top_left_x":244,"top_left_y":1319,"width":1611,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cebf2c63e62e4e2a9896296bf5462f37","type":"text","conversion_output":true,"text":"treatment crossovers will distinguish the patients randomized to the drug arm who subsequently","text_display":" treatment crossovers will distinguish the patients randomized to the drug arm who subsequently","confidence":1,"confidence_rate":1},{"cnt":[[245,1366],[1833,1366],[1833,1416],[245,1416]],"region":{"top_left_x":244,"top_left_y":1366,"width":1589,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc86a53118c4429184c866ce33609cb0","type":"text","conversion_output":true,"text":"underwent catheter ablation (crossed over to ablation) during the course of their follow-up and","text_display":" underwent catheter ablation (crossed over to ablation) during the course of their follow-up and","confidence":1,"confidence_rate":1},{"cnt":[[245,1414],[1858,1414],[1858,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1413,"width":1615,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f8f52455bba42e49ee305e0b24611bd","type":"text","conversion_output":true,"text":"the patients randomized to the ablation arm who never received an ablation. The distribution of","text_display":" the patients randomized to the ablation arm who never received an ablation. The distribution of","confidence":1,"confidence_rate":1},{"cnt":[[245,1461],[1800,1461],[1800,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1460,"width":1557,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4b541531f2940ab9a4ac3ba08d2f3a3","type":"text","conversion_output":true,"text":"the length of follow-up for the overall study population and for each randomized arm will be","text_display":" the length of follow-up for the overall study population and for each randomized arm will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1504],[1755,1504],[1755,1558],[245,1558]],"region":{"top_left_x":244,"top_left_y":1503,"width":1512,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d4fc93163994c2baacdeedc849d9635","type":"text","conversion_output":true,"text":"characterized in terms of percentiles (median, \\(25^{\\text {th }}\\), and \\(75^{\\text {th }}\\) percentiles). The number and","text_display":" characterized in terms of percentiles (median, \\(25^{\\text {th }}\\), and \\(75^{\\text {th }}\\) percentiles). The number and","confidence":0.9936599708162248,"confidence_rate":0.9999495233968226},{"cnt":[[245,1558],[1807,1558],[1807,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1557,"width":1563,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69ff7aa9b2f64d8d9cd0beef4fb09b0f","type":"text","conversion_output":true,"text":"percentage of patients who had at least 3 years of follow-up, and at least 5 years of follow-up","text_display":" percentage of patients who had at least 3 years of follow-up, and at least 5 years of follow-up","confidence":1,"confidence_rate":1},{"cnt":[[245,1607],[1738,1607],[1738,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1607,"width":1495,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f77db9854dbf4ec8af888ac2da515680","type":"text","conversion_output":true,"text":"will also be tabulated and reported. Among patients in the drug arm who crossed over to","text_display":" will also be tabulated and reported. Among patients in the drug arm who crossed over to","confidence":1,"confidence_rate":1},{"cnt":[[245,1654],[1850,1654],[1850,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1654,"width":1606,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fa9415566d24eb3a0e065002e531abf","type":"text","conversion_output":true,"text":"ablation, the distribution of length of follow-up prior to the crossover will be described in terms","text_display":" ablation, the distribution of length of follow-up prior to the crossover will be described in terms","confidence":1,"confidence_rate":1},{"cnt":[[245,1702],[1811,1702],[1811,1751],[245,1751]],"region":{"top_left_x":244,"top_left_y":1701,"width":1568,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d016a75c1f6f4d199c19e13bbfe8c83c","type":"text","conversion_output":true,"text":"of percentiles. Also the distribution of follow-up among patients who withdrew consent (i.e.,","text_display":" of percentiles. Also the distribution of follow-up among patients who withdrew consent (i.e.,","confidence":0.998046875,"confidence_rate":0.9999800508639274},{"cnt":[[245,1749],[1848,1749],[1848,1800],[245,1800]],"region":{"top_left_x":244,"top_left_y":1748,"width":1604,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac8d78f0d6234022a5bea48399b45144","type":"text","conversion_output":true,"text":"patients who withdrew prior to the protocol-specified 3 years of follow-up) will be summarized","text_display":" patients who withdrew prior to the protocol-specified 3 years of follow-up) will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,1796],[1772,1796],[1772,1848],[245,1848]],"region":{"top_left_x":244,"top_left_y":1796,"width":1529,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"508bdbfacc214bd6a1afd19b66f813dc","type":"text","conversion_output":true,"text":"in terms of percentiles. Additionally, the number and percentage of patients who withdrew","text_display":" in terms of percentiles. Additionally, the number and percentage of patients who withdrew","confidence":1,"confidence_rate":1},{"cnt":[[245,1843],[1549,1843],[1549,1897],[245,1897]],"region":{"top_left_x":244,"top_left_y":1843,"width":1306,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fe3765582864a63a59121034414fc80","type":"text","conversion_output":true,"text":"consent before 3 years, after 3 to \\(<5\\) years, and after 5 years will be tabulated.","text_display":" consent before 3 years, after 3 to \\(<5\\) years, and after 5 years will be tabulated.","confidence":0.9970703125,"confidence_rate":0.999970061800863},{"cnt":[[243,1938],[578,1938],[578,1996],[243,1996]],"region":{"top_left_x":242,"top_left_y":1937,"width":336,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f173daae62f94cb983a727502753fccc","type":"section_header","conversion_output":false,"children_ids":["932d0bd4ccd24f96900d74db68212b66"],"text":"","text_display":""},{"cnt":[[245,1942],[574,1942],[574,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":330,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"932d0bd4ccd24f96900d74db68212b66","type":"text","conversion_output":true,"parent_id":"f173daae62f94cb983a727502753fccc","text":"7.3 Missing Data","text_display":"\n\n\\subsection*{7.3 Missing Data}","confidence":1,"confidence_rate":1},{"cnt":[[245,2030],[1820,2030],[1820,2080],[245,2080]],"region":{"top_left_x":244,"top_left_y":2030,"width":1576,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97d8632e45ef453f8ee9ab43efa51978","type":"text","conversion_output":true,"text":"Missing data will be handled differently for covariates and endpoints. Data for covariates (see","text_display":"\n\nMissing data will be handled differently for covariates and endpoints. Data for covariates (see","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1878,2075],[1878,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1634,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cc50690b1b44569a797c30729633012","type":"text","conversion_output":true,"text":"Section 8.1) are expected to be complete or near complete for all patients. Where missing data do","text_display":" Section 8.1) are expected to be complete or near complete for all patients. Where missing data do","confidence":1,"confidence_rate":1},{"cnt":[[245,2125],[1848,2125],[1848,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2124,"width":1604,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3286b960f7aa47f388ad6739f564b0df","type":"text","conversion_output":true,"text":"occur, using single-imputation methods, continuous variables will be imputed using the median","text_display":" occur, using single-imputation methods, continuous variables will be imputed using the median","confidence":1,"confidence_rate":1},{"cnt":[[245,2174],[1317,2174],[1317,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2174,"width":1073,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7dfbcfd48ceb4a0a927394028614a249","type":"text","conversion_output":true,"text":"value and categorical variables will be imputed using the mode.","text_display":" value and categorical variables will be imputed using the mode.","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1815,2260],[1815,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1572,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"097c92c7113e4097bf451d3e2396e459","type":"text","conversion_output":true,"text":"Most primary and secondary endpoints are time-to-event analyses which rely on the ability to","text_display":"\n\nMost primary and secondary endpoints are time-to-event analyses which rely on the ability to","confidence":1,"confidence_rate":1},{"cnt":[[245,2307],[1732,2307],[1732,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2307,"width":1488,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fe90e69b6d5495588cb45f903459baa","type":"text","conversion_output":true,"text":"calculate the time from randomization (or in some cases time from the end of the 90-day","text_display":" calculate the time from randomization (or in some cases time from the end of the 90-day","confidence":0.515625,"confidence_rate":0.9928261220614288},{"cnt":[[245,2355],[1846,2355],[1846,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2354,"width":1602,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9947a0b7916042e196514b16beca37b4","type":"text","conversion_output":true,"text":"blanking period) to when the event occurred or the date of last contact for censored individuals.","text_display":" blanking period) to when the event occurred or the date of last contact for censored individuals.","confidence":1,"confidence_rate":1},{"cnt":[[245,2406],[1727,2406],[1727,2456],[245,2456]],"region":{"top_left_x":244,"top_left_y":2406,"width":1484,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b827ce838b16432e855041910a5777db","type":"text","conversion_output":true,"text":"Here, missing data may occur when: 1) a visit form or question that indicates if an event","text_display":" Here, missing data may occur when: 1) a visit form or question that indicates if an event","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[245,2454],[1880,2454],[1880,2503],[245,2503]],"region":{"top_left_x":244,"top_left_y":2453,"width":1636,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61fbebd18c554a2798226b39ddccf9e9","type":"text","conversion_output":true,"text":"occurred (or not) is not completed, and 2) a form or question indicates that an event occurred, but","text_display":" occurred (or not) is not completed, and 2) a form or question indicates that an event occurred, but","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ef297e7d696e4e1ca50e8fe7af5af191","type":"page_info","conversion_output":false,"text":"6","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-08","page":8,"lines":[{"cnt":[[245,251],[1747,251],[1747,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1503,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02dc9257068f416dbe8a44a236751bbf","type":"text","conversion_output":true,"text":"the event date is missing. The first category prevents the assignment of whether an event","text_display":"\nthe event date is missing. The first category prevents the assignment of whether an event","confidence":0.99951171875,"confidence_rate":0.9999948042635181},{"cnt":[[245,301],[1764,301],[1764,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1520,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3b2ca29d83446268047ceb30b014f3c","type":"text","conversion_output":true,"text":"occurred or not, while the second category prevents calculation of time to the event. In all","text_display":" occurred or not, while the second category prevents calculation of time to the event. In all","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1798,348],[1798,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1555,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f6807aec34648a6b07dc4fdfbbde0fb","type":"text","conversion_output":true,"text":"analyses, we consider only non-missing data in the determination of whether or not an event","text_display":" analyses, we consider only non-missing data in the determination of whether or not an event","confidence":1,"confidence_rate":1},{"cnt":[[245,395],[1878,395],[1878,445],[245,445]],"region":{"top_left_x":244,"top_left_y":395,"width":1634,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c1254e74d5347cd87ef90f4b1f623a8","type":"text","conversion_output":true,"text":"occurred (i.e., cases in category 1 will not be considered). Time-to-event for known events when","text_display":" occurred (i.e., cases in category 1 will not be considered). Time-to-event for known events when","confidence":0.9975602623308077,"confidence_rate":0.9999765125962303},{"cnt":[[245,443],[1869,443],[1869,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1626,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49d848f9b75548c39de695ea1d6702de","type":"text","conversion_output":true,"text":"the event date is missing (category 2), will be assigned based on the visit with which the event is","text_display":" the event date is missing (category 2), will be assigned based on the visit with which the event is","confidence":0.6923828125,"confidence_rate":0.9964714680376995},{"cnt":[[245,490],[1880,490],[1880,541],[245,541]],"region":{"top_left_x":244,"top_left_y":489,"width":1636,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9f27e7e4a754536884ce4977beffb3f","type":"text","conversion_output":true,"text":"recorded. For example, if the event is reported on the month 3 visit, then the time to event would","text_display":" recorded. For example, if the event is reported on the month 3 visit, then the time to event would","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1828,537],[1828,589],[245,589]],"region":{"top_left_x":244,"top_left_y":537,"width":1585,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f896bdf9e2c44d5bb3dd9c1161a76c63","type":"text","conversion_output":true,"text":"be set to 91.26 days \\((365 / 12 * 3)\\). If the event is reported on the month 6 visit, then the time to","text_display":" be set to 91.26 days \\((365 / 12 * 3)\\). If the event is reported on the month 6 visit, then the time to","confidence":0.9990236759185791,"confidence_rate":0.9999912000297451},{"cnt":[[245,587],[1882,587],[1882,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1639,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed5a418825594600a69bca8c6f738e12","type":"text","conversion_output":true,"text":"event would be set to 182.52 days \\((365 / 12 * 6)\\), and so on for all visits up to month 96 . If patients","text_display":" event would be set to 182.52 days \\((365 / 12 * 6)\\), and so on for all visits up to month 96 . If patients","confidence":0.8922457695007324,"confidence_rate":0.9990003801460554},{"cnt":[[245,636],[1863,636],[1863,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1619,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e1651c505c743858147bba07ffe659d","type":"text","conversion_output":true,"text":"do not experience an event, and have an event-free status associated with a visit but no visit date","text_display":" do not experience an event, and have an event-free status associated with a visit but no visit date","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1815,683],[1815,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1572,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"751322eccad642ebb6d2f413dcb24d10","type":"text","conversion_output":true,"text":"on their last known visit, they will be assigned a censor date in the same manner. For patients","text_display":" on their last known visit, they will be assigned a censor date in the same manner. For patients","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1846,730],[1846,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1602,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44415e2b5c9e43e89167cd2069c5520c","type":"text","conversion_output":true,"text":"with multiple events including a death, any imputed non-death event dates (e.g., cardiovascular","text_display":" with multiple events including a death, any imputed non-death event dates (e.g., cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[245,778],[1412,778],[1412,831],[245,831]],"region":{"top_left_x":244,"top_left_y":777,"width":1168,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9edbfe555cb4c329ad973b3afe618fd","type":"text","conversion_output":true,"text":"(CV) hospitalization) will be forced to occur before the date of death.","text_display":" (CV) hospitalization) will be forced to occur before the date of death.","confidence":1,"confidence_rate":1},{"cnt":[[245,872],[1843,872],[1843,926],[245,926]],"region":{"top_left_x":244,"top_left_y":872,"width":1600,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f346a3e8e6d74792ab1b6a20fcbc5780","type":"text","conversion_output":true,"text":"If an event or censored status is reported, but both the visit number and event/censored date are","text_display":"\n\nIf an event or censored status is reported, but both the visit number and event/censored date are","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[245,922],[1828,922],[1828,973],[245,973]],"region":{"top_left_x":244,"top_left_y":921,"width":1585,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99451c09a3d045f6a2b88865a2907ec7","type":"text","conversion_output":true,"text":"missing, then the date of event/censor will be imputed using relevant data and considered on a","text_display":" missing, then the date of event/censor will be imputed using relevant data and considered on a","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[571,971],[571,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":328,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8fcd2612cfc4499b86886bd032f18a3","type":"text","conversion_output":true,"text":"case-by-case basis.","text_display":" case-by-case basis.","confidence":1,"confidence_rate":1},{"cnt":[[236,1109],[896,1109],[896,1182],[236,1182]],"region":{"top_left_x":236,"top_left_y":1108,"width":660,"height":74},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b0d16a87af4b2aad26fe34d92e3175","type":"section_header","conversion_output":false,"children_ids":["a2151abd7c7d449b957f95071d304634"],"text":"","text_display":""},{"cnt":[[245,1117],[887,1117],[887,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1117,"width":644,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2151abd7c7d449b957f95071d304634","type":"text","conversion_output":true,"parent_id":"11b0d16a87af4b2aad26fe34d92e3175","text":"8. Primary Endpoint Analysis","text_display":"\n\n\\section*{8. Primary Endpoint Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[243,1216],[1803,1216],[1803,1270],[243,1270]],"region":{"top_left_x":242,"top_left_y":1216,"width":1561,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"673b32b43c6741658e7c8630ffc406a9","type":"text","conversion_output":true,"text":"Primary Endpoint: Time from randomization to the first event among a composite of major","text_display":"\n\nPrimary Endpoint: Time from randomization to the first event among a composite of major","confidence":1,"confidence_rate":1},{"cnt":[[245,1265],[780,1265],[780,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1265,"width":536,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14b8c33e33fd4476acdf20dc1fb982d9","type":"text","conversion_output":true,"text":"clinical outcomes consisting of","text_display":" clinical outcomes consisting of","confidence":1,"confidence_rate":1},{"cnt":[[683,1319],[1040,1319],[1040,1369],[683,1369]],"region":{"top_left_x":683,"top_left_y":1319,"width":357,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad8c2d07106f479697ada462d5e4a9ea","type":"text","conversion_output":true,"text":"- Death (all-cause)","text_display":"\n- Death (all-cause)","confidence":1,"confidence_rate":1},{"cnt":[[683,1366],[1029,1366],[1029,1420],[683,1420]],"region":{"top_left_x":683,"top_left_y":1366,"width":347,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c52b4870b2a94d9cbc60d59b071240a8","type":"text","conversion_output":true,"text":"- Disabling stroke","text_display":"\n- Disabling stroke","confidence":1,"confidence_rate":1},{"cnt":[[683,1418],[1038,1418],[1038,1472],[683,1472]],"region":{"top_left_x":683,"top_left_y":1417,"width":355,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e32518600967439c81562acb6b4a933f","type":"text","conversion_output":true,"text":"- Serious bleeding","text_display":"\n- Serious bleeding","confidence":1,"confidence_rate":1},{"cnt":[[683,1470],[990,1470],[990,1517],[683,1517]],"region":{"top_left_x":683,"top_left_y":1469,"width":308,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe9805b0b0064bd5b427ee5ee020395f","type":"text","conversion_output":true,"text":"- Cardiac arrest","text_display":"\n- Cardiac arrest","confidence":1,"confidence_rate":1},{"cnt":[[245,1566],[1772,1566],[1772,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1566,"width":1529,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a8954ba44d142d6a919a6a52f174b6e","type":"text","conversion_output":true,"text":"All possible events are carefully reviewed and adjudicated by a Clinical Events Committee","text_display":"\n\nAll possible events are carefully reviewed and adjudicated by a Clinical Events Committee","confidence":1,"confidence_rate":1},{"cnt":[[245,1611],[1381,1611],[1381,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1611,"width":1138,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f811dfff736f45e0aeb7cfc27b3a7bde","type":"text","conversion_output":true,"text":"(CEC) completely blinded to the randomized treatment assignment.","text_display":" (CEC) completely blinded to the randomized treatment assignment.","confidence":1,"confidence_rate":1},{"cnt":[[245,1710],[1755,1710],[1755,1760],[245,1760]],"region":{"top_left_x":244,"top_left_y":1710,"width":1512,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"081896a5d9474e81bc9f3123bcd6823b","type":"text","conversion_output":true,"text":"Endpoint Definitions: Detailed definitions for each of the events are outlined in the CEC","text_display":"\n\nEndpoint Definitions: Detailed definitions for each of the events are outlined in the CEC","confidence":1,"confidence_rate":1},{"cnt":[[245,1757],[1800,1757],[1800,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":1757,"width":1557,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ba0f0af048441dfb2c37e47ab6ec267","type":"text","conversion_output":true,"text":"charter. We note that a disabling stroke during follow-up must be documented by a neurologic","text_display":" charter. We note that a disabling stroke during follow-up must be documented by a neurologic","confidence":1,"confidence_rate":1},{"cnt":[[245,1805],[1867,1805],[1867,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1804,"width":1623,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07a5b54cfa4b4186bb4ae0b514f9d7c9","type":"text","conversion_output":true,"text":"evaluation or brain CT / MR studies and result in a disabling, irreversible physical limitation defined","text_display":" evaluation or brain CT / MR studies and result in a disabling, irreversible physical limitation defined","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,1850],[1880,1850],[1880,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1849,"width":1636,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cccfcc5ff37d4e429b82a6a2af82bcbe","type":"text","conversion_output":true,"text":"by a Rankin Stroke Scale \\(\\geq 2\\). Serious (or life-threatening) bleeding is considered to have occurred if","text_display":" by a Rankin Stroke Scale \\(\\geq 2\\). Serious (or life-threatening) bleeding is considered to have occurred if","confidence":0.9970715045928955,"confidence_rate":0.9999733386114222},{"cnt":[[245,1899],[1723,1899],[1723,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1899,"width":1480,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4df30eb8b2334fbd9d951e441efccc54","type":"text","conversion_output":true,"text":"intracranial bleeding or other bleeding occurs at any time during follow-up accompanied by","text_display":" intracranial bleeding or other bleeding occurs at any time during follow-up accompanied by","confidence":1,"confidence_rate":1},{"cnt":[[245,1942],[1841,1942],[1841,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":1598,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce921a3497e94e84979886b04cfbe640","type":"text","conversion_output":true,"text":"hemodynamic compromise that requires surgical intervention or a transfusion of \\(\\geq 3\\) units of blood.","text_display":" hemodynamic compromise that requires surgical intervention or a transfusion of \\(\\geq 3\\) units of blood.","confidence":1,"confidence_rate":1},{"cnt":[[245,1989],[1775,1989],[1775,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1989,"width":1531,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89182ad0d9e9453488d71f1fc05b542b","type":"text","conversion_output":true,"text":"The serious bleeding definition does not include bleeding occurring with cardiac perforation or","text_display":" The serious bleeding definition does not include bleeding occurring with cardiac perforation or","confidence":1,"confidence_rate":1},{"cnt":[[245,2037],[440,2037],[440,2084],[245,2084]],"region":{"top_left_x":244,"top_left_y":2036,"width":197,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf47e86443674a9890ee016f7d908e27","type":"text","conversion_output":true,"text":"tamponade.","text_display":" tamponade.","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[1858,2127],[1858,2179],[245,2179]],"region":{"top_left_x":244,"top_left_y":2126,"width":1615,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c906ad1682004c8ea16ea8ba2e4d5f52","type":"text","conversion_output":true,"text":"The time from randomization to the first event among the components of the primary composite","text_display":"\n\nThe time from randomization to the first event among the components of the primary composite","confidence":1,"confidence_rate":1},{"cnt":[[245,2176],[1813,2176],[1813,2228],[245,2228]],"region":{"top_left_x":244,"top_left_y":2176,"width":1570,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27dacc33d5454092914b5344b2acfab5","type":"text","conversion_output":true,"text":"endpoint will be measured (in days) for those who experienced an event and calculated as the","text_display":" endpoint will be measured (in days) for those who experienced an event and calculated as the","confidence":1,"confidence_rate":1},{"cnt":[[245,2226],[1850,2226],[1850,2275],[245,2275]],"region":{"top_left_x":244,"top_left_y":2225,"width":1606,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2800fce4d9d4a4a8b5c723449f2d401","type":"text","conversion_output":true,"text":"date of the first event minus the date of randomization. For patients who do not experience any","text_display":" date of the first event minus the date of randomization. For patients who do not experience any","confidence":1,"confidence_rate":1},{"cnt":[[245,2273],[1846,2273],[1846,2322],[245,2322]],"region":{"top_left_x":244,"top_left_y":2273,"width":1602,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76e7b6decc044391b28eb8abea100964","type":"text","conversion_output":true,"text":"of the component events or who withdraw consent or drop out of the study before experiencing","text_display":" of the component events or who withdraw consent or drop out of the study before experiencing","confidence":1,"confidence_rate":1},{"cnt":[[245,2320],[1807,2320],[1807,2370],[245,2370]],"region":{"top_left_x":244,"top_left_y":2320,"width":1563,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"816a7aad2cb2437f95d9c335129458ff","type":"text","conversion_output":true,"text":"an event, time from randomization to the date of last contact will be used in the analysis, and","text_display":" an event, time from randomization to the date of last contact will be used in the analysis, and","confidence":1,"confidence_rate":1},{"cnt":[[245,2368],[1820,2368],[1820,2419],[245,2419]],"region":{"top_left_x":244,"top_left_y":2367,"width":1576,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b556c41a334accb4228ed777cf7750","type":"text","conversion_output":true,"text":"those patients will be considered as censored observations in the time-to-event analysis. For","text_display":" those patients will be considered as censored observations in the time-to-event analysis. For","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27fa6f8eec94425b9f0bb3825417cb43","type":"page_info","conversion_output":false,"text":"7","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-09","page":9,"lines":[{"cnt":[[245,251],[1755,251],[1755,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1512,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15a1a417ddca46acb14c4d2dc2428c27","type":"text","conversion_output":true,"text":"interim analyses, the best available endpoint data will be used (i.e., adjudicated data when","text_display":"\ninterim analyses, the best available endpoint data will be used (i.e., adjudicated data when","confidence":0.998046875,"confidence_rate":0.9999798452048033},{"cnt":[[245,301],[1016,301],[1016,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":773,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57a4372cfbcc47a5856eccf373325508","type":"text","conversion_output":true,"text":"available; otherwise site-reported event data).","text_display":" available; otherwise site-reported event data).","confidence":1,"confidence_rate":1},{"cnt":[[243,387],[1725,387],[1725,449],[243,449]],"region":{"top_left_x":242,"top_left_y":386,"width":1484,"height":64},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34dde1f779114be3ad66ca366494ee48","type":"text","conversion_output":true,"text":"Statistical Methods: The log-rank test \\({ }^{1}\\) will be the primary analytic tool for statistically","text_display":"\n\nStatistical Methods: The log-rank test \\({ }^{1}\\) will be the primary analytic tool for statistically","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1841,447],[1841,494],[245,494]],"region":{"top_left_x":244,"top_left_y":446,"width":1598,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bab49702773c4c4a9900b0b9865f95b7","type":"text","conversion_output":true,"text":"assessing outcome differences between the two randomized treatment strategies with respect to","text_display":" assessing outcome differences between the two randomized treatment strategies with respect to","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[1794,492],[1794,544],[245,544]],"region":{"top_left_x":244,"top_left_y":491,"width":1550,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7692660d10b427fbb0d7262d7f789d7","type":"text","conversion_output":true,"text":"the primary composite endpoint. This analysis will be conducted using PROC LIFETEST in","text_display":" the primary composite endpoint. This analysis will be conducted using PROC LIFETEST in","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1779,541],[1779,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1535,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ada295e40c44b55a1c08e1563bac381","type":"text","conversion_output":true,"text":"SAS. A hazard ratio (HR) and \\(95 \\%\\) confidence interval (CI) summarizing the difference in","text_display":" SAS. A hazard ratio (HR) and \\(95 \\%\\) confidence interval (CI) summarizing the difference in","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[245,589],[1876,589],[1876,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1632,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4aca476cf277469e97cd78df5e9bc524","type":"text","conversion_output":true,"text":"outcome between the two randomized arms will be computed using the Cox proportional hazards","text_display":" outcome between the two randomized arms will be computed using the Cox proportional hazards","confidence":1,"confidence_rate":1},{"cnt":[[245,629],[1665,629],[1665,685],[245,685]],"region":{"top_left_x":244,"top_left_y":629,"width":1422,"height":57},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d993d35d9ef4432691a82454e208d91d","type":"text","conversion_output":true,"text":"model \\({ }^{2}\\) (PROC PHREG in SAS), using treatment as the only predictor in the model.","text_display":" model \\({ }^{2}\\) (PROC PHREG in SAS), using treatment as the only predictor in the model.","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1721,730],[1721,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1477,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46e4f6a001f84dd1872317c288cd4630","type":"text","conversion_output":true,"text":"In addition to the statistical hypothesis testing, cumulative event rates will be calculated","text_display":"\n\nIn addition to the statistical hypothesis testing, cumulative event rates will be calculated","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,776],[1811,776],[1811,831],[245,831]],"region":{"top_left_x":244,"top_left_y":775,"width":1568,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e14f910060f450bb710cbfa45b2eda5","type":"text","conversion_output":true,"text":"according to the method of Kaplan and Meier \\({ }^{3}\\) for each randomized arm as a function of time","text_display":" according to the method of Kaplan and Meier \\({ }^{3}\\) for each randomized arm as a function of time","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1721,829],[1721,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1477,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13daf21ab7b946a2ac1fca0aeb1575ae","type":"text","conversion_output":true,"text":"from randomization, and the estimated event probabilities will be displayed graphically.","text_display":" from randomization, and the estimated event probabilities will be displayed graphically.","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1880,924],[1880,975],[245,975]],"region":{"top_left_x":244,"top_left_y":923,"width":1636,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbda24f8b2714a0ab9bc1a4e9c3ff916","type":"text","conversion_output":true,"text":"The methods described above will constitute the primary analysis of this endpoint. The primary","text_display":"\n\nThe methods described above will constitute the primary analysis of this endpoint. The primary","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[664,971],[664,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":420,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ea953e9459d44868d2d69aa891cb858","type":"text","conversion_output":true,"text":"hypothesis is defined as:","text_display":" hypothesis is defined as:","confidence":1,"confidence_rate":1},{"cnt":[[859,1033],[1257,1033],[1257,1199],[859,1199]],"region":{"top_left_x":859,"top_left_y":1033,"width":398,"height":166},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0c10248d3bb48178681995ff76f2599","type":"math","conversion_output":true,"text":"\\[\n\\begin{array}{ll}\nH_{0}: & S_{a}(t)=S_{d}(t), \\text { vs. } \\\\\nH_{a}: & S_{a}(t) \\neq S_{d}(t)\n\\end{array}\n\\]","text_display":"\n\\[\n\\begin{array}{ll}\nH_{0}: & S_{a}(t)=S_{d}(t), \\text { vs. } \\\\\nH_{a}: & S_{a}(t) \\neq S_{d}(t)\n\\end{array}\n\\]","confidence":0.5473413594816634,"confidence_rate":0.9957647503155959},{"cnt":[[245,1242],[1811,1242],[1811,1291],[245,1291]],"region":{"top_left_x":244,"top_left_y":1241,"width":1568,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bdaf5d1f0604b768faafe92781c2d02","type":"text","conversion_output":true,"text":"where \\(S _{ a }( t )\\) is the event-free survivor function for the ablation arm of the trial, and \\(S _{ d }( t )\\) is the","text_display":"\nwhere \\(S _{ a }( t )\\) is the event-free survivor function for the ablation arm of the trial, and \\(S _{ d }( t )\\) is the","confidence":0.9322261810302734,"confidence_rate":0.9995058980928636},{"cnt":[[245,1291],[1833,1291],[1833,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1291,"width":1589,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad93c3ce57ad44cb8b6f003cfb8b5f99","type":"text","conversion_output":true,"text":"event-free survivor function for the drug arm, both of which are a function of follow-up time \\(t\\).","text_display":" event-free survivor function for the drug arm, both of which are a function of follow-up time \\(t\\).","confidence":0.83984375,"confidence_rate":0.9983391006667152},{"cnt":[[245,1336],[1850,1336],[1850,1388],[245,1388]],"region":{"top_left_x":244,"top_left_y":1336,"width":1606,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc0eb0300c2f402d96a240cdcb27e008","type":"text","conversion_output":true,"text":"In other words, we are testing whether the event-free survival experience of the two arms of the","text_display":" In other words, we are testing whether the event-free survival experience of the two arms of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1386],[1777,1386],[1777,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1385,"width":1533,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"555cdd8554a14ecbb952b03b0676bcff","type":"text","conversion_output":true,"text":"trial is the same vs. whether it is different. The above hypothesis will be tested at a 2 -sided","text_display":" trial is the same vs. whether it is different. The above hypothesis will be tested at a 2 -sided","confidence":0.9931783592328429,"confidence_rate":0.9999341847186379},{"cnt":[[245,1435],[1798,1435],[1798,1485],[245,1485]],"region":{"top_left_x":244,"top_left_y":1435,"width":1555,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d314dff2483b41f0aee8a55b3be64be0","type":"text","conversion_output":true,"text":"significance level of 0.049 in the ITT population to account for a single interim analysis (see","text_display":" significance level of 0.049 in the ITT population to account for a single interim analysis (see","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,1482],[455,1482],[455,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1482,"width":212,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a372cdf4817b4ca58a97b2d8b45f5fe4","type":"text","conversion_output":true,"text":"Section 13).","text_display":" Section 13).","confidence":1,"confidence_rate":1},{"cnt":[[245,1573],[1796,1573],[1796,1622],[245,1622]],"region":{"top_left_x":244,"top_left_y":1572,"width":1553,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5d9918c70ee496c9de9ae8d54bb1e0f","type":"text","conversion_output":true,"text":"Because the Cox model will be used for calculating a hazard ratio and confidence interval to","text_display":"\n\nBecause the Cox model will be used for calculating a hazard ratio and confidence interval to","confidence":1,"confidence_rate":1},{"cnt":[[245,1620],[1792,1620],[1792,1669],[245,1669]],"region":{"top_left_x":244,"top_left_y":1619,"width":1548,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5757e28473344590a7da850eed11722f","type":"text","conversion_output":true,"text":"summarize the difference in outcome between the two randomized arms, the proportionality","text_display":" summarize the difference in outcome between the two randomized arms, the proportionality","confidence":1,"confidence_rate":1},{"cnt":[[245,1667],[1824,1667],[1824,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1667,"width":1581,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b7fef245cf747ab992566bbb2667677","type":"text","conversion_output":true,"text":"assumption in the Cox model (i.e., constant hazard ratio over time) will be checked and tested","text_display":" assumption in the Cox model (i.e., constant hazard ratio over time) will be checked and tested","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[1867,1714],[1867,1766],[245,1766]],"region":{"top_left_x":244,"top_left_y":1714,"width":1623,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52996e112e1e4969bfc21e6c27c4cc0b","type":"text","conversion_output":true,"text":"through adding an interaction term (treatment* \\(\\log ( t )\\) ) to the Cox model, and by examining a plot","text_display":" through adding an interaction term (treatment* \\(\\log ( t )\\) ) to the Cox model, and by examining a plot","confidence":0.5023624456771358,"confidence_rate":0.9938170904886312},{"cnt":[[245,1764],[655,1764],[655,1811],[245,1811]],"region":{"top_left_x":244,"top_left_y":1763,"width":412,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9ee40e6350d4931b1237f737afcad33","type":"text","conversion_output":true,"text":"of Schoenfeld residuals.","text_display":" of Schoenfeld residuals.","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[1858,1852],[1858,1904],[245,1904]],"region":{"top_left_x":244,"top_left_y":1851,"width":1615,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f5a5ebe3a7347059c3300e604e42c88","type":"text","conversion_output":true,"text":"The hypothesis as expressed above will also be used for the time-to-event analyses of secondary","text_display":"\n\nThe hypothesis as expressed above will also be used for the time-to-event analyses of secondary","confidence":1,"confidence_rate":1},{"cnt":[[245,1901],[1403,1901],[1403,1953],[245,1953]],"region":{"top_left_x":244,"top_left_y":1901,"width":1159,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1c2190ff2be461db3f03b853990a657","type":"text","conversion_output":true,"text":"endpoints described below using a 2 -sided significance level of 0.05 .","text_display":" endpoints described below using a 2 -sided significance level of 0.05 .","confidence":0.9282917976379395,"confidence_rate":0.9990929828266438},{"cnt":[[236,2013],[1386,2013],[1386,2075],[236,2075]],"region":{"top_left_x":236,"top_left_y":2013,"width":1150,"height":63},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae56b2bf2f214990afba8b07704ddcaa","type":"section_header","conversion_output":false,"children_ids":["21fd710d99aa409bb94deb39812dddcf"],"text":"","text_display":""},{"cnt":[[245,2020],[1381,2020],[1381,2069],[245,2069]],"region":{"top_left_x":244,"top_left_y":2019,"width":1138,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21fd710d99aa409bb94deb39812dddcf","type":"text","conversion_output":true,"parent_id":"ae56b2bf2f214990afba8b07704ddcaa","text":"8.1 Other Analyses of Primary Endpoint Data (as randomized):","text_display":"\n\n\\subsection*{8.1 Other Analyses of Primary Endpoint Data (as 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Using the Cox model, the effect of treatment","text_display":"\n\nTreatment comparison with covariate adjustment. 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Analysis of Secondary Endpoints","text_display":"\n\n\\section*{9. Analysis of Secondary Endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[236,2271],[1124,2271],[1124,2335],[236,2335]],"region":{"top_left_x":236,"top_left_y":2270,"width":888,"height":66},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d00d1f0afae846d88a27961362abc771","type":"section_header","conversion_output":false,"children_ids":["5fc023db7ea8451b816bf4fc896cd6f3"],"text":"","text_display":""},{"cnt":[[245,2277],[1119,2277],[1119,2329],[245,2329]],"region":{"top_left_x":244,"top_left_y":2277,"width":876,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fc023db7ea8451b816bf4fc896cd6f3","type":"text","conversion_output":true,"parent_id":"d00d1f0afae846d88a27961362abc771","text":"9.1 All-cause mortality (key secondary endpoint)","text_display":"\n\n\\subsection*{9.1 All-cause mortality (key secondary endpoint)}","confidence":1,"confidence_rate":1},{"cnt":[[245,2372],[1265,2372],[1265,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2371,"width":1022,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b95e8832d64d4dcf9323bbd38133d332","type":"text","conversion_output":true,"text":"Endpoint Definition: Time from randomization until death.","text_display":"\n\nEndpoint Definition: Time from randomization until death.","confidence":1,"confidence_rate":1},{"cnt":[[1048,2548],[1079,2548],[1079,2593],[1048,2593]],"region":{"top_left_x":1048,"top_left_y":2548,"width":31,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e649b605477042f0a79fc627e59d9848","type":"page_info","conversion_output":false,"text":"9","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-11","page":11,"lines":[{"cnt":[[245,254],[1798,254],[1798,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1555,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b61f984f660044febff4c7f96abcbcbc","type":"text","conversion_output":true,"text":"For subjects who have not met this endpoint (and thus are censored observations), time from","text_display":"\n\nFor subjects who have not met this endpoint (and thus are censored observations), time from","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1646,301],[1646,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1402,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfdd09aec8d1425b8ea71477640cfe09","type":"text","conversion_output":true,"text":"randomization until the subject's last follow-up contact will be used in the analysis.","text_display":" randomization until the subject's last follow-up contact will be used in the analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1785,397],[1785,447],[245,447]],"region":{"top_left_x":244,"top_left_y":397,"width":1542,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17ad290f476842728d851b14552a938c","type":"text","conversion_output":true,"text":"Great effort will be made to gather mortality information on every randomized subject. For","text_display":"\n\nGreat effort will be made to gather mortality information on every randomized subject. For","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1824,447],[1824,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1581,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98c2ad9179d541e6ac65a6c7c39b9b28","type":"text","conversion_output":true,"text":"patients who withdraw consent or are lost to follow-up during the course of the trial, mortality","text_display":" patients who withdraw consent or are lost to follow-up during the course of the trial, mortality","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1835,494],[1835,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1591,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48df73495f0b4fd0afec6e606a989d6a","type":"text","conversion_output":true,"text":"databases such as the National Death Index, the Social Security Death Index, Ancestry.com, as","text_display":" databases such as the National Death Index, the Social Security Death Index, Ancestry.com, as","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1824,541],[1824,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1581,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e50c60673484d85bb866a195062f980","type":"text","conversion_output":true,"text":"well as any other sources of information or national registries, will be consulted in an effort to","text_display":" well as any other sources of information or national registries, will be consulted in an effort to","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1813,589],[1813,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1570,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c791e9029d040efab4668d81a5a1132","type":"text","conversion_output":true,"text":"determine whether the subjects have died. Any subject found through one of these sources to","text_display":" determine whether the subjects have died. Any subject found through one of these sources to","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1738,636],[1738,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1495,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7b9ee91b30b4ca989caf49b73197a6f","type":"text","conversion_output":true,"text":"have died will be considered to have met this key secondary endpoint even if not enough","text_display":" have died will be considered to have met this key secondary endpoint even if not enough","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1837,683],[1837,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1593,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0675617bb3d64ebabc353af826c7239c","type":"text","conversion_output":true,"text":"information is available for the CEC to classify the mode of death. Subjects for whom no vital","text_display":" information is available for the CEC to classify the mode of death. Subjects for whom no vital","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1833,730],[1833,780],[245,780]],"region":{"top_left_x":244,"top_left_y":730,"width":1589,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94a682a44f594ce08c6fa684a37cd0fd","type":"text","conversion_output":true,"text":"status information can be found in these database searches will be censored at the time of their","text_display":" status information can be found in these database searches will be censored at the time of their","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[245,780],[629,780],[629,831],[245,831]],"region":{"top_left_x":244,"top_left_y":779,"width":386,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1528a152dfd443aa9b715b9105f1376d","type":"text","conversion_output":true,"text":"last follow-up contact.","text_display":" last follow-up contact.","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1846,877],[1846,926],[245,926]],"region":{"top_left_x":244,"top_left_y":876,"width":1602,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1c02cade4e34b5ba0bf8ce69589872b","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this key secondary endpoint will use the same methods as","text_display":"\n\nStatistical Methods: The analysis of this key secondary endpoint will use the same methods as","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1751,924],[1751,973],[245,973]],"region":{"top_left_x":244,"top_left_y":923,"width":1507,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53e6028172bb4c1badf14fb8ebc79905","type":"text","conversion_output":true,"text":"described for the primary endpoint in Section 8. Specifically, the log-rank test will be the","text_display":" described for the primary endpoint in Section 8. Specifically, the log-rank test will be the","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1880,971],[1880,1023],[245,1023]],"region":{"top_left_x":244,"top_left_y":971,"width":1636,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b73601a99a84b42b8e6775293a21c9b","type":"text","conversion_output":true,"text":"primary analytic tool for statistically assessing mortality differences between the two randomized","text_display":" primary analytic tool for statistically assessing mortality differences between the two randomized","confidence":1,"confidence_rate":1},{"cnt":[[245,1021],[1850,1021],[1850,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1020,"width":1606,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5478246fcb6a49f88536cf5d98d534be","type":"text","conversion_output":true,"text":"treatment strategies. A hazard ratio and \\(95 \\%\\) confidence interval summarizing the difference in","text_display":" treatment strategies. A hazard ratio and \\(95 \\%\\) confidence interval summarizing the difference in","confidence":0.99462890625,"confidence_rate":0.9999472016886584},{"cnt":[[245,1068],[1876,1068],[1876,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1067,"width":1632,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00a47e4b8f5c4499b250811bde7ab184","type":"text","conversion_output":true,"text":"outcome between the two randomized arms will be computed using the Cox model. The level of","text_display":" outcome between the two randomized arms will be computed using the Cox model. The level of","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1863,1117],[1863,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1117,"width":1619,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95660bed41c94831bafe6d58d42e33f6","type":"text","conversion_output":true,"text":"significance for the assessment of this endpoint will be \\(\\alpha=0.05\\). Also, Kaplan-Meier cumulative","text_display":" significance for the assessment of this endpoint will be \\(\\alpha=0.05\\). Also, Kaplan-Meier cumulative","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1871,1164],[1871,1216],[245,1216]],"region":{"top_left_x":244,"top_left_y":1164,"width":1628,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cad2fab853084fd98d93496d260eadc6","type":"text","conversion_output":true,"text":"event rates will be calculated for each randomized arm as a function of time from randomization,","text_display":" event rates will be calculated for each randomized arm as a function of time from randomization,","confidence":1,"confidence_rate":1},{"cnt":[[245,1214],[1369,1214],[1369,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1213,"width":1125,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2255b1bef41647e9a0e5e1c14bc2fbb7","type":"text","conversion_output":true,"text":"and the estimated event probabilities will be displayed graphically.","text_display":" and the estimated event probabilities will be displayed graphically.","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1828,1311],[1828,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1585,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"809b705a314e4b8badfe4da2029f0984","type":"text","conversion_output":true,"text":"Supplementary analyses of this secondary endpoint will be performed using the same methods","text_display":"\n\nSupplementary analyses of this secondary endpoint will be performed using the same methods","confidence":1,"confidence_rate":1},{"cnt":[[245,1358],[1085,1358],[1085,1412],[245,1412]],"region":{"top_left_x":244,"top_left_y":1357,"width":841,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2286c9342af4a9db3e43b797de2f22c","type":"text","conversion_output":true,"text":"described for the primary endpoint in Section 8.1.","text_display":" described for the primary endpoint in Section 8.1.","confidence":1,"confidence_rate":1},{"cnt":[[236,1446],[1287,1446],[1287,1510],[236,1510]],"region":{"top_left_x":236,"top_left_y":1445,"width":1051,"height":66},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec93579e97c043a19686f1227a53b642","type":"section_header","conversion_output":false,"children_ids":["a6efb2755f07461ab6fd6f4fccc7f3db"],"text":"","text_display":""},{"cnt":[[245,1452],[1280,1452],[1280,1504],[245,1504]],"region":{"top_left_x":244,"top_left_y":1452,"width":1037,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6efb2755f07461ab6fd6f4fccc7f3db","type":"text","conversion_output":true,"parent_id":"ec93579e97c043a19686f1227a53b642","text":"9.2 All-cause Mortality or Cardiovascular Hospitalization","text_display":"\n\n\\subsection*{9.2 All-cause Mortality or Cardiovascular Hospitalization}","confidence":1,"confidence_rate":1},{"cnt":[[245,1549],[1863,1549],[1863,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1549,"width":1619,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd154230bfb04e03869e9ba128e405ea","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the first event in this composite endpoint (i.e.,","text_display":"\n\nEndpoint definition: Time from randomization to the first event in this composite endpoint (i.e.,","confidence":0.93701171875,"confidence_rate":0.9993623652367609},{"cnt":[[245,1598],[1796,1598],[1796,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1598,"width":1553,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b60290b988d54a2c8aca995d59984125","type":"text","conversion_output":true,"text":"time from randomization to either death or the subject's first cardiovascular hospitalization).","text_display":" time from randomization to either death or the subject's first cardiovascular hospitalization).","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,1693],[1865,1693],[1865,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1692,"width":1621,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fa3ee3661964389ac24b4c7ceb32396","type":"text","conversion_output":true,"text":"For subjects who have not experienced either component of this endpoint (i.e., who are censored","text_display":"\n\nFor subjects who have not experienced either component of this endpoint (i.e., who are censored","confidence":0.99072265625,"confidence_rate":0.9999067978802516},{"cnt":[[245,1740],[1852,1740],[1852,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1608,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"031e330829de4094a48531d381994025","type":"text","conversion_output":true,"text":"observations), time from randomization until the subject's last follow-up contact will be used in","text_display":" observations), time from randomization until the subject's last follow-up contact will be used in","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[458,1788],[458,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1787,"width":214,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01feafc205ef4bcab98519815d33ccc5","type":"text","conversion_output":true,"text":"the analysis.","text_display":" the analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1837,1886],[1837,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1886,"width":1593,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af0fe69ca3b44000aab4bb428db488d8","type":"text","conversion_output":true,"text":"The cause of hospitalization will be based on the site-reported data in the CABANA electronic","text_display":"\n\nThe cause of hospitalization will be based on the site-reported data in the CABANA electronic","confidence":1,"confidence_rate":1},{"cnt":[[245,1934],[1841,1934],[1841,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1933,"width":1598,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1db3147046b74f7e9b39f9d653117985","type":"text","conversion_output":true,"text":"data capture (EDC) system. For this endpoint, cardiovascular hospitalization will not include a","text_display":" data capture (EDC) system. For this endpoint, cardiovascular hospitalization will not include a","confidence":1,"confidence_rate":1},{"cnt":[[245,1981],[1858,1981],[1858,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1980,"width":1615,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"319d7406ef6b4330af051432dd5b4e0a","type":"text","conversion_output":true,"text":"hospitalization to initiate therapy. For example, among patients randomized to the ablation arm,","text_display":" hospitalization to initiate therapy. For example, among patients randomized to the ablation arm,","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1760,2028],[1760,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2028,"width":1516,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d43f13f259ef44bba97be4b209674d92","type":"text","conversion_output":true,"text":"the hospitalization to perform the ablation will not be counted for this secondary endpoint.","text_display":" the hospitalization to perform the ablation will not be counted for this secondary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1807,2075],[1807,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1563,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6af5bddf3b0443428c57e9acd1b54c43","type":"text","conversion_output":true,"text":"Similarly, if a patient randomized to the drug arm is hospitalized to monitor the patient while","text_display":" Similarly, if a patient randomized to the drug arm is hospitalized to monitor the patient while","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[1622,2127],[1622,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2126,"width":1379,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"265ee66137cc4f21974d583904a88007","type":"text","conversion_output":true,"text":"loading the initial drug therapy, that hospitalization will not be counted. All other","text_display":" loading the initial drug therapy, that hospitalization will not be counted. All other","confidence":1,"confidence_rate":1},{"cnt":[[245,2172],[1835,2172],[1835,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2172,"width":1591,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e77e0b6ac43045a9bb620b02b49425a5","type":"text","conversion_output":true,"text":"hospitalizations designated by the clinical site as cardiovascular will be counted, including the","text_display":" hospitalizations designated by the clinical site as cardiovascular will be counted, including the","confidence":1,"confidence_rate":1},{"cnt":[[245,2219],[1854,2219],[1854,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2219,"width":1611,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3a4f1680d89496bbe6f898e5201b4a0","type":"text","conversion_output":true,"text":"hospitalization of a patient randomized to the drug arm who is hospitalized for a therapy change","text_display":" hospitalization of a patient randomized to the drug arm who is hospitalized for a therapy change","confidence":1,"confidence_rate":1},{"cnt":[[245,2269],[1826,2269],[1826,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2268,"width":1583,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e981022229a48d7b710aa22f203d6f4","type":"text","conversion_output":true,"text":"(either a change to a different drug therapy or for crossing over to ablation). Hospitalization to","text_display":" (either a change to a different drug therapy or for crossing over to ablation). Hospitalization to","confidence":1,"confidence_rate":1},{"cnt":[[245,2316],[1867,2316],[1867,2368],[245,2368]],"region":{"top_left_x":244,"top_left_y":2316,"width":1623,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"737e912c4a3a47f4af24f03981de324b","type":"text","conversion_output":true,"text":"perform second or subsequent ablation procedures will be counted as a CV hospitalization event.","text_display":" perform second or subsequent ablation procedures will be counted as a CV hospitalization event.","confidence":0.9833984375,"confidence_rate":0.9998326048833174},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e5ca680678e4f4492146aa9cefb677a","type":"page_info","conversion_output":false,"text":"10","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-12","page":12,"lines":[{"cnt":[[245,254],[1775,254],[1775,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1531,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"509ed39ef6644f1198e047ec9ad3865b","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will use the same methods as","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will use the same methods as","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":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c7b44f6fc43462caa6297edffb4775c","type":"text","conversion_output":true,"text":"described for the primary endpoint and key secondary endpoint in sections 8 and 9.1, including","text_display":" described for the primary endpoint and key secondary endpoint in sections 8 and 9.1, including","confidence":0.99658203125,"confidence_rate":0.999966433667778},{"cnt":[[245,348],[1751,348],[1751,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1507,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a38117ce6365497babe41f1830cba916","type":"text","conversion_output":true,"text":"statistical testing using the log-rank test, calculation of a hazard ratio and \\(95 \\%\\) confidence","text_display":" statistical testing using the log-rank test, calculation of a hazard ratio and \\(95 \\%\\) confidence","confidence":0.9931640625,"confidence_rate":0.9999320873601193},{"cnt":[[245,397],[1867,397],[1867,445],[245,445]],"region":{"top_left_x":244,"top_left_y":397,"width":1623,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f017e43fc3f143a98c0b8c3e9a6531a4","type":"text","conversion_output":true,"text":"interval using the Cox model, and Kaplan-Meier cumulative event rate calculations. The level of","text_display":" interval using the Cox model, and Kaplan-Meier cumulative event rate calculations. The level of","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[245,447],[1311,447],[1311,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1067,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c67aeaff33c0415eaf75614450eef824","type":"text","conversion_output":true,"text":"significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","text_display":" significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[241,539],[1871,539],[1871,640],[241,640]],"region":{"top_left_x":240,"top_left_y":539,"width":1632,"height":102},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"884cd2b68d604a699c6e223a29339df3","type":"section_header","conversion_output":false,"children_ids":["e820c403ab9749798cf0f31d248f6732","4334e04b33ee4e1a80745ba10ea3a4df"],"text":"","text_display":""},{"cnt":[[245,546],[1867,546],[1867,593],[245,593]],"region":{"top_left_x":244,"top_left_y":545,"width":1623,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e820c403ab9749798cf0f31d248f6732","type":"text","conversion_output":true,"parent_id":"884cd2b68d604a699c6e223a29339df3","text":"9.3 All-cause Mortality, Stroke, or Hospitalization for Heart Failure or an Acute Ischemic","text_display":"\n\n\\subsection*{9.3 All-cause Mortality, Stroke, or Hospitalization for Heart Failure or an Acute Ischemic","confidence":1,"confidence_rate":1},{"cnt":[[245,593],[359,593],[359,634],[245,634]],"region":{"top_left_x":244,"top_left_y":592,"width":115,"height":42},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4334e04b33ee4e1a80745ba10ea3a4df","type":"text","conversion_output":true,"parent_id":"884cd2b68d604a699c6e223a29339df3","text":"Event","text_display":" Event}","confidence":1,"confidence_rate":1},{"cnt":[[245,688],[1785,688],[1785,737],[245,737]],"region":{"top_left_x":244,"top_left_y":687,"width":1542,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04b303747d6644a18f234f7b9fb31b4a","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the first event in this composite endpoint.","text_display":"\n\nEndpoint definition: Time from randomization to the first event in this composite endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[1687,782],[1687,831],[245,831]],"region":{"top_left_x":244,"top_left_y":782,"width":1443,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1605710748d84fffad73ec69dca3de62","type":"text","conversion_output":true,"text":"For subjects who have not experienced any component of this endpoint (i.e., censored","text_display":"\nFor subjects who have not experienced any component of this endpoint (i.e., censored","confidence":0.998046875,"confidence_rate":0.9999780335577175},{"cnt":[[245,829],[1850,829],[1850,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1606,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebce045eb190470bb529be2dd5b3bb7e","type":"text","conversion_output":true,"text":"observations), time from randomization until the subject's last follow-up contact will be used in","text_display":" observations), time from randomization until the subject's last follow-up contact will be used in","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,879],[1871,879],[1871,930],[245,930]],"region":{"top_left_x":244,"top_left_y":878,"width":1628,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34fc3cda2b07456e94cb059cfeae7822","type":"text","conversion_output":true,"text":"the analysis. The stroke component of this endpoint is defined the same as the stroke component","text_display":" the analysis. The stroke component of this endpoint is defined the same as the stroke component","confidence":1,"confidence_rate":1},{"cnt":[[245,928],[1848,928],[1848,978],[245,978]],"region":{"top_left_x":244,"top_left_y":928,"width":1604,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c46f31ba9ba4d5b871f17cdedc8fb0e","type":"text","conversion_output":true,"text":"of the primary endpoint, namely as a disabling stroke characterized by a Rankin Scale \\(\\geq 2\\). The","text_display":" of the primary endpoint, namely as a disabling stroke characterized by a Rankin Scale \\(\\geq 2\\). The","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1843,975],[1843,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1600,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62ac18873284479d8e97615f4e65bb55","type":"text","conversion_output":true,"text":"cause of hospitalization will be based on the site-reported data in the CABANA electronic data","text_display":" cause of hospitalization will be based on the site-reported data in the CABANA electronic data","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[634,1023],[634,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":390,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d82602b00e047f8a755071fde826370","type":"text","conversion_output":true,"text":"capture (EDC) system.","text_display":" capture (EDC) system.","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1772,1117],[1772,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1529,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"857e8a6233fe40c18483005f6b08c060","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will use the same methods as","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will use the same methods as","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1858,1164],[1858,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1615,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9696e96cc0546479ee7509ded3478ba","type":"text","conversion_output":true,"text":"described for the primary endpoint and secondary endpoints in the sections above, including use","text_display":" described for the primary endpoint and secondary endpoints in the sections above, including use","confidence":1,"confidence_rate":1},{"cnt":[[245,1214],[1824,1214],[1824,1263],[245,1263]],"region":{"top_left_x":244,"top_left_y":1213,"width":1581,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47ba1c3a33a747ffb46038ddbcb96ffd","type":"text","conversion_output":true,"text":"of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval calculated using the Cox model,","text_display":" of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval calculated using the Cox model,","confidence":0.96533203125,"confidence_rate":0.9996541464584943},{"cnt":[[245,1263],[1691,1263],[1691,1311],[245,1311]],"region":{"top_left_x":244,"top_left_y":1263,"width":1447,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4c9432c4ea94588a9b9442ca3380389","type":"text","conversion_output":true,"text":"and Kaplan-Meier cumulative event rate calculations. The level of significance for the","text_display":" and Kaplan-Meier cumulative event rate calculations. The level of significance for the","confidence":1,"confidence_rate":1},{"cnt":[[245,1315],[1055,1315],[1055,1362],[245,1362]],"region":{"top_left_x":244,"top_left_y":1314,"width":811,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3c65d20c40f436f8793b02bfb44fd59","type":"text","conversion_output":true,"text":"assessment of this endpoint will also be \\(\\alpha=0.05\\).","text_display":" assessment of this endpoint will also be \\(\\alpha=0.05\\).","confidence":0.99853515625,"confidence_rate":0.9999742824766223},{"cnt":[[245,1409],[1708,1409],[1708,1459],[245,1459]],"region":{"top_left_x":244,"top_left_y":1409,"width":1465,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba4de0880ea3460e928280997b6234ae","type":"text","conversion_output":true,"text":"This endpoint is similar to the first co-primary endpoint of the Early treatment of Atrial","text_display":"\n\nThis endpoint is similar to the first co-primary endpoint of the Early treatment of Atrial","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1693,1452],[1693,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1452,"width":1449,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b320531488224766a887ab48a39bef1a","type":"text","conversion_output":true,"text":"fibrillation for Stroke prevention Trial (EAST) \\({ }^{4}\\) with the exception that EAST is using","text_display":" fibrillation for Stroke prevention Trial (EAST) \\({ }^{4}\\) with the exception that EAST is using","confidence":1,"confidence_rate":1},{"cnt":[[245,1506],[1841,1506],[1841,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1506,"width":1598,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a2ec2b17c4d4ac4b40167cba607cdab","type":"text","conversion_output":true,"text":"cardiovascular mortality rather than all-cause mortality as the death component of the endpoint","text_display":" cardiovascular mortality rather than all-cause mortality as the death component of the endpoint","confidence":1,"confidence_rate":1},{"cnt":[[245,1553],[1858,1553],[1858,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1553,"width":1615,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29adb87836dc425db6b77ebb214f8cee","type":"text","conversion_output":true,"text":"and also a different definition of stroke (any stroke rather than a disabling stroke). Therefore, to","text_display":" and also a different definition of stroke (any stroke rather than a disabling stroke). Therefore, to","confidence":1,"confidence_rate":1},{"cnt":[[245,1603],[1854,1603],[1854,1650],[245,1650]],"region":{"top_left_x":244,"top_left_y":1602,"width":1611,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21f7a8376f2d48b6a54d39b1ddefeef0","type":"text","conversion_output":true,"text":"provide results that can be compared to those of EAST, supplemental comparative analyses will","text_display":" provide results that can be compared to those of EAST, supplemental comparative analyses will","confidence":1,"confidence_rate":1},{"cnt":[[245,1650],[1858,1650],[1858,1697],[245,1697]],"region":{"top_left_x":244,"top_left_y":1650,"width":1615,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6c301b8fcf24797b9b3e0639e0d28d6","type":"text","conversion_output":true,"text":"be performed using cardiovascular mortality in this endpoint rather than all-cause mortality, and","text_display":" be performed using cardiovascular mortality in this endpoint rather than all-cause mortality, and","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1697],[1850,1697],[1850,1745],[245,1745]],"region":{"top_left_x":244,"top_left_y":1697,"width":1606,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0519646ee2534565ac9f7e455cf7334b","type":"text","conversion_output":true,"text":"a definition of stroke that corresponds to the EAST definition. The statistical methods for these","text_display":" a definition of stroke that corresponds to the EAST definition. The statistical methods for these","confidence":1,"confidence_rate":1},{"cnt":[[245,1745],[1876,1745],[1876,1794],[245,1794]],"region":{"top_left_x":244,"top_left_y":1744,"width":1632,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02e052f4e520498e9755b42e5ce1b9f0","type":"text","conversion_output":true,"text":"analyses will employ the competing risk methodology described in the next section for analyzing","text_display":" analyses will employ the competing risk methodology described in the next section for analyzing","confidence":1,"confidence_rate":1},{"cnt":[[245,1792],[1809,1792],[1809,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1791,"width":1565,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbdb32a5b84343a2bd601aa90beef1db","type":"text","conversion_output":true,"text":"cardiovascular death, as well as the approach described in the preceding paragraph where all-","text_display":" cardiovascular death, as well as the approach described in the preceding paragraph where all","confidence":1,"confidence_rate":1},{"cnt":[[245,1841],[1044,1841],[1044,1888],[245,1888]],"region":{"top_left_x":244,"top_left_y":1841,"width":801,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"752c1cae7ce447d08b556505bb6e82ca","type":"text","conversion_output":true,"text":"cause mortality is a component of the endpoint.","text_display":"cause mortality is a component of the endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[243,1934],[724,1934],[724,1983],[243,1983]],"region":{"top_left_x":242,"top_left_y":1933,"width":483,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d907c820d7a741f5bab607ce6dba4580","type":"section_header","conversion_output":false,"children_ids":["df3b6f10ccd14b29920ed26d31c58472"],"text":"","text_display":""},{"cnt":[[245,1938],[720,1938],[720,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1937,"width":476,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df3b6f10ccd14b29920ed26d31c58472","type":"text","conversion_output":true,"parent_id":"d907c820d7a741f5bab607ce6dba4580","text":"9.4 Cardiovascular Death","text_display":"\n\n\\subsection*{9.4 Cardiovascular Death}","confidence":1,"confidence_rate":1},{"cnt":[[245,2032],[1876,2032],[1876,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2032,"width":1632,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63e5bde111ea4a999569697adf8fc091","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of a cardiovascular (CV) death.","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of a cardiovascular (CV) death.","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[1871,2127],[1871,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2126,"width":1628,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db581919be57491984a6e2c67d595c0e","type":"text","conversion_output":true,"text":"Patient deaths will be classified by the Clinical Events Committee (CEC) as to whether the mode","text_display":"\nPatient deaths will be classified by the Clinical Events Committee (CEC) as to whether the mode","confidence":0.9990236759185791,"confidence_rate":0.9999902320377447},{"cnt":[[245,2176],[1846,2176],[1846,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2176,"width":1602,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9500e842fd6e43308a7214a02636a0f7","type":"text","conversion_output":true,"text":"of death was due to a cardiovascular (CV) cause. If insufficient source documents are obtained","text_display":" of death was due to a cardiovascular (CV) cause. If insufficient source documents are obtained","confidence":1,"confidence_rate":1},{"cnt":[[245,2224],[1807,2224],[1807,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2223,"width":1563,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"808eabed61b7401d9a3a2fd049891947","type":"text","conversion_output":true,"text":"to allow CEC adjudication of the cause of death, and the CEC classifies the cause of death as","text_display":" to allow CEC adjudication of the cause of death, and the CEC classifies the cause of death as","confidence":1,"confidence_rate":1},{"cnt":[[245,2320],[245,2271],[1820,2273],[1820,2322]],"region":{"top_left_x":244,"top_left_y":2270,"width":1576,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5bf52854c374820b58c60b09f7d2831","type":"text","conversion_output":true,"text":"\"unknown,\" then the site-reported cause of death (if available) will be used. If neither the site","text_display":" \"unknown,\" then the site-reported cause of death (if available) will be used. 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As supplemental analyses, however, this endpoint will also be","text_display":" as a cardiovascular death. As supplemental analyses, however, this endpoint will also be","confidence":1,"confidence_rate":1},{"cnt":[[245,2415],[1865,2415],[1865,2464],[245,2464]],"region":{"top_left_x":244,"top_left_y":2414,"width":1621,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6588ef86f00f470a87b5325cc88bbea6","type":"text","conversion_output":true,"text":"examined using (a) only the deaths classified by the CEC as cardiovascular, and (b) using deaths","text_display":" examined using (a) only the deaths classified by the CEC as cardiovascular, and (b) using deaths","confidence":1,"confidence_rate":1},{"cnt":[[1040,2548],[1083,2548],[1083,2593],[1040,2593]],"region":{"top_left_x":1039,"top_left_y":2548,"width":44,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"393b6d09738943d6b9178903b0ca32ac","type":"page_info","conversion_output":false,"text":"11","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-13","page":13,"lines":[{"cnt":[[245,251],[1781,251],[1781,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1538,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7296cd5f1d1449a79482847a65e6bc1d","type":"text","conversion_output":true,"text":"classified by the CEC as cardiovascular, but also including any deaths in the cardiovascular","text_display":"\nclassified by the CEC as cardiovascular, but also including any deaths in the cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1124,301],[1124,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":880,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0a081b9c1a44012be72d7fdedb5b1b6","type":"text","conversion_output":true,"text":"category that are classified as unknown by the CEC.","text_display":" category that are classified as unknown by the CEC.","confidence":1,"confidence_rate":1},{"cnt":[[245,395],[1846,395],[1846,445],[245,445]],"region":{"top_left_x":244,"top_left_y":395,"width":1602,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46772f69fa8443fa92e82d49d30c9ade","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this endpoint will be performed using the competing risks","text_display":"\n\nStatistical Methods: The analysis of this endpoint will be performed using the competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,438],[1854,438],[1854,494],[245,494]],"region":{"top_left_x":244,"top_left_y":438,"width":1611,"height":57},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bae6842d57064699bc63915f927e5c6e","type":"text","conversion_output":true,"text":"methodology of Fine and Gray \\({ }^{5}\\), where death due to a non-cardiovascular cause is considered as","text_display":" methodology of Fine and Gray \\({ }^{5}\\), where death due to a non-cardiovascular cause is considered as","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[245,492],[1712,492],[1712,541],[245,541]],"region":{"top_left_x":244,"top_left_y":491,"width":1469,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b9ac8a5f4d443ffb2f0493a14610266","type":"text","conversion_output":true,"text":"a competing risk. This methodology, rather than treating non-cardiovascular death as a","text_display":" a competing risk. 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The features of the Fine-Gray approach for handling","text_display":" event of interest (cardiovascular death). The features of the Fine-Gray approach for handling","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1796,683],[1796,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1553,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff1505dd7a15454d98ca8144b28705e4","type":"text","conversion_output":true,"text":"competing risks data are available as part of the PHREG procedure in SAS. The cumulative","text_display":" competing risks data are available as part of the PHREG procedure in SAS. The cumulative","confidence":0.99755859375,"confidence_rate":0.9999737165675469},{"cnt":[[245,730],[1809,730],[1809,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1565,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7ae1f8cae854454917313a5812670e8","type":"text","conversion_output":true,"text":"incidence function for the two arms will be estimated, statistically compared, and graphically","text_display":" incidence function for the two arms will be estimated, statistically compared, and graphically","confidence":1,"confidence_rate":1},{"cnt":[[245,780],[1796,780],[1796,829],[245,829]],"region":{"top_left_x":244,"top_left_y":779,"width":1553,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f3cb2764f174091bf66dcf9fdcd6576","type":"text","conversion_output":true,"text":"presented using the PHREG software features in SAS. For subjects who have not died, time","text_display":" presented using the PHREG software features in SAS. For subjects who have not died, time","confidence":1,"confidence_rate":1},{"cnt":[[245,827],[1824,827],[1824,879],[245,879]],"region":{"top_left_x":244,"top_left_y":827,"width":1581,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b48479473924f8393b8e926dbb9728f","type":"text","conversion_output":true,"text":"from randomization until the subject's last follow-up contact will be used in the analysis. The","text_display":" from randomization until the subject's last follow-up contact will be used in the analysis. The","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1446,877],[1446,930],[245,930]],"region":{"top_left_x":244,"top_left_y":876,"width":1202,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27ba9a7769cc452499320ed87178e878","type":"text","conversion_output":true,"text":"level of significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","text_display":" level of significance for the assessment of this endpoint will be \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1794,975],[1794,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1550,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ed53883b73c489c9b29f75363baca7f","type":"text","conversion_output":true,"text":"Additional analysis of this secondary endpoint will be performed using the same methods as","text_display":"\n\nAdditional analysis of this secondary endpoint will be performed using the same methods as","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1858,1023],[1858,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":1615,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a86c1a0ead804dcbbb919a7e861506fb","type":"text","conversion_output":true,"text":"described for the primary endpoint and secondary endpoints in the sections above, including use","text_display":" described for the primary endpoint and secondary endpoints in the sections above, including use","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1815,1070],[1815,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1572,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce993c1f18704571b80a4b0ae12a7663","type":"text","conversion_output":true,"text":"of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox model,","text_display":" of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox model,","confidence":0.96875,"confidence_rate":0.9996857058530875},{"cnt":[[245,1117],[1876,1117],[1876,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1632,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a43d8e797243460484a0be684c379a6e","type":"text","conversion_output":true,"text":"and Kaplan-Meier cumulative event rate calculations. Patients who have died but whose cause of","text_display":" and Kaplan-Meier cumulative event rate calculations. Patients who have died but whose cause of","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1878,1164],[1878,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1634,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b047a882b29c4b18a22df867a6647223","type":"text","conversion_output":true,"text":"death is classified by the CEC as non-cardiovascular will be censored at the time of their non-CV","text_display":" death is classified by the CEC as non-cardiovascular will be censored at the time of their non-CV","confidence":0.9941432476043701,"confidence_rate":0.9999424137127548},{"cnt":[[245,1214],[1837,1214],[1837,1263],[245,1263]],"region":{"top_left_x":244,"top_left_y":1213,"width":1593,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"516614282be6483aa8dd4d70d9d3cbdd","type":"text","conversion_output":true,"text":"death. The number of such patients is expected to be relatively small in this study. The results","text_display":" death. The number of such patients is expected to be relatively small in this study. The results","confidence":1,"confidence_rate":1},{"cnt":[[245,1261],[1792,1261],[1792,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1261,"width":1548,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06597c051c3d4f84b97842e5f0ab82ec","type":"text","conversion_output":true,"text":"of these two different approaches will be carefully examined and synthesized into an overall","text_display":" of these two different approaches will be carefully examined and synthesized into an overall","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1319,1311],[1319,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1076,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1599424804ac4a60b59306048e4ef056","type":"text","conversion_output":true,"text":"interpretation of treatment differences with respect to CV death.","text_display":" interpretation of treatment differences with respect to CV death.","confidence":1,"confidence_rate":1},{"cnt":[[236,1401],[1072,1401],[1072,1463],[236,1463]],"region":{"top_left_x":236,"top_left_y":1400,"width":837,"height":64},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"183d112a7e864649b0d064c661a2692f","type":"section_header","conversion_output":false,"children_ids":["ffa42621c7804e57abfebbc806edd595"],"text":"","text_display":""},{"cnt":[[245,1405],[1068,1405],[1068,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1405,"width":824,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffa42621c7804e57abfebbc806edd595","type":"text","conversion_output":true,"parent_id":"183d112a7e864649b0d064c661a2692f","text":"9.5 Cardiovascular Death or Disabling Stroke","text_display":"\n\n\\subsection*{9.5 Cardiovascular Death or Disabling Stroke}","confidence":1,"confidence_rate":1},{"cnt":[[245,1493],[1785,1493],[1785,1543],[245,1543]],"region":{"top_left_x":244,"top_left_y":1493,"width":1542,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3340751ecfa4596aa9f058df3f4035f","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of either a cardiovascular","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of either a cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[245,1543],[675,1543],[675,1592],[245,1592]],"region":{"top_left_x":244,"top_left_y":1542,"width":431,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a51156dd106e42e19cef79895a18e550","type":"text","conversion_output":true,"text":"death or disabling stroke.","text_display":" death or disabling stroke.","confidence":1,"confidence_rate":1},{"cnt":[[245,1637],[1818,1637],[1818,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1637,"width":1574,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f270db5f29614455aefd518bea3697c2","type":"text","conversion_output":true,"text":"All potential strokes will be carefully reviewed and classified as disabling by the neurological","text_display":"\n\nAll potential strokes will be carefully reviewed and classified as disabling by the neurological","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[1800,1684],[1800,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1684,"width":1557,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"054acc065c3746bdbe39bcf4f855a226","type":"text","conversion_output":true,"text":"events committee using the Rankin Stroke Scale as described in Section 8. The neurological","text_display":" events committee using the Rankin Stroke Scale as described in Section 8. The neurological","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1803,1732],[1803,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1731,"width":1559,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbbbbcc9648c40b9a7f9323c63e7bcdc","type":"text","conversion_output":true,"text":"committee that reviews and adjudicates the strokes is an important part of the overall clinical","text_display":" committee that reviews and adjudicates the strokes is an important part of the overall clinical","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[245,1779],[1867,1779],[1867,1830],[245,1830]],"region":{"top_left_x":244,"top_left_y":1778,"width":1623,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eea3fb42ab3d44d698757cefddda4a46","type":"text","conversion_output":true,"text":"events adjudication process. A disabling stroke will be defined as a stroke whose severity on the","text_display":" events adjudication process. A disabling stroke will be defined as a stroke whose severity on the","confidence":1,"confidence_rate":1},{"cnt":[[245,1828],[1846,1828],[1846,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1828,"width":1602,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcde1aa2083041d48b1127fefef05ad5","type":"text","conversion_output":true,"text":"Rankin Scale is \\(\\geq 2\\). Cardiovascular deaths will be classified as described in Section 9.4 above.","text_display":" Rankin Scale is \\(\\geq 2\\). Cardiovascular deaths will be classified as described in Section 9.4 above.","confidence":1,"confidence_rate":1},{"cnt":[[245,1925],[1833,1925],[1833,1974],[245,1974]],"region":{"top_left_x":244,"top_left_y":1925,"width":1589,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98e13ab2bc0544c9a7d058c142bf2488","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will also use the competing risks","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will also use the competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,1968],[1863,1968],[1863,2022],[245,2022]],"region":{"top_left_x":244,"top_left_y":1967,"width":1619,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d9588b39c9b46b8a4ccb8d156ba18f1","type":"text","conversion_output":true,"text":"methodology of Fine and Gray \\({ }^{5}\\) described in Section 9.4 for the secondary endpoint of CV death","text_display":" methodology of Fine and Gray \\({ }^{5}\\) described in Section 9.4 for the secondary endpoint of CV death","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1813,2020],[1813,2069],[245,2069]],"region":{"top_left_x":244,"top_left_y":2019,"width":1570,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc5420b9e12c4da0bdda6523f147099c","type":"text","conversion_output":true,"text":"where death due to a non-cardiovascular cause is considered as a competing risk rather than a","text_display":" where death due to a non-cardiovascular cause is considered as a competing risk rather than a","confidence":1,"confidence_rate":1},{"cnt":[[245,2067],[1760,2067],[1760,2116],[245,2116]],"region":{"top_left_x":244,"top_left_y":2066,"width":1516,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"236efbf29cd24c4fa57aacdc10467088","type":"text","conversion_output":true,"text":"censoring event. The analysis will make use of the cumulative incidence function, and (as","text_display":" censoring event. The analysis will make use of the cumulative incidence function, and (as","confidence":1,"confidence_rate":1},{"cnt":[[245,2116],[1865,2116],[1865,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2116,"width":1621,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e035329695db4d8b9b3e1120e1142084","type":"text","conversion_output":true,"text":"described in Section 9.4) will be performed within the proportional hazards framework using the","text_display":" described in Section 9.4) will be performed within the proportional hazards framework using the","confidence":1,"confidence_rate":1},{"cnt":[[245,2166],[1865,2166],[1865,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2165,"width":1621,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5cf8a6f770c4a65aad8bb67b1984874","type":"text","conversion_output":true,"text":"marginal failure sub-distribution associated with the event of interest. The cumulative incidence","text_display":" marginal failure sub-distribution associated with the event of interest. The cumulative incidence","confidence":1,"confidence_rate":1},{"cnt":[[245,2213],[1809,2213],[1809,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":1565,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f4f4102004b43368b2fbfbfb26e4c55","type":"text","conversion_output":true,"text":"function for the two arms will be estimated, statistically compared, and graphically presented","text_display":" function for the two arms will be estimated, statistically compared, and graphically presented","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1850,2260],[1850,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1606,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"714711c7ce684598b81e538c22933cda","type":"text","conversion_output":true,"text":"using the PHREG procedure in SAS. For subjects who have not died, time from randomization","text_display":" using the PHREG procedure in SAS. For subjects who have not died, time from randomization","confidence":1,"confidence_rate":1},{"cnt":[[245,2307],[1830,2307],[1830,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2307,"width":1587,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ccb93235b1f4337a22fd26fb0b38700","type":"text","conversion_output":true,"text":"until the subject's last follow-up contact will be used in the analysis. The level of significance","text_display":" until the subject's last follow-up contact will be used in the analysis. The level of significance","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,2359],[1098,2359],[1098,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2358,"width":854,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9393c134a028495eab602dcecd1a0bec","type":"text","conversion_output":true,"text":"for the assessment of this endpoint will be \\(\\alpha=0.05\\).","text_display":" for the assessment of this endpoint will be \\(\\alpha=0.05\\).","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[1040,2548],[1089,2548],[1089,2593],[1040,2593]],"region":{"top_left_x":1039,"top_left_y":2548,"width":51,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac417e2565b0427eb396b4d091a8ee5b","type":"page_info","conversion_output":false,"text":"12","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-14","page":14,"lines":[{"cnt":[[245,254],[1732,254],[1732,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1488,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e84ba41290e4cf2b77906e3d3894559","type":"text","conversion_output":true,"text":"As in the case of the cardiovascular death endpoint, additional analysis of this secondary","text_display":"\n\nAs in the case of the cardiovascular death endpoint, additional analysis of this secondary","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1798,301],[1798,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1555,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38ee50db17074bfcb6e0044d56cd2998","type":"text","conversion_output":true,"text":"endpoint will be performed using the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval","text_display":" endpoint will be performed using the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[245,348],[1830,348],[1830,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1587,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7979147215245539d7ee9643044d294","type":"text","conversion_output":true,"text":"generated using the Cox model, and Kaplan-Meier cumulative event rate calculations. Patients","text_display":" generated using the Cox model, and Kaplan-Meier cumulative event rate calculations. Patients","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1837,397],[1837,445],[245,445]],"region":{"top_left_x":244,"top_left_y":397,"width":1593,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8903433e9fe47ac99fc548c6d7a7063","type":"text","conversion_output":true,"text":"who have died but whose cause of death is classified by the CEC as non-cardiovascular will be","text_display":" who have died but whose cause of death is classified by the CEC as non-cardiovascular will be","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,443],[1811,443],[1811,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1568,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56b65e6765f84b988e0f1cbc5259d30e","type":"text","conversion_output":true,"text":"censored at the time of their non-CV death. Results of these two different approaches will be","text_display":" censored at the time of their non-CV death. Results of these two different approaches will be","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":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e97b6050fdb24fc585963bc7a64104e7","type":"text","conversion_output":true,"text":"carefully compared and synthesized into an overall interpretation of treatment differences with","text_display":" carefully compared and synthesized into an overall interpretation of treatment differences with","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1177,541],[1177,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":934,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c62a0131b2144adb5ebb14bf13b4acd","type":"text","conversion_output":true,"text":"respect to the endpoint of CV death or disabling stroke.","text_display":" respect to the endpoint of CV death or disabling stroke.","confidence":1,"confidence_rate":1},{"cnt":[[236,632],[995,632],[995,692],[236,692]],"region":{"top_left_x":236,"top_left_y":631,"width":759,"height":61},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"434a98c136b44bc1a4254d7963aeb2b4","type":"section_header","conversion_output":false,"children_ids":["02205c9e2fdf4e12b24e38e260e37474"],"text":"","text_display":""},{"cnt":[[245,636],[986,636],[986,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":743,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02205c9e2fdf4e12b24e38e260e37474","type":"text","conversion_output":true,"parent_id":"434a98c136b44bc1a4254d7963aeb2b4","text":"9.6 Arrhythmic Death or Cardiac Arrest","text_display":"\n\n\\subsection*{9.6 Arrhythmic Death or Cardiac Arrest}","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1846,730],[1846,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1602,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a75861c7b5db4289a12e17f0069b7c47","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of either an arrhythmic death","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of either an arrhythmic death","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[531,782],[531,823],[245,823]],"region":{"top_left_x":244,"top_left_y":782,"width":287,"height":41},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bd4301c1ed844f9b64385a1056d8661","type":"text","conversion_output":true,"text":"or cardiac arrest.","text_display":" or cardiac arrest.","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1841,877],[1841,926],[245,926]],"region":{"top_left_x":244,"top_left_y":876,"width":1598,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bafe1d8101146b2b609e806200c3587","type":"text","conversion_output":true,"text":"Since cardiac arrest is a component of the primary endpoint, all potential cardiac arrests will be","text_display":"\n\nSince cardiac arrest is a component of the primary endpoint, all potential cardiac arrests will be","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1850,924],[1850,973],[245,973]],"region":{"top_left_x":244,"top_left_y":923,"width":1606,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"049b7c644ab94e1783959d17cc95726e","type":"text","conversion_output":true,"text":"reviewed and adjudicated by the Clinical Endpoints Committee. As described earlier, the mode","text_display":" reviewed and adjudicated by the Clinical Endpoints Committee. As described earlier, the mode","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1313,971],[1313,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":1069,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3134821322ed4e2391d42b199e311977","type":"text","conversion_output":true,"text":"of death is also classified by the Clinical Endpoints Committee.","text_display":" of death is also classified by the Clinical Endpoints Committee.","confidence":0.99951171875,"confidence_rate":0.9999929217569623},{"cnt":[[245,1066],[1880,1066],[1880,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1065,"width":1636,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ed2cb4f96e7441b86489e3672978e26","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this secondary endpoint will proceed in much the same way","text_display":"\n\nStatistical Methods: The analysis of this secondary endpoint will proceed in much the same way","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1854,1113],[1854,1164],[245,1164]],"region":{"top_left_x":244,"top_left_y":1112,"width":1611,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e1ea8972a7e479895fb7ba166229a89","type":"text","conversion_output":true,"text":"as described above for the endpoint of CV death or disabling stroke and use the competing risks","text_display":" as described above for the endpoint of CV death or disabling stroke and use the competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,1158],[1828,1158],[1828,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1158,"width":1585,"height":56},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fab4619e05d841b49779983fe8e5c54a","type":"text","conversion_output":true,"text":"methodology of Fine and Gray \\({ }^{5}\\) described in previous sections. In this analysis, death due to a","text_display":" methodology of Fine and Gray \\({ }^{5}\\) described in previous sections. In this analysis, death due to a","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1867,1212],[1867,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1623,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a90af12965b469ebf6384a83e109b82","type":"text","conversion_output":true,"text":"cause other than arrhythmic is considered as a competing risk rather than a censoring event. The","text_display":" cause other than arrhythmic is considered as a competing risk rather than a censoring event. The","confidence":0.998046875,"confidence_rate":0.9999806434067887},{"cnt":[[245,1259],[1820,1259],[1820,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1576,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6b0591e5a3440148174b928751c531c","type":"text","conversion_output":true,"text":"analysis will make use of the cumulative incidence function, and will be performed within the","text_display":" analysis will make use of the cumulative incidence function, and will be performed within the","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1833,1306],[1833,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":1589,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9947d886807c4d0da6bb74934c903bfa","type":"text","conversion_output":true,"text":"proportional hazards framework using the marginal failure sub-distribution associated with the","text_display":" proportional hazards framework using the marginal failure sub-distribution associated with the","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1723,1354],[1723,1403],[245,1403]],"region":{"top_left_x":244,"top_left_y":1353,"width":1480,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03adb44d1d0c43d183de5c4aedb8e87e","type":"text","conversion_output":true,"text":"event of interest. The cumulative incidence function for the two arms will be estimated,","text_display":" event of interest. The cumulative incidence function for the two arms will be estimated,","confidence":1,"confidence_rate":1},{"cnt":[[245,1401],[1783,1401],[1783,1452],[245,1452]],"region":{"top_left_x":244,"top_left_y":1400,"width":1540,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ab5a92ea49e4a8096448229ca1d9e86","type":"text","conversion_output":true,"text":"statistically compared, and graphically presented using the features available in the PHREG","text_display":" statistically compared, and graphically presented using the features available in the PHREG","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1846,1452],[1846,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":1602,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"259a50c757e944cfbd31c326ea5c05ee","type":"text","conversion_output":true,"text":"procedure in SAS. For subjects who have not died, time from randomization until the subject's","text_display":" procedure in SAS. For subjects who have not died, time from randomization until the subject's","confidence":1,"confidence_rate":1},{"cnt":[[245,1500],[1841,1500],[1841,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1499,"width":1598,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45bf6f8f97874c92be55f5568eec8868","type":"text","conversion_output":true,"text":"last follow-up contact will be used in the analysis. The level of significance for the assessment","text_display":" last follow-up contact will be used in the analysis. The level of significance for the assessment","confidence":1,"confidence_rate":1},{"cnt":[[245,1549],[784,1549],[784,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1549,"width":541,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c1a4941f61848a3bbbc011977a07c38","type":"text","conversion_output":true,"text":"of this endpoint will be \\(\\alpha=0.05\\).","text_display":" of this endpoint will be \\(\\alpha=0.05\\).","confidence":0.99951171875,"confidence_rate":0.9999880878636791},{"cnt":[[245,1646],[1828,1646],[1828,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1645,"width":1585,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9f52477c4164b1e89c3b99354a5b8c0","type":"text","conversion_output":true,"text":"For this endpoint, we will also perform additional analysis using the log-rank test, hazard ratio","text_display":"\n\nFor this endpoint, we will also perform additional analysis using the log-rank test, hazard ratio","confidence":1,"confidence_rate":1},{"cnt":[[245,1693],[1781,1693],[1781,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1692,"width":1538,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0d017609bdc48ff806dd330ed5f1116","type":"text","conversion_output":true,"text":"and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier cumulative","text_display":" and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier cumulative","confidence":1,"confidence_rate":1},{"cnt":[[245,1740],[1876,1740],[1876,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1632,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3cef161766e455b95c3fe27ed0ccbda","type":"text","conversion_output":true,"text":"event rate calculations. Patients who have died but whose cause of death is classified by the CEC","text_display":" event rate calculations. Patients who have died but whose cause of death is classified by the CEC","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[1871,1788],[1871,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1787,"width":1628,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acd7bfc81e5b4900b39f2d49065aadd9","type":"text","conversion_output":true,"text":"as other than arrhythmic will be censored at the time of the non-arrhythmic death. The results of","text_display":" as other than arrhythmic will be censored at the time of the non-arrhythmic death. The results of","confidence":1,"confidence_rate":1},{"cnt":[[245,1835],[1876,1835],[1876,1886],[245,1886]],"region":{"top_left_x":244,"top_left_y":1834,"width":1632,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"457c504588094c14bf2ea5a32f61e8c4","type":"text","conversion_output":true,"text":"these two different approaches will be compared and synthesized into an overall interpretation of","text_display":" these two different approaches will be compared and synthesized into an overall interpretation of","confidence":1,"confidence_rate":1},{"cnt":[[245,1884],[1708,1884],[1708,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1884,"width":1465,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a2da1e00cfd43a5984cc9d3c4a31ba9","type":"text","conversion_output":true,"text":"treatment differences with respect to the endpoint of arrhythmic death or cardiac arrest.","text_display":" treatment differences with respect to the endpoint of arrhythmic death or cardiac arrest.","confidence":1,"confidence_rate":1},{"cnt":[[241,1977],[694,1977],[694,2030],[241,2030]],"region":{"top_left_x":240,"top_left_y":1976,"width":454,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f399a43907ae433baed7eacab43756da","type":"section_header","conversion_output":false,"children_ids":["6ace58f8c8a04727b5839b3bd33e1d11"],"text":"","text_display":""},{"cnt":[[245,1981],[690,1981],[690,2026],[245,2026]],"region":{"top_left_x":244,"top_left_y":1980,"width":446,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ace58f8c8a04727b5839b3bd33e1d11","type":"text","conversion_output":true,"parent_id":"f399a43907ae433baed7eacab43756da","text":"9.7 Heart Failure Death","text_display":"\n\n\\subsection*{9.7 Heart Failure Death}","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1747,2075],[1747,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1503,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"644f61b4f7be41c4a5d4ddfb258674eb","type":"text","conversion_output":true,"text":"Endpoint definition: Time from randomization to the occurrence of a heart failure death.","text_display":"\n\nEndpoint definition: Time from randomization to the occurrence of a heart failure death.","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1820,2170],[1820,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2169,"width":1576,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a17f95db30b4da9ac7b025f37d540ba","type":"text","conversion_output":true,"text":"Classification of deaths as being due to heart failure will be performed by the blinded Clinical","text_display":"\nClassification of deaths as being due to heart failure will be performed by the blinded Clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,2219],[627,2219],[627,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2219,"width":384,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4437e9ec793843ec846d734ca281447b","type":"text","conversion_output":true,"text":"Endpoints Committee.","text_display":" Endpoints Committee.","confidence":1,"confidence_rate":1},{"cnt":[[245,2316],[1721,2316],[1721,2365],[245,2365]],"region":{"top_left_x":244,"top_left_y":2316,"width":1477,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1688eeaa85684193918b4ebb5b1f0e93","type":"text","conversion_output":true,"text":"Statistical Methods: The analysis of this endpoint will make use of the competing risks","text_display":"\n\nStatistical Methods: The analysis of this endpoint will make use of the competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[1863,2359],[1863,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2358,"width":1619,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaa13663b30c4e39a9d64a163362bc3d","type":"text","conversion_output":true,"text":"methodology of Fine and Gray \\({ }^{5}\\) described in previous sections for other secondary endpoints. In","text_display":" methodology of Fine and Gray \\({ }^{5}\\) described in previous sections for other secondary endpoints. In","confidence":1,"confidence_rate":1},{"cnt":[[245,2411],[1841,2411],[1841,2460],[245,2460]],"region":{"top_left_x":244,"top_left_y":2410,"width":1598,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4e6ab55ff004cecbf649c4d1650b43b","type":"text","conversion_output":true,"text":"this case, death due to a cause other than heart failure will considered as a competing risk. The","text_display":" this case, death due to a cause other than heart failure will considered as a competing risk. The","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90dc47c05772454e85f1aee5a1be2d64","type":"page_info","conversion_output":false,"text":"13","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-15","page":15,"lines":[{"cnt":[[245,251],[1798,251],[1798,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1555,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e1d2a0a4ebb435f9cbd0d4148aba57d","type":"text","conversion_output":true,"text":"features of the Fine-Gray approach for handling competing risks data available as part of the","text_display":"\nfeatures of the Fine-Gray approach for handling competing risks data available as part of the","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,301],[1830,301],[1830,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1587,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5efc00266fc4990b70048d201027927","type":"text","conversion_output":true,"text":"PHREG procedure in SAS will be employed to estimate the cumulative incidence function for","text_display":" PHREG procedure in SAS will be employed to estimate the cumulative incidence function for","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1876,348],[1876,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1632,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98ea78f88f924b2ebe097dd63195ea5f","type":"text","conversion_output":true,"text":"each of the two arms, to statistically compare these functions, and graphically present them using","text_display":" each of the two arms, to statistically compare these functions, and graphically present them using","confidence":0.98779296875,"confidence_rate":0.9998807629443354},{"cnt":[[245,397],[1841,397],[1841,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1598,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fec0728e4214b9e8bab0534b2f4897b","type":"text","conversion_output":true,"text":"the software features in SAS. The level of significance for the assessment of this endpoint will","text_display":" the software features in SAS. The level of significance for the assessment of this endpoint will","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[518,447],[518,494],[245,494]],"region":{"top_left_x":244,"top_left_y":446,"width":274,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7061c1c5b864469aa98034ff5ec6197e","type":"text","conversion_output":true,"text":"also be \\(\\alpha=0.05\\).","text_display":" also be \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1809,541],[1809,593],[245,593]],"region":{"top_left_x":244,"top_left_y":541,"width":1565,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f26639d1cd8748b19d3ec1e2f32d88f2","type":"text","conversion_output":true,"text":"Additional analysis of this secondary endpoint will also be performed using the log-rank test,","text_display":"\n\nAdditional analysis of this secondary endpoint will also be performed using the log-rank test,","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1878,589],[1878,642],[245,642]],"region":{"top_left_x":244,"top_left_y":588,"width":1634,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b78dfafb2c7c4f0b9d641fd8dfec7041","type":"text","conversion_output":true,"text":"hazard ratio and \\(95 \\%\\) confidence interval (CI) generated using the Cox model, and Kaplan-Meier","text_display":" hazard ratio and \\(95 \\%\\) confidence interval (CI) generated using the Cox model, and Kaplan-Meier","confidence":0.768956184387207,"confidence_rate":0.9974021793153767},{"cnt":[[245,638],[1833,638],[1833,690],[245,690]],"region":{"top_left_x":244,"top_left_y":638,"width":1589,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef655e5a7f8849339d0d12744a98fc86","type":"text","conversion_output":true,"text":"cumulative event rate calculations. For this analysis, patients who have died, but their death is","text_display":" cumulative event rate calculations. For this analysis, patients who have died, but their death is","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1833,683],[1833,737],[245,737]],"region":{"top_left_x":244,"top_left_y":683,"width":1589,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84642b6b665d44b39fb880e0d134314b","type":"text","conversion_output":true,"text":"classified by the CEC as due to a cause other than heart failure, will be censored at the time of","text_display":" classified by the CEC as due to a cause other than heart failure, will be censored at the time of","confidence":0.998046875,"confidence_rate":0.9999808331754918},{"cnt":[[245,733],[1809,733],[1809,784],[245,784]],"region":{"top_left_x":244,"top_left_y":732,"width":1565,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c205c2cdcd5f498aba5733fea31e3617","type":"text","conversion_output":true,"text":"their non-heart failure death. The results of the competing risk analysis and of this traditional","text_display":" their non-heart failure death. The results of the competing risk analysis and of this traditional","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[1807,782],[1807,834],[245,834]],"region":{"top_left_x":244,"top_left_y":782,"width":1563,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b070576eff1444469c76c59bcf0a16fb","type":"text","conversion_output":true,"text":"analysis will be compared to synthesize an overall interpretation of the treatment differences.","text_display":" analysis will be compared to synthesize an overall interpretation of the treatment differences.","confidence":1,"confidence_rate":1},{"cnt":[[236,870],[853,870],[853,935],[236,935]],"region":{"top_left_x":236,"top_left_y":870,"width":617,"height":65},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"746d7596de574cc8aed86909aabcf295","type":"section_header","conversion_output":false,"children_ids":["71f9ac2f413a478e9f0e6d7a02f2980a"],"text":"","text_display":""},{"cnt":[[245,877],[844,877],[844,926],[245,926]],"region":{"top_left_x":244,"top_left_y":876,"width":601,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71f9ac2f413a478e9f0e6d7a02f2980a","type":"text","conversion_output":true,"parent_id":"746d7596de574cc8aed86909aabcf295","text":"9.8 Recurrent Atrial Fibrillation","text_display":"\n\n\\subsection*{9.8 Recurrent Atrial Fibrillation}","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1695,975],[1695,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1452,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7972fdecde704a8c85f36b97feb17bbf","type":"text","conversion_output":true,"text":"Endpoint definition: This particular outcome will be analyzed with different endpoint","text_display":"\n\nEndpoint definition: This particular outcome will be analyzed with different endpoint","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1861,1023],[1861,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":1617,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"004d5880da49411aaf7df4303ab69a4a","type":"text","conversion_output":true,"text":"definitions in order to provide an overall perspective of the extent of the AF burden experienced","text_display":" definitions in order to provide an overall perspective of the extent of the AF burden experienced","confidence":0.7431640625,"confidence_rate":0.9972552695336833},{"cnt":[[245,1070],[1794,1070],[1794,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1550,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bcb8252d6754ecba8daf24ab85474f7","type":"text","conversion_output":true,"text":"by the study subjects. The first analysis will consider the first episode of recurrent AF as the","text_display":" by the study subjects. The first analysis will consider the first episode of recurrent AF as the","confidence":0.99560546875,"confidence_rate":0.9999588399537807},{"cnt":[[245,1117],[1820,1117],[1820,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1117,"width":1576,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dcf7a4f091f45c399a8abec21f0985a","type":"text","conversion_output":true,"text":"endpoint, defined as an episode \\(\\geq 30\\) seconds following the end of the 90 -day blanking period,","text_display":" endpoint, defined as an episode \\(\\geq 30\\) seconds following the end of the 90 -day blanking period,","confidence":0.9951171875,"confidence_rate":0.9999529359885383},{"cnt":[[245,1164],[1721,1164],[1721,1216],[245,1216]],"region":{"top_left_x":244,"top_left_y":1164,"width":1477,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3695092fbaa74337b27382ac3cb26d24","type":"text","conversion_output":true,"text":"where the 90 -day blanking period begins at the time of receiving the randomly assigned","text_display":" where the 90 -day blanking period begins at the time of receiving the randomly assigned","confidence":0.80322265625,"confidence_rate":0.9976960967741285},{"cnt":[[245,1212],[1880,1212],[1880,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1211,"width":1636,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0604dc316d3f4ce0915b5d32d1cb6036","type":"text","conversion_output":true,"text":"treatment (either ablation or drug therapy). The endpoint will be defined as the time until the first","text_display":" treatment (either ablation or drug therapy). The endpoint will be defined as the time until the first","confidence":1,"confidence_rate":1},{"cnt":[[245,1261],[1790,1261],[1790,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1261,"width":1546,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c55386c80ce948e89f2a39791e725eaa","type":"text","conversion_output":true,"text":"recurrence of AF according to this definition. Similar analyses will be performed where the","text_display":" recurrence of AF according to this definition. Similar analyses will be performed where the","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1766,1311],[1766,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1523,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6eda746c40f41e798cfdca7c5cb6080","type":"text","conversion_output":true,"text":"endpoint is defined as: (a) an episode of symptomatic recurrent AF , (b) an episode of atrial","text_display":" endpoint is defined as: (a) an episode of symptomatic recurrent AF , (b) an episode of atrial","confidence":0.9501953125,"confidence_rate":0.9995088925230297},{"cnt":[[245,1358],[1721,1358],[1721,1407],[245,1407]],"region":{"top_left_x":244,"top_left_y":1357,"width":1477,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efe5114acccc42c987d8398477c71966","type":"text","conversion_output":true,"text":"fibrillation or atrial flutter or atrial tachycardia, and (c) an episode of symptomatic atrial","text_display":" fibrillation or atrial flutter or atrial tachycardia, and (c) an episode of symptomatic atrial","confidence":1,"confidence_rate":1},{"cnt":[[245,1405],[1016,1405],[1016,1457],[245,1457]],"region":{"top_left_x":244,"top_left_y":1405,"width":773,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a58d50a6486541de91ead7151cc75b69","type":"text","conversion_output":true,"text":"fibrillation, atrial flutter, or atrial tachycardia.","text_display":" fibrillation, atrial flutter, or atrial tachycardia.","confidence":1,"confidence_rate":1},{"cnt":[[243,1500],[1880,1500],[1880,1553],[243,1553]],"region":{"top_left_x":242,"top_left_y":1499,"width":1638,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adc31c1d2efb4f55ba0e6b83d90c115b","type":"text","conversion_output":true,"text":"Analysis Population: Because recurrent atrial fibrillation is defined with respect to the end of the","text_display":"\n\nAnalysis Population: Because recurrent atrial fibrillation is defined with respect to the end of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1549],[1835,1549],[1835,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1549,"width":1591,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"192a733f26d1412eb22b8101168d234e","type":"text","conversion_output":true,"text":"blanking period, which begins after receipt of the assigned treatment, all analyses for recurrent","text_display":" blanking period, which begins after receipt of the assigned treatment, all analyses for recurrent","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1867,1594],[1867,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1594,"width":1623,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b81301544b74b83bd7c149e527eb9b4","type":"text","conversion_output":true,"text":"atrial fibrillation will include only patients who have received their randomly assigned treatment","text_display":" atrial fibrillation will include only patients who have received their randomly assigned treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1644],[952,1644],[952,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1643,"width":708,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4cdd78f697b44968fed96a31381af77","type":"text","conversion_output":true,"text":"and live to the end of the blanking period.","text_display":" and live to the end of the blanking period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1740],[1878,1740],[1878,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1634,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc8fd5147f8745a888f4373a1385e49f","type":"text","conversion_output":true,"text":"In addition, separate analyses will be performed according to the method used for monitoring AF","text_display":"\n\nIn addition, separate analyses will be performed according to the method used for monitoring AF","confidence":0.7060546875,"confidence_rate":0.9965254245219815},{"cnt":[[245,1788],[1772,1788],[1772,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1787,"width":1529,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9ffe07052d24ca4baff958afccd2715","type":"text","conversion_output":true,"text":"recurrence. As indicated in Section 6 (Data Sources), rhythm data for many of the patients","text_display":" recurrence. As indicated in Section 6 (Data Sources), rhythm data for many of the patients","confidence":1,"confidence_rate":1},{"cnt":[[245,1835],[1803,1835],[1803,1886],[245,1886]],"region":{"top_left_x":244,"top_left_y":1834,"width":1559,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0aec8b63bb34a1b816b8cf6865fb6ce","type":"text","conversion_output":true,"text":"enrolled in CABANA (approximately \\(2 / 3\\) of the randomized patients) are collected using the","text_display":" enrolled in CABANA (approximately \\(2 / 3\\) of the randomized patients) are collected using the","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[245,1882],[1785,1882],[1785,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1882,"width":1542,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc24080f8e0c43e1adcccfcbdf513cd6","type":"text","conversion_output":true,"text":"\"CABANA Box,\" a robust rhythm monitoring system provided by Medicomp. The rhythm","text_display":" \"CABANA Box,\" a robust rhythm monitoring system provided by Medicomp. The rhythm","confidence":1,"confidence_rate":1},{"cnt":[[245,1934],[1858,1934],[1858,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1933,"width":1615,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"113dd86d06d248dca625b0b379ae543f","type":"text","conversion_output":true,"text":"monitoring data are sent from Medicomp to the Duke Clinical Research Institute (DCRI), where","text_display":" monitoring data are sent from Medicomp to the Duke Clinical Research Institute (DCRI), where","confidence":1,"confidence_rate":1},{"cnt":[[245,1981],[1843,1981],[1843,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1980,"width":1600,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"358f8329ed8f4b189b71261c75ed0366","type":"text","conversion_output":true,"text":"a set of programmed rules are run to determine which rhythms should be submitted to the ECG","text_display":" a set of programmed rules are run to determine which rhythms should be submitted to the ECG","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1783,2028],[1783,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2028,"width":1540,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de189866bd1244858835f894b0617c4f","type":"text","conversion_output":true,"text":"core lab for review and adjudication. Following core lab review, the adjudicated results are","text_display":" core lab for review and adjudication. Following core lab review, the adjudicated results are","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1760,2075],[1760,2127],[245,2127]],"region":{"top_left_x":244,"top_left_y":2075,"width":1516,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cf2c63790d4411db20d8a18f7798c75","type":"text","conversion_output":true,"text":"electronically transmitted back to the DCRI. Sites that are not using the \"CABANA Box\"","text_display":" electronically transmitted back to the DCRI. Sites that are not using the \"CABANA Box\"","confidence":1,"confidence_rate":1},{"cnt":[[245,2123],[1880,2123],[1880,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2122,"width":1636,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"551e64bb9448475481bc5c0321474cd7","type":"text","conversion_output":true,"text":"(generally these are international sites where use of the CABANA Box was not approved) submit","text_display":" (generally these are international sites where use of the CABANA Box was not approved) submit","confidence":1,"confidence_rate":1},{"cnt":[[245,2172],[1826,2172],[1826,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2172,"width":1583,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ff741fba40e44a8b8f7499738c0994a","type":"text","conversion_output":true,"text":"rhythm data through a secure portal using the CABANA website, which is then processed and","text_display":" rhythm data through a secure portal using the CABANA website, which is then processed and","confidence":1,"confidence_rate":1},{"cnt":[[245,2219],[1691,2219],[1691,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2219,"width":1447,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ada0f0fe91a463b8e6ab013cbea8c1a","type":"text","conversion_output":true,"text":"submitted to the core lab for adjudication. Because the CABANA Box data are more","text_display":" submitted to the core lab for adjudication. Because the CABANA Box data are more","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[1858,2264],[1858,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2264,"width":1615,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9bb4463333d4b12a7e1d2a950dafe8e","type":"text","conversion_output":true,"text":"comprehensive and more routinely and rigorously collected, separate analyses of recurrent atrial","text_display":" comprehensive and more routinely and rigorously collected, separate analyses of recurrent atrial","confidence":1,"confidence_rate":1},{"cnt":[[245,2316],[1760,2316],[1760,2365],[245,2365]],"region":{"top_left_x":244,"top_left_y":2316,"width":1516,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f38bf79318aa476ea1a9814e433a761b","type":"text","conversion_output":true,"text":"arrhythmias will be performed using (a) patients whose rhythms were monitored using the","text_display":" arrhythmias will be performed using (a) patients whose rhythms were monitored using the","confidence":1,"confidence_rate":1},{"cnt":[[245,2363],[1858,2363],[1858,2415],[245,2415]],"region":{"top_left_x":244,"top_left_y":2363,"width":1615,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"297b87fd2219479494dc1dc33c2266f1","type":"text","conversion_output":true,"text":"CABANA Box, (b) all remaining patients (i.e., non-CABANA Box patients), and (c) the pooled","text_display":" CABANA Box, (b) all remaining patients (i.e., non-CABANA Box patients), and (c) the pooled","confidence":1,"confidence_rate":1},{"cnt":[[245,2411],[1760,2411],[1760,2464],[245,2464]],"region":{"top_left_x":244,"top_left_y":2410,"width":1516,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e113fe9c9baf441aaeb338efdf0eaa4b","type":"text","conversion_output":true,"text":"group of all patients (with use of CABANA Box as a covariate if justified). In the case of","text_display":" group of all patients (with use of CABANA Box as a covariate if justified). In the case of","confidence":1,"confidence_rate":1},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96281de50f694ac1b65df8733dc65e3c","type":"page_info","conversion_output":false,"text":"14","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-16","page":16,"lines":[{"cnt":[[245,254],[1749,254],[1749,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1505,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"174e5388513e45cb9eb55b47b69efbc8","type":"text","conversion_output":true,"text":"patients who initially used the CABANA Box and later ceased to provide information via","text_display":"\npatients who initially used the CABANA Box and later ceased to provide information via","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1820,301],[1820,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1576,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"758d448a5b194db883a42129834b5342","type":"text","conversion_output":true,"text":"CABANA Box, the analysis will censor that data at the time of last CABANA Box recording.","text_display":" CABANA Box, the analysis will censor that data at the time of last CABANA Box recording.","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[245,348],[1828,348],[1828,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1585,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df924880232d4ab79685bb5472b5f792","type":"text","conversion_output":true,"text":"The primary analysis of this endpoint will be the analysis of patients with CABANA Box data","text_display":" The primary analysis of this endpoint will be the analysis of patients with CABANA Box data","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[1854,397],[1854,449],[245,449]],"region":{"top_left_x":244,"top_left_y":397,"width":1611,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb0a77a8341b415e99e3a4f31dfd710a","type":"text","conversion_output":true,"text":"because of the more comprehensive collection of that rhythm monitoring information. Analysis","text_display":" because of the more comprehensive collection of that rhythm monitoring information. Analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1648,443],[1648,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1404,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93d2fe9d0a6f46bb9c6ba3fbaedf568d","type":"text","conversion_output":true,"text":"which includes non-CABANA Box patients (\"b\" and \"c\" above) will be considered","text_display":" which includes non-CABANA Box patients (\"b\" and \"c\" above) will be considered","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[655,492],[655,544],[245,544]],"region":{"top_left_x":244,"top_left_y":491,"width":412,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49c92e74fd9f4367892d47772c6c38ce","type":"text","conversion_output":true,"text":"supplementary analysis.","text_display":" supplementary analysis.","confidence":1,"confidence_rate":1},{"cnt":[[243,587],[1717,587],[1717,638],[243,638]],"region":{"top_left_x":242,"top_left_y":586,"width":1475,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b314c433c7149839acc296446e4c49a","type":"text","conversion_output":true,"text":"Statistical Analysis: First, descriptive summaries of baseline characteristics of subjects","text_display":"\n\nStatistical Analysis: First, descriptive summaries of baseline characteristics of subjects","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[245,636],[1848,636],[1848,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1604,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e4a60e1737f43d09ba96f03b30e6026","type":"text","conversion_output":true,"text":"receiving their assigned treatment and living to the end of the blanking period in both treatment","text_display":" receiving their assigned treatment and living to the end of the blanking period in both treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1798,683],[1798,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1555,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37b00fb934234fe2a1d4d111707aadfb","type":"text","conversion_output":true,"text":"arms will be presented to determine how comparable the patients in the two arms are for this","text_display":" arms will be presented to determine how comparable the patients in the two arms are for this","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1815,726],[1815,782],[245,782]],"region":{"top_left_x":244,"top_left_y":726,"width":1572,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91956caeb5bd4d86bd2365900f73bba6","type":"text","conversion_output":true,"text":"analysis. Continuous variables will be presented in terms of percentiles (median, \\(25{ }^{\\text {th }}\\) and \\(75{ }^{\\text {th }}\\)","text_display":" analysis. Continuous variables will be presented in terms of percentiles (median, \\(25{ }^{\\text {th }}\\) and \\(75{ }^{\\text {th }}\\)","confidence":0.8045542240142822,"confidence_rate":0.9982755606686755},{"cnt":[[245,778],[1669,778],[1669,831],[245,831]],"region":{"top_left_x":244,"top_left_y":777,"width":1426,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ce021529aec42939fc4559e031a7d93","type":"text","conversion_output":true,"text":"percentiles), while discrete variables will be summarized in terms of frequencies and","text_display":" percentiles), while discrete variables will be summarized in terms of frequencies and","confidence":1,"confidence_rate":1},{"cnt":[[245,831],[460,831],[460,879],[245,879]],"region":{"top_left_x":244,"top_left_y":831,"width":216,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d3a3927b3214463a3d8b53d4ffe0318","type":"text","conversion_output":true,"text":"percentages.","text_display":" percentages.","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1826,924],[1826,973],[245,973]],"region":{"top_left_x":244,"top_left_y":923,"width":1583,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"477c4f42053a47d39ab7ff8db7ab8122","type":"text","conversion_output":true,"text":"The treatment arms will be compared using statistical methods described in the sections above","text_display":"\n\nThe treatment arms will be compared using statistical methods described in the sections above","confidence":1,"confidence_rate":1},{"cnt":[[245,965],[1876,965],[1876,1023],[245,1023]],"region":{"top_left_x":244,"top_left_y":964,"width":1632,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b091894fbcec4482b690c1bdb7365fce","type":"text","conversion_output":true,"text":"for other secondary endpoints, including the competing risk method of Fine and Gray \\({ }^{4}\\), as well as","text_display":" for other secondary endpoints, including the competing risk method of Fine and Gray \\({ }^{4}\\), as well as","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1760,1018],[1760,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1018,"width":1516,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29601d1cc4b849d2aecd167d9e8ffabd","type":"text","conversion_output":true,"text":"use of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox","text_display":" use of the log-rank test, hazard ratio and \\(95 \\%\\) confidence interval generated using the Cox","confidence":0.99267578125,"confidence_rate":0.9999249908487245},{"cnt":[[245,1066],[1815,1066],[1815,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1065,"width":1572,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20cbbf4337924b73a5e4001097479ef0","type":"text","conversion_output":true,"text":"model, and Kaplan-Meier cumulative event rate calculations. In this case, all-cause mortality","text_display":" model, and Kaplan-Meier cumulative event rate calculations. In this case, all-cause mortality","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1820,1113],[1820,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1112,"width":1576,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25f1dd9e5a7545ecb50291eb8ff73781","type":"text","conversion_output":true,"text":"will be a competing risk and zero-time (i.e., when the clock starts) for this analysis will be the","text_display":" will be a competing risk and zero-time (i.e., when the clock starts) for this analysis will be the","confidence":0.998046875,"confidence_rate":0.9999810192594005},{"cnt":[[245,1162],[1815,1162],[1815,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1162,"width":1572,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52417efe78e94a54a2a4e071be3c9741","type":"text","conversion_output":true,"text":"end of the 90 -day blanking period. Analyses will be repeated with adjustment for the baseline","text_display":" end of the 90 -day blanking period. Analyses will be repeated with adjustment for the baseline","confidence":0.93115234375,"confidence_rate":0.9993009074148665},{"cnt":[[245,1212],[836,1212],[836,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1211,"width":592,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"625e7b593eff4895b151144bff3aaddd","type":"text","conversion_output":true,"text":"covariates described in section 8.1.","text_display":" covariates described in section 8.1.","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1858,1306],[1858,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":1615,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8701c10ede2e4841ad0536ee53ffa014","type":"text","conversion_output":true,"text":"Of key interest will be whether the effect of ablation on recurrent atrial arrhythmias is similar or","text_display":"\n\nOf key interest will be whether the effect of ablation on recurrent atrial arrhythmias is similar or","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1843,1354],[1843,1405],[245,1405]],"region":{"top_left_x":244,"top_left_y":1353,"width":1600,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8754d1cbae2a46c0abd3d89424cdf576","type":"text","conversion_output":true,"text":"different according to the type of AF the patients experienced prior to enrolling in the trial (i.e.,","text_display":" different according to the type of AF the patients experienced prior to enrolling in the trial (i.e.,","confidence":0.83544921875,"confidence_rate":0.9983053459253841},{"cnt":[[245,1401],[1854,1401],[1854,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1400,"width":1611,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9612dc010bee467da920b5478c6c6ab7","type":"text","conversion_output":true,"text":"whether the effect varies according to whether patients' baseline AF was paroxysmal, persistent","text_display":" whether the effect varies according to whether patients' baseline AF was paroxysmal, persistent","confidence":0.998046875,"confidence_rate":0.9999815564452184},{"cnt":[[245,1452],[1818,1452],[1818,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":1574,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb6209130d424c1dbcdcfaf8037f8ec0","type":"text","conversion_output":true,"text":"or long-standing persistent). This analysis will utilize the Cox model to test for an interaction","text_display":" or long-standing persistent). This analysis will utilize the Cox model to test for an interaction","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1497],[1712,1497],[1712,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1497,"width":1469,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4ac77a8a3704e9fb1db48bb8a969697","type":"text","conversion_output":true,"text":"between the randomized treatment strategy and the baseline type of AF classified as (a)","text_display":" between the randomized treatment strategy and the baseline type of AF classified as (a)","confidence":1,"confidence_rate":1},{"cnt":[[245,1547],[1811,1547],[1811,1596],[245,1596]],"region":{"top_left_x":244,"top_left_y":1546,"width":1568,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de989c19e3bc4a3da33bdcff67d5ef60","type":"text","conversion_output":true,"text":"paroxysmal or (b) persistent or longstanding persistent. In addition to the interaction test, the","text_display":" paroxysmal or (b) persistent or longstanding persistent. In addition to the interaction test, the","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1848,1594],[1848,1644],[245,1644]],"region":{"top_left_x":244,"top_left_y":1594,"width":1604,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1956b04555f043729ae01d9640820ce6","type":"text","conversion_output":true,"text":"effect of the treatment strategy characterized by a hazard ratio and \\(95 \\%\\) confidence interval and","text_display":" effect of the treatment strategy characterized by a hazard ratio and \\(95 \\%\\) confidence interval and","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[245,1641],[1768,1641],[1768,1691],[245,1691]],"region":{"top_left_x":244,"top_left_y":1641,"width":1525,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f7fd31124914bb092f62912fe73d218","type":"text","conversion_output":true,"text":"Kaplan-Meier event rate calculations will be calculated and displayed for the subgroups of","text_display":" Kaplan-Meier event rate calculations will be calculated and displayed for the subgroups of","confidence":0.98876953125,"confidence_rate":0.9998811227862585},{"cnt":[[245,1689],[1747,1689],[1747,1740],[245,1740]],"region":{"top_left_x":244,"top_left_y":1688,"width":1503,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9adc0934720e4fe0ab0dc8e131133f2e","type":"text","conversion_output":true,"text":"patients whose baseline AF history was (a) paroxysmal and (b) persistent or longstanding","text_display":" patients whose baseline AF history was (a) paroxysmal and (b) persistent or longstanding","confidence":0.98486328125,"confidence_rate":0.9998360086286446},{"cnt":[[245,1738],[1835,1738],[1835,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1738,"width":1591,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e43446a27ec249fb91b7c04e997d77c5","type":"text","conversion_output":true,"text":"persistent. Similar comparative analyses will be performed in subgroups defined by age (<65,","text_display":" persistent. Similar comparative analyses will be performed in subgroups defined by age (<65,","confidence":0.994140625,"confidence_rate":0.9999394182424788},{"cnt":[[245,1783],[1291,1783],[1291,1835],[245,1835]],"region":{"top_left_x":244,"top_left_y":1783,"width":1048,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc33ae9c13f146aea20171e7c3a91a4f","type":"text","conversion_output":true,"text":"65-74, and \\(\\geq 75\\) ) and by \\(CHA _{2} DS _{2}\\)-VASc Score (0 or 1 vs \\(>1\\) ).","text_display":" 65-74, and \\(\\geq 75\\) ) and by \\(CHA _{2} DS _{2}\\)-VASc Score (0 or 1 vs \\(>1\\) ).","confidence":0.7257777138147503,"confidence_rate":0.9967012108318472},{"cnt":[[236,1878],[889,1878],[889,1938],[236,1938]],"region":{"top_left_x":236,"top_left_y":1877,"width":654,"height":61},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a322b7711b804f5e8fb2ba7f0416b52e","type":"section_header","conversion_output":false,"children_ids":["fcf0a83d1df443cc840f52fcb94b31c7"],"text":"","text_display":""},{"cnt":[[245,1882],[883,1882],[883,1931],[245,1931]],"region":{"top_left_x":244,"top_left_y":1882,"width":640,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcf0a83d1df443cc840f52fcb94b31c7","type":"text","conversion_output":true,"parent_id":"a322b7711b804f5e8fb2ba7f0416b52e","text":"9.9 Cardiovascular Hospitalization","text_display":"\n\n\\subsection*{9.9 Cardiovascular Hospitalization}","confidence":1,"confidence_rate":1},{"cnt":[[245,1979],[1815,1979],[1815,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1978,"width":1572,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2227a2c320748e28c64f0d70c3de974","type":"text","conversion_output":true,"text":"A key part of the analysis and interpretation of the results of this endpoint will be the analysis","text_display":"\n\nA key part of the analysis and interpretation of the results of this endpoint will be the analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,2024],[1841,2024],[1841,2078],[245,2078]],"region":{"top_left_x":244,"top_left_y":2023,"width":1598,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37d3a2ae0edb4073925a29e8c043f290","type":"text","conversion_output":true,"text":"performed in connection with secondary endpoint \\#2 (the composite of death or cardiovascular","text_display":" performed in connection with secondary endpoint \\#2 (the composite of death or cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[245,2073],[1785,2073],[1785,2125],[245,2125]],"region":{"top_left_x":244,"top_left_y":2073,"width":1542,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"607d9ceb86cb4750b689c67f5fa68830","type":"text","conversion_output":true,"text":"hospitalization). Analysis of cardiovascular hospitalization as an endpoint by itself must be","text_display":" hospitalization). Analysis of cardiovascular hospitalization as an endpoint by itself must be","confidence":1,"confidence_rate":1},{"cnt":[[245,2123],[1809,2123],[1809,2172],[245,2172]],"region":{"top_left_x":244,"top_left_y":2122,"width":1565,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4848fa3c9b5448e2871dcfd948cf3ee0","type":"text","conversion_output":true,"text":"analyzed and interpreted cautiously, particularly if there is a mortality difference between the","text_display":" analyzed and interpreted cautiously, particularly if there is a mortality difference between the","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1764,2170],[1764,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1520,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8d63ab9a81047379795d59b6821b58c","type":"text","conversion_output":true,"text":"two arms of the trial. If patients in one arm have lower mortality, that arm may have more","text_display":" two arms of the trial. If patients in one arm have lower mortality, that arm may have more","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1869,2217],[1869,2267],[245,2267]],"region":{"top_left_x":244,"top_left_y":2217,"width":1626,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a479c0b06d242a1a1d29b2f60b6c9c7","type":"text","conversion_output":true,"text":"hospitalizations simply because more patients are alive and at risk for needing to be hospitalized.","text_display":" hospitalizations simply because more patients are alive and at risk for needing to be hospitalized.","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[1772,2264],[1772,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2264,"width":1529,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"092d2a9b048f4e0a939ad68ff5365066","type":"text","conversion_output":true,"text":"Another important aspect of the analysis of this endpoint is that patients may have multiple","text_display":" Another important aspect of the analysis of this endpoint is that patients may have multiple","confidence":1,"confidence_rate":1},{"cnt":[[245,2312],[1846,2312],[1846,2363],[245,2363]],"region":{"top_left_x":244,"top_left_y":2311,"width":1602,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45c1495d38f04dccaa2cf2d4dd907e93","type":"text","conversion_output":true,"text":"hospitalizations, and so a comprehensive analysis of hospitalizations must take into account the","text_display":" hospitalizations, and so a comprehensive analysis of hospitalizations must take into account the","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[1792,2359],[1792,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2358,"width":1548,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2468805f8d174370893ca2ce53abe714","type":"text","conversion_output":true,"text":"recurrent hospitalization events rather than simply the first one. Consequently, there will be","text_display":" recurrent hospitalization events rather than simply the first one. Consequently, there will be","confidence":0.99609375,"confidence_rate":0.9999604664448944},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac3d70e6fd3f4d7eac6222fd743c0803","type":"page_info","conversion_output":false,"text":"15","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-17","page":17,"lines":[{"cnt":[[245,251],[1867,251],[1867,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1623,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe896603ecd04694bf58f24cda586223","type":"text","conversion_output":true,"text":"several parts to the analysis of this endpoint in addition to a careful examination of the results of","text_display":"\nseveral parts to the analysis of this endpoint in addition to a careful examination of the results of","confidence":0.9990236759185791,"confidence_rate":0.9999907849387211},{"cnt":[[245,301],[1824,301],[1824,352],[245,352]],"region":{"top_left_x":244,"top_left_y":300,"width":1581,"height":53},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51ad16106dcc4dbbbdfbc64d46c052ae","type":"text","conversion_output":true,"text":"the composite endpoint consisting of death or cardiovascular hospitalization (see Section 9.2).","text_display":" the composite endpoint consisting of death or cardiovascular hospitalization (see Section 9.2).","confidence":1,"confidence_rate":1},{"cnt":[[234,387],[606,387],[606,449],[234,449]],"region":{"top_left_x":234,"top_left_y":386,"width":372,"height":64},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cef44aa17d146c1a037118a66d5b122","type":"section_header","conversion_output":false,"children_ids":["2515e713ad924ef1b5cb672cec82005a"],"text":"","text_display":""},{"cnt":[[243,395],[595,395],[595,440],[243,440]],"region":{"top_left_x":242,"top_left_y":395,"width":354,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2515e713ad924ef1b5cb672cec82005a","type":"text","conversion_output":true,"parent_id":"4cef44aa17d146c1a037118a66d5b122","text":"Statistical Methods:","text_display":"\n\n\\section*{Statistical Methods:}","confidence":1,"confidence_rate":1},{"cnt":[[305,443],[1818,443],[1818,494],[305,494]],"region":{"top_left_x":305,"top_left_y":442,"width":1513,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3db0d31eb59d4fae9c4628b51886a8f0","type":"text","conversion_output":true,"text":"a. The first analysis will consider time until the first cardiovascular hospitalization in each","text_display":"\na. The first analysis will consider time until the first cardiovascular hospitalization in each","confidence":1,"confidence_rate":1},{"cnt":[[370,486],[1833,486],[1833,544],[370,544]],"region":{"top_left_x":369,"top_left_y":485,"width":1464,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"125609af2eba4863bbcfbb14e5ef6e1f","type":"text","conversion_output":true,"text":"arm and use the competing risks methodology of Fine and Gray \\({ }^{5}\\) where death from any","text_display":" arm and use the competing risks methodology of Fine and Gray \\({ }^{5}\\) where death from any","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[370,541],[1820,541],[1820,591],[370,591]],"region":{"top_left_x":369,"top_left_y":541,"width":1451,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acc1d5b1ae8c494883b6198f12e1db57","type":"text","conversion_output":true,"text":"cause is considered as a competing risk. The analysis will make use of the cumulative","text_display":" cause is considered as a competing risk. The analysis will make use of the cumulative","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[370,589],[1807,589],[1807,638],[370,638]],"region":{"top_left_x":369,"top_left_y":588,"width":1438,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b7d68b872104f048a0f423c29a099be","type":"text","conversion_output":true,"text":"incidence function, and will be performed within the proportional hazards framework","text_display":" incidence function, and will be performed within the proportional hazards framework","confidence":1,"confidence_rate":1},{"cnt":[[370,636],[1865,636],[1865,685],[370,685]],"region":{"top_left_x":369,"top_left_y":635,"width":1496,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a69f00e1dcac4cd9b2dc31c42ef45bfe","type":"text","conversion_output":true,"text":"using the approach described in Section 9.4. The cumulative incidence function for each","text_display":" using the approach described in Section 9.4. The cumulative incidence function for each","confidence":1,"confidence_rate":1},{"cnt":[[370,683],[1871,683],[1871,735],[370,735]],"region":{"top_left_x":369,"top_left_y":683,"width":1503,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20daac88093441d4adaa873eebc3371b","type":"text","conversion_output":true,"text":"of the two arms will be estimated, statistically compared, and graphically presented using","text_display":" of the two arms will be estimated, statistically compared, and graphically presented using","confidence":1,"confidence_rate":1},{"cnt":[[370,730],[1665,730],[1665,782],[370,782]],"region":{"top_left_x":369,"top_left_y":730,"width":1297,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"214adf9197f54e7e8ceb1faf8a10b03f","type":"text","conversion_output":true,"text":"the PHREG procedure in SAS. For subjects who have not experienced a CV","text_display":" the PHREG procedure in SAS. For subjects who have not experienced a CV","confidence":0.9990234375,"confidence_rate":0.9999869728895492},{"cnt":[[370,778],[1867,778],[1867,831],[370,831]],"region":{"top_left_x":369,"top_left_y":777,"width":1498,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a262f00697f94d4da09a0627ee7232f3","type":"text","conversion_output":true,"text":"hospitalization, time from randomization until the subject's last follow-up contact will be","text_display":" hospitalization, time from randomization until the subject's last follow-up contact will be","confidence":1,"confidence_rate":1},{"cnt":[[370,829],[1863,829],[1863,879],[370,879]],"region":{"top_left_x":369,"top_left_y":829,"width":1494,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9e78766a2394f5bb1ded59ca2ce5f2d","type":"text","conversion_output":true,"text":"used in the analysis. The level of significance for the assessment of this endpoint will be","text_display":" used in the analysis. The level of significance for the assessment of this endpoint will be","confidence":1,"confidence_rate":1},{"cnt":[[370,877],[511,877],[511,922],[370,922]],"region":{"top_left_x":369,"top_left_y":876,"width":143,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a48d939aa194db9a2f2ced88901b858","type":"text","conversion_output":true,"text":"\\(\\alpha=0.05\\).","text_display":" \\(\\alpha=0.05\\).","confidence":1,"confidence_rate":1},{"cnt":[[305,924],[1846,924],[1846,978],[305,978]],"region":{"top_left_x":305,"top_left_y":923,"width":1541,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20ddcb9b824a49f2b9b8395d24772ad1","type":"text","conversion_output":true,"text":"b. An additional analysis of this endpoint will be performed using the log-rank test, hazard","text_display":"\nb. An additional analysis of this endpoint will be performed using the log-rank test, hazard","confidence":1,"confidence_rate":1},{"cnt":[[370,975],[1800,975],[1800,1025],[370,1025]],"region":{"top_left_x":369,"top_left_y":975,"width":1432,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc9fa54208564f7cacb152e6633e125f","type":"text","conversion_output":true,"text":"ratio and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier","text_display":" ratio and \\(95 \\%\\) confidence interval generated using the Cox model, and Kaplan-Meier","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[370,1023],[1876,1023],[1876,1072],[370,1072]],"region":{"top_left_x":369,"top_left_y":1022,"width":1507,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"307442686fe246acb2767579f1b472af","type":"text","conversion_output":true,"text":"cumulative event rate calculations. Patients who have died will be censored at the time of","text_display":" cumulative event rate calculations. Patients who have died will be censored at the time of","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[370,1070],[1687,1070],[1687,1119],[370,1119]],"region":{"top_left_x":369,"top_left_y":1069,"width":1318,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71947fa974064b2d9dadee775d247541","type":"text","conversion_output":true,"text":"their death. This analysis and the approach in (a) above will be compared and","text_display":" their death. This analysis and the approach in (a) above will be compared and","confidence":1,"confidence_rate":1},{"cnt":[[370,1117],[1796,1117],[1796,1171],[370,1171]],"region":{"top_left_x":369,"top_left_y":1117,"width":1428,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ab1316c67b3439393be6991320518b1","type":"text","conversion_output":true,"text":"summarized into an overall interpretation of treatment differences with respect to the","text_display":" summarized into an overall interpretation of treatment differences with respect to the","confidence":1,"confidence_rate":1},{"cnt":[[370,1164],[1171,1164],[1171,1216],[370,1216]],"region":{"top_left_x":369,"top_left_y":1164,"width":802,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e53b1d7dff449238e02edcb9e674e6a","type":"text","conversion_output":true,"text":"endpoint of time to the first CV hospitalization.","text_display":" endpoint of time to the first CV hospitalization.","confidence":1,"confidence_rate":1},{"cnt":[[305,1212],[1841,1212],[1841,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1211,"width":1537,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c0fbfecd2b549cf9ea68ad9ec0f5a64","type":"text","conversion_output":true,"text":"c. The analyses described above will be extended to a multiple events analysis, designed to","text_display":"\nc. The analyses described above will be extended to a multiple events analysis, designed to","confidence":1,"confidence_rate":1},{"cnt":[[370,1261],[1820,1261],[1820,1313],[370,1313]],"region":{"top_left_x":369,"top_left_y":1261,"width":1451,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"912a3eb2798249fdb851a561ba12a0d8","type":"text","conversion_output":true,"text":"take into account multiple hospitalization events that may occur during the course of a","text_display":" take into account multiple hospitalization events that may occur during the course of a","confidence":1,"confidence_rate":1},{"cnt":[[370,1311],[1837,1311],[1837,1360],[370,1360]],"region":{"top_left_x":369,"top_left_y":1310,"width":1468,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd4e428bb73c46f1afa0c21e319bb810","type":"text","conversion_output":true,"text":"patient's follow-up. When considering one event per patient as in (a) or (b) above (i.e.,","text_display":" patient's follow-up. When considering one event per patient as in (a) or (b) above (i.e.,","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[370,1358],[1729,1358],[1729,1407],[370,1407]],"region":{"top_left_x":369,"top_left_y":1357,"width":1361,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34b63afc9a474c958f7593455229b728","type":"text","conversion_output":true,"text":"the time until the first event), those events are independent because they occur in","text_display":" the time until the first event), those events are independent because they occur in","confidence":1,"confidence_rate":1},{"cnt":[[370,1405],[1779,1405],[1779,1454],[370,1454]],"region":{"top_left_x":369,"top_left_y":1405,"width":1410,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e57d39494104ff6ae4ea7ad0322098a","type":"text","conversion_output":true,"text":"different patients. When considering multiple events for a patient, the events are no","text_display":" different patients. When considering multiple events for a patient, the events are no","confidence":1,"confidence_rate":1},{"cnt":[[370,1452],[1878,1452],[1878,1504],[370,1504]],"region":{"top_left_x":369,"top_left_y":1452,"width":1509,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"287c77d6175b4021bf75aa2ea380a207","type":"text","conversion_output":true,"text":"longer all independent because some of them are occurring within the same patient. This","text_display":" longer all independent because some of them are occurring within the same patient. This","confidence":1,"confidence_rate":1},{"cnt":[[370,1502],[1869,1502],[1869,1553],[370,1553]],"region":{"top_left_x":369,"top_left_y":1501,"width":1501,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0721c96c16b245d8920585838d693704","type":"text","conversion_output":true,"text":"correlation (covariance) must be taken into account in deriving inferences. The multiple-","text_display":" correlation (covariance) must be taken into account in deriving inferences. The multiple","confidence":1,"confidence_rate":1},{"cnt":[[370,1549],[1652,1549],[1652,1601],[370,1601]],"region":{"top_left_x":369,"top_left_y":1549,"width":1284,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce17f2b8f21247fbab4c13a2621b256d","type":"text","conversion_output":true,"text":"event methods that will be used represent different extensions of Cox model","text_display":"event methods that will be used represent different extensions of Cox model","confidence":1,"confidence_rate":1},{"cnt":[[370,1594],[1828,1594],[1828,1648],[370,1648]],"region":{"top_left_x":369,"top_left_y":1594,"width":1460,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4059fa8100d41d88f6e18c6e7c5cadf","type":"text","conversion_output":true,"text":"methodology, and take into account the timing of the events and the correlation among","text_display":" methodology, and take into account the timing of the events and the correlation among","confidence":1,"confidence_rate":1},{"cnt":[[370,1646],[1285,1646],[1285,1695],[370,1695]],"region":{"top_left_x":369,"top_left_y":1645,"width":916,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d84ecedca174d2cabdceac664d2b015","type":"text","conversion_output":true,"text":"multiple events occurring within an individual patient.","text_display":" multiple events occurring within an individual patient.","confidence":1,"confidence_rate":1},{"cnt":[[370,1740],[1820,1740],[1820,1790],[370,1790]],"region":{"top_left_x":369,"top_left_y":1740,"width":1451,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89040d4adb7341b8874b311cff3a5d2e","type":"text","conversion_output":true,"text":"The main statistical approach will use a generalization of the Cox model developed by","text_display":"\n\nThe main statistical approach will use a generalization of the Cox model developed by","confidence":0.99267578125,"confidence_rate":0.9999183236409059},{"cnt":[[370,1781],[1833,1781],[1833,1841],[370,1841]],"region":{"top_left_x":369,"top_left_y":1781,"width":1464,"height":61},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86c631b43d594bf58eada0822915dc72","type":"text","conversion_output":true,"text":"Andersen \\& Gill \\({ }^{6,7}\\), with robust standard errors to account for heterogeneity and for the","text_display":" Andersen \\& Gill \\({ }^{6,7}\\), with robust standard errors to account for heterogeneity and for the","confidence":1,"confidence_rate":1},{"cnt":[[370,1835],[1265,1835],[1265,1888],[370,1888]],"region":{"top_left_x":369,"top_left_y":1834,"width":897,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9cb61ea2d0948b18a4cb008c521b342","type":"text","conversion_output":true,"text":"correlation between recurrent events within a patient.","text_display":" correlation between recurrent events within a patient.","confidence":1,"confidence_rate":1},{"cnt":[[370,1931],[1863,1931],[1863,1983],[370,1983]],"region":{"top_left_x":369,"top_left_y":1931,"width":1494,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"854619ba0dda4d9cbe4bd0c9f604e819","type":"text","conversion_output":true,"text":"Similar to time-to-1st event methods, a terminal event (death) could introduce bias in the","text_display":"\n\nSimilar to time-to-1st event methods, a terminal event (death) could introduce bias in the","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[370,1981],[1846,1981],[1846,2030],[370,2030]],"region":{"top_left_x":369,"top_left_y":1980,"width":1477,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca6eedd01a354a3eb5af893b1fc0677c","type":"text","conversion_output":true,"text":"recurrent events analysis, especially if there is a differential mortality between the study","text_display":" recurrent events analysis, especially if there is a differential mortality between the study","confidence":1,"confidence_rate":1},{"cnt":[[370,2024],[1858,2024],[1858,2078],[370,2078]],"region":{"top_left_x":369,"top_left_y":2023,"width":1490,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b199ce0ef4334f8c8b1dca460c427705","type":"text","conversion_output":true,"text":"arms. Thus, the Ghosh and Lin \\({ }^{8}\\) nonparametric method can be utilized in calculating the","text_display":" arms. Thus, the Ghosh and Lin \\({ }^{8}\\) nonparametric method can be utilized in calculating the","confidence":0.9365541934967041,"confidence_rate":0.9993575800611881},{"cnt":[[370,2075],[1815,2075],[1815,2127],[370,2127]],"region":{"top_left_x":369,"top_left_y":2075,"width":1447,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11a27984625e44718b051e788594fa62","type":"text","conversion_output":true,"text":"cumulative rate of CV hospitalizations, while accounting for mortality as a competing","text_display":" cumulative rate of CV hospitalizations, while accounting for mortality as a competing","confidence":0.9794921875,"confidence_rate":0.9997697929723993},{"cnt":[[370,2123],[1751,2123],[1751,2176],[370,2176]],"region":{"top_left_x":369,"top_left_y":2122,"width":1382,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4119dac163db4269a31fc9340c5acdf1","type":"text","conversion_output":true,"text":"risk. In addition, the average number of CV hospitalizations per 100-person years","text_display":" risk. In addition, the average number of CV hospitalizations per 100-person years","confidence":1,"confidence_rate":1},{"cnt":[[370,2172],[1646,2172],[1646,2224],[370,2224]],"region":{"top_left_x":369,"top_left_y":2172,"width":1277,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81f150abb6b044e4b2e83dc7afadb9b9","type":"text","conversion_output":true,"text":"utilizing the Ghosh-Lin method can be calculated for each treatment group.","text_display":" utilizing the Ghosh-Lin method can be calculated for each treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[370,2264],[1826,2264],[1826,2318],[370,2318]],"region":{"top_left_x":369,"top_left_y":2264,"width":1458,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fdb036b5b85471b9ab659a2907aa2f8","type":"text","conversion_output":true,"text":"The Andersen-Gill recurrent events method will be performed using PROC PHREG in","text_display":"\n\nThe Andersen-Gill recurrent events method will be performed using PROC PHREG in","confidence":1,"confidence_rate":1},{"cnt":[[370,2316],[1858,2316],[1858,2365],[370,2365]],"region":{"top_left_x":369,"top_left_y":2316,"width":1490,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"168d07b00fa14fb38848c8bda262b91f","type":"text","conversion_output":true,"text":"SAS software. However, the Ghosh-Lin method requires implementation of a validated","text_display":" SAS software. However, the Ghosh-Lin method requires implementation of a validated","confidence":1,"confidence_rate":1},{"cnt":[[370,2363],[761,2363],[761,2415],[370,2415]],"region":{"top_left_x":369,"top_left_y":2363,"width":392,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce04359d049f4801b3e2821d9c72bd37","type":"text","conversion_output":true,"text":"package in R software.","text_display":" package in R 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Medical Costs, Resource Use and Cost Effectiveness.","text_display":"\n\n\\subsection*{9.10 Medical Costs, Resource Use and Cost Effectiveness.}","confidence":1,"confidence_rate":1},{"cnt":[[245,363],[1880,363],[1880,415],[245,415]],"region":{"top_left_x":244,"top_left_y":363,"width":1636,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"923bfd73abfe40e98621d6c1131a5f42","type":"text","conversion_output":true,"text":"Cost data will be analyzed by the CABANA EQOL Coordinating Center in close collaboration","text_display":"\n\nCost data will be analyzed by the CABANA EQOL Coordinating Center in close collaboration","confidence":1,"confidence_rate":1},{"cnt":[[245,408],[1880,408],[1880,462],[245,462]],"region":{"top_left_x":244,"top_left_y":408,"width":1636,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32ebc8669a9647399427add10fe27eab","type":"text","conversion_output":true,"text":"with the Data Coordinating Center, and the analysis approach will be detailed in a separate","text_display":" with the Data Coordinating Center, and the analysis approach will be detailed in a separate","confidence":0.9970715045928955,"confidence_rate":0.9999694505516451},{"cnt":[[245,455],[477,455],[477,509],[245,509]],"region":{"top_left_x":244,"top_left_y":455,"width":233,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e91a4a079a3443b0a1c6175badcaad99","type":"text","conversion_output":true,"text":"analytic plan.","text_display":" analytic 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Again, the analysis approach will be detailed","text_display":" collaboration with the Data Coordinating Center. Again, the analysis approach will be detailed","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[696,786],[696,836],[245,836]],"region":{"top_left_x":244,"top_left_y":786,"width":453,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dc255c76648486884097806eeb3e81d","type":"text","conversion_output":true,"text":"in a separate analytic plan.","text_display":" in a separate analytic plan.","confidence":1,"confidence_rate":1},{"cnt":[[241,907],[1018,907],[1018,967],[241,967]],"region":{"top_left_x":240,"top_left_y":906,"width":779,"height":61},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71ec8f938a1b44e482625f7fb34c7327","type":"section_header","conversion_output":false,"children_ids":["2272c0087411472e86e4d5d32268005c"],"text":"","text_display":""},{"cnt":[[245,911],[1012,911],[1012,960],[245,960]],"region":{"top_left_x":244,"top_left_y":910,"width":768,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2272c0087411472e86e4d5d32268005c","type":"text","conversion_output":true,"parent_id":"71ec8f938a1b44e482625f7fb34c7327","text":"9.12 Major Non-Endpoint Adverse Events.","text_display":"\n\n\\subsection*{9.12 Major Non-Endpoint Adverse Events.}","confidence":1,"confidence_rate":1},{"cnt":[[245,1021],[1871,1021],[1871,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1020,"width":1628,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca481668477b4759b533378267966fea","type":"text","conversion_output":true,"text":"Major adverse events (AE) will be monitored and reported during the trial. For drug therapy, the","text_display":"\n\nMajor adverse events (AE) will be monitored and reported during the trial. For drug therapy, the","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1830,1070],[1830,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1587,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"389217d6252d4e8cbc5fc765283c4efc","type":"text","conversion_output":true,"text":"major serious or life-threatening events include unanticipated hospitalizations for heart failure,","text_display":" major serious or life-threatening events include unanticipated hospitalizations for heart failure,","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1841,1117],[1841,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1598,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cda16d4e4b104a76a8f51b5750e28f18","type":"text","conversion_output":true,"text":"drug-related pro-arrhythmic events, and pulmonary toxicity from amiodarone. For the ablation","text_display":" drug-related pro-arrhythmic events, and pulmonary toxicity from amiodarone. For the ablation","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1775,1164],[1775,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1531,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65b592545d7e4567adc4197710853c5e","type":"text","conversion_output":true,"text":"arm, the major events include symptomatic pulmonary vein stenosis requiring intervention,","text_display":" arm, the major events include symptomatic pulmonary vein stenosis requiring intervention,","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1878,1212],[1878,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1634,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d945000d9b194dffb5fb88a448fb9d8d","type":"text","conversion_output":true,"text":"myocardial perforation/tamponade requiring intervention, and atrial-esophageal fistula formation.","text_display":" myocardial perforation/tamponade requiring intervention, and atrial-esophageal fistula formation.","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1762,1259],[1762,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1518,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6454720b1f94dfc842f66b07f0feaf0","type":"text","conversion_output":true,"text":"The frequency of each of these events (and other serious adverse events such as peripheral","text_display":" The frequency of each of these events (and other serious adverse events such as peripheral","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1807,1306],[1807,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1306,"width":1563,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69bb9c822f234f17ade36a2ab3345005","type":"text","conversion_output":true,"text":"thromboembolic events) will be descriptively tabulated using MedDRA System Organ Class.","text_display":" thromboembolic events) will be descriptively tabulated using MedDRA System Organ Class.","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1798,1354],[1798,1405],[245,1405]],"region":{"top_left_x":244,"top_left_y":1353,"width":1555,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8c0ea04073f403aa8e086eb15df3547","type":"text","conversion_output":true,"text":"Treatment comparisons with respect to these serious adverse events will be more descriptive","text_display":" Treatment comparisons with respect to these serious adverse events will be more descriptive","confidence":1,"confidence_rate":1},{"cnt":[[245,1403],[1813,1403],[1813,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1402,"width":1570,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c24333d23383487383c9635c56147abe","type":"text","conversion_output":true,"text":"rather than statistically rigorous (since different adverse events are expected in the two arms),","text_display":" rather than statistically rigorous (since different adverse events are expected in the two arms),","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1843,1452],[1843,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":1600,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce69584c4a4349e58a462df0e2461edb","type":"text","conversion_output":true,"text":"bringing to bear clinical judgment as to the relative seriousness of these various adverse events.","text_display":" bringing to bear clinical judgment as to the relative seriousness of these various adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[245,1500],[1676,1500],[1676,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1499,"width":1432,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8094413d7f646f4ad7e54c98c6d6f4c","type":"text","conversion_output":true,"text":"Other adverse complications or adverse events of either therapy will be tabulated and","text_display":" Other adverse complications or adverse events of either therapy will be tabulated and","confidence":1,"confidence_rate":1},{"cnt":[[245,1547],[1815,1547],[1815,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1546,"width":1572,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1f4439f99464f7b85b48997b71e1adf","type":"text","conversion_output":true,"text":"descriptively summarized, using statistical comparisons of the treatment groups based on chi-","text_display":" descriptively summarized, using statistical comparisons of the treatment groups based on chi","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1807,1594],[1807,1646],[245,1646]],"region":{"top_left_x":244,"top_left_y":1594,"width":1563,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2503fb3d9a02402a98cd5a06bd6f6fc1","type":"text","conversion_output":true,"text":"square tests where appropriate, and interpreting such comparisons in the context of treatment","text_display":"square tests where appropriate, and interpreting such comparisons in the context of treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1641],[1360,1641],[1360,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1641,"width":1116,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd6d26f3fe62480495cec20fb45e28a0","type":"text","conversion_output":true,"text":"differences in the primary and major secondary clinical endpoints.","text_display":" differences in the primary and major secondary clinical endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[241,1762],[990,1762],[990,1824],[241,1824]],"region":{"top_left_x":240,"top_left_y":1761,"width":751,"height":64},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56bbec5d28404ec1b50842199ad9497d","type":"section_header","conversion_output":false,"children_ids":["52c0f1ef758b42a28eda07a1de2d6531"],"text":"","text_display":""},{"cnt":[[245,1766],[986,1766],[986,1820],[245,1820]],"region":{"top_left_x":244,"top_left_y":1766,"width":743,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52c0f1ef758b42a28eda07a1de2d6531","type":"text","conversion_output":true,"parent_id":"56bbec5d28404ec1b50842199ad9497d","text":"9.13 LA Size, Morphology and Function.","text_display":"\n\n\\subsection*{9.13 LA Size, Morphology and 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Of interest will be the change in atrial size (volume) and function","text_display":" function will be examined. Of interest will be the change in atrial size (volume) and function","confidence":1,"confidence_rate":1},{"cnt":[[245,1951],[1772,1951],[1772,2002],[245,2002]],"region":{"top_left_x":244,"top_left_y":1950,"width":1529,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b474abdbcacb481e961e4c31c15f304f","type":"text","conversion_output":true,"text":"(i.e., atrial ejection fraction) from the pre-treatment to the post-treatment study within each","text_display":" (i.e., atrial ejection fraction) from the pre-treatment to the post-treatment study within each","confidence":0.99658203125,"confidence_rate":0.9999657623526261},{"cnt":[[245,1998],[1863,1998],[1863,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1998,"width":1619,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86e4beeccd7e4d39bf65e11b7a9bd1ef","type":"text","conversion_output":true,"text":"treatment arm, and then importantly, a comparison of whether the change in size and function in","text_display":" treatment arm, and then importantly, a comparison of whether the change in size and function in","confidence":1,"confidence_rate":1},{"cnt":[[245,2045],[1824,2045],[1824,2099],[245,2099]],"region":{"top_left_x":244,"top_left_y":2045,"width":1581,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d9f1c075a16412e8a07b82d2fac7eb9","type":"text","conversion_output":true,"text":"the patients randomized to ablation therapy differs from the change in size and function of the","text_display":" the patients randomized to ablation therapy differs from the change in size and function of the","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[866,2093],[866,2146],[245,2146]],"region":{"top_left_x":244,"top_left_y":2092,"width":622,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20d25ae5deb543b69f0778c5d8e5e37c","type":"text","conversion_output":true,"text":"patients randomized to drug therapy.","text_display":" patients randomized to drug therapy.","confidence":1,"confidence_rate":1},{"cnt":[[245,2204],[1880,2204],[1880,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2204,"width":1636,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0c401e0c0b4451eafe9418965a02b7f","type":"text","conversion_output":true,"text":"The distribution of these measures from the pre- and post-treatment studies in each treatment arm","text_display":"\n\nThe distribution of these measures from the pre- and post-treatment studies in each treatment arm","confidence":1,"confidence_rate":1},{"cnt":[[245,2252],[1772,2252],[1772,2301],[245,2301]],"region":{"top_left_x":244,"top_left_y":2251,"width":1529,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f50ac572f30d42d7970740ffb35bd42e","type":"text","conversion_output":true,"text":"will be descriptively characterized using summary descriptive statistics and graphical tools","text_display":" will be descriptively characterized using summary descriptive statistics and graphical tools","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1848,2299],[1848,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2298,"width":1604,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cafa7d09fb24b7b9abb063c3e4c5dca","type":"text","conversion_output":true,"text":"including box and whisker plots. The statistical significance of the changes in left atrial volume","text_display":" including box and whisker plots. The statistical significance of the changes in left atrial volume","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1854,2346],[1854,2398],[245,2398]],"region":{"top_left_x":244,"top_left_y":2346,"width":1611,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8eaaf6b48ed1444e9a69fbb098842212","type":"text","conversion_output":true,"text":"and atrial ejection fraction from pre- to post-treatment studies within each treatment arm will be","text_display":" and atrial ejection fraction from pre- to post-treatment studies within each treatment arm will be","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,2393],[1807,2393],[1807,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2393,"width":1563,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b692e67e82cd413181b87b58a8fccea6","type":"text","conversion_output":true,"text":"assessed using general linear models (GLM), including the baseline value as a covariate, and","text_display":" assessed using general linear models (GLM), including the baseline value as a covariate, and","confidence":0.9970703125,"confidence_rate":0.9999697531643026},{"cnt":[[245,2443],[1738,2443],[1738,2494],[245,2494]],"region":{"top_left_x":244,"top_left_y":2442,"width":1495,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"653d7244383641a58aae09879d427209","type":"text","conversion_output":true,"text":"assessing treatment group differences. If there appears to be differences in other baseline","text_display":" assessing treatment group differences. If there appears to be differences in other baseline","confidence":1,"confidence_rate":1},{"cnt":[[1040,2548],[1089,2548],[1089,2593],[1040,2593]],"region":{"top_left_x":1039,"top_left_y":2548,"width":51,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98f47156356d4680a50f96156435c9df","type":"page_info","conversion_output":false,"text":"17","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-19","page":19,"lines":[{"cnt":[[245,251],[1880,251],[1880,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1636,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"446a668a88834b25aa02aee94fcbca65","type":"text","conversion_output":true,"text":"covariates between groups, adjustment for covariates will be considered. Secondary analyses will","text_display":"\ncovariates between groups, adjustment for covariates will be considered. Secondary analyses will","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[965,301],[965,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":721,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4be3a9299c384affa081316de770588e","type":"text","conversion_output":true,"text":"use a paired-sample t-test instead of GLM.","text_display":" use a paired-sample t-test instead of GLM.","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[245,395],[1833,395],[1833,447],[245,447]],"region":{"top_left_x":244,"top_left_y":395,"width":1589,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"451efe378f4547b4924e804fd772d76c","type":"text","conversion_output":true,"text":"In dealing with this type of data, the completeness of which is dependent on obtaining both the","text_display":"\n\nIn dealing with this type of data, the completeness of which is dependent on obtaining both the","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1828,443],[1828,496],[245,496]],"region":{"top_left_x":244,"top_left_y":442,"width":1585,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"204d257ecb0d4b048ede3a209fb2cdb8","type":"text","conversion_output":true,"text":"pre- and post-treatment studies, there will inherently be missing data resulting from patients in","text_display":" pre- and post-treatment studies, there will inherently be missing data resulting from patients in","confidence":1,"confidence_rate":1},{"cnt":[[245,492],[1828,492],[1828,544],[245,544]],"region":{"top_left_x":244,"top_left_y":491,"width":1585,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93deba5a0ff048828c4cff23d02af80c","type":"text","conversion_output":true,"text":"whom it was not possible to obtain both studies (because they died or failed to return for other","text_display":" whom it was not possible to obtain both studies (because they died or failed to return for other","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1876,537],[1876,591],[245,591]],"region":{"top_left_x":244,"top_left_y":537,"width":1632,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d72cba57134419ea9638e7152a1d124","type":"text","conversion_output":true,"text":"reasons to enable the follow-up measurements to be made). The completeness of the data will be","text_display":" reasons to enable the follow-up measurements to be made). The completeness of the data will be","confidence":1,"confidence_rate":1},{"cnt":[[245,589],[1777,589],[1777,638],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1533,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37477209fa824638a272dc28a282efc4","type":"text","conversion_output":true,"text":"fully described, and the statistical comparisons will be based on patients for whom both the","text_display":" fully described, and the statistical comparisons will be based on patients for whom both the","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[995,636],[995,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":751,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"230b5838f4ff48b7bbec3dabe958eb8a","type":"text","conversion_output":true,"text":"baseline and follow-up studies are available.","text_display":" baseline and follow-up studies are available.","confidence":1,"confidence_rate":1},{"cnt":[[241,786],[872,786],[872,862],[241,862]],"region":{"top_left_x":240,"top_left_y":786,"width":633,"height":76},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab7727dd2699489187baca459e7d5c64","type":"section_header","conversion_output":false,"children_ids":["48e97c8d4bad4d83a7d0ae582683d23a"],"text":"","text_display":""},{"cnt":[[245,795],[866,795],[866,853],[245,853]],"region":{"top_left_x":244,"top_left_y":794,"width":622,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48e97c8d4bad4d83a7d0ae582683d23a","type":"text","conversion_output":true,"parent_id":"ab7727dd2699489187baca459e7d5c64","text":"10. \"On-Treatment\" Analysis","text_display":"\n\n\\section*{10. \"On-Treatment\" Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[245,911],[1848,911],[1848,960],[245,960]],"region":{"top_left_x":244,"top_left_y":910,"width":1604,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad862c7d7a72481cacec6d0470279b0e","type":"text","conversion_output":true,"text":"The intention-to-treat analyses in this trial will constitute the primary analyses and will serve as","text_display":"\n\nThe intention-to-treat analyses in this trial will constitute the primary analyses and will serve as","confidence":1,"confidence_rate":1},{"cnt":[[245,958],[1755,958],[1755,1008],[245,1008]],"region":{"top_left_x":244,"top_left_y":958,"width":1512,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"500661b66ef8446c8a3f37be2bab10e8","type":"text","conversion_output":true,"text":"the standard for interpreting treatment differences in the key clinical outcomes. However,","text_display":" the standard for interpreting treatment differences in the key clinical outcomes. However,","confidence":1,"confidence_rate":1},{"cnt":[[245,1005],[1850,1005],[1850,1057],[245,1057]],"region":{"top_left_x":244,"top_left_y":1005,"width":1606,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a471d9402a740f494691b6b8b362193","type":"text","conversion_output":true,"text":"because a number of patients in the drug arm may cross over to receive ablation during the trial,","text_display":" because a number of patients in the drug arm may cross over to receive ablation during the trial,","confidence":1,"confidence_rate":1},{"cnt":[[245,1055],[1826,1055],[1826,1106],[245,1106]],"region":{"top_left_x":244,"top_left_y":1054,"width":1583,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4305fbf4ee24f50a568214b34e093c8","type":"text","conversion_output":true,"text":"and some patients randomized to ablation may not undergo the procedure, we will supplement","text_display":" and some patients randomized to ablation may not undergo the procedure, we will supplement","confidence":1,"confidence_rate":1},{"cnt":[[245,1104],[1824,1104],[1824,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1104,"width":1581,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d30a19dcd2a4e88921a9fd8982633a8","type":"text","conversion_output":true,"text":"the intent-to-treat comparisons of the primary endpoint and selected secondary endpoints with","text_display":" the intent-to-treat comparisons of the primary endpoint and selected secondary endpoints with","confidence":1,"confidence_rate":1},{"cnt":[[245,1152],[1846,1152],[1846,1201],[245,1201]],"region":{"top_left_x":244,"top_left_y":1151,"width":1602,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c8292d098034a048a2eba4fa4dfaf45","type":"text","conversion_output":true,"text":"\"on-treatment\" comparisons. The \"on-treatment\" analysis will involve a comparison of patients","text_display":" \"on-treatment\" comparisons. The \"on-treatment\" analysis will involve a comparison of patients","confidence":0.9931640625,"confidence_rate":0.999930008474512},{"cnt":[[245,1199],[1800,1199],[1800,1248],[245,1248]],"region":{"top_left_x":244,"top_left_y":1198,"width":1557,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"948390c1dc27427c845d2462ff27b809","type":"text","conversion_output":true,"text":"who received ablation (even if originally assigned to the drug arm) versus those who did not.","text_display":" who received ablation (even if originally assigned to the drug arm) versus those who did not.","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[245,1246],[1837,1246],[1837,1298],[245,1298]],"region":{"top_left_x":244,"top_left_y":1246,"width":1593,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e76a6bdb05f84a04a2bc15bb72e199a4","type":"text","conversion_output":true,"text":"Statistically, this will be accomplished using the Cox proportional hazards model with ablation","text_display":" Statistically, this will be accomplished using the Cox proportional hazards model with ablation","confidence":1,"confidence_rate":1},{"cnt":[[245,1293],[1790,1293],[1790,1345],[245,1345]],"region":{"top_left_x":244,"top_left_y":1293,"width":1546,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0538800534945c494f774cdf9fbf0b5","type":"text","conversion_output":true,"text":"included in the analysis as a time-dependent covariate. This analysis will be repeated for the","text_display":" included in the analysis as a time-dependent covariate. This analysis will be repeated for the","confidence":1,"confidence_rate":1},{"cnt":[[245,1343],[1837,1343],[1837,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1342,"width":1593,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6cafea443774ff188b1474ecf4e4b4b","type":"text","conversion_output":true,"text":"primary endpoint, all-cause mortality, all-cause mortality or cardiovascular hospitalization, all-","text_display":" primary endpoint, all-cause mortality, all-cause mortality or cardiovascular hospitalization, all","confidence":1,"confidence_rate":1},{"cnt":[[245,1392],[1644,1392],[1644,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1392,"width":1400,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"979d295104d24ba4b89911850501f8d9","type":"text","conversion_output":true,"text":"cause mortality, stroke, or hospitalization for heart failure or acute ischemic events,","text_display":"cause mortality, stroke, or hospitalization for heart failure or acute ischemic events,","confidence":1,"confidence_rate":1},{"cnt":[[245,1439],[1876,1439],[1876,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1439,"width":1632,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da88a0f8bfb942e29276cde9fc6505d8","type":"text","conversion_output":true,"text":"cardiovascular death, cardiovascular death or disabling stroke, arrhythmic death or cardiac arrest,","text_display":" cardiovascular death, cardiovascular death or disabling stroke, arrhythmic death or cardiac arrest,","confidence":1,"confidence_rate":1},{"cnt":[[245,1487],[1871,1487],[1871,1536],[245,1536]],"region":{"top_left_x":244,"top_left_y":1486,"width":1628,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd9493ed35f6425cb2c327ed62040d27","type":"text","conversion_output":true,"text":"heart failure death, and cardiovascular hospitalization with and without adjustment for covariates","text_display":" heart failure death, and cardiovascular hospitalization with and without adjustment for covariates","confidence":1,"confidence_rate":1},{"cnt":[[245,1534],[1820,1534],[1820,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1533,"width":1576,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7944be0c60d4f83b2a89dd8b40238c3","type":"text","conversion_output":true,"text":"listed in section 8.1. No analyses will include competing risks, and on-treatment analysis will","text_display":" listed in section 8.1. No analyses will include competing risks, and on-treatment analysis will","confidence":1,"confidence_rate":1},{"cnt":[[245,1581],[1828,1581],[1828,1631],[245,1631]],"region":{"top_left_x":244,"top_left_y":1581,"width":1585,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3aa6e413bb644dec9565d8ce4cee269e","type":"text","conversion_output":true,"text":"not be conducted for multiple events analyses (section 9.9). For recurrent atrial fibrillation, we","text_display":" not be conducted for multiple events analyses (section 9.9). For recurrent atrial fibrillation, we","confidence":1,"confidence_rate":1},{"cnt":[[245,1629],[1729,1629],[1729,1680],[245,1680]],"region":{"top_left_x":244,"top_left_y":1628,"width":1486,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"877589f06bdb470e8040d2052318fdf2","type":"text","conversion_output":true,"text":"will only conduct this on-treatment analysis for the first episode of recurrent AF without","text_display":" will only conduct this on-treatment analysis for the first episode of recurrent AF without","confidence":0.994140625,"confidence_rate":0.9999418174502049},{"cnt":[[245,1678],[1721,1678],[1721,1729],[245,1729]],"region":{"top_left_x":244,"top_left_y":1677,"width":1477,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a365063f23a64d07b658991e4f797c65","type":"text","conversion_output":true,"text":"competing risks in the 3 patient populations (Cabana box, non-cabana box, and pooled).","text_display":" competing risks in the 3 patient populations (Cabana box, non-cabana box, and pooled).","confidence":1,"confidence_rate":1},{"cnt":[[245,1727],[1661,1727],[1661,1777],[245,1777]],"region":{"top_left_x":244,"top_left_y":1727,"width":1417,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ccec71374674dc0be41bcc29bdaa74d","type":"text","conversion_output":true,"text":"Secondary analyses may consider other measures of recurrent atrial fibrillation (e.g.,","text_display":" Secondary analyses may consider other measures of recurrent atrial fibrillation (e.g.,","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[245,1775],[1665,1775],[1665,1824],[245,1824]],"region":{"top_left_x":244,"top_left_y":1774,"width":1422,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84b5118791c84491b09145c2e2e24581","type":"text","conversion_output":true,"text":"symptomatic recurrent AF , atrial fibrillation or atrial flutter or atrial tachycardia, and","text_display":" symptomatic recurrent AF , atrial fibrillation or atrial flutter or atrial tachycardia, and","confidence":0.8740234375,"confidence_rate":0.998680791633896},{"cnt":[[243,1822],[1345,1822],[1345,1876],[243,1876]],"region":{"top_left_x":242,"top_left_y":1821,"width":1103,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb64e29ff23947a8b5fc3bcb02746672","type":"text","conversion_output":true,"text":"symptomatic atrial fibrillation, atrial flutter, or atrial tachycardia).","text_display":" symptomatic atrial fibrillation, atrial flutter, or atrial tachycardia).","confidence":1,"confidence_rate":1},{"cnt":[[245,1916],[1760,1916],[1760,1968],[245,1968]],"region":{"top_left_x":244,"top_left_y":1916,"width":1516,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed071c4034954e4abaea26ffee247eaa","type":"text","conversion_output":true,"text":"The time-dependent ablation variable to be included in the analysis will be created using 3","text_display":"\n\nThe time-dependent ablation variable to be included in the analysis will be created using 3","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,1966],[1815,1966],[1815,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1965,"width":1572,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43a7cf64351143938a1384639e57d0d4","type":"text","conversion_output":true,"text":"different methods: For method 1 , the ablation variable starts as 0 (no ablation) for all patients.","text_display":" different methods: For method 1 , the ablation variable starts as 0 (no ablation) for all patients.","confidence":0.9848771095275879,"confidence_rate":0.999861478617751},{"cnt":[[245,2013],[1807,2013],[1807,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2013,"width":1563,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"943d2a57e6c946499549855912db82af","type":"text","conversion_output":true,"text":"For patients who received ablation, the ablation variable is set to 1 at the time of ablation. In","text_display":" For patients who received ablation, the ablation variable is set to 1 at the time of ablation. In","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[1841,2058],[1841,2110],[245,2110]],"region":{"top_left_x":244,"top_left_y":2058,"width":1598,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27f2560739f34714bce2bffd00112081","type":"text","conversion_output":true,"text":"method 2, the ablation variable starts as 1 for all patients who were randomized to ablation and","text_display":" method 2, the ablation variable starts as 1 for all patients who were randomized to ablation and","confidence":0.9960973262786865,"confidence_rate":0.9999624015816049},{"cnt":[[245,2110],[1858,2110],[1858,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2109,"width":1615,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf73c9952a7b4960bd2c7a49d683d503","type":"text","conversion_output":true,"text":"actually received ablation. For all other patients, the ablation variable is started as 0 and set to 1","text_display":" actually received ablation. For all other patients, the ablation variable is started as 0 and set to 1","confidence":1,"confidence_rate":1},{"cnt":[[245,2157],[1760,2157],[1760,2206],[245,2206]],"region":{"top_left_x":244,"top_left_y":2157,"width":1516,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44de97513b8a4b1faffae11033c9c35a","type":"text","conversion_output":true,"text":"at the time of ablation if they received ablation during the trial. Method 3 has the ablation","text_display":" at the time of ablation if they received ablation during the trial. Method 3 has the ablation","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[245,2204],[1815,2204],[1815,2256],[245,2256]],"region":{"top_left_x":244,"top_left_y":2204,"width":1572,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e313a2abc4df477bac0bc621e35d0fa7","type":"text","conversion_output":true,"text":"variable started as 1 for patients who were randomized to ablation. For all other patients (i.e.,","text_display":" variable started as 1 for patients who were randomized to ablation. For all other patients (i.e.,","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[245,2252],[1717,2252],[1717,2305],[245,2305]],"region":{"top_left_x":244,"top_left_y":2251,"width":1473,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3fce074822a4dab994152bde4072efb","type":"text","conversion_output":true,"text":"randomized to drug), the ablation variable is started as 0 and set to 1 at time of ablation.","text_display":" randomized to drug), the ablation variable is started as 0 and set to 1 at time of ablation.","confidence":1,"confidence_rate":1},{"cnt":[[245,2348],[1858,2348],[1858,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2348,"width":1615,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2ab59682e2d4678b5046459e111c7bc","type":"text","conversion_output":true,"text":"Among the 3 methods described above, method 2 will be considered the main statistical method","text_display":"\n\nAmong the 3 methods described above, method 2 will be considered the main statistical method","confidence":0.9990234375,"confidence_rate":0.9999905142231666},{"cnt":[[245,2398],[1824,2398],[1824,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2397,"width":1581,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aee215eface44fc09cf1183186ffe845","type":"text","conversion_output":true,"text":"in handling cross-overs via a time-dependent variable in Cox model. The other 2 methods are","text_display":" in handling cross-overs via a time-dependent variable in Cox model. The other 2 methods are","confidence":1,"confidence_rate":1},{"cnt":[[245,2445],[823,2445],[823,2494],[245,2494]],"region":{"top_left_x":244,"top_left_y":2444,"width":579,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdd3b257cab0475eb25bc474ffb63b7c","type":"text","conversion_output":true,"text":"considered as sensitivity analyses.","text_display":" considered as sensitivity analyses.","confidence":1,"confidence_rate":1},{"cnt":[[1040,2548],[1089,2548],[1089,2593],[1040,2593]],"region":{"top_left_x":1039,"top_left_y":2548,"width":51,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e05b88feddd8493da94d4dd1bd34ff05","type":"page_info","conversion_output":false,"text":"18","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-20","page":20,"lines":[{"cnt":[[245,301],[1867,301],[1867,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1623,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38c6b25b4c8a4356be334314cfc6c648","type":"text","conversion_output":true,"text":"Differential treatment effects for the primary endpoint and major secondary endpoints of interest","text_display":"\n\nDifferential treatment effects for the primary endpoint and major secondary endpoints of interest","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1792,348],[1792,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1548,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb010d35988d48718d11298431f2e39e","type":"text","conversion_output":true,"text":"using on-treatment analyses will also be conducted. Subgroups of interest will include those","text_display":" using on-treatment analyses will also be conducted. Subgroups of interest will include those","confidence":1,"confidence_rate":1},{"cnt":[[245,397],[589,397],[589,440],[245,440]],"region":{"top_left_x":244,"top_left_y":397,"width":345,"height":44},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8f82fa3722b4e2ba14166f924f2b384","type":"text","conversion_output":true,"text":"listed in section 8.1.","text_display":" listed in section 8.1.","confidence":1,"confidence_rate":1},{"cnt":[[245,490],[1768,490],[1768,541],[245,541]],"region":{"top_left_x":244,"top_left_y":489,"width":1525,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"463990305fda4d26b6104579275e858b","type":"text","conversion_output":true,"text":"Because treatment assignment is no longer random, results can be biased by an association","text_display":"\n\nBecause treatment assignment is no longer random, results can be biased by an association","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1871,537],[1871,589],[245,589]],"region":{"top_left_x":244,"top_left_y":537,"width":1628,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fb2869abd2c467cb9901be9baec2e1c","type":"text","conversion_output":true,"text":"between the likelihood of treatment change and the risk of a clinical event (i.e., factors that make","text_display":" between the likelihood of treatment change and the risk of a clinical event (i.e., factors that make","confidence":0.9912149906158447,"confidence_rate":0.9999159671016559},{"cnt":[[245,587],[1798,587],[1798,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1555,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da8417d7dcce4fb89a3ce2f6afef375c","type":"text","conversion_output":true,"text":"a patient more likely to cross over may also make them more likely to have an event). Thus,","text_display":" a patient more likely to cross over may also make them more likely to have an event). Thus,","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1841,636],[1841,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1598,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f77a40415d8b4f57a1345b7cbe9d64b8","type":"text","conversion_output":true,"text":"such analyses will be cautiously interpreted. Each of the analyses described in this section will","text_display":" such analyses will be cautiously interpreted. Each of the analyses described in this section will","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1781,683],[1781,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1538,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c31c52310e494fbb999241f5265d54ba","type":"text","conversion_output":true,"text":"be covariate adjusted using the covariates described in section 8.1 for the primary endpoint.","text_display":" be covariate adjusted using the covariates described in section 8.1 for the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[241,851],[797,851],[797,922],[241,922]],"region":{"top_left_x":240,"top_left_y":850,"width":558,"height":72},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2af088e0224d4b13a121b8f60d210299","type":"section_header","conversion_output":false,"children_ids":["81e88658bc0a45ddbd0bbc85a3452cd7"],"text":"","text_display":""},{"cnt":[[245,859],[793,859],[793,915],[245,915]],"region":{"top_left_x":244,"top_left_y":859,"width":549,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81e88658bc0a45ddbd0bbc85a3452cd7","type":"text","conversion_output":true,"parent_id":"2af088e0224d4b13a121b8f60d210299","text":"11. Per-Protocol Analysis","text_display":"\n\n\\section*{11. Per-Protocol Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1777,971],[1777,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":971,"width":1533,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d8c539d1d984f0287d34b3bc9f4ca84","type":"text","conversion_output":true,"text":"Using the methods described for the primary endpoint in Section 8, an analysis will also be","text_display":"\n\nUsing the methods described for the primary endpoint in Section 8, an analysis will also be","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1850,1018],[1850,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1018,"width":1606,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18439e14e8bf457499b68da46b2db77a","type":"text","conversion_output":true,"text":"performed to compare the primary endpoint and the key secondary clinical outcomes of the two","text_display":" performed to compare the primary endpoint and the key secondary clinical outcomes of the two","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1783,1070],[1783,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1540,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2cc6440e8c54b1ba7bdf959b4ca4354","type":"text","conversion_output":true,"text":"treatment strategies among the subset of patients who fully satisfied the inclusion/exclusion","text_display":" treatment strategies among the subset of patients who fully satisfied the inclusion/exclusion","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1811,1113],[1811,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1112,"width":1568,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5b46e847eb94d97996bc0605b2ee3b6","type":"text","conversion_output":true,"text":"criteria and received the treatment to which they were randomly allocated. This analysis will","text_display":" criteria and received the treatment to which they were randomly allocated. This analysis will","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1815,1164],[1815,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1572,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e4e4cad19444c7e80817ea477172994","type":"text","conversion_output":true,"text":"include patients randomized to the drug arm who were treated with drug therapy, and patients","text_display":" include patients randomized to the drug arm who were treated with drug therapy, and patients","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1708,1212],[1708,1263],[245,1263]],"region":{"top_left_x":244,"top_left_y":1211,"width":1465,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b4bb1928bcb47f78124ae5247c3b3a3","type":"text","conversion_output":true,"text":"randomized to the ablation arm who underwent the ablation within 6 months following","text_display":" randomized to the ablation arm who underwent the ablation within 6 months following","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1846,1259],[1846,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1258,"width":1602,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a0358d8c86d4548becb52d63f873cf8","type":"text","conversion_output":true,"text":"enrollment in the trial. The follow-up of drug-arm patients who crossed over to ablation will be","text_display":" enrollment in the trial. The follow-up of drug-arm patients who crossed over to ablation will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1308],[1777,1308],[1777,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1308,"width":1533,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81792a0240f04a23984eb2caaab1f61e","type":"text","conversion_output":true,"text":"censored at the time of the ablation. Patients randomized to the ablation arm who were not","text_display":" censored at the time of the ablation. Patients randomized to the ablation arm who were not","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[1867,1354],[1867,1407],[245,1407]],"region":{"top_left_x":244,"top_left_y":1353,"width":1623,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c55c5ac166b43b7bcf877ac113a34dd","type":"text","conversion_output":true,"text":"ablated within 6 months will be excluded from this analysis. Additional sensitivity analyses will","text_display":" ablated within 6 months will be excluded from this analysis. Additional sensitivity analyses will","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[245,1403],[1858,1403],[1858,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1402,"width":1615,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9684159233584e55b19ec901e75a7e9b","type":"text","conversion_output":true,"text":"be performed in which the window for ablation is varied to include a shorter interval (3 months)","text_display":" be performed in which the window for ablation is varied to include a shorter interval (3 months)","confidence":0.990234375,"confidence_rate":0.9999028401515285},{"cnt":[[245,1452],[758,1452],[758,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":515,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76eb9bf8754f44c7a24664435009db2a","type":"text","conversion_output":true,"text":"and a longer window (1 year).","text_display":" and a longer window (1 year).","confidence":0.78515625,"confidence_rate":0.9929113457470278},{"cnt":[[245,1575],[1841,1575],[1841,1626],[245,1626]],"region":{"top_left_x":244,"top_left_y":1574,"width":1598,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f780fea6c4454cf0a935e364b1b26c34","type":"text","conversion_output":true,"text":"The analyses outlined in Sections 10 and 11 will be strictly supplementary to the intent-to-treat","text_display":"\n\nThe analyses outlined in Sections 10 and 11 will be strictly supplementary to the intent-to-treat","confidence":0.99609375,"confidence_rate":0.9999637608481249},{"cnt":[[245,1624],[694,1624],[694,1674],[245,1674]],"region":{"top_left_x":244,"top_left_y":1624,"width":450,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ea67aff8af545d4bc1361bd82f9eb9f","type":"text","conversion_output":true,"text":"analyses described earlier.","text_display":" analyses described earlier.","confidence":1,"confidence_rate":1},{"cnt":[[241,1792],[801,1792],[801,1861],[241,1861]],"region":{"top_left_x":240,"top_left_y":1791,"width":562,"height":70},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2974bf189f34a08bf0dea8538df21e1","type":"section_header","conversion_output":false,"children_ids":["ff86fbe2bbd2487fbbd3f2c31294f31e"],"text":"","text_display":""},{"cnt":[[247,1796],[793,1796],[793,1854],[247,1854]],"region":{"top_left_x":247,"top_left_y":1796,"width":546,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff86fbe2bbd2487fbbd3f2c31294f31e","type":"text","conversion_output":true,"parent_id":"f2974bf189f34a08bf0dea8538df21e1","text":"12. Multiple Comparisons","text_display":"\n\n\\section*{12. Multiple Comparisons}","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[1852,1912],[1852,1964],[245,1964]],"region":{"top_left_x":244,"top_left_y":1912,"width":1608,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46c3f022ddb140dd93c30469110ca533","type":"text","conversion_output":true,"text":"With the primary hypothesis and the various secondary endpoints that have been outlined, there","text_display":"\n\nWith the primary hypothesis and the various secondary endpoints that have been outlined, there","confidence":1,"confidence_rate":1},{"cnt":[[245,1959],[1865,1959],[1865,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1959,"width":1621,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca6d49a2c12f4bec92064e5740848c34","type":"text","conversion_output":true,"text":"is a multiplicity of analyses to be performed, which leads to an increased probability that at least","text_display":" is a multiplicity of analyses to be performed, which leads to an increased probability that at least","confidence":1,"confidence_rate":1},{"cnt":[[245,2007],[1848,2007],[1848,2058],[245,2058]],"region":{"top_left_x":244,"top_left_y":2006,"width":1604,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31a5353101324cc1b6ebb671a20dff89","type":"text","conversion_output":true,"text":"one of the comparisons could be \"significant\" by chance. There are adjustments (e.g., based on","text_display":" one of the comparisons could be \"significant\" by chance. There are adjustments (e.g., based on","confidence":1,"confidence_rate":1},{"cnt":[[245,2056],[1880,2056],[1880,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2056,"width":1636,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92b60d3095d5424b8018b46fd41e76ce","type":"text","conversion_output":true,"text":"the Bonferroni inequality) that could be used to preserve the overall type I error level. To attempt","text_display":" the Bonferroni inequality) that could be used to preserve the overall type I error level. To attempt","confidence":1,"confidence_rate":1},{"cnt":[[245,2105],[1841,2105],[1841,2155],[245,2155]],"region":{"top_left_x":244,"top_left_y":2105,"width":1598,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"318b51406d4d46b6b449c61382412897","type":"text","conversion_output":true,"text":"to adjust for the effects of the repeated significance testing that will occur as part of the interim","text_display":" to adjust for the effects of the repeated significance testing that will occur as part of the interim","confidence":1,"confidence_rate":1},{"cnt":[[245,2153],[1800,2153],[1800,2202],[245,2202]],"region":{"top_left_x":244,"top_left_y":2152,"width":1557,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a548318e5c844c22a8ffcf4132765689","type":"text","conversion_output":true,"text":"monitoring (discussed below), plus adjust for the multiplicity of secondary endpoints, would","text_display":" monitoring (discussed below), plus adjust for the multiplicity of secondary endpoints, would","confidence":1,"confidence_rate":1},{"cnt":[[245,2200],[1820,2200],[1820,2249],[245,2249]],"region":{"top_left_x":244,"top_left_y":2200,"width":1576,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edef3371d2af45a09ae531e3066b881c","type":"text","conversion_output":true,"text":"require that very small significance levels be used for every comparison. The overall level of","text_display":" require that very small significance levels be used for every comparison. The overall level of","confidence":1,"confidence_rate":1},{"cnt":[[245,2247],[1841,2247],[1841,2297],[245,2297]],"region":{"top_left_x":244,"top_left_y":2247,"width":1598,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eec218e9638440f8a8de5d5a229dbf0a","type":"text","conversion_output":true,"text":"significance will be 0.049 for the assessment of the primary endpoint (see Section 13) and 0.05","text_display":" significance will be 0.049 for the assessment of the primary endpoint (see Section 13) and 0.05","confidence":0.998046875,"confidence_rate":0.9999808331754918},{"cnt":[[245,2295],[1794,2295],[1794,2346],[245,2346]],"region":{"top_left_x":244,"top_left_y":2294,"width":1550,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37e3781b391b465cb49b79d46558b4f0","type":"text","conversion_output":true,"text":"for all secondary endpoints. However, to account in part for the multiplicity of comparisons","text_display":" for all secondary endpoints. However, to account in part for the multiplicity of comparisons","confidence":1,"confidence_rate":1},{"cnt":[[245,2342],[1792,2342],[1792,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2341,"width":1548,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4166000746fc401a87ca146c78c146f5","type":"text","conversion_output":true,"text":"involving secondary endpoints, we will be conservative in the interpretation of the analyses,","text_display":" involving secondary endpoints, we will be conservative in the interpretation of the analyses,","confidence":1,"confidence_rate":1},{"cnt":[[245,2391],[1880,2391],[1880,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2391,"width":1636,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69705bee9f154d89965bdec94ee679f9","type":"text","conversion_output":true,"text":"taking into account the degree of significance, and looking for consistency across endpoints. The","text_display":" taking into account the degree of significance, and looking for consistency across endpoints. The","confidence":1,"confidence_rate":1},{"cnt":[[245,2436],[1852,2436],[1852,2490],[245,2490]],"region":{"top_left_x":244,"top_left_y":2436,"width":1608,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0019d2b865e14b62b251122d24853175","type":"text","conversion_output":true,"text":"actual p -value for each comparison will be reported to aid in the overall interpretation. We have","text_display":" actual p -value for each comparison will be reported to aid in the overall interpretation. We have","confidence":0.8372287750244141,"confidence_rate":0.9983714383878862},{"cnt":[[1038,2548],[1089,2548],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2548,"width":53,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a971379903443c8a481f92acc191ad3","type":"page_info","conversion_output":false,"text":"19","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d1666cbe-f68a-4898-bf95-267fcf3b44bb-21","page":21,"lines":[{"cnt":[[245,254],[1837,254],[1837,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1593,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a99cb250c54453ebc658792f0c73758","type":"text","conversion_output":true,"text":"also pre-specified the primary and secondary outcome variables to avoid over-interpretation of","text_display":"\nalso pre-specified the primary and secondary outcome variables to avoid over-interpretation of","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[804,301],[804,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":560,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01ba6d6913a04c029b2899ad88d6c2c7","type":"text","conversion_output":true,"text":"strictly exploratory comparisons.","text_display":" strictly exploratory comparisons.","confidence":1,"confidence_rate":1},{"cnt":[[241,455],[690,455],[690,524],[241,524]],"region":{"top_left_x":240,"top_left_y":455,"width":450,"height":70},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f680e69bda0447bab8a6fdc3b1693868","type":"section_header","conversion_output":false,"children_ids":["0a93bb3190ea4910ac5eb19c8c5d27e3"],"text":"","text_display":""},{"cnt":[[245,460],[683,460],[683,518],[245,518]],"region":{"top_left_x":244,"top_left_y":459,"width":440,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a93bb3190ea4910ac5eb19c8c5d27e3","type":"text","conversion_output":true,"parent_id":"f680e69bda0447bab8a6fdc3b1693868","text":"13. Interim Analyses","text_display":"\n\n\\section*{13. Interim Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[245,576],[1850,576],[1850,625],[245,625]],"region":{"top_left_x":244,"top_left_y":575,"width":1606,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38497392914e456a9311a32b548fdbce","type":"text","conversion_output":true,"text":"For ethical reasons, an interim examination of key safety and endpoint data has been performed","text_display":"\n\nFor ethical reasons, an interim examination of key safety and endpoint data has been performed","confidence":1,"confidence_rate":1},{"cnt":[[245,623],[1863,623],[1863,672],[245,672]],"region":{"top_left_x":244,"top_left_y":623,"width":1619,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16c004bf47ec4076bf93f3a8154d0758","type":"text","conversion_output":true,"text":"at regular intervals during the course of the trial. The primary objective of these analyses was to","text_display":" at regular intervals during the course of the trial. The primary objective of these analyses was to","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1867,670],[1867,722],[245,722]],"region":{"top_left_x":244,"top_left_y":670,"width":1623,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40ac27c176af46d99a7c082530135f30","type":"text","conversion_output":true,"text":"evaluate the accumulating data for an unacceptably high frequency of negative clinical outcomes","text_display":" evaluate the accumulating data for an unacceptably high frequency of negative clinical outcomes","confidence":1,"confidence_rate":1},{"cnt":[[245,718],[1785,718],[1785,769],[245,769]],"region":{"top_left_x":244,"top_left_y":717,"width":1542,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a28034be2bc425587192cfde9cd1252","type":"text","conversion_output":true,"text":"in either of the treatment arms. In addition, the interim monitoring involved a review of the","text_display":" in either of the treatment arms. In addition, the interim monitoring involved a review of the","confidence":1,"confidence_rate":1},{"cnt":[[245,767],[1815,767],[1815,819],[245,819]],"region":{"top_left_x":244,"top_left_y":766,"width":1572,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d581062854a34a39a1e4296c8c133214","type":"text","conversion_output":true,"text":"aggregated event rates, patient recruitment, compliance with the study protocol, status of data","text_display":" aggregated event rates, patient recruitment, compliance with the study protocol, status of data","confidence":1,"confidence_rate":1},{"cnt":[[245,816],[1852,816],[1852,866],[245,866]],"region":{"top_left_x":244,"top_left_y":816,"width":1608,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"658b7c70cce34619883086db92904da7","type":"text","conversion_output":true,"text":"collection, and other factors which reflected the overall progress and integrity of the study. The","text_display":" collection, and other factors which reflected the overall progress and integrity of the study. The","confidence":1,"confidence_rate":1},{"cnt":[[245,864],[1833,864],[1833,913],[245,913]],"region":{"top_left_x":244,"top_left_y":863,"width":1589,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"510224bc958c4f23bd27ad65a01971e5","type":"text","conversion_output":true,"text":"results of the interim analyses and status reports were carefully and confidentially reviewed by","text_display":" results of the interim analyses and status reports were carefully and confidentially reviewed by","confidence":0.99755859375,"confidence_rate":0.9999757983983905},{"cnt":[[245,911],[1364,911],[1364,960],[245,960]],"region":{"top_left_x":244,"top_left_y":910,"width":1121,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a7869bae3f1462eb715896e59f896c6","type":"text","conversion_output":true,"text":"an NHLBI-appointed Data and Safety Monitoring Board (DSMB).","text_display":" an NHLBI-appointed Data and Safety Monitoring Board (DSMB).","confidence":1,"confidence_rate":1},{"cnt":[[245,1036],[1807,1036],[1807,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1035,"width":1563,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe255fac41344311bac5b646431aae5c","type":"text","conversion_output":true,"text":"The DSMB met at approximately 6 -month intervals to review the accumulating data. Prior to","text_display":"\n\nThe DSMB met at approximately 6 -month intervals to review the accumulating data. Prior to","confidence":0.874241828918457,"confidence_rate":0.9986295292450272},{"cnt":[[245,1083],[1837,1083],[1837,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1082,"width":1593,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dce3dc1bd97a45f98dbc0e1e59ce0a32","type":"text","conversion_output":true,"text":"each meeting, the Statistical and Data Coordinating Center (SDCC) at the DCRI conducted the","text_display":" each meeting, the Statistical and Data Coordinating Center (SDCC) at the DCRI conducted the","confidence":1,"confidence_rate":1},{"cnt":[[245,1130],[1747,1130],[1747,1179],[245,1179]],"region":{"top_left_x":244,"top_left_y":1130,"width":1503,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4215fdc3a2f245deb6cbcc5ff5291661","type":"text","conversion_output":true,"text":"desired statistical analyses and prepared a summary report for review by the DSMB. The","text_display":" desired statistical analyses and prepared a summary report for review by the DSMB. The","confidence":1,"confidence_rate":1},{"cnt":[[245,1177],[1850,1177],[1850,1227],[245,1227]],"region":{"top_left_x":244,"top_left_y":1177,"width":1606,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa555ef904354f82b744fe9cbaf2769c","type":"text","conversion_output":true,"text":"extracted data files and analysis programs for each DSMB report were archived and maintained","text_display":" extracted data files and analysis programs for each DSMB report were archived and maintained","confidence":1,"confidence_rate":1},{"cnt":[[245,1227],[1846,1227],[1846,1276],[245,1276]],"region":{"top_left_x":244,"top_left_y":1226,"width":1602,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ba1f634d466474f99a067c8b3c7c168","type":"text","conversion_output":true,"text":"at the DCRI. Reports were presented describing the progress of patient enrollment, the rates of","text_display":" at the DCRI. Reports were presented describing the progress of patient enrollment, the rates of","confidence":1,"confidence_rate":1},{"cnt":[[245,1276],[1850,1276],[1850,1326],[245,1326]],"region":{"top_left_x":244,"top_left_y":1276,"width":1606,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eeef3c431854a6d8af121f182aaf5d7","type":"text","conversion_output":true,"text":"compliance with therapy, and the frequency of protocol violations. The SDCC also reported on","text_display":" compliance with therapy, and the frequency of protocol violations. The SDCC also reported on","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,1323],[1790,1323],[1790,1373],[245,1373]],"region":{"top_left_x":244,"top_left_y":1323,"width":1546,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21cf9d02a0c04381ae1d0f61ed4d9134","type":"text","conversion_output":true,"text":"the number (status) of data forms completed and the overall quality and completeness of the","text_display":" the number (status) of data forms completed and the overall quality and completeness of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1371],[460,1371],[460,1416],[245,1416]],"region":{"top_left_x":244,"top_left_y":1370,"width":216,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7172c2fc2cfd4123b9143485bebabb48","type":"text","conversion_output":true,"text":"information.","text_display":" information.","confidence":1,"confidence_rate":1},{"cnt":[[245,1487],[1846,1487],[1846,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1486,"width":1602,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1348562ac322443396e788df4162a94c","type":"text","conversion_output":true,"text":"In CABANA, a group sequential method similar to that proposed by O'Brien and Fleming \\({ }^{9}\\) was","text_display":"\n\nIn CABANA, a group sequential method similar to that proposed by O'Brien and Fleming \\({ }^{9}\\) was","confidence":0.9843823909759521,"confidence_rate":0.9998500983915757},{"cnt":[[245,1543],[1807,1543],[1807,1592],[245,1592]],"region":{"top_left_x":244,"top_left_y":1542,"width":1563,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6159dabd3f047329f8e3a074220de64","type":"text","conversion_output":true,"text":"used as a guide in interpreting interim analyses. This procedure required large critical values","text_display":" used as a guide in interpreting interim analyses. This procedure required large critical values","confidence":1,"confidence_rate":1},{"cnt":[[245,1590],[1858,1590],[1858,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1589,"width":1615,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7adf4cea4c294ff3988ed7bcef349a21","type":"text","conversion_output":true,"text":"early in the study, but relaxed (i.e., decreased) the critical value as the trial progressed. Because","text_display":" early in the study, but relaxed (i.e., decreased) the critical value as the trial progressed. Because","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,1637],[1852,1637],[1852,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1637,"width":1608,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d20f9fc1e6894a5ba762448a93da7a01","type":"text","conversion_output":true,"text":"of the conservatism early in the trial, the critical value at the final analysis is near the \"nominal\"","text_display":" of the conservatism early in the trial, the critical value at the final analysis is near the \"nominal\"","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[245,1680],[1800,1680],[1800,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1680,"width":1557,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14ee1b9e3ddc4690a9ca4fe88e638159","type":"text","conversion_output":true,"text":"critical value. The actual method used for the interim monitoring was the Lan and DeMets \\({ }^{10}\\)","text_display":" critical value. The actual method used for the interim monitoring was the Lan and DeMets \\({ }^{10}\\)","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1852,1732],[1852,1783],[245,1783]],"region":{"top_left_x":244,"top_left_y":1731,"width":1608,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e4d90b3f14b40c3996572c281a3d2b5","type":"text","conversion_output":true,"text":"group sequential method with monitoring boundaries based on a two-sided, symmetric O'Brien-","text_display":" group sequential method with monitoring boundaries based on a two-sided, symmetric O'Brien","confidence":1,"confidence_rate":1},{"cnt":[[245,1781],[1833,1781],[1833,1833],[245,1833]],"region":{"top_left_x":244,"top_left_y":1781,"width":1589,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bccd7b917a584f329467c5d69bb0ce81","type":"text","conversion_output":true,"text":"Fleming type spending function. The Lan-DeMets approach only required specification of the","text_display":"Fleming type spending function. The Lan-DeMets approach only required specification of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1833],[1751,1833],[1751,1884],[245,1884]],"region":{"top_left_x":244,"top_left_y":1832,"width":1507,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87efa53396ea4d9bab4dd4c494a9c1c8","type":"text","conversion_output":true,"text":"rate at which the Type I error (which in this trial is \\(\\alpha=0.05\\) for the primary endpoint) was","text_display":" rate at which the Type I error (which in this trial is \\(\\alpha=0.05\\) for the primary endpoint) was","confidence":1,"confidence_rate":1},{"cnt":[[245,1882],[1869,1882],[1869,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1882,"width":1626,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49fcef8c84864f0f9c0e300a6ffcef52","type":"text","conversion_output":true,"text":"\"spent\". The procedure allowed \"spending\" a portion of \\(\\alpha\\) at each interim analysis in such a way","text_display":" \"spent\". The procedure allowed \"spending\" a portion of \\(\\alpha\\) at each interim analysis in such a way","confidence":0.9951212396845222,"confidence_rate":0.9999525185999244},{"cnt":[[245,1934],[1846,1934],[1846,1981],[245,1981]],"region":{"top_left_x":244,"top_left_y":1933,"width":1602,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21e15f1c2fba4913aaf2019107032b45","type":"text","conversion_output":true,"text":"that at the end of the study, the total Type I error did not exceed 0.05 . The specific formulation","text_display":" that at the end of the study, the total Type I error did not exceed 0.05 . The specific formulation","confidence":0.9716796875,"confidence_rate":0.9997315400750793},{"cnt":[[245,1972],[1824,1972],[1824,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1972,"width":1581,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62a61871e92c45d18d7d7d1635aa2054","type":"text","conversion_output":true,"text":"of the spending function is described in Chapter 5 of Proschan et al (formula 5.4) \\({ }^{11}\\). Since the","text_display":" of the spending function is described in Chapter 5 of Proschan et al (formula 5.4) \\({ }^{11}\\). 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Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. \\(2^{ nd }\\) edition. 2002,","text_display":"\n1. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. \\(2^{ nd }\\) edition. 2002,","confidence":0.6202478408813477,"confidence_rate":0.9958552555443234},{"cnt":[[305,404],[1109,404],[1109,453],[305,453]],"region":{"top_left_x":305,"top_left_y":403,"width":804,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f47a70e764f4425ea7904f87d55885ec","type":"text","conversion_output":true,"text":"John Wiley \\& Sons, Inc. Hoboken, New Jersey.","text_display":" John Wiley \\& Sons, Inc. 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J Royal Statist Soc B 1972;","confidence":1,"confidence_rate":1},{"cnt":[[305,498],[518,498],[518,544],[305,544]],"region":{"top_left_x":305,"top_left_y":498,"width":213,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd1f31be5a2545b4ba275fef2b8cb69a","type":"text","conversion_output":true,"text":"34:187-220.","text_display":" 34:187-220.","confidence":0.99951171875,"confidence_rate":0.9999694754347522},{"cnt":[[243,546],[1852,546],[1852,597],[243,597]],"region":{"top_left_x":242,"top_left_y":545,"width":1610,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f80b3646d2d4ecb9971f18fc66945a4","type":"text","conversion_output":true,"text":"3. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Statist","text_display":"\n3. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Statist","confidence":1,"confidence_rate":1},{"cnt":[[305,597],[715,597],[715,642],[305,642]],"region":{"top_left_x":305,"top_left_y":597,"width":411,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4be8a0f3eddf48e68d27c2c3dd5e5677","type":"text","conversion_output":true,"text":"Assn 1958; 53:457-481.","text_display":" Assn 1958; 53:457-481.","confidence":1,"confidence_rate":1},{"cnt":[[243,645],[1729,645],[1729,694],[243,694]],"region":{"top_left_x":242,"top_left_y":644,"width":1488,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aac380a7bb64a7b9fdaf9e9d27906c8","type":"text","conversion_output":true,"text":"4. Kirchhof P, Breithardt G, Camm AJ, Crijns HJ, Kuck K-H, Vardas P, Wegscheider K.","text_display":"\n4. 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