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The purpose of this study is to compare a vaginal","text_display":" prolapse desiring vaginal surgical treatment. The purpose of this study is to compare a vaginal","confidence":1,"confidence_rate":1},{"cnt":[[309,1779],[1828,1779],[1828,1824],[309,1824]],"region":{"top_left_x":309,"top_left_y":1778,"width":1520,"height":47},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"808c057b0c004ec5b53378d7fffee410","type":"text","conversion_output":true,"text":"hysterectomy with native tissue apical repairs with a non-trocar mesh hysteropexy repair. Eligible","text_display":" hysterectomy with native tissue apical repairs with a non-trocar mesh hysteropexy repair. Eligible","confidence":1,"confidence_rate":1},{"cnt":[[309,1824],[1772,1824],[1772,1867],[309,1867]],"region":{"top_left_x":309,"top_left_y":1824,"width":1464,"height":43},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f8995cf908742299a57d390b03c8995","type":"text","conversion_output":true,"text":"subjects will be randomized \\(1: 1\\) to receive either vaginal hysterectomy with native tissue apical","text_display":" subjects will be randomized \\(1: 1\\) to receive either vaginal hysterectomy with native tissue apical","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[309,1867],[1850,1867],[1850,1910],[309,1910]],"region":{"top_left_x":309,"top_left_y":1866,"width":1541,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92bfc90e6cd045e0acf3c598c3e45185","type":"text","conversion_output":true,"text":"repairs or a non-trocar mesh hysteropexy repair for treatment of their uterovaginal prolapse. Each of","text_display":" repairs or a non-trocar mesh hysteropexy repair for treatment of their uterovaginal prolapse. Each of","confidence":0.9990236759185791,"confidence_rate":0.9999907849387211},{"cnt":[[309,1912],[1863,1912],[1863,1955],[309,1955]],"region":{"top_left_x":309,"top_left_y":1912,"width":1554,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57afc857a06c4f7185c137250d8f7a61","type":"text","conversion_output":true,"text":"the participants will be followed until 36 months after the last participant is randomized meaning that","text_display":" the participants will be followed until 36 months after the last participant is randomized meaning that","confidence":1,"confidence_rate":1},{"cnt":[[309,1955],[1854,1955],[1854,2000],[309,2000]],"region":{"top_left_x":309,"top_left_y":1955,"width":1546,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48386683eb2e4edd86848130537f3493","type":"text","conversion_output":true,"text":"participants are expected to be followed for a period of 36 to 60 months to assess treatment outcome.","text_display":" participants are expected to be followed for a period of 36 to 60 months to assess treatment outcome.","confidence":1,"confidence_rate":1},{"cnt":[[309,2022],[853,2022],[853,2065],[309,2065]],"region":{"top_left_x":309,"top_left_y":2021,"width":544,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff2d96b729f14632a091302a8b834182","type":"text","conversion_output":true,"text":"A study schematic is shown below:","text_display":"\n\nA study schematic is shown below:","confidence":1,"confidence_rate":1},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":38,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b924d8664f024f9c930472cbab0a031c","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 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All subjects will be assigned to","confidence":1,"confidence_rate":1},{"cnt":[[309,597],[1452,597],[1452,642],[309,642]],"region":{"top_left_x":309,"top_left_y":597,"width":1144,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fff0bde948345afabf068c5b936f569","type":"text","conversion_output":true,"text":"the arm to which they were randomized irrespective of treatment received.","text_display":" the arm to which they were randomized irrespective of treatment received.","confidence":1,"confidence_rate":1},{"cnt":[[305,662],[715,662],[715,711],[305,711]],"region":{"top_left_x":305,"top_left_y":661,"width":411,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a489c46f6bc40898e39ff79c14b591e","type":"section_header","conversion_output":false,"children_ids":["5e03101379e04a8dadcdf40cafeb207b"],"text":"","text_display":""},{"cnt":[[309,666],[713,666],[713,707],[309,707]],"region":{"top_left_x":309,"top_left_y":666,"width":405,"height":41},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e03101379e04a8dadcdf40cafeb207b","type":"text","conversion_output":true,"parent_id":"6a489c46f6bc40898e39ff79c14b591e","text":"Safety (SAF) Population","text_display":"\n\n\\section*{Safety (SAF) Population}","confidence":1,"confidence_rate":1},{"cnt":[[309,726],[1858,726],[1858,776],[309,776]],"region":{"top_left_x":309,"top_left_y":726,"width":1550,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"592575fa537740fdbb4f34fbce2ebb9f","type":"text","conversion_output":true,"text":"The safety population will comprise all subjects who received any study treatment grouped by actual","text_display":"\n\nThe safety population will comprise all subjects who received any study treatment grouped by actual","confidence":1,"confidence_rate":1},{"cnt":[[309,773],[1218,773],[1218,819],[309,819]],"region":{"top_left_x":309,"top_left_y":773,"width":910,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a90e2cdde3574de096c32cb71ced1314","type":"text","conversion_output":true,"text":"treatment received, irrespective of treatment dose received.","text_display":" treatment received, irrespective of treatment dose received.","confidence":1,"confidence_rate":1},{"cnt":[[305,855],[965,855],[965,904],[305,904]],"region":{"top_left_x":305,"top_left_y":855,"width":660,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57b0fb1ed9054dff9a08c0b1971bc070","type":"section_header","conversion_output":false,"children_ids":["f1d94db3b7304ed3af95fa7b9dd24446"],"text":"","text_display":""},{"cnt":[[309,859],[960,859],[960,900],[309,900]],"region":{"top_left_x":309,"top_left_y":859,"width":652,"height":42},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1d94db3b7304ed3af95fa7b9dd24446","type":"text","conversion_output":true,"parent_id":"57b0fb1ed9054dff9a08c0b1971bc070","text":"6 SAMPLE SIZE DETERMINATION","text_display":"\n\n\\section*{6 SAMPLE SIZE DETERMINATION}","confidence":1,"confidence_rate":1},{"cnt":[[309,945],[1807,945],[1807,990],[309,990]],"region":{"top_left_x":309,"top_left_y":945,"width":1498,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68a8774d00ba477b84a0188fc6a5680d","type":"text","conversion_output":true,"text":"This study is designed to compare the relative effectiveness of two transvaginal apical suspension","text_display":"\n\nThis study is designed to compare the relative effectiveness of two transvaginal apical suspension","confidence":1,"confidence_rate":1},{"cnt":[[309,990],[1811,990],[1811,1038],[309,1038]],"region":{"top_left_x":309,"top_left_y":990,"width":1503,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c64da04bb590476ea99dfa3496fc63a3","type":"text","conversion_output":true,"text":"strategies for uterovaginal prolapse: a mesh augmented hysteropexy vs. vaginal hysterectomy and","text_display":" strategies for uterovaginal prolapse: a mesh augmented hysteropexy vs. vaginal hysterectomy and","confidence":1,"confidence_rate":1},{"cnt":[[309,1036],[1863,1036],[1863,1081],[309,1081]],"region":{"top_left_x":309,"top_left_y":1035,"width":1554,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5595f0ffe3504e349130f9a59fb6c21d","type":"text","conversion_output":true,"text":"uterosacral ligament suspension. Power and sample size calculations were generated to determine the","text_display":" uterosacral ligament suspension. Power and sample size calculations were generated to determine the","confidence":1,"confidence_rate":1},{"cnt":[[309,1079],[1783,1079],[1783,1124],[309,1124]],"region":{"top_left_x":309,"top_left_y":1078,"width":1475,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe78082345dc4782af8ae250867be4d9","type":"text","conversion_output":true,"text":"sample size needed to test for treatment difference favoring the mesh augmented strategy (i.e., a","text_display":" sample size needed to test for treatment difference favoring the mesh augmented strategy (i.e., a","confidence":1,"confidence_rate":1},{"cnt":[[309,1121],[1876,1121],[1876,1167],[309,1167]],"region":{"top_left_x":309,"top_left_y":1121,"width":1567,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"163d6187b2aa4db4b674af1616fd6047","type":"text","conversion_output":true,"text":"superiority trial) across the study arms for a variety of assumptions about effect size and study follow-","text_display":" superiority trial) across the study arms for a variety of assumptions about effect size and study follow","confidence":1,"confidence_rate":1},{"cnt":[[309,1164],[1869,1164],[1869,1212],[309,1212]],"region":{"top_left_x":309,"top_left_y":1164,"width":1561,"height":48},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e65cfc9de8c14191b0ab7ccefb52aeb1","type":"text","conversion_output":true,"text":"up time. For all power analyses, we assumed that failure in both arms follows an exponential survival","text_display":"up time. For all power analyses, we assumed that failure in both arms follows an exponential survival","confidence":1,"confidence_rate":1},{"cnt":[[309,1210],[1858,1210],[1858,1257],[309,1257]],"region":{"top_left_x":309,"top_left_y":1209,"width":1550,"height":48},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19172d3982a04cd1bf082bdc163337bb","type":"text","conversion_output":true,"text":"model and that the native tissue repair has a success rate of \\(80 \\%\\) at 24 months. This \\(80 \\%\\) calculation","text_display":" model and that the native tissue repair has a success rate of \\(80 \\%\\) at 24 months. This \\(80 \\%\\) calculation","confidence":0.9145922660827637,"confidence_rate":0.9992171756559343},{"cnt":[[309,1253],[1858,1253],[1858,1300],[309,1300]],"region":{"top_left_x":309,"top_left_y":1252,"width":1550,"height":48},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bebe83a4af4e498daee263b448069ef6","type":"text","conversion_output":true,"text":"is based on an assumed \\(85 \\%\\) anatomic success rate for uterosacral ligament suspension (Table 2) and","text_display":" is based on an assumed \\(85 \\%\\) anatomic success rate for uterosacral ligament suspension (Table 2) and","confidence":0.9786300659179688,"confidence_rate":0.9997962322993041},{"cnt":[[309,1298],[1876,1298],[1876,1343],[309,1343]],"region":{"top_left_x":309,"top_left_y":1297,"width":1567,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4db05321f5f145fc8b37dfea23b5196f","type":"text","conversion_output":true,"text":"an additional \\(5 \\%\\) failure rate based on symptom failure. In the only published Uphold series there is a","text_display":" an additional \\(5 \\%\\) failure rate based on symptom failure. In the only published Uphold series there is a","confidence":0.982421875,"confidence_rate":0.9998387906779852},{"cnt":[[309,1341],[1777,1341],[1777,1386],[309,1386]],"region":{"top_left_x":309,"top_left_y":1340,"width":1468,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9220898c09014d3eb5f6e5e84871bba4","type":"text","conversion_output":true,"text":"\\(98 \\% 12\\) month anatomic success rate. 32 Although no 2-year outcome data are available for the","text_display":" \\(98 \\% 12\\) month anatomic success rate. 32 Although no 2-year outcome data are available for the","confidence":0.9663562620989978,"confidence_rate":0.9996508496262099},{"cnt":[[309,1384],[1871,1384],[1871,1433],[309,1433]],"region":{"top_left_x":309,"top_left_y":1383,"width":1563,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49fc48ba576645eeafa65f803a3c308b","type":"text","conversion_output":true,"text":"UPHOLD procedure, under an assumption of a constant hazard, the 1-year success rate of \\(98 \\%\\) yields","text_display":" UPHOLD procedure, under an assumption of a constant hazard, the 1-year success rate of \\(98 \\%\\) yields","confidence":0.7301044464111328,"confidence_rate":0.9970086005325681},{"cnt":[[309,1431],[1865,1431],[1865,1476],[309,1476]],"region":{"top_left_x":309,"top_left_y":1430,"width":1556,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01765e2320344cf38d132501236722af","type":"text","conversion_output":true,"text":"an estimated 2 -year anatomic success rate of \\(96 \\%\\); combining this estimate with a similar \\(5 \\%\\) rate for","text_display":" an estimated 2 -year anatomic success rate of \\(96 \\%\\); combining this estimate with a similar \\(5 \\%\\) rate for","confidence":0.9561169147491455,"confidence_rate":0.9996132207007719},{"cnt":[[309,1474],[1828,1474],[1828,1519],[309,1519]],"region":{"top_left_x":309,"top_left_y":1473,"width":1520,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"093231f9ce7a46579a65d499252a7abf","type":"text","conversion_output":true,"text":"symptom failure yields a \\(91 \\%\\) composite (anatomic and symptom) success rate. All analyses also","text_display":" symptom failure yields a \\(91 \\%\\) composite (anatomic and symptom) success rate. All analyses also","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[309,1517],[1850,1517],[1850,1566],[309,1566]],"region":{"top_left_x":309,"top_left_y":1516,"width":1541,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75b9c2290b4e4a24af40640b484e52d4","type":"text","conversion_output":true,"text":"assumed that statistical tests would be conducted with a Type I error rate of 0.05 with no adjustment","text_display":" assumed that statistical tests would be conducted with a Type I error rate of 0.05 with no adjustment","confidence":1,"confidence_rate":1},{"cnt":[[309,1560],[1815,1560],[1815,1605],[309,1605]],"region":{"top_left_x":309,"top_left_y":1559,"width":1507,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e24e46dea6fb46fdb7b3f356c06f68ea","type":"text","conversion_output":true,"text":"for multiple comparisons. Sample size estimates assumed that the 2 -year success rate in the mesh-","text_display":" for multiple comparisons. Sample size estimates assumed that the 2 -year success rate in the mesh","confidence":0.99365234375,"confidence_rate":0.9999399273866704},{"cnt":[[309,1603],[1867,1603],[1867,1652],[309,1652]],"region":{"top_left_x":309,"top_left_y":1602,"width":1558,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64e2c52b3d37460392de6540d93fd42d","type":"text","conversion_output":true,"text":"augmented arm is in the range of \\(90 \\%\\) to \\(93 \\%\\) at 24 months (note that this represents a hazard ratio in","text_display":"augmented arm is in the range of \\(90 \\%\\) to \\(93 \\%\\) at 24 months (note that this represents a hazard ratio in","confidence":0.998046875,"confidence_rate":0.9999829998415843},{"cnt":[[309,1646],[1863,1646],[1863,1695],[309,1695]],"region":{"top_left_x":309,"top_left_y":1645,"width":1554,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca501943959c4963805bdf823aba7e7b","type":"text","conversion_output":true,"text":"the range of 0.33 to 0.47 under the assumed exponential survival model), that the enrollment time for","text_display":" the range of 0.33 to 0.47 under the assumed exponential survival model), that the enrollment time for","confidence":1,"confidence_rate":1},{"cnt":[[309,1693],[1807,1693],[1807,1738],[309,1738]],"region":{"top_left_x":309,"top_left_y":1692,"width":1498,"height":47},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06ab69ebfbce42d5b7d0ad0b16830633","type":"text","conversion_output":true,"text":"the study is 2 years, the loss-to-follow-up on both arms is no more than \\(5 \\%\\) per year, and the total","text_display":" the study is 2 years, the loss-to-follow-up on both arms is no more than \\(5 \\%\\) per year, and the total","confidence":0.9980475902557373,"confidence_rate":0.9999822336289093},{"cnt":[[309,1736],[1867,1736],[1867,1781],[309,1781]],"region":{"top_left_x":309,"top_left_y":1735,"width":1558,"height":47},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6c1284f9fe4461595c53f98b0620167","type":"text","conversion_output":true,"text":"study duration from last participant enrolled to stopping the study for final analysis is 36 months with","text_display":" study duration from last participant enrolled to stopping the study for final analysis is 36 months with","confidence":0.9970703125,"confidence_rate":0.9999738040267384},{"cnt":[[309,1779],[1835,1779],[1835,1826],[309,1826]],"region":{"top_left_x":309,"top_left_y":1778,"width":1526,"height":49},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3d9efde5ff0438286d1eea44f39bd84","type":"text","conversion_output":true,"text":"one interim analyses for efficacy when the last participant reaches the 24 -month follow-up. Table 6","text_display":" one interim analyses for efficacy when the last participant reaches the 24 -month follow-up. Table 6","confidence":0.8037109375,"confidence_rate":0.9979598819603624},{"cnt":[[309,1824],[1820,1824],[1820,1871],[309,1871]],"region":{"top_left_x":309,"top_left_y":1824,"width":1511,"height":48},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d01ef2b88984e66b64f1608ede7bb52","type":"text","conversion_output":true,"text":"provides estimates of the power for the different assumptions for total sample sizes in the range of","text_display":" provides estimates of the power for the different assumptions for total sample sizes in the range of","confidence":1,"confidence_rate":1},{"cnt":[[309,1869],[677,1869],[677,1914],[309,1914]],"region":{"top_left_x":309,"top_left_y":1869,"width":368,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e17ecdd414774000a1fe474ee52321c2","type":"text","conversion_output":true,"text":"160 to 300 participants.","text_display":" 160 to 300 participants.","confidence":1,"confidence_rate":1},{"cnt":[[322,1927],[1818,1927],[1818,2473],[322,2473]],"region":{"top_left_x":322,"top_left_y":1927,"width":1496,"height":546},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41f7e3c4e69246c0810d73ecf266da0a","type":"table","conversion_output":true,"children_ids":["db0e26a1c4d043dd9d4233e2721d13f2","c488498dad6a40ed9d629ae7b494261b","ae4e05653fbe4d86b7a0a68fb3e73a0e","4d25961e136443c0a5c445dcd32d0f55","00287a9d09ed4ff88692ede96e848300","cb2ff86d21ca4a84b4b449646d0d967e","983155a4c532407da0e9aacd180a94d3","0178f0b96aa644e58cde439901148acd","a1fa5573f7c04701bc24375de5f67ce7","feea10adef71485b8cd0a62c9c3aeeab","3558b8213c87418e85ef7f3d92b48511","ce37fad6af98444582d40a399b5a2515","2871fb5552214995820fc012396a905b","980b641eba3b4177874e0ede2c327d66","7706d38883c545a3b36dfa0ee20e1b56","ad9b3da9aeac41efb33da0e4c24df168","433251dc59e64e26bdff533c03ff28d1","33fbd2bc7578494ba1ae3d5bf2fd24d8","ba27669eaeb34b34b927f7a126e2074d","0c13f8e6698544e283518a52f1d0a7bb","4f0a3043da6242f4be117c71abc3cf6a","d051aa1fca8a422db1817771ff808c93","416155ce64564e75b831c1a3793ebe5d","401bbac995f24b0db2919b41f45bf8b6","08e22fe0c4924a8c946c3cd5d0c6aaab","dcfe680b26d7498391106afc43a84fa5","73fc5150d1744fbf8685b89ca5da03fb","fb797141853342e1bf14b1454e66dc9c","da523bae556247afa15901f2a1da722c","e7ced294595b422e9116d37812379c6e","98691d6d02534939810b86652d2f69d8","4a9f0b6bd24e48a383163b9765ed56c7","2d3c21151c304a42a620356f765c957b","4f509dc6f71745f3a8f5e8a871cd745e","01bd408337cf4239ad87417a43bca1bf","4c1301fb7cc64e7986b8bc6e5049796f","79d76bbdba714f84a675bc84c0abd028","4fd947d6c58c4461bdfa1d6faad3062f","a8bf835c272e46979e392240f5ffd77c","f1cf86c4c8a54014bb5756b38eb93653","c56a4c61ab2d4f00a4c6f2e7314fc27b","7eb559a2ed374c6e9025073e1c6e484d","fa88e5fdb8d74b889609be141105a4e3","befd7ed685434ab0bba8107eb7991f24","a06c064085e6411c9ff4f43c56fafbf9","7bd18ce0bd9347dd84dac175ed4c74b7","938898ad13214cbb9fa97dcc2c99d949","b003334d773a4be9a5c27694df141e8a","35d9dd75b2764ec397b3c0e6750daf34","aba57089507a4e578f6150dfc31a6fac","8cb99f30293b48049024e473c04220fc","ba6c2336e7454a35a00320657d2a330c","c71231e7c17e496d949c618dbee5f348","0ee46c13fd714483bd6213c6c30a4342","9ddc77518e26405bb8d79ae460e22228","0f21a76240fc450485b1ad902584685c","23c0c31e042948088c4d9174121d6096","74d37bd8f7234e40bd7f75e801d92d73","7f54ca1bcfd14bbe8b076b7f28d36b53","881fb5a305744092b1e67ab6a148516f","8234ace413774732bc78911ea1bad0a3"],"text":"\\begin{tabular}{|l|l|l|l|l|}\n\\hline 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For","confidence":1,"confidence_rate":1},{"cnt":[[309,778],[1863,778],[1863,823],[309,823]],"region":{"top_left_x":309,"top_left_y":777,"width":1554,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a8d0c6419c14f1cb533711b076cf8fb","type":"text","conversion_output":true,"text":"summaries of study data, categorical measures will be summarized in tables listing the frequency and","text_display":" summaries of study data, categorical measures will be summarized in tables listing the frequency and","confidence":1,"confidence_rate":1},{"cnt":[[309,821],[1781,821],[1781,866],[309,866]],"region":{"top_left_x":309,"top_left_y":820,"width":1473,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f61d3b9a5bf74c819b0ac74ae1f242bc","type":"text","conversion_output":true,"text":"the percentage of subjects in each study arm; continuous data will be summarized by presenting","text_display":" the percentage of subjects in each study arm; continuous data will be summarized by presenting","confidence":1,"confidence_rate":1},{"cnt":[[309,866],[1861,866],[1861,913],[309,913]],"region":{"top_left_x":309,"top_left_y":865,"width":1552,"height":49},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9f766ff40f04ed499ea97ff2270da86","type":"text","conversion_output":true,"text":"mean, standard deviation, median and range; and ordinal data will be summarized by only presenting","text_display":" mean, standard deviation, median and range; and ordinal data will be summarized by only presenting","confidence":1,"confidence_rate":1},{"cnt":[[309,911],[595,911],[595,956],[309,956]],"region":{"top_left_x":309,"top_left_y":910,"width":287,"height":47},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc65ab7089444e19b628ec767d1c9297","type":"text","conversion_output":true,"text":"median and range.","text_display":" median and range.","confidence":1,"confidence_rate":1},{"cnt":[[370,971],[941,971],[941,1025],[370,1025]],"region":{"top_left_x":369,"top_left_y":971,"width":573,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f19b910e88543cc8d31ed07a5a6f34e","type":"section_header","conversion_output":false,"children_ids":["7240cc7aa9e04e2dafc45ce5c493dd30"],"text":"","text_display":""},{"cnt":[[374,975],[939,975],[939,1021],[374,1021]],"region":{"top_left_x":373,"top_left_y":975,"width":566,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7240cc7aa9e04e2dafc45ce5c493dd30","type":"text","conversion_output":true,"parent_id":"7f19b910e88543cc8d31ed07a5a6f34e","text":"7.2 Adjustments for Covariates","text_display":"\n\n\\subsection*{7.2 Adjustments for Covariates}","confidence":1,"confidence_rate":1},{"cnt":[[309,1042],[1828,1042],[1828,1087],[309,1087]],"region":{"top_left_x":309,"top_left_y":1041,"width":1520,"height":47},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b7afe6918b14d268255140743ab05b1","type":"text","conversion_output":true,"text":"Indicator variables for the study stratification of site will be included as covariates in most efficacy","text_display":"\n\nIndicator variables for the study stratification of site will be included as covariates in most efficacy","confidence":1,"confidence_rate":1},{"cnt":[[309,1087],[1775,1087],[1775,1132],[309,1132]],"region":{"top_left_x":309,"top_left_y":1087,"width":1466,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc53ad30d7b546858b781686994ab697","type":"text","conversion_output":true,"text":"analyses performed for this study (details in section 9). Additionally, demographic and baseline","text_display":" analyses performed for this study (details in section 9). 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If sample sizes allow, these analyses will control for the study","text_display":" association for categorical measures. If sample sizes allow, these analyses will control for the study","confidence":1,"confidence_rate":1},{"cnt":[[309,1306],[1841,1306],[1841,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1306,"width":1533,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0f1b24e0bb8486abf5a70c185478adf","type":"text","conversion_output":true,"text":"stratification factors. If these analyses suggest that substantial differences exist among arms, the use","text_display":" stratification factors. If these analyses suggest that substantial differences exist among arms, the use","confidence":1,"confidence_rate":1},{"cnt":[[309,1349],[1850,1349],[1850,1394],[309,1394]],"region":{"top_left_x":309,"top_left_y":1349,"width":1541,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ea490b424f644cd845c4fdf6593fa08","type":"text","conversion_output":true,"text":"as covariates of these parameters on which the arms differ will be explored in secondary exploratory","text_display":" as covariates of these parameters on which the arms differ will be explored in secondary exploratory","confidence":1,"confidence_rate":1},{"cnt":[[309,1394],[758,1394],[758,1437],[309,1437]],"region":{"top_left_x":309,"top_left_y":1394,"width":450,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea50ad0b994a4790b54a31dafeb9e7df","type":"text","conversion_output":true,"text":"analyses of the efficacy data.","text_display":" analyses of the efficacy data.","confidence":0.99853515625,"confidence_rate":0.9999581175147387},{"cnt":[[370,1457],[1158,1457],[1158,1508],[370,1508]],"region":{"top_left_x":369,"top_left_y":1456,"width":790,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3487de1ca47b49e6b123658600b1fe3e","type":"section_header","conversion_output":false,"children_ids":["721314ae663c4063a3114a4d0112dfaa"],"text":"","text_display":""},{"cnt":[[374,1461],[1154,1461],[1154,1506],[374,1506]],"region":{"top_left_x":373,"top_left_y":1460,"width":781,"height":47},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"721314ae663c4063a3114a4d0112dfaa","type":"text","conversion_output":true,"parent_id":"3487de1ca47b49e6b123658600b1fe3e","text":"7.3 Handling of Dropouts and Missing Data","text_display":"\n\n\\subsection*{7.3 Handling of Dropouts and Missing Data}","confidence":1,"confidence_rate":1},{"cnt":[[309,1525],[1815,1525],[1815,1571],[309,1571]],"region":{"top_left_x":309,"top_left_y":1525,"width":1507,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6484c39581094979aa6d17a230c51e39","type":"text","conversion_output":true,"text":"Standard procedures will be used to ensure that data are as complete and accurate as possible. The","text_display":"\n\nStandard procedures will be used to ensure that data are as complete and accurate as possible. The","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[309,1571],[1772,1571],[1772,1613],[309,1613]],"region":{"top_left_x":309,"top_left_y":1570,"width":1464,"height":44},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f9c80318bc345b6950baa952637e3e8","type":"text","conversion_output":true,"text":"study was designed to obtain as much follow-up data as possible on all randomized subjects. In","text_display":" study was designed to obtain as much follow-up data as possible on all randomized subjects. In","confidence":1,"confidence_rate":1},{"cnt":[[309,1613],[1820,1613],[1820,1659],[309,1659]],"region":{"top_left_x":309,"top_left_y":1613,"width":1511,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a83174f6a65484191495c9d8d92b6c3","type":"text","conversion_output":true,"text":"analyses, a full accounting will be made for all data items. Generally, missing data will initially be","text_display":" analyses, a full accounting will be made for all data items. Generally, missing data will initially be","confidence":1,"confidence_rate":1},{"cnt":[[309,1659],[1781,1659],[1781,1704],[309,1704]],"region":{"top_left_x":309,"top_left_y":1658,"width":1473,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84b4907e34a34dd5a06698225846561d","type":"text","conversion_output":true,"text":"treated as randomly missing (either missing at random (MAR) or missing completely at random","text_display":" treated as randomly missing (either missing at random (MAR) or missing completely at random","confidence":1,"confidence_rate":1},{"cnt":[[309,1702],[1815,1702],[1815,1747],[309,1747]],"region":{"top_left_x":309,"top_left_y":1701,"width":1507,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"534b4ca897154698bfca4d6e3e11390d","type":"text","conversion_output":true,"text":"(MCAR) as appropriate for the analytic approach) with no data imputation. Because we anticipate","text_display":" (MCAR) as appropriate for the analytic approach) with no data imputation. Because we anticipate","confidence":1,"confidence_rate":1},{"cnt":[[309,1745],[1798,1745],[1798,1790],[309,1790]],"region":{"top_left_x":309,"top_left_y":1744,"width":1490,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cdb3aacf95354d5f813ec5693280d535","type":"text","conversion_output":true,"text":"that the amount of missing data will be minimal, we will use straightforward multiple imputation","text_display":" that the amount of missing data will be minimal, we will use straightforward multiple imputation","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[309,1790],[1777,1790],[1777,1835],[309,1835]],"region":{"top_left_x":309,"top_left_y":1789,"width":1468,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7983e8b1ddb94d19a8ab22cfa27d7b9a","type":"text","conversion_output":true,"text":"procedures based on baseline covariates and treatment group to assess sensitivity to the random","text_display":" procedures based on baseline covariates and treatment group to assess sensitivity to the random","confidence":1,"confidence_rate":1},{"cnt":[[309,1835],[1321,1835],[1321,1880],[309,1880]],"region":{"top_left_x":309,"top_left_y":1834,"width":1013,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b37140c6c3547478d8c42f1ee89b89e","type":"text","conversion_output":true,"text":"missingness assumption for both primary and secondary analyses.","text_display":" missingness assumption for both primary and secondary analyses.","confidence":1,"confidence_rate":1},{"cnt":[[370,1895],[1128,1895],[1128,1949],[370,1949]],"region":{"top_left_x":369,"top_left_y":1894,"width":759,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f2c886ae34946088da34d1927e81d5e","type":"section_header","conversion_output":false,"children_ids":["a691f83440b746caa83e799275e6a4c5"],"text":"","text_display":""},{"cnt":[[374,1899],[1124,1899],[1124,1944],[374,1944]],"region":{"top_left_x":373,"top_left_y":1899,"width":751,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a691f83440b746caa83e799275e6a4c5","type":"text","conversion_output":true,"parent_id":"0f2c886ae34946088da34d1927e81d5e","text":"7.4 Interim Analyses and Data Monitoring","text_display":"\n\n\\subsection*{7.4 Interim Analyses and Data Monitoring}","confidence":1,"confidence_rate":1},{"cnt":[[309,1968],[1794,1968],[1794,2013],[309,2013]],"region":{"top_left_x":309,"top_left_y":1967,"width":1485,"height":47},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ac59ea1290a4f909643339571e620b5","type":"text","conversion_output":true,"text":"A single planned interim analysis is planned with the last randomized participant reaches the 24-","text_display":"\n\nA single planned interim analysis is planned with the last randomized participant reaches the 24","confidence":0.99462890625,"confidence_rate":0.9999472016886584},{"cnt":[[309,2011],[1710,2011],[1710,2056],[309,2056]],"region":{"top_left_x":309,"top_left_y":2010,"width":1402,"height":47},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0581bbfef0a247f5a728192eded9a384","type":"text","conversion_output":true,"text":"month follow-up exam. The purpose of the interim analysis is to stop for benefit. Stopping","text_display":"month follow-up exam. The purpose of the interim analysis is to stop for benefit. 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The alpha level for the interim analysis is expected to be about 0.003 and to allow for","text_display":" type approach. The alpha level for the interim analysis is expected to be about 0.003 and to allow for","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[309,2187],[309,2140],[1575,2142],[1575,2189]],"region":{"top_left_x":309,"top_left_y":2140,"width":1266,"height":50},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d6ec209973f4f6e8a7f4886e9691c7d","type":"text","conversion_output":true,"text":"this interim look, the final test will be conducted at the 0.047 level of significance.","text_display":" this interim look, the final test will be conducted at the 0.047 level of significance.","confidence":0.99658203125,"confidence_rate":0.9999639604036571},{"cnt":[[309,2209],[1824,2209],[1824,2254],[309,2254]],"region":{"top_left_x":309,"top_left_y":2208,"width":1516,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3f2caae045c45dfa48c94364cbd9259","type":"text","conversion_output":true,"text":"The DSMB will also review enrollment data and safety data at 3 -month intervals and will have the","text_display":"\n\nThe DSMB will also review enrollment data and safety data at 3 -month intervals and will have the","confidence":0.78271484375,"confidence_rate":0.997669511875364},{"cnt":[[309,2252],[1794,2252],[1794,2297],[309,2297]],"region":{"top_left_x":309,"top_left_y":2251,"width":1485,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a5a4676da0941b9b488b744e6aa3b37","type":"text","conversion_output":true,"text":"responsibility of recommending to the Director of NICHD that the study be stopped for safety or","text_display":" responsibility of recommending to the Director of NICHD that the study be stopped for safety or","confidence":1,"confidence_rate":1},{"cnt":[[309,2295],[1334,2295],[1334,2340],[309,2340]],"region":{"top_left_x":309,"top_left_y":2294,"width":1026,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7db3c3639d14493390b0ceb08004894b","type":"text","conversion_output":true,"text":"futility. Each of these issues is addressed in the paragraphs below.","text_display":" futility. Each of these issues is addressed in the paragraphs below.","confidence":1,"confidence_rate":1},{"cnt":[[309,2359],[1796,2359],[1796,2404],[309,2404]],"region":{"top_left_x":309,"top_left_y":2358,"width":1488,"height":47},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6e47a94aa6349a7a91b7ba3957cb4e0","type":"text","conversion_output":true,"text":"The interim safety analyses conducted by the DSMB will be conducted based on a review of any","text_display":"\n\nThe interim safety analyses conducted by the DSMB will be conducted based on a review of any","confidence":1,"confidence_rate":1},{"cnt":[[309,2402],[1863,2402],[1863,2449],[309,2449]],"region":{"top_left_x":309,"top_left_y":2401,"width":1554,"height":49},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b02b1e6c90f478f94dfc9403bdae8cc","type":"text","conversion_output":true,"text":"study deaths (note that the number of deaths in the population under study is expected to be minimal)","text_display":" study deaths (note that the number of deaths in the population under study is expected to be minimal)","confidence":1,"confidence_rate":1},{"cnt":[[309,2447],[1777,2447],[1777,2494],[309,2494]],"region":{"top_left_x":309,"top_left_y":2447,"width":1468,"height":48},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21307033619e40c194e8382aed460c53","type":"text","conversion_output":true,"text":"and important complications as defined in Section 3.2. The important complication rate will be","text_display":" and important complications as defined in Section 3.2. The important complication rate will be","confidence":1,"confidence_rate":1},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":51,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"48c398a31daa4c19a7c61f8c305583af","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 16","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-18","page":18,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"58285553fa8847fbbdb63054a1fa8a64","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e8d4ff05321a45b8ba297c8febadee30","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,318],[1721,318],[1721,359],[309,359]],"region":{"top_left_x":309,"top_left_y":317,"width":1412,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"edb47bad353a426994c5c50eac75fb46","type":"text","conversion_output":true,"text":"calculated at 6 month intervals for both groups; the protocol committee considers that a true","text_display":"\ncalculated at 6 month intervals for both groups; the protocol committee considers that a true","confidence":0.9985356330871582,"confidence_rate":0.9999854907968839},{"cnt":[[309,361],[1871,361],[1871,402],[309,402]],"region":{"top_left_x":309,"top_left_y":360,"width":1563,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cbc920c584143908b2c6a755bd417c4","type":"text","conversion_output":true,"text":"difference of more than 15 percentage points in the complication rates for the two surgical procedures","text_display":" difference of more than 15 percentage points in the complication rates for the two surgical procedures","confidence":0.99755859375,"confidence_rate":0.9999777785074303},{"cnt":[[309,404],[1824,404],[1824,449],[309,449]],"region":{"top_left_x":309,"top_left_y":403,"width":1516,"height":47},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa225f84fa2e4ca8ba4a7bf841918630","type":"text","conversion_output":true,"text":"to represent an important difference between groups. Stopping the study will be considered by the","text_display":" to represent an important difference between groups. Stopping the study will be considered by the","confidence":1,"confidence_rate":1},{"cnt":[[309,447],[1835,447],[1835,492],[309,492]],"region":{"top_left_x":309,"top_left_y":446,"width":1526,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0aecde750294caa9de34782be031f47","type":"text","conversion_output":true,"text":"DSMB during their six-month reviews if they find compelling evidence based on point and interval","text_display":" DSMB during their six-month reviews if they find compelling evidence based on point and interval","confidence":1,"confidence_rate":1},{"cnt":[[309,490],[1779,490],[1779,535],[309,535]],"region":{"top_left_x":309,"top_left_y":489,"width":1470,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fdf715d0a23045d5a6996a5e2297df7d","type":"text","conversion_output":true,"text":"estimates of the important complication rates in the two study arms that the true difference is 15","text_display":" estimates of the important complication rates in the two study arms that the true difference is 15","confidence":0.97509765625,"confidence_rate":0.9997527986696422},{"cnt":[[309,537],[1854,537],[1854,580],[309,580]],"region":{"top_left_x":309,"top_left_y":537,"width":1546,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d919c9bf952a4f6088d074c7a7f7fdbe","type":"text","conversion_output":true,"text":"percentage points or greater. The DSMB is charged with determining the level of evidence that they","text_display":" percentage points or greater. The DSMB is charged with determining the level of evidence that they","confidence":1,"confidence_rate":1},{"cnt":[[309,580],[1257,580],[1257,625],[309,625]],"region":{"top_left_x":309,"top_left_y":580,"width":948,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"825a5fa0f18e42e3919528bb0335f5f2","type":"text","conversion_output":true,"text":"consider compelling for stopping the study for safety reasons.","text_display":" consider compelling for stopping the study for safety reasons.","confidence":1,"confidence_rate":1},{"cnt":[[309,645],[1785,645],[1785,690],[309,690]],"region":{"top_left_x":309,"top_left_y":644,"width":1477,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a8756577a4443e58b51bbd191d83dd4","type":"text","conversion_output":true,"text":"While the study is designed to demonstrate the superiority of either of the two treatment arms in","text_display":"\n\nWhile the study is designed to demonstrate the superiority of either of the two treatment arms in","confidence":1,"confidence_rate":1},{"cnt":[[309,690],[1815,690],[1815,733],[309,733]],"region":{"top_left_x":309,"top_left_y":689,"width":1507,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"394bc8cf9b6f41c195702b25d182b8c6","type":"text","conversion_output":true,"text":"comparison to the other, the comparison of the efficacy and safety outcomes for the two treatment","text_display":" comparison to the other, the comparison of the efficacy and safety outcomes for the two treatment","confidence":1,"confidence_rate":1},{"cnt":[[309,733],[1740,733],[1740,776],[309,776]],"region":{"top_left_x":309,"top_left_y":732,"width":1432,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d3da682e48a40e8a660eb348ff586a5","type":"text","conversion_output":true,"text":"arms has important public health implications even if a statistical difference in efficacy is not","text_display":" arms has important public health implications even if a statistical difference in efficacy is not","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[309,776],[1858,776],[1858,819],[309,819]],"region":{"top_left_x":309,"top_left_y":775,"width":1550,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29d15708916b4f5c91a842d887bafe97","type":"text","conversion_output":true,"text":"demonstrated. Consequently, the futility analyses will focus on failure to adequately enroll the study","text_display":" demonstrated. Consequently, the futility analyses will focus on failure to adequately enroll the study","confidence":1,"confidence_rate":1},{"cnt":[[309,821],[1833,821],[1833,862],[309,862]],"region":{"top_left_x":309,"top_left_y":820,"width":1524,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3af66678bd644568a4f4469d5c2034ee","type":"text","conversion_output":true,"text":"rather than on inability to show a difference in efficacy between the arms. The study is designed to","text_display":" rather than on inability to show a difference in efficacy between the arms. The study is designed to","confidence":1,"confidence_rate":1},{"cnt":[[309,864],[1869,864],[1869,909],[309,909]],"region":{"top_left_x":309,"top_left_y":863,"width":1561,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"176fb94028ef422796b1ddd7f3065589","type":"text","conversion_output":true,"text":"enroll 180 participants over a 24 month period or 7.5 participants per month across the 8 participating","text_display":" enroll 180 participants over a 24 month period or 7.5 participants per month across the 8 participating","confidence":0.99951171875,"confidence_rate":0.9999959300041316},{"cnt":[[309,907],[1742,907],[1742,952],[309,952]],"region":{"top_left_x":309,"top_left_y":906,"width":1434,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89fa25d01768424c8adb0f94466d2027","type":"text","conversion_output":true,"text":"sites. The DSMB will evaluate enrollment at 6 -month intervals starting after the first site has","text_display":" sites. The DSMB will evaluate enrollment at 6 -month intervals starting after the first site has","confidence":0.994140625,"confidence_rate":0.9999434957455698},{"cnt":[[309,952],[1876,952],[1876,995],[309,995]],"region":{"top_left_x":309,"top_left_y":951,"width":1567,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aaa95edae8084e10a9130ae2d9663bea","type":"text","conversion_output":true,"text":"achieved IRB approval. If at these 6 -month reviews, the DSMB finds that the study is not enrolling at","text_display":" achieved IRB approval. If at these 6 -month reviews, the DSMB finds that the study is not enrolling at","confidence":0.90576171875,"confidence_rate":0.999100595514915},{"cnt":[[309,997],[1871,997],[1871,1040],[309,1040]],"region":{"top_left_x":309,"top_left_y":996,"width":1563,"height":44},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c54f5673b27e4a10ae1754f97c08f7cd","type":"text","conversion_output":true,"text":"a rate of at least 5 participants per month (which would allow the study to enroll over a 3 -year period)","text_display":" a rate of at least 5 participants per month (which would allow the study to enroll over a 3 -year period)","confidence":0.9342069625854492,"confidence_rate":0.9994134714032065},{"cnt":[[309,1040],[1291,1040],[1291,1085],[309,1085]],"region":{"top_left_x":309,"top_left_y":1039,"width":983,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b93272f93f6e410a8dfd6f054b30dfc4","type":"text","conversion_output":true,"text":"they will consider recommending stopping the study for futility.","text_display":" they will consider recommending stopping the study for futility.","confidence":1,"confidence_rate":1},{"cnt":[[370,1104],[819,1104],[819,1147],[370,1147]],"region":{"top_left_x":369,"top_left_y":1104,"width":450,"height":44},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"175e5603d3fb4c01a8aa46c15d068697","type":"section_header","conversion_output":false,"children_ids":["8cc7306ca9304dbca1e541d72bcb47cf"],"text":"","text_display":""},{"cnt":[[374,1109],[816,1109],[816,1145],[374,1145]],"region":{"top_left_x":373,"top_left_y":1108,"width":444,"height":38},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cc7306ca9304dbca1e541d72bcb47cf","type":"text","conversion_output":true,"parent_id":"175e5603d3fb4c01a8aa46c15d068697","text":"7.5 Masked Data Review","text_display":"\n\n\\subsection*{7.5 Masked Data Review}","confidence":1,"confidence_rate":1},{"cnt":[[309,1173],[1867,1173],[1867,1216],[309,1216]],"region":{"top_left_x":309,"top_left_y":1173,"width":1558,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f04e1c25b8e442668296ce0f4ffd06c2","type":"text","conversion_output":true,"text":"A masked data review is planned prior to the data lock once all study participants reach the 36-month","text_display":"\n\nA masked data review is planned prior to the data lock once all study participants reach the 36-month","confidence":0.99853515625,"confidence_rate":0.9999861706835269},{"cnt":[[309,1216],[1850,1216],[1850,1261],[309,1261]],"region":{"top_left_x":309,"top_left_y":1216,"width":1541,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0d5def66616460fa1fe71d3dc2cc379","type":"text","conversion_output":true,"text":"visit. All eligibility, protocol deviation, and visit window data will be reviewed by the protocol team","text_display":" visit. All eligibility, protocol deviation, and visit window data will be reviewed by the protocol team","confidence":0.9990236759185791,"confidence_rate":0.9999909555872323},{"cnt":[[309,1261],[1798,1261],[1798,1300],[309,1300]],"region":{"top_left_x":309,"top_left_y":1261,"width":1490,"height":39},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b812353d3a14d0e887e97a78fc131e3","type":"text","conversion_output":true,"text":"in a masked fashion. Details of the results from the masked review will be documented in a SAP","text_display":" in a masked fashion. Details of the results from the masked review will be documented in a SAP","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[309,1306],[1867,1306],[1867,1347],[309,1347]],"region":{"top_left_x":309,"top_left_y":1306,"width":1558,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"656daa57cbb24ed28e9efbc431d40a64","type":"text","conversion_output":true,"text":"addendum once the review is complete. Specific items to be addressed in the masked data review are:","text_display":" addendum once the review is complete. Specific items to be addressed in the masked data review are:","confidence":0.99609375,"confidence_rate":0.9999623670608182},{"cnt":[[372,1371],[1850,1371],[1850,1412],[372,1412]],"region":{"top_left_x":371,"top_left_y":1370,"width":1479,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f4f81781de14d9c80ccfad89e289a69","type":"text","conversion_output":true,"text":"- Reason for study withdrawal and missed visits (adverse event, death, patient moved, lack of","text_display":"\n- Reason for study withdrawal and missed visits (adverse event, death, patient moved, lack of","confidence":1,"confidence_rate":1},{"cnt":[[434,1414],[1704,1414],[1704,1459],[434,1459]],"region":{"top_left_x":433,"top_left_y":1413,"width":1271,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eaadc78277c642d5a52dfc370892bfb4","type":"text","conversion_output":true,"text":"efficacy, etc. to determine whether the event was likely to be missing at random or","text_display":" efficacy, etc. to determine whether the event was likely to be missing at random or","confidence":1,"confidence_rate":1},{"cnt":[[434,1457],[797,1457],[797,1502],[434,1502]],"region":{"top_left_x":433,"top_left_y":1456,"width":365,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0a4dd79eebc4926840ae8b0a34940eb","type":"text","conversion_output":true,"text":"informatively missing).","text_display":" informatively missing).","confidence":1,"confidence_rate":1},{"cnt":[[372,1504],[1807,1504],[1807,1547],[372,1547]],"region":{"top_left_x":371,"top_left_y":1503,"width":1436,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e7632671ad24c85935ee306553a132b","type":"text","conversion_output":true,"text":"- Characterization of individual failures (by time and reason for failure) to ascertain failure","text_display":"\n- Characterization of individual failures (by time and reason for failure) to ascertain failure","confidence":1,"confidence_rate":1},{"cnt":[[434,1547],[1837,1547],[1837,1592],[434,1592]],"region":{"top_left_x":433,"top_left_y":1546,"width":1404,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3252e751087416dbfd509d9dba879be","type":"text","conversion_output":true,"text":"time for the primary outcome and failure across time span for secondary analyses related to","text_display":" time for the primary outcome and failure across time span for secondary analyses related to","confidence":1,"confidence_rate":1},{"cnt":[[434,1590],[1476,1590],[1476,1635],[434,1635]],"region":{"top_left_x":433,"top_left_y":1589,"width":1043,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"669a233c65634e1facc070e0b967312c","type":"text","conversion_output":true,"text":"changing status of anatomical prolapse failure and bulge symptoms.","text_display":" changing status of anatomical prolapse failure and bulge symptoms.","confidence":1,"confidence_rate":1},{"cnt":[[372,1637],[1532,1637],[1532,1678],[372,1678]],"region":{"top_left_x":371,"top_left_y":1637,"width":1161,"height":41},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8faec9be1fb4bbfaedd583bde5d53a3","type":"text","conversion_output":true,"text":"- Review of deviations (excluding missed/incomplete visits/assessments)","text_display":"\n- Review of deviations (excluding missed/incomplete visits/assessments)","confidence":1,"confidence_rate":1},{"cnt":[[370,1680],[1833,1680],[1833,1725],[370,1725]],"region":{"top_left_x":369,"top_left_y":1680,"width":1464,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82264b9b626c4c4c9c50f8ac096830b9","type":"text","conversion_output":true,"text":"- Summary of interoperative complications from C3 in Form 9. The summary will include a","text_display":"\n- Summary of interoperative complications from C3 in Form 9. The summary will include a","confidence":1,"confidence_rate":1},{"cnt":[[434,1723],[1828,1723],[1828,1768],[434,1768]],"region":{"top_left_x":433,"top_left_y":1723,"width":1396,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a4e60c50d5648689e60c4989cd49479","type":"text","conversion_output":true,"text":"count and percentage for each of the complications listed in the table as well as a table that","text_display":" count and percentage for each of the complications listed in the table as well as a table that","confidence":1,"confidence_rate":1},{"cnt":[[434,1766],[1846,1766],[1846,1811],[434,1811]],"region":{"top_left_x":433,"top_left_y":1766,"width":1413,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eda65a57b2cc4be98bb44a8eb9db5951","type":"text","conversion_output":true,"text":"shows the percentage of individuals have different numbers of complications. The summary","text_display":" shows the percentage of individuals have different numbers of complications. 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For both primary and secondary","confidence":1,"confidence_rate":1},{"cnt":[[309,1551],[309,1506],[1790,1508],[1790,1553]],"region":{"top_left_x":309,"top_left_y":1506,"width":1481,"height":48},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59dc79bbe432462cad275d99f204a454","type":"text","conversion_output":true,"text":"analysis, decisions about how to treat out-of-window visits will be made during the masked data","text_display":" analysis, decisions about how to treat out-of-window visits will be made during the masked data","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[309,1551],[801,1551],[801,1596],[309,1596]],"region":{"top_left_x":309,"top_left_y":1551,"width":493,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8fb3b1fd3390438980233bf25aee8aea","type":"text","conversion_output":true,"text":"review prior to unmasking data.","text_display":" review prior to unmasking data.","confidence":1,"confidence_rate":1},{"cnt":[[305,1635],[1102,1635],[1102,1678],[305,1678]],"region":{"top_left_x":305,"top_left_y":1634,"width":798,"height":44},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd3fcbc8df90405f8fd53ab2b2237e39","type":"section_header","conversion_output":false,"children_ids":["458df20cb858406aa3f2a98d74702674"],"text":"","text_display":""},{"cnt":[[309,1637],[1102,1637],[1102,1678],[309,1678]],"region":{"top_left_x":309,"top_left_y":1637,"width":794,"height":41},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"458df20cb858406aa3f2a98d74702674","type":"text","conversion_output":true,"parent_id":"bd3fcbc8df90405f8fd53ab2b2237e39","text":"8 STUDY SUBJECT CHARACTERIZATION","text_display":"\n\n\\section*{8 STUDY SUBJECT CHARACTERIZATION}","confidence":0.994140625,"confidence_rate":0.9998367741980869},{"cnt":[[370,1723],[862,1723],[862,1775],[370,1775]],"region":{"top_left_x":369,"top_left_y":1723,"width":493,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a04050780af48ee9fbf8cf5f74b7882","type":"section_header","conversion_output":false,"children_ids":["cace542de2924927b7f5f3c9efbcbec2"],"text":"","text_display":""},{"cnt":[[374,1727],[857,1727],[857,1772],[374,1772]],"region":{"top_left_x":373,"top_left_y":1727,"width":485,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cace542de2924927b7f5f3c9efbcbec2","type":"text","conversion_output":true,"parent_id":"3a04050780af48ee9fbf8cf5f74b7882","text":"8.1 Participant Disposition","text_display":"\n\n\\subsection*{8.1 Participant Disposition}","confidence":1,"confidence_rate":1},{"cnt":[[309,1792],[1818,1792],[1818,1837],[309,1837]],"region":{"top_left_x":309,"top_left_y":1791,"width":1509,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0198adb18a44d5785c1aa3b4a1420fc","type":"text","conversion_output":true,"text":"Participant eligibility status will be summarized and listed by study arm and overall disposition of","text_display":"\n\nParticipant eligibility status will be summarized and listed by study arm and overall disposition of","confidence":1,"confidence_rate":1},{"cnt":[[309,1835],[1738,1835],[1738,1880],[309,1880]],"region":{"top_left_x":309,"top_left_y":1834,"width":1430,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8268d12c682344aba3f89382a8d7b916","type":"text","conversion_output":true,"text":"study participants will be described using a standard cohort diagram. The number of subjects","text_display":" study participants will be described using a standard cohort diagram. The number of subjects","confidence":1,"confidence_rate":1},{"cnt":[[309,1882],[1820,1882],[1820,1927],[309,1927]],"region":{"top_left_x":309,"top_left_y":1882,"width":1511,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e64ff8095f04ca49712189041f9506f","type":"text","conversion_output":true,"text":"randomized; completing or discontinuing from study therapy; completing each 6-month follow-up","text_display":" randomized; completing or discontinuing from study therapy; completing each 6-month follow-up","confidence":1,"confidence_rate":1},{"cnt":[[309,1925],[1751,1925],[1751,1970],[309,1970]],"region":{"top_left_x":309,"top_left_y":1925,"width":1442,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73b76dd7686a4897ae5c6bb13b50abbe","type":"text","conversion_output":true,"text":"visit will be summarized by study arm. Reasons for study treatment discontinuation and study","text_display":" visit will be summarized by study arm. Reasons for study treatment discontinuation and study","confidence":1,"confidence_rate":1},{"cnt":[[309,1968],[703,1968],[703,2007],[309,2007]],"region":{"top_left_x":309,"top_left_y":1967,"width":394,"height":40},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"980070ed234446e09bf5f98c2db75edd","type":"text","conversion_output":true,"text":"withdrawal will be listed.","text_display":" withdrawal will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[370,2032],[1240,2032],[1240,2082],[370,2082]],"region":{"top_left_x":369,"top_left_y":2032,"width":871,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9ade51ac80f481da702b8caada6b6eb","type":"section_header","conversion_output":false,"children_ids":["72827b52249d4410ac8c461045d64538"],"text":"","text_display":""},{"cnt":[[374,2035],[1238,2035],[1238,2082],[374,2082]],"region":{"top_left_x":373,"top_left_y":2034,"width":865,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72827b52249d4410ac8c461045d64538","type":"text","conversion_output":true,"parent_id":"d9ade51ac80f481da702b8caada6b6eb","text":"8.2 Study Treatment Exposure And Compliance","text_display":"\n\n\\subsection*{8.2 Study Treatment Exposure And Compliance}","confidence":1,"confidence_rate":1},{"cnt":[[309,2101],[1745,2101],[1745,2146],[309,2146]],"region":{"top_left_x":309,"top_left_y":2101,"width":1436,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44d43213f2214d938f87f82832e5ec1f","type":"text","conversion_output":true,"text":"Because of the surgical nature of the intervention, treatment exposure and compliance are not","text_display":"\n\nBecause of the surgical nature of the intervention, treatment exposure and compliance are not","confidence":1,"confidence_rate":1},{"cnt":[[309,2144],[917,2144],[917,2189],[309,2189]],"region":{"top_left_x":309,"top_left_y":2144,"width":609,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"350dabc6952149a6aee5c509de11b72f","type":"text","conversion_output":true,"text":"anticipated to be an issue for this study.","text_display":" anticipated to be an issue for this study.","confidence":1,"confidence_rate":1},{"cnt":[[370,2209],[801,2209],[801,2254],[370,2254]],"region":{"top_left_x":369,"top_left_y":2208,"width":433,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"299f50f5e9da42c59a5b201105caac2d","type":"section_header","conversion_output":false,"children_ids":["ed990f6d929c4062a8fcd7379efc7aa4"],"text":"","text_display":""},{"cnt":[[374,2213],[797,2213],[797,2249],[374,2249]],"region":{"top_left_x":373,"top_left_y":2212,"width":425,"height":38},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed990f6d929c4062a8fcd7379efc7aa4","type":"text","conversion_output":true,"parent_id":"299f50f5e9da42c59a5b201105caac2d","text":"8.3 Protocol Deviations","text_display":"\n\n\\subsection*{8.3 Protocol Deviations}","confidence":1,"confidence_rate":1},{"cnt":[[309,2277],[1837,2277],[1837,2322],[309,2322]],"region":{"top_left_x":309,"top_left_y":2277,"width":1528,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b257e60cf67c484ea915b782b3ae0af2","type":"text","conversion_output":true,"text":"Protocol deviations are identified via automated checks of the clinical database and reported by site","text_display":"\n\nProtocol deviations are identified via automated checks of the clinical database and reported by site","confidence":1,"confidence_rate":1},{"cnt":[[309,2320],[1815,2320],[1815,2365],[309,2365]],"region":{"top_left_x":309,"top_left_y":2320,"width":1507,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13b6d675d10c4bf8b348ce35b701a372","type":"text","conversion_output":true,"text":"study coordinators in the study data management system. Protocol deviations will be listed by site","text_display":" study coordinators in the study data management system. Protocol deviations will be listed by site","confidence":1,"confidence_rate":1},{"cnt":[[309,2365],[1863,2365],[1863,2408],[309,2408]],"region":{"top_left_x":309,"top_left_y":2365,"width":1554,"height":44},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a63e90a093b44f1b105e1cb3df41a08","type":"text","conversion_output":true,"text":"with information such as type of deviation, time of occurrence, and reason. Incidence rate of protocol","text_display":" with information such as type of deviation, time of occurrence, and reason. Incidence rate of protocol","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[309,2411],[1717,2411],[1717,2454],[309,2454]],"region":{"top_left_x":309,"top_left_y":2410,"width":1408,"height":44},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b17e1b7300d45aaa75d7c77d75908b2","type":"text","conversion_output":true,"text":"deviations will also be summarized overall and for each protocol deviation category by site.","text_display":" deviations will also be summarized overall and for each protocol deviation category by site.","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":50,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d96fbc5cc9074cf3b57319f8196cbfac","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 18","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-20","page":20,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0be84c0eefd74e54aa22254c433288c4","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"69489aab4505429d91e96e2fe894df8b","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[434,318],[1854,318],[1854,363],[434,363]],"region":{"top_left_x":433,"top_left_y":317,"width":1422,"height":47},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20e775d6aeab42b5839d521ef7150f75","type":"text","conversion_output":true,"text":"- Incidence rate of protocol deviations will be calculated as: number of deviations divided","text_display":"\n- Incidence rate of protocol deviations will be calculated as: number of deviations divided","confidence":1,"confidence_rate":1},{"cnt":[[494,361],[1162,361],[1162,406],[494,406]],"region":{"top_left_x":494,"top_left_y":360,"width":669,"height":47},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e44f619ab6df46d1a5c5a516f0096224","type":"text","conversion_output":true,"text":"by the number of subject months at the site","text_display":" by the number of subject months at the site","confidence":1,"confidence_rate":1},{"cnt":[[367,468],[1222,468],[1222,522],[367,522]],"region":{"top_left_x":367,"top_left_y":468,"width":856,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40889bc1676a4d8abb7c3fbd5540973a","type":"section_header","conversion_output":false,"children_ids":["79704d1b6ac9450892498a8f6c3673fe"],"text":"","text_display":""},{"cnt":[[374,473],[1218,473],[1218,518],[374,518]],"region":{"top_left_x":373,"top_left_y":472,"width":846,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79704d1b6ac9450892498a8f6c3673fe","type":"text","conversion_output":true,"parent_id":"40889bc1676a4d8abb7c3fbd5540973a","text":"8.4 Demographic and Baseline Characteristics","text_display":"\n\n\\subsection*{8.4 Demographic and Baseline Characteristics}","confidence":1,"confidence_rate":1},{"cnt":[[307,539],[1824,539],[1824,587],[307,587]],"region":{"top_left_x":307,"top_left_y":539,"width":1518,"height":48},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"307dbe6f2b4d4cce8e748133f345ff38","type":"text","conversion_output":true,"text":"Demographic and baseline clinical characteristics for the study participants will be summarized by","text_display":"\n\nDemographic and baseline clinical characteristics for the study participants will be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[307,584],[1850,584],[1850,629],[307,629]],"region":{"top_left_x":307,"top_left_y":584,"width":1543,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b24fe7da051f4e2db6da7019538801bc","type":"text","conversion_output":true,"text":"study arm using the general analysis rules describe above. Variables of interest include: age (years),","text_display":" study arm using the general analysis rules describe above. Variables of interest include: age (years),","confidence":1,"confidence_rate":1},{"cnt":[[307,627],[1818,627],[1818,672],[307,672]],"region":{"top_left_x":307,"top_left_y":627,"width":1511,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1ac7d4f1ae040b880e6b811a2fc5380","type":"text","conversion_output":true,"text":"parity, gravidity, race and ethnicity, marital status, education level (classified as binary variable as","text_display":" parity, gravidity, race and ethnicity, marital status, education level (classified as binary variable as","confidence":1,"confidence_rate":1},{"cnt":[[305,670],[1747,670],[1747,715],[305,715]],"region":{"top_left_x":305,"top_left_y":670,"width":1442,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4ca6800371e4ad3a3ae173b69909ebb","type":"text","conversion_output":true,"text":"having some college or greater or no college education), health insurance status (private only,","text_display":" having some college or greater or no college education), health insurance status (private only,","confidence":1,"confidence_rate":1},{"cnt":[[305,715],[1777,715],[1777,763],[305,763]],"region":{"top_left_x":305,"top_left_y":715,"width":1472,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c36cc693510240caa9375b5800d8e30a","type":"text","conversion_output":true,"text":"Medicare/Medicaid only, combination of both), smoking status (never, previous, current), prior","text_display":" Medicare/Medicaid only, combination of both), smoking status (never, previous, current), prior","confidence":1,"confidence_rate":1},{"cnt":[[305,761],[1308,761],[1308,806],[305,806]],"region":{"top_left_x":305,"top_left_y":760,"width":1004,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06a9761382d54da4b30ea83057274c9a","type":"text","conversion_output":true,"text":"prolapse surgery, BMI, and baseline levels of all QOL measures.","text_display":" prolapse surgery, BMI, and baseline levels of all QOL measures.","confidence":1,"confidence_rate":1},{"cnt":[[305,842],[793,842],[793,889],[305,889]],"region":{"top_left_x":305,"top_left_y":842,"width":488,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34ba3775164f488c9dc05a08cf913899","type":"section_header","conversion_output":false,"children_ids":["616a65ce0edd4b159719ded8ba9619a7"],"text":"","text_display":""},{"cnt":[[305,846],[788,846],[788,887],[305,887]],"region":{"top_left_x":305,"top_left_y":846,"width":484,"height":42},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"616a65ce0edd4b159719ded8ba9619a7","type":"text","conversion_output":true,"parent_id":"34ba3775164f488c9dc05a08cf913899","text":"9 EFFICACY ANALYSES","text_display":"\n\n\\section*{9 EFFICACY ANALYSES}","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[367,932],[1164,932],[1164,986],[367,986]],"region":{"top_left_x":367,"top_left_y":932,"width":798,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79d49c9e09f0494195bd221af17fda81","type":"section_header","conversion_output":false,"children_ids":["384dc68455b14d73a0f38479dba8a078"],"text":"","text_display":""},{"cnt":[[370,935],[1162,935],[1162,984],[370,984]],"region":{"top_left_x":369,"top_left_y":934,"width":794,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"384dc68455b14d73a0f38479dba8a078","type":"text","conversion_output":true,"parent_id":"79d49c9e09f0494195bd221af17fda81","text":"9.1 Overview of Efficacy Analyses Methods","text_display":"\n\n\\subsection*{9.1 Overview of Efficacy Analyses Methods}","confidence":0.9990236759185791,"confidence_rate":0.9999787654211912},{"cnt":[[305,1001],[1790,1001],[1790,1046],[305,1046]],"region":{"top_left_x":305,"top_left_y":1001,"width":1485,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"602faff9bbdc4f738d94d097e8af03d2","type":"text","conversion_output":true,"text":"All efficacy analyses will be performed using the ITT population unless otherwise specified. All","text_display":"\n\nAll efficacy analyses will be performed using the ITT population unless otherwise specified. All","confidence":1,"confidence_rate":1},{"cnt":[[305,1044],[1861,1044],[1861,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1044,"width":1556,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94ae01ef91284302808d9b8e0640430d","type":"text","conversion_output":true,"text":"efficacy variables will be listed by subject within study center and assessment time. The data will be","text_display":" efficacy variables will be listed by subject within study center and assessment time. The data will be","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[305,1089],[814,1089],[814,1137],[305,1137]],"region":{"top_left_x":305,"top_left_y":1089,"width":510,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce1ef40a08c7404dba4fab41b986f3b0","type":"text","conversion_output":true,"text":"summarized by treatment group.","text_display":" summarized by treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[305,1154],[1876,1154],[1876,1199],[305,1199]],"region":{"top_left_x":305,"top_left_y":1153,"width":1571,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e97a0405c30e43c4910feff3548d2af7","type":"text","conversion_output":true,"text":"The primary efficacy outcome measure is a binary measure of treatment failure/success as determined","text_display":"\n\nThe primary efficacy outcome measure is a binary measure of treatment failure/success as determined","confidence":1,"confidence_rate":1},{"cnt":[[305,1199],[1850,1199],[1850,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1198,"width":1545,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99d51719a331405cb4a45dca988f6f49","type":"text","conversion_output":true,"text":"at 6-month time intervals post-intervention, and the primary analytic approach will utilize a survival","text_display":" at 6-month time intervals post-intervention, and the primary analytic approach will utilize a survival","confidence":0.9115276336669922,"confidence_rate":0.9991346422211002},{"cnt":[[305,1242],[1876,1242],[1876,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1241,"width":1571,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebe0e8a4a347450c8801389c18eaaf80","type":"text","conversion_output":true,"text":"model to evaluate differences in time to treatment failure between the two treatment arms. Generally,","text_display":" model to evaluate differences in time to treatment failure between the two treatment arms. 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Specifically, continuous outcome variables will be analyzed using linear","text_display":" data collected across time. Specifically, continuous outcome variables will be analyzed using linear","confidence":1,"confidence_rate":1},{"cnt":[[305,1418],[1867,1418],[1867,1463],[305,1463]],"region":{"top_left_x":305,"top_left_y":1417,"width":1562,"height":47},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0e39c25a882490d96816458400ca22a","type":"text","conversion_output":true,"text":"mixed models and binary outcome variables will be analyzed using robust Poisson regression models","text_display":" mixed models and binary outcome variables will be analyzed using robust Poisson regression models","confidence":1,"confidence_rate":1},{"cnt":[[305,1461],[1760,1461],[1760,1506],[305,1506]],"region":{"top_left_x":305,"top_left_y":1460,"width":1455,"height":47},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5192d8702b9e4cf59b09462597149ba2","type":"text","conversion_output":true,"text":"with a log link. Most models will include terms for treatment, time, and the treatment by time","text_display":" with a log link. Most models will include terms for treatment, time, and the treatment by time","confidence":0.984375,"confidence_rate":0.9998409383388381},{"cnt":[[305,1504],[1835,1504],[1835,1553],[305,1553]],"region":{"top_left_x":305,"top_left_y":1503,"width":1530,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81373971e8934393a76fb674a694ced6","type":"text","conversion_output":true,"text":"interaction and for the stratification variables included in the study design (site). Additional details","text_display":" interaction and for the stratification variables included in the study design (site). Additional details","confidence":1,"confidence_rate":1},{"cnt":[[305,1549],[978,1549],[978,1596],[305,1596]],"region":{"top_left_x":305,"top_left_y":1549,"width":673,"height":48},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af3212162cb947bf9af8de205db95f7e","type":"text","conversion_output":true,"text":"are provided in the specific sections below.","text_display":" are provided in the specific sections below.","confidence":1,"confidence_rate":1},{"cnt":[[305,2522],[690,2522],[690,2554],[305,2554]],"region":{"top_left_x":305,"top_left_y":2522,"width":385,"height":33},"line":30,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"138e4581401c4e8e8ab99ccdc524454f","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 19","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-21","page":21,"lines":[{"cnt":[[309,129],[571,129],[571,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":263,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2b5b99392c2a417888d7d18186b3a21f","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a59078a251bb433da9ac3b66fc9b3dbc","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[771,249],[771,305],[370,305]],"region":{"top_left_x":369,"top_left_y":249,"width":403,"height":57},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a66fea294177448682263a49969d5b87","type":"section_header","conversion_output":false,"children_ids":["6aee188990144411a78bbf0a490d0bae"],"text":"","text_display":""},{"cnt":[[374,254],[767,254],[767,303],[374,303]],"region":{"top_left_x":373,"top_left_y":253,"width":394,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aee188990144411a78bbf0a490d0bae","type":"text","conversion_output":true,"parent_id":"a66fea294177448682263a49969d5b87","text":"9.2 Efficacy Variables","text_display":"\n\n\\subsection*{9.2 Efficacy Variables}","confidence":1,"confidence_rate":1},{"cnt":[[290,314],[2567,314],[2567,1798],[290,1798]],"region":{"top_left_x":290,"top_left_y":313,"width":2278,"height":1486},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afa31ab1a18f4c5eac18b91b5754f2fb","type":"table","conversion_output":true,"children_ids":["6f159136dcc04b5e86c98eeeb7a015fa","5c0b524eebb84288b174f63e92e810b1","42a6ec34c51b4328be920b13ebdd3343","4b3ad8b84e0f4819b58ebd15d2b6e9dc","515a0d980025476f8c26e878f08ecd86","c7e5e6f0cb9f4db8af560fa5603b5cc3","3c2ee90eaed84ce9af1df7c064b706ce","94e2f429567040c3ba1f368f867fc20d","a0f508a956614354a0f937917d60e2a5","4efb373fceaf4b47b86d77f89d17e9a7","77a2ddc7d5a14254aad43456fe7d6e67","b6d90c1cb2d74f2ca31075476f38032e","1fa662bf1725451a80cba340cedcf148","9834a3d47c0b4dd0bec1e70557fd09b7","63fa8fd8155c488ebb589e935c9beff5","899e318aa9604562bbb4aedf438deb72","712775eb993a48d5a6bb4faba05ca606","4f23f8576bac48b4b17ee956db771735","92e0ac56ad5e45d4a47660b20bfcf22f","22782788cda944139f8c7ac997ba42d5","716a008259184d28878222f09b183dd6","5b2c5baf2a12432ba96b67c7bef8a025","f215dfbb82a34a36911363d3bc57f9c0","1364bd9d4e3f4f33af895ccde454ad55","375f104a05644be7af15ff49d391390c","a0509eec85c9431dace055e9be20eeb0","a9cb2d39e7de48cd8093186940aa7578"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline \\multicolumn{3}{|l|}{Primary Outcome} \\\\\n\\hline Treatment failure/success obtained at 6 -month intervals for a period of 3 to 5 years after surgery & Binary & \\begin{tabular}{l}\nTreatment failure will be defined as the occurrence of any ONE of the following criteria: (1) report of bothersome vaginal bulge symptoms (see definition below); (2) re-treatment for prolapse (surgery or pessary); or (3) any prolapse measure (Ba, C, Bp) is beyond the hymen (i.e. \\(>0 cm\\) ). \\\\\nBothersome vaginal bulge symptoms are defined as positive response to Question 3 of the PFDI-20: Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? AND any degree of bother.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{Secondary Efficacy Outcomes} \\\\\n\\hline Anatomical measures of key pelvic floor metrics (Ba, Bp, and C) obtained at 6-month intervals post-operatively & Continuous & Data measurements obtained directly from the POPQ exam. \\\\\n\\hline Anatomical measure of cervical or cuff location relative to total vaginal length & Binary & Obtained by comparing the cervical or cuff location (Point C) to the total vaginal length (TVL) from the POPQ exam obtained at 6 -month post-operative intervals. A participant will be defined as positive at any time point if \\(C >-1 / 2\\) TVL. \\\\\n\\hline Prolapse symptoms at 6month post-operative levels as defined by & Binary & The PGI-I is a single question form collected every 6 months that asks for a response to the question: \"Check the number that best describes how your post-operative condition is now, compared with how it was before you had the surgery.\" The response is a 7 -level Likert scale from 1 Very much better to 7 Very much worse. If the participant response is either 1 (very much better), 2 (much better), and 3 (better) then the indicator will be coded as Yes. If the participant response is 4 or greater, the indicator will be coded as No. If the PGI-I is missing for a visit then the indicator will be coded as missing for that visit. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline \\multicolumn{3}{|l|}{Primary Outcome} \\\\\n\\hline Treatment failure/success obtained at 6 -month intervals for a period of 3 to 5 years after surgery & Binary & \\begin{tabular}{l}\nTreatment failure will be defined as the occurrence of any ONE of the following criteria: (1) report of bothersome vaginal bulge symptoms (see definition below); (2) re-treatment for prolapse (surgery or pessary); or (3) any prolapse measure (Ba, C, Bp) is beyond the hymen (i.e. \\(>0 cm\\) ). \\\\\nBothersome vaginal bulge symptoms are defined as positive response to Question 3 of the PFDI-20: Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? AND any degree of bother.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{Secondary Efficacy Outcomes} \\\\\n\\hline Anatomical measures of key pelvic floor metrics (Ba, Bp, and C) obtained at 6-month intervals post-operatively & Continuous & Data measurements obtained directly from the POPQ exam. \\\\\n\\hline Anatomical measure of cervical or cuff location relative to total vaginal length & Binary & Obtained by comparing the cervical or cuff location (Point C) to the total vaginal length (TVL) from the POPQ exam obtained at 6 -month post-operative intervals. A participant will be defined as positive at any time point if \\(C >-1 / 2\\) TVL. \\\\\n\\hline Prolapse symptoms at 6month post-operative levels as defined by & Binary & The PGI-I is a single question form collected every 6 months that asks for a response to the question: \"Check the number that best describes how your post-operative condition is now, compared with how it was before you had the surgery.\" The response is a 7 -level Likert scale from 1 Very much better to 7 Very much worse. If the participant response is either 1 (very much better), 2 (much better), and 3 (better) then the indicator will be coded as Yes. If the participant response is 4 or greater, the indicator will be coded as No. If the PGI-I is missing for a visit then the indicator will be coded as missing for that visit. 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surgery","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.861328125,"confidence_rate":0.9990183784901759},{"cnt":[[306,504],[707,504],[707,545],[306,545]],"region":{"top_left_x":306,"top_left_y":503,"width":402,"height":42},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ae5af0e776d4d20a322212981d3fea5","type":"text","conversion_output":false,"parent_id":"63fa8fd8155c488ebb589e935c9beff5","text":"Treatment failure/success","text_display":"Treatment failure/success","confidence":1,"confidence_rate":1},{"cnt":[[306,553],[765,553],[765,589],[306,589]],"region":{"top_left_x":306,"top_left_y":553,"width":459,"height":36},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f547808e659494182b39936b899d5cf","type":"text","conversion_output":false,"parent_id":"63fa8fd8155c488ebb589e935c9beff5","text":"obtained at 6 -month intervals","text_display":" obtained at 6 -month 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failure will be defined as the occurrence of any ONE of the following criteria: (1) report of bothersome vaginal bulge symptoms (see definition below); (2) re-treatment for prolapse (surgery or pessary); or (3) any prolapse measure (Ba, C, Bp) is beyond the hymen (i.e. \\(>0 cm\\) ). \\\\\nBothersome vaginal bulge symptoms are defined as positive response to Question 3 of the PFDI-20: Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? AND any degree of bother.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTreatment failure will be defined as the occurrence of any ONE of the following criteria: (1) report of bothersome vaginal bulge symptoms (see definition below); (2) re-treatment for prolapse (surgery or pessary); or (3) any prolapse measure (Ba, C, Bp) is beyond the hymen (i.e. \\(>0 cm\\) ). \\\\\nBothersome vaginal bulge symptoms are defined as positive response to Question 3 of the PFDI-20: Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? AND any degree of bother.\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9371309280395508,"confidence_rate":0.9998995204398768},{"cnt":[[1169,509],[2535,509],[2535,550],[1169,550]],"region":{"top_left_x":1168,"top_left_y":509,"width":1368,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26554600facb498d958203e3020dd9f7","type":"text","conversion_output":false,"parent_id":"712775eb993a48d5a6bb4faba05ca606","text":"Treatment failure will be defined as the occurrence of any ONE of the following criteria:","text_display":"Treatment failure will be defined as the occurrence of any ONE of the following criteria:","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[1169,550],[2541,550],[2541,594],[1169,594]],"region":{"top_left_x":1168,"top_left_y":550,"width":1373,"height":45},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ffaa56dc52444c8beab7a710a922440","type":"text","conversion_output":false,"parent_id":"712775eb993a48d5a6bb4faba05ca606","text":"(1) report of bothersome vaginal bulge symptoms (see definition below); (2) re-treatment","text_display":" (1) report of bothersome vaginal bulge symptoms (see definition below); (2) re-treatment","confidence":1,"confidence_rate":1},{"cnt":[[1169,597],[2541,597],[2541,643],[1169,643]],"region":{"top_left_x":1168,"top_left_y":596,"width":1373,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"484225714d8c4d46adec33a391af6e05","type":"text","conversion_output":false,"parent_id":"712775eb993a48d5a6bb4faba05ca606","text":"for prolapse (surgery or pessary); or (3) any prolapse measure (Ba, C, Bp) is beyond the","text_display":" for prolapse (surgery or pessary); or (3) any prolapse measure (Ba, C, Bp) is beyond the","confidence":0.9371309280395508,"confidence_rate":0.9993020471727206},{"cnt":[[1169,640],[1477,640],[1477,687],[1169,687]],"region":{"top_left_x":1168,"top_left_y":640,"width":309,"height":47},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e7f567d8af4406ab88680f58cb8a23a","type":"text","conversion_output":false,"parent_id":"712775eb993a48d5a6bb4faba05ca606","text":"hymen (i.e. \\(>0 cm\\) ).","text_display":" hymen (i.e. \\(>0 cm\\) ).","confidence":1,"confidence_rate":1},{"cnt":[[1169,690],[2503,690],[2503,736],[1169,736]],"region":{"top_left_x":1168,"top_left_y":689,"width":1335,"height":47},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b18267dc87c4ac492cec0ea8ba59b86","type":"text","conversion_output":false,"parent_id":"712775eb993a48d5a6bb4faba05ca606","text":"Bothersome vaginal bulge symptoms are defined as positive response to Question 3 of","text_display":"\nBothersome vaginal bulge symptoms are defined as positive response to Question 3 of","confidence":1,"confidence_rate":1},{"cnt":[[1169,733],[2503,733],[2503,780],[1169,780]],"region":{"top_left_x":1168,"top_left_y":733,"width":1335,"height":47},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31fc133d2a684ed898e2642c6ecaa3f9","type":"text","conversion_output":false,"parent_id":"712775eb993a48d5a6bb4faba05ca606","text":"the PFDI-20: Do you usually have a bulge or something falling out that you can see or","text_display":" the PFDI-20: Do you usually have a bulge or something falling out that you can see or","confidence":1,"confidence_rate":1},{"cnt":[[1169,777],[1995,777],[1995,823],[1169,823]],"region":{"top_left_x":1168,"top_left_y":776,"width":828,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a0dda1d817647c49988e008c9f204e8","type":"text","conversion_output":false,"parent_id":"712775eb993a48d5a6bb4faba05ca606","text":"feel in your vaginal area? AND any degree of bother.","text_display":" feel in your vaginal area? 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If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. \\\\\n\\hline Duration of post-operative catheterization & Continuous & Time to removal of the catheter post-operatively obtained directly from CRF data. \\\\\n\\hline Urinary functional distress as measured PFDI-SF Urinary Distress Inventory scale at 6month post-operative intervals & Continuous & The PFDI-SF UDI scale will be computed at 6 month post-operative intervals using standard scoring algorithms described by Barber (2006) to create a measure scaled 0 to 100 at each time point. If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. \\\\\n\\hline Incontinence severity at 6month post-operative intervals as measures by the Hunskaar Incontinence Severity Index & Ordinal & The ISI scale will be computed at 6-month post operative intervals using the standardized scoring algorithm to generate an ordinal scale (no incontinence or incontinence levels of slight, moderate, severe, or very severe) as described by Sandvik (2000). \\\\\n\\hline Risk of de novo voiding dysfunction defined at 6month post-operative intervals (evaluated in aggregate fashion) & Binary & Defined as any incidence of a specific voiding dysfunction based on patient-supplied AE information. Rather than reporting data at six-month intervals, results will be aggregated across the follow-up period based on decision at masked review. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Prolapse symptoms at 6month post-operative levels as defined by POPDI-6 scores from the PFDI-SF & Continuous & The PFDI-SF Pelvic Organ Prolapse Distress Inventory (POPDI) scale will be computed at 6 month intervals using standard scoring algorithms described by Barber (2006) to create a measure scaled 0 to 100 at each time point based in data collected on the PFDI. If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. \\\\\n\\hline Duration of post-operative catheterization & Continuous & Time to removal of the catheter post-operatively obtained directly from CRF data. \\\\\n\\hline Urinary functional distress as measured PFDI-SF Urinary Distress Inventory scale at 6month post-operative intervals & Continuous & The PFDI-SF UDI scale will be computed at 6 month post-operative intervals using standard scoring algorithms described by Barber (2006) to create a measure scaled 0 to 100 at each time point. If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. \\\\\n\\hline Incontinence severity at 6month post-operative intervals as measures by the Hunskaar Incontinence Severity Index & Ordinal & The ISI scale will be computed at 6-month post operative intervals using the standardized scoring algorithm to generate an ordinal scale (no incontinence or incontinence levels of slight, moderate, severe, or very severe) as described by Sandvik (2000). \\\\\n\\hline Risk of de novo voiding dysfunction defined at 6month post-operative intervals (evaluated in aggregate fashion) & Binary & Defined as any incidence of a specific voiding dysfunction based on patient-supplied AE information. Rather than reporting data at six-month intervals, results will be aggregated across the follow-up period based on decision at masked review. 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Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline PISQ-IR not sexually active - condition specific subscale score change from baseline & Continuous & The PISQ-IR not sexually active - condition specific subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q2c, Q2d, Q2e (1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. 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Based on masked","text_display":" forms or on the complication form obtained at six-month intervals. Based on masked","confidence":1,"confidence_rate":1},{"cnt":[[1171,478],[2513,478],[2513,523],[1171,523]],"region":{"top_left_x":1170,"top_left_y":477,"width":1344,"height":47},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8601fd3bc844438a25138751fca3b2b","type":"text","conversion_output":false,"parent_id":"123936c4d0ea4168b2ed63f2a590e4ab","text":"data review, results will be aggregated across the reporting period rather than evaluated","text_display":" data review, results will be aggregated across the reporting period rather than evaluated","confidence":0.99853515625,"confidence_rate":0.9999844052526367},{"cnt":[[1171,521],[1511,521],[1511,558],[1171,558]],"region":{"top_left_x":1170,"top_left_y":521,"width":341,"height":37},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6506f13817934a4c821a4bf3a62f67d3","type":"text","conversion_output":false,"parent_id":"123936c4d0ea4168b2ed63f2a590e4ab","text":"at six-month intervals","text_display":" at six-month intervals","confidence":1,"confidence_rate":1},{"cnt":[[304,610],[748,610],[748,749],[304,749]],"region":{"top_left_x":304,"top_left_y":609,"width":445,"height":140},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c61b7017dac40a2bb2f5938e64a60dd","type":"complex_cell","conversion_output":false,"parent_id":"b654442b22dd4238827226574fa4a85f","children_ids":["efaf3f759b0848cfac8cf7b664441a5e","eff5a0571c1c44aab536952cd46119e1","86f3de2a10c6406ab2cd9992aee7ae0e"],"text":"PISQ-IR not sexually active - partner related subscale score change from baseline","text_display":"PISQ-IR not sexually active - partner related subscale score change from baseline","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,612],[744,612],[744,655],[309,655]],"region":{"top_left_x":308,"top_left_y":612,"width":436,"height":44},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efaf3f759b0848cfac8cf7b664441a5e","type":"text","conversion_output":false,"parent_id":"2c61b7017dac40a2bb2f5938e64a60dd","text":"PISQ-IR not sexually active","text_display":"PISQ-IR not sexually active","confidence":1,"confidence_rate":1},{"cnt":[[309,655],[705,655],[705,701],[309,701]],"region":{"top_left_x":308,"top_left_y":655,"width":397,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eff5a0571c1c44aab536952cd46119e1","type":"text","conversion_output":false,"parent_id":"2c61b7017dac40a2bb2f5938e64a60dd","text":"- partner related subscale","text_display":" - partner related subscale","confidence":1,"confidence_rate":1},{"cnt":[[309,701],[733,701],[733,744],[309,744]],"region":{"top_left_x":308,"top_left_y":700,"width":426,"height":45},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86f3de2a10c6406ab2cd9992aee7ae0e","type":"text","conversion_output":false,"parent_id":"2c61b7017dac40a2bb2f5938e64a60dd","text":"score change from baseline","text_display":" score change from baseline","confidence":1,"confidence_rate":1},{"cnt":[[794,612],[978,612],[978,649],[794,649]],"region":{"top_left_x":793,"top_left_y":612,"width":185,"height":37},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"186cf1129e644869a5dcd7585c53da27","type":"simple_cell","conversion_output":false,"parent_id":"b654442b22dd4238827226574fa4a85f","text":"Continuous","text_display":"Continuous","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1166,608],[2533,608],[2533,967],[1166,967]],"region":{"top_left_x":1166,"top_left_y":607,"width":1367,"height":361},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8a2a73da55b4bca9dfd39da1f8305ed","type":"complex_cell","conversion_output":false,"parent_id":"b654442b22dd4238827226574fa4a85f","children_ids":["f694be2ab65f4806a99df00c5472a7d2","4400d4e2485e47f483fa78d4d35661b5","0e12be3a63bb43dfb4f4e55710acb4ce","513db5205b0c4cf1a7944adba5dd1aac","d745a9846b0448b7affe60e857937faa","41e91512441c4efca571fc0258ea074b","0a107f497bc040ad8c743386c9cf1471","544f981b34d041ef8509bd21f0c690e3"],"text":"The PISQ-IR not sexually active - partner related subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q2a, Q2b (1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","text_display":"The PISQ-IR not sexually active - partner related subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q2a, Q2b (1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.49077733721640016,"confidence_rate":0.999011284327296},{"cnt":[[1171,612],[2520,612],[2520,655],[1171,655]],"region":{"top_left_x":1170,"top_left_y":612,"width":1350,"height":44},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f694be2ab65f4806a99df00c5472a7d2","type":"text","conversion_output":false,"parent_id":"b8a2a73da55b4bca9dfd39da1f8305ed","text":"The PISQ-IR not sexually active - partner related subscale score will be computed at 6-","text_display":"The PISQ-IR not sexually active - partner related subscale score will be computed at 6","confidence":1,"confidence_rate":1},{"cnt":[[1171,655],[2455,655],[2455,701],[1171,701]],"region":{"top_left_x":1170,"top_left_y":655,"width":1285,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4400d4e2485e47f483fa78d4d35661b5","type":"text","conversion_output":false,"parent_id":"b8a2a73da55b4bca9dfd39da1f8305ed","text":"month intervals using standard scoring algorithms. Specifically, sum the scores for","text_display":"month intervals using standard scoring algorithms. Specifically, sum the scores for","confidence":1,"confidence_rate":1},{"cnt":[[1171,699],[2485,699],[2485,744],[1171,744]],"region":{"top_left_x":1170,"top_left_y":698,"width":1315,"height":47},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e12be3a63bb43dfb4f4e55710acb4ce","type":"text","conversion_output":false,"parent_id":"b8a2a73da55b4bca9dfd39da1f8305ed","text":"questions Q2a, Q2b (1=strongly agree,... 4=strongly disagree). If there is more than 1","text_display":" questions Q2a, Q2b (1=strongly agree,... 4=strongly disagree). 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To handle missing values, the final","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[1171,788],[2485,788],[2485,831],[1171,831]],"region":{"top_left_x":1170,"top_left_y":787,"width":1315,"height":44},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d745a9846b0448b7affe60e857937faa","type":"text","conversion_output":false,"parent_id":"b8a2a73da55b4bca9dfd39da1f8305ed","text":"score is obtained by dividing the sum by the number of items answered. The outcome","text_display":" score is obtained by dividing the sum by the number of items answered. The outcome","confidence":1,"confidence_rate":1},{"cnt":[[1171,829],[2528,829],[2528,874],[1171,874]],"region":{"top_left_x":1170,"top_left_y":828,"width":1359,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41e91512441c4efca571fc0258ea074b","type":"text","conversion_output":false,"parent_id":"b8a2a73da55b4bca9dfd39da1f8305ed","text":"will then be computed as the difference in score at Month 1 and the score at baseline. If","text_display":" will then be computed as the difference in score at Month 1 and the score at baseline. If","confidence":1,"confidence_rate":1},{"cnt":[[1171,876],[2481,876],[2481,922],[1171,922]],"region":{"top_left_x":1170,"top_left_y":876,"width":1311,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a107f497bc040ad8c743386c9cf1471","type":"text","conversion_output":false,"parent_id":"b8a2a73da55b4bca9dfd39da1f8305ed","text":"data at any month are missing, the outcome variable will be coded as missing. Scores","text_display":" data at any month are missing, the outcome variable will be coded as missing. Scores","confidence":1,"confidence_rate":1},{"cnt":[[1171,920],[2234,920],[2234,965],[1171,965]],"region":{"top_left_x":1170,"top_left_y":919,"width":1064,"height":47},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"544f981b34d041ef8509bd21f0c690e3","type":"text","conversion_output":false,"parent_id":"b8a2a73da55b4bca9dfd39da1f8305ed","text":"should only be calculated for participants that are not sexually active.","text_display":" should only be calculated for participants that are not sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[304,998],[757,998],[757,1138],[304,1138]],"region":{"top_left_x":304,"top_left_y":997,"width":453,"height":142},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba1f3082b41a45afa6cc4f1d2a9c5840","type":"complex_cell","conversion_output":false,"parent_id":"b654442b22dd4238827226574fa4a85f","children_ids":["0b78ef6a795e4ef59213da87a5d71f8b","b59b2244ede64e47a1b2e7c9ac276f12","9a93c9eae9384ed6bac451b1e37c1f07"],"text":"PISQ-IR not sexually active - condition specific subscale score change from baseline","text_display":"PISQ-IR not sexually active - condition specific subscale score change from baseline","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,1002],[744,1002],[744,1047],[309,1047]],"region":{"top_left_x":308,"top_left_y":1001,"width":436,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b78ef6a795e4ef59213da87a5d71f8b","type":"text","conversion_output":false,"parent_id":"ba1f3082b41a45afa6cc4f1d2a9c5840","text":"PISQ-IR not sexually active","text_display":"PISQ-IR not sexually active","confidence":1,"confidence_rate":1},{"cnt":[[309,1045],[757,1045],[757,1091],[309,1091]],"region":{"top_left_x":308,"top_left_y":1045,"width":449,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b59b2244ede64e47a1b2e7c9ac276f12","type":"text","conversion_output":false,"parent_id":"ba1f3082b41a45afa6cc4f1d2a9c5840","text":"- condition specific subscale","text_display":" - condition specific subscale","confidence":1,"confidence_rate":1},{"cnt":[[309,1093],[733,1093],[733,1136],[309,1136]],"region":{"top_left_x":308,"top_left_y":1092,"width":426,"height":45},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a93c9eae9384ed6bac451b1e37c1f07","type":"text","conversion_output":false,"parent_id":"ba1f3082b41a45afa6cc4f1d2a9c5840","text":"score change from baseline","text_display":" score change from baseline","confidence":1,"confidence_rate":1},{"cnt":[[794,1002],[978,1002],[978,1043],[794,1043]],"region":{"top_left_x":793,"top_left_y":1001,"width":185,"height":43},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba84f8d73c5f44eb982a50f8155b8699","type":"simple_cell","conversion_output":false,"parent_id":"b654442b22dd4238827226574fa4a85f","text":"Continuous","text_display":"Continuous","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1166,998],[2548,998],[2548,1359],[1166,1359]],"region":{"top_left_x":1166,"top_left_y":997,"width":1382,"height":363},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b13c175678849738f3f256b7ef3360c","type":"complex_cell","conversion_output":false,"parent_id":"b654442b22dd4238827226574fa4a85f","children_ids":["62be9394f11442b8a9af237f2fa03691","8db5e1ba455a4335832739f54d246163","3269167f89c549deb2a4eeb15bcb6526","0e7e831fa9df43e6abe428c8b0e528e0","e6de939eb75f453e8cd7657808f761aa","887a2d89e300422fb8f8a3b54b6969f7","c142e55c3d4b431abbeade4a601bcabc","627f300e91e343b48be2ca76209761a8"],"text":"The PISQ-IR not sexually active - condition specific subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q2c, Q2d, Q2e (1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","text_display":"The PISQ-IR not sexually active - condition specific subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q2c, Q2d, Q2e (1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.7260248522165966,"confidence_rate":0.999434491453273},{"cnt":[[1171,1002],[2530,1002],[2530,1047],[1171,1047]],"region":{"top_left_x":1170,"top_left_y":1001,"width":1361,"height":47},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62be9394f11442b8a9af237f2fa03691","type":"text","conversion_output":false,"parent_id":"5b13c175678849738f3f256b7ef3360c","text":"The PISQ-IR not sexually active - condition specific subscale score will be computed at","text_display":"The PISQ-IR not sexually active - condition specific subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1171,1045],[2485,1045],[2485,1091],[1171,1091]],"region":{"top_left_x":1170,"top_left_y":1045,"width":1315,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8db5e1ba455a4335832739f54d246163","type":"text","conversion_output":false,"parent_id":"5b13c175678849738f3f256b7ef3360c","text":"6-month intervals using standard scoring algorithms. Specifically, sum the scores for","text_display":" 6-month intervals using standard scoring algorithms. Specifically, sum the scores for","confidence":0.9072716236114502,"confidence_rate":0.9989193243627718},{"cnt":[[1171,1089],[2546,1089],[2546,1134],[1171,1134]],"region":{"top_left_x":1170,"top_left_y":1088,"width":1376,"height":47},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3269167f89c549deb2a4eeb15bcb6526","type":"text","conversion_output":false,"parent_id":"5b13c175678849738f3f256b7ef3360c","text":"questions Q2c, Q2d, Q2e (1=strongly agree,... 4=strongly disagree). If there is more than","text_display":" questions Q2c, Q2d, Q2e (1=strongly agree,... 4=strongly disagree). If there is more than","confidence":0.7260248522165966,"confidence_rate":0.9965997192730268},{"cnt":[[1173,1134],[2468,1134],[2468,1177],[1173,1177]],"region":{"top_left_x":1172,"top_left_y":1134,"width":1296,"height":44},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e7e831fa9df43e6abe428c8b0e528e0","type":"text","conversion_output":false,"parent_id":"5b13c175678849738f3f256b7ef3360c","text":"1 missing response then a total score is not calculated. To handle missing values, the","text_display":" 1 missing response then a total score is not calculated. To handle missing values, the","confidence":0.9965846532722935,"confidence_rate":0.9999619874742944},{"cnt":[[1170,1221],[1171,1175],[2424,1177],[2424,1223]],"region":{"top_left_x":1170,"top_left_y":1175,"width":1255,"height":48},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6de939eb75f453e8cd7657808f761aa","type":"text","conversion_output":false,"parent_id":"5b13c175678849738f3f256b7ef3360c","text":"final score is obtained by dividing the sum by the number of items answered. The","text_display":" final score is obtained by dividing the sum by the number of items answered. 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If data at any month are missing, the outcome variable will be coded as","text_display":" baseline. If data at any month are missing, the outcome variable will be coded as","confidence":1,"confidence_rate":1},{"cnt":[[1171,1309],[2483,1309],[2483,1355],[1171,1355]],"region":{"top_left_x":1170,"top_left_y":1309,"width":1313,"height":46},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"627f300e91e343b48be2ca76209761a8","type":"text","conversion_output":false,"parent_id":"5b13c175678849738f3f256b7ef3360c","text":"missing. Scores should only be calculated for participants that are not sexually active.","text_display":" missing. 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Specifically, sum the scores for questions Q4a, Q4b, Q5a, and Q6 using reverse scores for all but Q5a (Q4a and Q4b are likert scales of 1 to 5; Q5a: 1=strongly agree, . . 4=strongly disagree; Q6: 1=Not at all, ..., 4=a lot). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline PISQ-IR not sexually active - condition impact subscale score change from baseline & Continuous & The PISQ-IR not sexually active - condition subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q3, Q5b, Q5c using reverse scores for Q3 (Q3: 1=Not at all,...,4=a lot; Q5b, Q5c: 1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline PISQ-IR sexually active arousal, orgasm subscale score change from baseline & Continuous & The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q7, Q8a, Q10, and Q11 using reverse scores for Q11 (Q7, Q8a, Q11: 1=never, ..., \\(5=[\\) almost \\(]\\) always; Q10: 1=much less intense, \\(. .5=\\) much more intense; check box response to \\(Q 11=1\\) ). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline PISQ-IR not sexually active - global quality subscale score change from baseline & Continuous & The PISQ-IR not sexually active - global quality subscale score will be at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q4a, Q4b, Q5a, and Q6 using reverse scores for all but Q5a (Q4a and Q4b are likert scales of 1 to 5; Q5a: 1=strongly agree, . . 4=strongly disagree; Q6: 1=Not at all, ..., 4=a lot). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline PISQ-IR not sexually active - condition impact subscale score change from baseline & Continuous & The PISQ-IR not sexually active - condition subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q3, Q5b, Q5c using reverse scores for Q3 (Q3: 1=Not at all,...,4=a lot; Q5b, Q5c: 1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline PISQ-IR sexually active arousal, orgasm subscale score change from baseline & Continuous & The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q7, Q8a, Q10, and Q11 using reverse scores for Q11 (Q7, Q8a, Q11: 1=never, ..., \\(5=[\\) almost \\(]\\) always; Q10: 1=much less intense, \\(. .5=\\) much more intense; check box response to \\(Q 11=1\\) ). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. 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Specifically, sum the scores for questions Q3, Q5b, Q5c using reverse scores for Q3 (Q3: 1=Not at all,...,4=a lot; Q5b, Q5c: 1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","text_display":"The PISQ-IR not sexually active - condition subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q3, Q5b, Q5c using reverse scores for Q3 (Q3: 1=Not at all,...,4=a lot; Q5b, Q5c: 1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.20933711082286302,"confidence_rate":0.9979426587245062},{"cnt":[[1171,824],[2537,824],[2537,870],[1171,870]],"region":{"top_left_x":1170,"top_left_y":824,"width":1367,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e605ae364df4b44b50718f008d05b88","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"The PISQ-IR not sexually active - condition subscale score will be computed at 6-month","text_display":"The PISQ-IR not sexually active - condition subscale score will be computed at 6-month","confidence":0.79541015625,"confidence_rate":0.9974878050592783},{"cnt":[[1171,868],[2496,868],[2496,911],[1171,911]],"region":{"top_left_x":1170,"top_left_y":867,"width":1326,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35078e5edcc643c987b35122af5bb435","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"intervals using standard scoring algorithms. Specifically, sum the scores for questions","text_display":" intervals using standard scoring algorithms. Specifically, sum the scores for questions","confidence":1,"confidence_rate":1},{"cnt":[[1171,911],[2433,911],[2433,956],[1171,956]],"region":{"top_left_x":1170,"top_left_y":910,"width":1263,"height":47},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9490a494a74c425e823e25d8996c784c","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"Q3, Q5b, Q5c using reverse scores for Q3 (Q3: 1=Not at all,...,4=a lot; Q5b, Q5c:","text_display":" Q3, Q5b, Q5c using reverse scores for Q3 (Q3: 1=Not at all,...,4=a lot; Q5b, Q5c:","confidence":0.9946351032704115,"confidence_rate":0.9999374514973197},{"cnt":[[1173,956],[2537,956],[2537,1000],[1173,1000]],"region":{"top_left_x":1172,"top_left_y":956,"width":1365,"height":44},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"503b913c72c04319a28b06227e2c7d58","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a","text_display":" 1=strongly agree,... 4=strongly disagree). If there is more than 1 missing response then a","confidence":0.20933711082286302,"confidence_rate":0.984169403886051},{"cnt":[[1171,1000],[2459,1000],[2459,1043],[1171,1043]],"region":{"top_left_x":1170,"top_left_y":999,"width":1289,"height":45},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa5f0d940c4447b39a9a6f610b2f4d90","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"total score is not calculated. To handle missing values, the final score is obtained by","text_display":" total score is not calculated. To handle missing values, the final score is obtained by","confidence":1,"confidence_rate":1},{"cnt":[[1171,1045],[2524,1045],[2524,1086],[1171,1086]],"region":{"top_left_x":1170,"top_left_y":1045,"width":1354,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db8662d77bd6407f9b1c319a31227d25","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"dividing the sum by the number of items answered. The outcome will then be computed","text_display":" dividing the sum by the number of items answered. The outcome will then be computed","confidence":1,"confidence_rate":1},{"cnt":[[1171,1089],[2511,1089],[2511,1130],[1171,1130]],"region":{"top_left_x":1170,"top_left_y":1088,"width":1341,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1c45b183eb0481b9933e10d336ab042","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"as the difference in score at Month 1 and the score at baseline. If data at any month are","text_display":" as the difference in score at Month 1 and the score at baseline. If data at any month are","confidence":1,"confidence_rate":1},{"cnt":[[1171,1132],[2541,1132],[2541,1173],[1171,1173]],"region":{"top_left_x":1170,"top_left_y":1131,"width":1372,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf32f31c9d2c46d3b21a428d1bf981a4","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"missing, the outcome variable will be coded as missing. Scores should only be calculated","text_display":" missing, the outcome variable will be coded as missing. Scores should only be calculated","confidence":1,"confidence_rate":1},{"cnt":[[1171,1175],[1835,1175],[1835,1218],[1171,1218]],"region":{"top_left_x":1170,"top_left_y":1175,"width":666,"height":44},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6597522106d14ab0a4f99def7f28c78f","type":"text","conversion_output":false,"parent_id":"90f270520f574c608aa211ac234b0ec5","text":"for participants that are not sexually active.","text_display":" for participants that are not sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[306,1255],[735,1255],[735,1392],[306,1392]],"region":{"top_left_x":306,"top_left_y":1255,"width":430,"height":137},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11c53f50774e4960a590347024dd90b0","type":"complex_cell","conversion_output":false,"parent_id":"c54186eb5fae488098f3f6b1551d6454","children_ids":["8b79c53c091e45809f4e573dfea6083d","fe0442273ac94969853eb06083c218fd","f062604f49b846cea66581ea2ceacd28"],"text":"PISQ-IR sexually active arousal, orgasm subscale score change from baseline","text_display":"PISQ-IR sexually active arousal, orgasm subscale score change from baseline","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[309,1260],[718,1260],[718,1303],[309,1303]],"region":{"top_left_x":308,"top_left_y":1259,"width":410,"height":44},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b79c53c091e45809f4e573dfea6083d","type":"text","conversion_output":false,"parent_id":"11c53f50774e4960a590347024dd90b0","text":"PISQ-IR sexually active -","text_display":"PISQ-IR sexually active ","confidence":0.9990234375,"confidence_rate":0.9999674325420703},{"cnt":[[309,1303],[696,1303],[696,1346],[309,1346]],"region":{"top_left_x":308,"top_left_y":1302,"width":389,"height":45},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe0442273ac94969853eb06083c218fd","type":"text","conversion_output":false,"parent_id":"11c53f50774e4960a590347024dd90b0","text":"arousal, orgasm subscale","text_display":"arousal, orgasm subscale","confidence":1,"confidence_rate":1},{"cnt":[[309,1348],[731,1348],[731,1390],[309,1390]],"region":{"top_left_x":308,"top_left_y":1348,"width":423,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f062604f49b846cea66581ea2ceacd28","type":"text","conversion_output":false,"parent_id":"11c53f50774e4960a590347024dd90b0","text":"score change from baseline","text_display":" score change from baseline","confidence":1,"confidence_rate":1},{"cnt":[[794,1257],[978,1257],[978,1294],[794,1294]],"region":{"top_left_x":793,"top_left_y":1257,"width":185,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a343455abcdd47a0962a8c111047017a","type":"simple_cell","conversion_output":false,"parent_id":"c54186eb5fae488098f3f6b1551d6454","text":"Continuous","text_display":"Continuous","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1166,1255],[2548,1255],[2548,1701],[1166,1701]],"region":{"top_left_x":1166,"top_left_y":1255,"width":1382,"height":447},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20110f938ada4d3a9a06f80388eb6194","type":"complex_cell","conversion_output":false,"parent_id":"c54186eb5fae488098f3f6b1551d6454","children_ids":["676cbbeaa11b4aaa9121da5a10d86fbb","7fc6b82aa4b74662b9aba08082e8e9c1","d33878c87c5644aba7a2d9a061ef02c8","2e3c592600b84313854eaeefcc52a982","65620f58dcde40ba96ce953faa15d0a5","319fb12fa671468382379e4213b033b6","f9bb31948749491599ac7bfeabe049f3","69d8773f248147bcbac9cda9ce559b9f","e1fb78c525bf4101a7e09665fb5bb5d1","b37300b7fb224578921719a77e4fa973"],"text":"The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q7, Q8a, Q10, and Q11 using reverse scores for Q11 (Q7, Q8a, Q11: 1=never, ..., \\(5=[\\) almost \\(]\\) always; Q10: 1=much less intense, \\(. .5=\\) much more intense; check box response to \\(Q 11=1\\) ). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","text_display":"The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q7, Q8a, Q10, and Q11 using reverse scores for Q11 (Q7, Q8a, Q11: 1=never, ..., \\(5=[\\) almost \\(]\\) always; Q10: 1=much less intense, \\(. .5=\\) much more intense; check box response to \\(Q 11=1\\) ). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.32120899619266224,"confidence_rate":0.9987524566053695},{"cnt":[[1171,1257],[2481,1257],[2481,1303],[1171,1303]],"region":{"top_left_x":1170,"top_left_y":1257,"width":1311,"height":46},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"676cbbeaa11b4aaa9121da5a10d86fbb","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at 6-","text_display":"The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at 6","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[1171,1303],[2450,1303],[2450,1346],[1171,1346]],"region":{"top_left_x":1170,"top_left_y":1302,"width":1281,"height":45},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7fc6b82aa4b74662b9aba08082e8e9c1","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"month intervals using standard scoring algorithms. Specifically, sum the scores for","text_display":"month intervals using standard scoring algorithms. Specifically, sum the scores for","confidence":1,"confidence_rate":1},{"cnt":[[1171,1348],[2533,1348],[2533,1390],[1171,1390]],"region":{"top_left_x":1170,"top_left_y":1348,"width":1363,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d33878c87c5644aba7a2d9a061ef02c8","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"questions Q7, Q8a, Q10, and Q11 using reverse scores for Q11 (Q7, Q8a, Q11: 1=never,","text_display":" questions Q7, Q8a, Q10, and Q11 using reverse scores for Q11 (Q7, Q8a, Q11: 1=never,","confidence":1,"confidence_rate":1},{"cnt":[[1171,1392],[2478,1392],[2478,1433],[1171,1433]],"region":{"top_left_x":1170,"top_left_y":1391,"width":1309,"height":42},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e3c592600b84313854eaeefcc52a982","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"..., \\(5=[\\) almost \\(]\\) always; Q10: 1=much less intense, \\(. .5=\\) much more intense; check box","text_display":" ..., \\(5=[\\) almost \\(]\\) always; Q10: 1=much less intense, \\(. .5=\\) much more intense; check box","confidence":0.32120899619266224,"confidence_rate":0.9879911642376997},{"cnt":[[1171,1435],[2524,1435],[2524,1478],[1171,1478]],"region":{"top_left_x":1170,"top_left_y":1435,"width":1354,"height":44},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65620f58dcde40ba96ce953faa15d0a5","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"response to \\(Q 11=1\\) ). If there are more than 2 missing responses then a total score is not","text_display":" response to \\(Q 11=1\\) ). If there are more than 2 missing responses then a total score is not","confidence":0.9610463439528221,"confidence_rate":0.9996143205443446},{"cnt":[[1171,1478],[2513,1478],[2513,1522],[1171,1522]],"region":{"top_left_x":1170,"top_left_y":1478,"width":1344,"height":44},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"319fb12fa671468382379e4213b033b6","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"calculated. To handle missing values, the final score is obtained by dividing the sum by","text_display":" calculated. To handle missing values, the final score is obtained by dividing the sum by","confidence":1,"confidence_rate":1},{"cnt":[[1171,1522],[2509,1522],[2509,1567],[1171,1567]],"region":{"top_left_x":1170,"top_left_y":1521,"width":1339,"height":47},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9bb31948749491599ac7bfeabe049f3","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"the number of items answered. The outcome will then be computed as the difference in","text_display":" the number of items answered. The outcome will then be computed as the difference in","confidence":1,"confidence_rate":1},{"cnt":[[1171,1565],[2546,1565],[2546,1608],[1171,1608]],"region":{"top_left_x":1170,"top_left_y":1564,"width":1376,"height":45},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69d8773f248147bcbac9cda9ce559b9f","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"score at Month 1 and the score at baseline. If data at any month are missing, the outcome","text_display":" score at Month 1 and the score at baseline. If data at any month are missing, the outcome","confidence":1,"confidence_rate":1},{"cnt":[[1171,1608],[2515,1608],[2515,1654],[1171,1654]],"region":{"top_left_x":1170,"top_left_y":1608,"width":1346,"height":46},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1fb78c525bf4101a7e09665fb5bb5d1","type":"text","conversion_output":false,"parent_id":"20110f938ada4d3a9a06f80388eb6194","text":"variable will be coded as missing. Scores should only be calculated for participants that","text_display":" variable will be coded as missing. 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Specifically, sum the scores for questions Q8b, Q8c, Q9 using reverse scores for all (Q8b, Q8c, Q9: 1=never, ..., \\(5=\\) [almost] always). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline PISQ-IR sexually active partner related subscale score change from baseline & Continuous & The PISQ-IR sexually active - partner related subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q13, Q14a, Q14b using reverse scores for Q14a and Q14b (Q13: 1=all of the time,...4=hardly ever/rarely; Q14a, Q14b: 1=very positive, ...,4=very negative). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner. \\\\\n\\hline PISQ-IR sexually active desire subscale score change from baseline & Continuous & The PISQ-IR sexually active - desire subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: \\(1=\\) Never,\\(\\ldots 5=\\) Always; Q16: 1=Daily,...,5=Never; Q17: 1=Very high,...,5=Very low or none at all). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline PISQ-IR sexually active condition specific subscale score change from baseline & Continuous & The PISQ-IR sexually active - condition specific subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q8b, Q8c, Q9 using reverse scores for all (Q8b, Q8c, Q9: 1=never, ..., \\(5=\\) [almost] always). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline PISQ-IR sexually active partner related subscale score change from baseline & Continuous & The PISQ-IR sexually active - partner related subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q13, Q14a, Q14b using reverse scores for Q14a and Q14b (Q13: 1=all of the time,...4=hardly ever/rarely; Q14a, Q14b: 1=very positive, ...,4=very negative). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner. \\\\\n\\hline PISQ-IR sexually active desire subscale score change from baseline & Continuous & The PISQ-IR sexually active - desire subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: \\(1=\\) Never,\\(\\ldots 5=\\) Always; Q16: 1=Daily,...,5=Never; Q17: 1=Very high,...,5=Very low or none at all). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. 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PISQ-IR sexually active - condition specific subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q8b, Q8c, Q9 using reverse scores for all (Q8b, Q8c, Q9: 1=never, ..., \\(5=\\) [almost] always). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","text_display":"The PISQ-IR sexually active - condition specific subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q8b, Q8c, Q9 using reverse scores for all (Q8b, Q8c, Q9: 1=never, ..., \\(5=\\) [almost] always). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9481144804688029,"confidence_rate":0.999941352322607},{"cnt":[[1171,344],[2511,344],[2511,389],[1171,389]],"region":{"top_left_x":1170,"top_left_y":343,"width":1341,"height":47},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0c7a588a2ea467db3fc6d51b1b62d4d","type":"text","conversion_output":false,"parent_id":"3832090c04ba4c2a97b9d103cf402e69","text":"The PISQ-IR sexually active - condition specific subscale score will be computed at 6-","text_display":"The PISQ-IR sexually active - condition specific subscale score will be computed at 6","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[1171,391],[2455,391],[2455,432],[1171,432]],"region":{"top_left_x":1170,"top_left_y":391,"width":1285,"height":42},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c23fd02e31a41ddaca920cd65aef967","type":"text","conversion_output":false,"parent_id":"3832090c04ba4c2a97b9d103cf402e69","text":"month intervals using standard scoring algorithms. 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If data at any month are missing, the outcome","confidence":1,"confidence_rate":1},{"cnt":[[1171,653],[2515,653],[2515,697],[1171,697]],"region":{"top_left_x":1170,"top_left_y":653,"width":1346,"height":44},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4fdaffdc9c5450c8bc81fbd7d3f215a","type":"text","conversion_output":false,"parent_id":"3832090c04ba4c2a97b9d103cf402e69","text":"variable will be coded as missing. Scores should only be calculated for participants that","text_display":" variable will be coded as missing. Scores should only be calculated for participants that","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[1171,699],[1469,699],[1469,740],[1171,740]],"region":{"top_left_x":1170,"top_left_y":698,"width":300,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13544078b4c74f8a925f59acc222d4b5","type":"text","conversion_output":false,"parent_id":"3832090c04ba4c2a97b9d103cf402e69","text":"are sexually active.","text_display":" are sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[306,777],[768,777],[768,915],[306,915]],"region":{"top_left_x":306,"top_left_y":776,"width":462,"height":140},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b612a2fa6dee482b8b2db994fad0b19a","type":"complex_cell","conversion_output":false,"parent_id":"c51079d0f69647138bb36bc9b6fa79cc","children_ids":["7db2dedfa7db473ca42c5c272b32023d","d5f712ad0eab4da2aeaa5d9bce4621d6","c8b388b5d213406b9d1c954c14724491"],"text":"PISQ-IR sexually active partner related subscale score change from baseline","text_display":"PISQ-IR sexually active partner related subscale score change from baseline","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[309,781],[718,781],[718,822],[309,822]],"region":{"top_left_x":308,"top_left_y":781,"width":410,"height":42},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7db2dedfa7db473ca42c5c272b32023d","type":"text","conversion_output":false,"parent_id":"b612a2fa6dee482b8b2db994fad0b19a","text":"PISQ-IR sexually active -","text_display":"PISQ-IR sexually active ","confidence":0.9990234375,"confidence_rate":0.9999674325420703},{"cnt":[[309,824],[766,824],[766,870],[309,870]],"region":{"top_left_x":308,"top_left_y":824,"width":458,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5f712ad0eab4da2aeaa5d9bce4621d6","type":"text","conversion_output":false,"parent_id":"b612a2fa6dee482b8b2db994fad0b19a","text":"partner related subscale score","text_display":"partner related subscale score","confidence":1,"confidence_rate":1},{"cnt":[[309,870],[644,870],[644,913],[309,913]],"region":{"top_left_x":308,"top_left_y":869,"width":337,"height":45},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8b388b5d213406b9d1c954c14724491","type":"text","conversion_output":false,"parent_id":"b612a2fa6dee482b8b2db994fad0b19a","text":"change from baseline","text_display":" change from baseline","confidence":1,"confidence_rate":1},{"cnt":[[794,781],[978,781],[978,818],[794,818]],"region":{"top_left_x":793,"top_left_y":781,"width":185,"height":37},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e94d418d59cc41b580e65e20f72b0c29","type":"simple_cell","conversion_output":false,"parent_id":"c51079d0f69647138bb36bc9b6fa79cc","text":"Continuous","text_display":"Continuous","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1166,777],[2550,777],[2550,1225],[1166,1225]],"region":{"top_left_x":1166,"top_left_y":776,"width":1384,"height":449},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7867f102ba64f228737775aef6f37cb","type":"complex_cell","conversion_output":false,"parent_id":"c51079d0f69647138bb36bc9b6fa79cc","children_ids":["95135d05546a4d4daa4ecd425c6271da","fc0d7f9492d34ef6bbf15a1e2cbd1dbc","625dd7b16340451395afa1d42d11b321","fd96641b3da54b90a348e1ad7771a9ed","28c88fc6db144a689ee76bb0c655d986","9a86f6c690c34d31a45eecaf8383b10b","d853174ee2ca44c38aec796a3849b857","cde2e80530014dbbbbfe320ea2189382","b8789d3fd60741a58706e685964cdcea","a6535c8837bd44b081676060c7127652"],"text":"The PISQ-IR sexually active - partner related subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q13, Q14a, Q14b using reverse scores for Q14a and Q14b (Q13: 1=all of the time,...4=hardly ever/rarely; Q14a, Q14b: 1=very positive, ...,4=very negative). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner.","text_display":"The PISQ-IR sexually active - partner related subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q13, Q14a, Q14b using reverse scores for Q14a and Q14b (Q13: 1=all of the time,...4=hardly ever/rarely; Q14a, Q14b: 1=very positive, ...,4=very negative). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.974609375,"confidence_rate":0.9999586550325351},{"cnt":[[1171,781],[2459,781],[2459,824],[1171,824]],"region":{"top_left_x":1170,"top_left_y":781,"width":1289,"height":44},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95135d05546a4d4daa4ecd425c6271da","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"The PISQ-IR sexually active - partner related subscale score will be computed at 6-","text_display":"The PISQ-IR sexually active - partner related subscale score will be computed at 6","confidence":0.9970703125,"confidence_rate":0.9999666597894927},{"cnt":[[1171,824],[2455,824],[2455,870],[1171,870]],"region":{"top_left_x":1170,"top_left_y":824,"width":1285,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc0d7f9492d34ef6bbf15a1e2cbd1dbc","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"month intervals using standard scoring algorithms. Specifically, sum the scores for","text_display":"month intervals using standard scoring algorithms. Specifically, sum the scores for","confidence":1,"confidence_rate":1},{"cnt":[[1171,868],[2511,868],[2511,913],[1171,913]],"region":{"top_left_x":1170,"top_left_y":867,"width":1341,"height":47},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"625dd7b16340451395afa1d42d11b321","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"questions Q13, Q14a, Q14b using reverse scores for Q14a and Q14b (Q13: 1=all of the","text_display":" questions Q13, Q14a, Q14b using reverse scores for Q14a and Q14b (Q13: 1=all of the","confidence":1,"confidence_rate":1},{"cnt":[[1171,911],[2528,911],[2528,956],[1171,956]],"region":{"top_left_x":1170,"top_left_y":910,"width":1359,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd96641b3da54b90a348e1ad7771a9ed","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"time,...4=hardly ever/rarely; Q14a, Q14b: 1=very positive, ...,4=very negative). If there","text_display":" time,...4=hardly ever/rarely; Q14a, Q14b: 1=very positive, ...,4=very negative). If there","confidence":0.989769458770752,"confidence_rate":0.9998906098888489},{"cnt":[[1171,956],[2494,956],[2494,1000],[1171,1000]],"region":{"top_left_x":1170,"top_left_y":956,"width":1324,"height":44},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28c88fc6db144a689ee76bb0c655d986","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"is more than 1 missing response then a total score is not calculated. To handle missing","text_display":" is more than 1 missing response then a total score is not calculated. To handle missing","confidence":0.974609375,"confidence_rate":0.9997293152807948},{"cnt":[[1171,1002],[2524,1002],[2524,1043],[1171,1043]],"region":{"top_left_x":1170,"top_left_y":1001,"width":1354,"height":43},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a86f6c690c34d31a45eecaf8383b10b","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"values, the final score is obtained by dividing the sum by the number of items answered.","text_display":" values, the final score is obtained by dividing the sum by the number of items answered.","confidence":1,"confidence_rate":1},{"cnt":[[1171,1045],[2546,1045],[2546,1089],[1171,1089]],"region":{"top_left_x":1170,"top_left_y":1045,"width":1376,"height":44},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d853174ee2ca44c38aec796a3849b857","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"The outcome will then be computed as the difference in score at Month 1 and the score at","text_display":" The outcome will then be computed as the difference in score at Month 1 and the score at","confidence":1,"confidence_rate":1},{"cnt":[[1171,1089],[2420,1089],[2420,1132],[1171,1132]],"region":{"top_left_x":1170,"top_left_y":1088,"width":1251,"height":44},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cde2e80530014dbbbbfe320ea2189382","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"baseline. If data at any month are missing, the outcome variable will be coded as","text_display":" baseline. If data at any month are missing, the outcome variable will be coded as","confidence":1,"confidence_rate":1},{"cnt":[[1171,1132],[2485,1132],[2485,1177],[1171,1177]],"region":{"top_left_x":1170,"top_left_y":1131,"width":1315,"height":47},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8789d3fd60741a58706e685964cdcea","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"missing. Scores should only be calculated for participants that are sexually active and","text_display":" missing. Scores should only be calculated for participants that are sexually active and","confidence":1,"confidence_rate":1},{"cnt":[[1171,1175],[1508,1175],[1508,1221],[1171,1221]],"region":{"top_left_x":1170,"top_left_y":1175,"width":339,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6535c8837bd44b081676060c7127652","type":"text","conversion_output":false,"parent_id":"e7867f102ba64f228737775aef6f37cb","text":"have a sexual partner.","text_display":" have a sexual partner.","confidence":1,"confidence_rate":1},{"cnt":[[306,1257],[757,1257],[757,1390],[306,1390]],"region":{"top_left_x":306,"top_left_y":1257,"width":451,"height":133},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ca16f53aaa14306a3f97169cba660a6","type":"complex_cell","conversion_output":false,"parent_id":"c51079d0f69647138bb36bc9b6fa79cc","children_ids":["ff2b9338c7e84fe5ad6f5643bccf50f6","aa71d58d54b341dcac84c225cb3b1a8d","55130cef451d4b4b8379ce47fd9a1845"],"text":"PISQ-IR sexually active desire subscale score change from baseline","text_display":"PISQ-IR sexually active desire subscale score change from baseline","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[309,1262],[718,1262],[718,1303],[309,1303]],"region":{"top_left_x":308,"top_left_y":1261,"width":410,"height":42},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff2b9338c7e84fe5ad6f5643bccf50f6","type":"text","conversion_output":false,"parent_id":"3ca16f53aaa14306a3f97169cba660a6","text":"PISQ-IR sexually active -","text_display":"PISQ-IR sexually active ","confidence":0.9990234375,"confidence_rate":0.9999674325420703},{"cnt":[[309,1305],[753,1305],[753,1346],[309,1346]],"region":{"top_left_x":308,"top_left_y":1305,"width":445,"height":42},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa71d58d54b341dcac84c225cb3b1a8d","type":"text","conversion_output":false,"parent_id":"3ca16f53aaa14306a3f97169cba660a6","text":"desire subscale score change","text_display":"desire subscale score change","confidence":1,"confidence_rate":1},{"cnt":[[309,1348],[525,1348],[525,1385],[309,1385]],"region":{"top_left_x":308,"top_left_y":1348,"width":218,"height":38},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55130cef451d4b4b8379ce47fd9a1845","type":"text","conversion_output":false,"parent_id":"3ca16f53aaa14306a3f97169cba660a6","text":"from baseline","text_display":" from baseline","confidence":1,"confidence_rate":1},{"cnt":[[794,1262],[978,1262],[978,1296],[794,1296]],"region":{"top_left_x":793,"top_left_y":1261,"width":185,"height":36},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7970ffabeb954dffb6e5b1f4f66b8457","type":"simple_cell","conversion_output":false,"parent_id":"c51079d0f69647138bb36bc9b6fa79cc","text":"Continuous","text_display":"Continuous","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1166,1257],[2548,1257],[2548,1660],[1166,1660]],"region":{"top_left_x":1166,"top_left_y":1257,"width":1382,"height":404},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43a276da641844ef9383cc0723aa1cb4","type":"complex_cell","conversion_output":false,"parent_id":"c51079d0f69647138bb36bc9b6fa79cc","children_ids":["eee938def3f04638b155394a47a74005","dfff9e3134084c6589ef803e65f07c35","3cbb8544c6dc4543a34a5e9f05e18931","f7a1b3c114a64644baad38679e88b4df","405ac2cbbf3743bc88e93e01eccef1a4","bf46cbb118764481811e60c9a0cbd37a","7cc294ddcf8b4a309ccb8de30c8f0bef","c9e1ac148b9846fd964dc280f28514e0","5046ef305110425f82670d5e39adb0d9"],"text":"The PISQ-IR sexually active - desire subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: \\(1=\\) Never,\\(\\ldots 5=\\) Always; Q16: 1=Daily,...,5=Never; Q17: 1=Very high,...,5=Very low or none at all). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","text_display":"The PISQ-IR sexually active - desire subscale score will be computed at 6-month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: \\(1=\\) Never,\\(\\ldots 5=\\) Always; Q16: 1=Daily,...,5=Never; Q17: 1=Very high,...,5=Very low or none at all). If there is more than 1 missing response then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.16280313934383325,"confidence_rate":0.9976867412078255},{"cnt":[[1171,1262],[2427,1262],[2427,1303],[1171,1303]],"region":{"top_left_x":1170,"top_left_y":1261,"width":1257,"height":42},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eee938def3f04638b155394a47a74005","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"The PISQ-IR sexually active - desire subscale score will be computed at 6-month","text_display":"The PISQ-IR sexually active - desire subscale score will be computed at 6-month","confidence":0.9990234375,"confidence_rate":0.9999883686432659},{"cnt":[[1171,1305],[2498,1305],[2498,1346],[1171,1346]],"region":{"top_left_x":1170,"top_left_y":1305,"width":1328,"height":42},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfff9e3134084c6589ef803e65f07c35","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"intervals using standard scoring algorithms. Specifically, sum the scores for questions","text_display":" intervals using standard scoring algorithms. Specifically, sum the scores for questions","confidence":1,"confidence_rate":1},{"cnt":[[1171,1348],[2541,1348],[2541,1392],[1171,1392]],"region":{"top_left_x":1170,"top_left_y":1348,"width":1372,"height":44},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cbb8544c6dc4543a34a5e9f05e18931","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: \\(1=\\) Never,\\(\\ldots 5=\\) Always; Q16:","text_display":" Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: \\(1=\\) Never,\\(\\ldots 5=\\) Always; Q16:","confidence":0.16280313934383325,"confidence_rate":0.9808744763807042},{"cnt":[[1173,1392],[2524,1392],[2524,1435],[1173,1435]],"region":{"top_left_x":1172,"top_left_y":1391,"width":1352,"height":45},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7a1b3c114a64644baad38679e88b4df","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"1=Daily,...,5=Never; Q17: 1=Very high,...,5=Very low or none at all). If there is more","text_display":" 1=Daily,...,5=Never; Q17: 1=Very high,...,5=Very low or none at all). If there is more","confidence":0.8719122209141072,"confidence_rate":0.9984949082473887},{"cnt":[[1171,1435],[2543,1435],[2543,1480],[1171,1480]],"region":{"top_left_x":1170,"top_left_y":1435,"width":1374,"height":46},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"405ac2cbbf3743bc88e93e01eccef1a4","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"than 1 missing response then a total score is not calculated. To handle missing values, the","text_display":" than 1 missing response then a total score is not calculated. To handle missing values, the","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[1171,1478],[2424,1478],[2424,1524],[1171,1524]],"region":{"top_left_x":1170,"top_left_y":1478,"width":1255,"height":46},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf46cbb118764481811e60c9a0cbd37a","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"final score is obtained by dividing the sum by the number of items answered. The","text_display":" final score is obtained by dividing the sum by the number of items answered. The","confidence":1,"confidence_rate":1},{"cnt":[[1171,1522],[2476,1522],[2476,1567],[1171,1567]],"region":{"top_left_x":1170,"top_left_y":1521,"width":1307,"height":47},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cc294ddcf8b4a309ccb8de30c8f0bef","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"outcome will then be computed as the difference in score at Month 1 and the score at","text_display":" outcome will then be computed as the difference in score at Month 1 and the score at","confidence":1,"confidence_rate":1},{"cnt":[[1171,1567],[2420,1567],[2420,1610],[1171,1610]],"region":{"top_left_x":1170,"top_left_y":1567,"width":1251,"height":44},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9e1ac148b9846fd964dc280f28514e0","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"baseline. If data at any month are missing, the outcome variable will be coded as","text_display":" baseline. If data at any month are missing, the outcome variable will be coded as","confidence":1,"confidence_rate":1},{"cnt":[[1171,1613],[2429,1613],[2429,1656],[1171,1656]],"region":{"top_left_x":1170,"top_left_y":1612,"width":1259,"height":44},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5046ef305110425f82670d5e39adb0d9","type":"text","conversion_output":false,"parent_id":"43a276da641844ef9383cc0723aa1cb4","text":"missing. Scores should only be calculated for participants that are sexually active.","text_display":" missing. 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Specifically, sum the scores for questions Q18, Q20b-d using reverse scores for Q18 (Q18: 1=not at all,...4=a lot; Q20b\\(d : 1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline PISQ-IR sexually active global quality rating subscale score change from baseline & Continuous & The PISQ-IR sexually active - global quality rating subscale score will be computed at 6 month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied,...5=dissatisfied; Q20a: 1=strongly agree,...,4=strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Risk of de novo dyspareunia defined at 6-month postoperative intervals (aggregated across postsurgical reporting period) & Binary & Defined via two different mechanisms: (a) as an event of dyspareunia as listed on AE form or the 6-month complication evaluation form; or (b) assessed via reporting on the PISQ-IR instrument. Note that because on masked review women moved in and out of the dyspareunia category after surgery, the decision was made to evaluate all incidents of dyspareunia irrespective of de novo status. \\\\\n\\hline Bowel function as measured by the PFDI-SF ColorectalAnal Distress Inventory scale at 6-month post-operative intervals & Continuous & The PFDI-SF Colorectal-Anal Distress Inventory (CRADI) scale will be computed at 6 month post-operative intervals using standard scoring algorithms described by Barber (2006) to create a measure scaled 0 to 100 at each time point. If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline PISQ-IR sexually active condition impact subscale score change from baseline & Continuous & The PISQ-IR sexually active - condition impact subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q18, Q20b-d using reverse scores for Q18 (Q18: 1=not at all,...4=a lot; Q20b\\(d : 1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline PISQ-IR sexually active global quality rating subscale score change from baseline & Continuous & The PISQ-IR sexually active - global quality rating subscale score will be computed at 6 month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied,...5=dissatisfied; Q20a: 1=strongly agree,...,4=strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Risk of de novo dyspareunia defined at 6-month postoperative intervals (aggregated across postsurgical reporting period) & Binary & Defined via two different mechanisms: (a) as an event of dyspareunia as listed on AE form or the 6-month complication evaluation form; or (b) assessed via reporting on the PISQ-IR instrument. Note that because on masked review women moved in and out of the dyspareunia category after surgery, the decision was made to evaluate all incidents of dyspareunia irrespective of de novo status. \\\\\n\\hline Bowel function as measured by the PFDI-SF ColorectalAnal Distress Inventory scale at 6-month post-operative intervals & Continuous & The PFDI-SF Colorectal-Anal Distress Inventory (CRADI) scale will be computed at 6 month post-operative intervals using standard scoring algorithms described by Barber (2006) to create a measure scaled 0 to 100 at each time point. If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. 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PISQ-IR sexually active - condition impact subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q18, Q20b-d using reverse scores for Q18 (Q18: 1=not at all,...4=a lot; Q20b\\(d : 1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","text_display":"The PISQ-IR sexually active - condition impact subscale score will be computed at 6month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q18, Q20b-d using reverse scores for Q18 (Q18: 1=not at all,...4=a lot; Q20b\\(d : 1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.4813394963022729,"confidence_rate":0.9990644962949164},{"cnt":[[1171,344],[2498,344],[2498,389],[1171,389]],"region":{"top_left_x":1170,"top_left_y":343,"width":1328,"height":47},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bde565f1773841e88d0bbe421c45b7fa","type":"text","conversion_output":false,"parent_id":"23076809087b44e1a700815aa2180454","text":"The PISQ-IR sexually active - condition impact subscale score will be computed at 6-","text_display":"The PISQ-IR sexually active - condition impact subscale score will be computed at 6","confidence":0.9072265625,"confidence_rate":0.9989066311212663},{"cnt":[[1171,391],[2455,391],[2455,432],[1171,432]],"region":{"top_left_x":1170,"top_left_y":391,"width":1285,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"685da88ce4b944ce9b9793c86ab033e1","type":"text","conversion_output":false,"parent_id":"23076809087b44e1a700815aa2180454","text":"month intervals using standard scoring algorithms. Specifically, sum the scores for","text_display":"month intervals using standard scoring algorithms. Specifically, sum the scores for","confidence":1,"confidence_rate":1},{"cnt":[[1171,435],[2535,435],[2535,476],[1171,476]],"region":{"top_left_x":1170,"top_left_y":434,"width":1365,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8bf8d1d39b84463a9dfbed51a0dba22f","type":"text","conversion_output":false,"parent_id":"23076809087b44e1a700815aa2180454","text":"questions Q18, Q20b-d using reverse scores for Q18 (Q18: 1=not at all,...4=a lot; Q20b-","text_display":" questions Q18, Q20b-d using reverse scores for Q18 (Q18: 1=not at all,...4=a lot; Q20b","confidence":0.97900390625,"confidence_rate":0.9997693782666429},{"cnt":[[1171,478],[2511,478],[2511,523],[1171,523]],"region":{"top_left_x":1170,"top_left_y":477,"width":1341,"height":47},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a102210b7164182a4aa1b801a78e514","type":"text","conversion_output":false,"parent_id":"23076809087b44e1a700815aa2180454","text":"\\(d : 1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses","text_display":"\\(d : 1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses","confidence":0.4813394963022729,"confidence_rate":0.992926278697102},{"cnt":[[1171,521],[2515,521],[2515,564],[1171,564]],"region":{"top_left_x":1170,"top_left_y":521,"width":1346,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c8fe975ed5d45f8893b63fa1200d9c8","type":"text","conversion_output":false,"parent_id":"23076809087b44e1a700815aa2180454","text":"then a total score is not calculated. To handle missing values, the final score is obtained","text_display":" then a total score is not calculated. 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If data at any","confidence":1,"confidence_rate":1},{"cnt":[[1171,651],[2541,651],[2541,697],[1171,697]],"region":{"top_left_x":1170,"top_left_y":651,"width":1372,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f557b49700c428493339ed7f8377dc7","type":"text","conversion_output":false,"parent_id":"23076809087b44e1a700815aa2180454","text":"month are missing, the outcome variable will be coded as missing. Scores should only be","text_display":" month are missing, the outcome variable will be coded as missing. Scores should only be","confidence":1,"confidence_rate":1},{"cnt":[[1171,697],[1944,697],[1944,740],[1171,740]],"region":{"top_left_x":1170,"top_left_y":696,"width":774,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a4479a5f7b0436f81e81404afe1b644","type":"text","conversion_output":false,"parent_id":"23076809087b44e1a700815aa2180454","text":"calculated for participants that are sexually active.","text_display":" calculated for participants that are sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[304,777],[768,777],[768,915],[304,915]],"region":{"top_left_x":304,"top_left_y":776,"width":464,"height":140},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"613be4e99c1a4489b5634797f4a980db","type":"complex_cell","conversion_output":false,"parent_id":"9eb130b5546043a58b2663621e9e2d7c","children_ids":["28c61e3b0df64b288c0ec108961cebf8","f6933cb7c4ba471793ec9e21c55c5760","7e458f89bfa64b4aa43267e9fbbe2551"],"text":"PISQ-IR sexually active global quality rating subscale score change from baseline","text_display":"PISQ-IR sexually active global quality rating subscale score change from baseline","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[309,781],[718,781],[718,822],[309,822]],"region":{"top_left_x":308,"top_left_y":781,"width":410,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28c61e3b0df64b288c0ec108961cebf8","type":"text","conversion_output":false,"parent_id":"613be4e99c1a4489b5634797f4a980db","text":"PISQ-IR sexually active -","text_display":"PISQ-IR sexually active ","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[309,824],[766,824],[766,870],[309,870]],"region":{"top_left_x":308,"top_left_y":824,"width":458,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6933cb7c4ba471793ec9e21c55c5760","type":"text","conversion_output":false,"parent_id":"613be4e99c1a4489b5634797f4a980db","text":"global quality rating subscale","text_display":"global quality rating subscale","confidence":1,"confidence_rate":1},{"cnt":[[309,868],[731,868],[731,913],[309,913]],"region":{"top_left_x":308,"top_left_y":867,"width":423,"height":47},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e458f89bfa64b4aa43267e9fbbe2551","type":"text","conversion_output":false,"parent_id":"613be4e99c1a4489b5634797f4a980db","text":"score change from baseline","text_display":" score change from baseline","confidence":1,"confidence_rate":1},{"cnt":[[794,781],[978,781],[978,818],[794,818]],"region":{"top_left_x":793,"top_left_y":781,"width":185,"height":37},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e91ee9862a0d4d58b3db87fc9aa2f037","type":"simple_cell","conversion_output":false,"parent_id":"9eb130b5546043a58b2663621e9e2d7c","text":"Continuous","text_display":"Continuous","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1166,777],[2550,777],[2550,1182],[1166,1182]],"region":{"top_left_x":1166,"top_left_y":776,"width":1384,"height":406},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42323d0c460b475fb584b4c10b95c267","type":"complex_cell","conversion_output":false,"parent_id":"9eb130b5546043a58b2663621e9e2d7c","children_ids":["f395a2a1a4044b29b24221d70d602149","4006a82339434f12be713697ec2d3ee9","58bd45186b3a4e829b2d6724f7decd0e","a22cd6cb7cf84d109fa3a8985e0d384d","f70cd6dbc75b403b9e3556bdc3d1cda0","c3133b0a5666478ca593e249ba5908e3","3f13f22f61684c9a9d74d738ee5819a8","453b2a27f3334a8aa5ad69e6b965ed0f","70b22be8c1f74354877f3aed2822b9b7"],"text":"The PISQ-IR sexually active - global quality rating subscale score will be computed at 6 month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied,...5=dissatisfied; Q20a: 1=strongly agree,...,4=strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","text_display":"The PISQ-IR sexually active - global quality rating subscale score will be computed at 6 month intervals using standard scoring algorithms. Specifically, sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied,...5=dissatisfied; Q20a: 1=strongly agree,...,4=strongly disagree). If there are more than 2 missing responses then a total score is not calculated. To handle missing values, the final score is obtained by dividing the sum by the number of items answered. The outcome will then be computed as the difference in score at Month 1 and the score at baseline. If data at any month are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.56982421875,"confidence_rate":0.9992638339541486},{"cnt":[[1171,781],[2548,781],[2548,822],[1171,822]],"region":{"top_left_x":1170,"top_left_y":781,"width":1378,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f395a2a1a4044b29b24221d70d602149","type":"text","conversion_output":false,"parent_id":"42323d0c460b475fb584b4c10b95c267","text":"The PISQ-IR sexually active - global quality rating subscale score will be computed at 6 -","text_display":"The PISQ-IR sexually active - global quality rating subscale score will be computed at 6 ","confidence":0.56982421875,"confidence_rate":0.9942773822835252},{"cnt":[[1171,824],[2455,824],[2455,870],[1171,870]],"region":{"top_left_x":1170,"top_left_y":824,"width":1285,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4006a82339434f12be713697ec2d3ee9","type":"text","conversion_output":false,"parent_id":"42323d0c460b475fb584b4c10b95c267","text":"month intervals using standard scoring algorithms. 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To handle missing","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[1171,1000],[2526,1000],[2526,1043],[1171,1043]],"region":{"top_left_x":1170,"top_left_y":999,"width":1357,"height":45},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3133b0a5666478ca593e249ba5908e3","type":"text","conversion_output":false,"parent_id":"42323d0c460b475fb584b4c10b95c267","text":"values, the final score is obtained by dividing the sum by the number of items answered.","text_display":" values, the final score is obtained by dividing the sum by the number of items answered.","confidence":1,"confidence_rate":1},{"cnt":[[1171,1043],[2546,1043],[2546,1086],[1171,1086]],"region":{"top_left_x":1170,"top_left_y":1043,"width":1376,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f13f22f61684c9a9d74d738ee5819a8","type":"text","conversion_output":false,"parent_id":"42323d0c460b475fb584b4c10b95c267","text":"The outcome will then be computed as the difference in score at Month 1 and the score at","text_display":" The outcome will then be computed as the difference in score at Month 1 and the score at","confidence":1,"confidence_rate":1},{"cnt":[[1171,1089],[2420,1089],[2420,1132],[1171,1132]],"region":{"top_left_x":1170,"top_left_y":1088,"width":1251,"height":44},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"453b2a27f3334a8aa5ad69e6b965ed0f","type":"text","conversion_output":false,"parent_id":"42323d0c460b475fb584b4c10b95c267","text":"baseline. If data at any month are missing, the outcome variable will be coded as","text_display":" baseline. If data at any month are missing, the outcome variable will be coded as","confidence":1,"confidence_rate":1},{"cnt":[[1171,1132],[2424,1132],[2424,1175],[1171,1175]],"region":{"top_left_x":1170,"top_left_y":1131,"width":1255,"height":45},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70b22be8c1f74354877f3aed2822b9b7","type":"text","conversion_output":false,"parent_id":"42323d0c460b475fb584b4c10b95c267","text":"missing. Scores should only be calculated for participants that are sexually active.","text_display":" missing. Scores should only be calculated for participants that are sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[304,1210],[757,1210],[757,1437],[304,1437]],"region":{"top_left_x":304,"top_left_y":1209,"width":453,"height":229},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cd8cdd6a5cd4a5fa969ba54171601a4","type":"complex_cell","conversion_output":false,"parent_id":"9eb130b5546043a58b2663621e9e2d7c","children_ids":["71244171f50c406b840fe7c41bff01ac","ad5a17b3bb204a47afe217aa7f98b1e5","30e41edbf099438cba2e5c5534842c4e","ec6f175156b640238e113f91fe3d23a2","3858502dd0e1426abbd5d390535d11ca"],"text":"Risk of de novo dyspareunia defined at 6-month postoperative intervals (aggregated across postsurgical reporting period)","text_display":"Risk of de novo dyspareunia defined at 6-month postoperative intervals (aggregated across postsurgical reporting period)","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,1214],[753,1214],[753,1260],[309,1260]],"region":{"top_left_x":308,"top_left_y":1214,"width":445,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71244171f50c406b840fe7c41bff01ac","type":"text","conversion_output":false,"parent_id":"1cd8cdd6a5cd4a5fa969ba54171601a4","text":"Risk of de novo dyspareunia","text_display":"Risk of de novo dyspareunia","confidence":1,"confidence_rate":1},{"cnt":[[309,1260],[692,1260],[692,1303],[309,1303]],"region":{"top_left_x":308,"top_left_y":1259,"width":384,"height":44},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad5a17b3bb204a47afe217aa7f98b1e5","type":"text","conversion_output":false,"parent_id":"1cd8cdd6a5cd4a5fa969ba54171601a4","text":"defined at 6-month post-","text_display":" defined at 6-month post","confidence":1,"confidence_rate":1},{"cnt":[[309,1305],[601,1305],[601,1346],[309,1346]],"region":{"top_left_x":308,"top_left_y":1305,"width":293,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30e41edbf099438cba2e5c5534842c4e","type":"text","conversion_output":false,"parent_id":"1cd8cdd6a5cd4a5fa969ba54171601a4","text":"operative intervals","text_display":"operative intervals","confidence":1,"confidence_rate":1},{"cnt":[[309,1348],[688,1348],[688,1392],[309,1392]],"region":{"top_left_x":308,"top_left_y":1348,"width":380,"height":44},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec6f175156b640238e113f91fe3d23a2","type":"text","conversion_output":false,"parent_id":"1cd8cdd6a5cd4a5fa969ba54171601a4","text":"(aggregated across post-","text_display":" (aggregated across post","confidence":1,"confidence_rate":1},{"cnt":[[309,1392],[705,1392],[705,1435],[309,1435]],"region":{"top_left_x":308,"top_left_y":1391,"width":397,"height":45},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3858502dd0e1426abbd5d390535d11ca","type":"text","conversion_output":false,"parent_id":"1cd8cdd6a5cd4a5fa969ba54171601a4","text":"surgical reporting period)","text_display":"surgical reporting period)","confidence":1,"confidence_rate":1},{"cnt":[[794,1214],[906,1214],[906,1260],[794,1260]],"region":{"top_left_x":793,"top_left_y":1214,"width":114,"height":46},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ff846507d2d4d1bade5a5e31555d6f4","type":"simple_cell","conversion_output":false,"parent_id":"9eb130b5546043a58b2663621e9e2d7c","text":"Binary","text_display":"Binary","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1166,1210],[2550,1210],[2550,1437],[1166,1437]],"region":{"top_left_x":1166,"top_left_y":1209,"width":1384,"height":229},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f2da53e3b74349b693ffde2a6c46323e","type":"complex_cell","conversion_output":false,"parent_id":"9eb130b5546043a58b2663621e9e2d7c","children_ids":["56511d2e3ead4f9e9f1f515147b68c32","b5baa865acda49e98d2b9a5ae3eb1a19","be060d3021e6405e8e80181087f6fbe1","3285a9f6757f4bf3954c6a1021f03af5","bdb437e81ad44340978888f3d20838d5"],"text":"Defined via two different mechanisms: (a) as an event of dyspareunia as listed on AE form or the 6-month complication evaluation form; or (b) assessed via reporting on the PISQ-IR instrument. Note that because on masked review women moved in and out of the dyspareunia category after surgery, the decision was made to evaluate all incidents of dyspareunia irrespective of de novo status.","text_display":"Defined via two different mechanisms: (a) as an event of dyspareunia as listed on AE form or the 6-month complication evaluation form; or (b) assessed via reporting on the PISQ-IR instrument. Note that because on masked review women moved in and out of the dyspareunia category after surgery, the decision was made to evaluate all incidents of dyspareunia irrespective of de novo status.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9892578125,"confidence_rate":0.99997518997404},{"cnt":[[1171,1214],[2481,1214],[2481,1260],[1171,1260]],"region":{"top_left_x":1170,"top_left_y":1214,"width":1311,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56511d2e3ead4f9e9f1f515147b68c32","type":"text","conversion_output":false,"parent_id":"f2da53e3b74349b693ffde2a6c46323e","text":"Defined via two different mechanisms: (a) as an event of dyspareunia as listed on AE","text_display":"Defined via two different mechanisms: (a) as an event of dyspareunia as listed on AE","confidence":0.9892578125,"confidence_rate":0.9998813224125138},{"cnt":[[1171,1257],[2507,1257],[2507,1303],[1171,1303]],"region":{"top_left_x":1170,"top_left_y":1257,"width":1337,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5baa865acda49e98d2b9a5ae3eb1a19","type":"text","conversion_output":false,"parent_id":"f2da53e3b74349b693ffde2a6c46323e","text":"form or the 6-month complication evaluation form; or (b) assessed via reporting on the","text_display":" form or the 6-month complication evaluation form; or (b) assessed via reporting on the","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[1171,1303],[2507,1303],[2507,1346],[1171,1346]],"region":{"top_left_x":1170,"top_left_y":1302,"width":1337,"height":45},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be060d3021e6405e8e80181087f6fbe1","type":"text","conversion_output":false,"parent_id":"f2da53e3b74349b693ffde2a6c46323e","text":"PISQ-IR instrument. 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If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. \\\\\n\\hline Mental component summary scale from SF-12 (MCS-12) at 6-month post-operative intervals & Continuous & MCS-12 will be computed at 6 month post-operative intervals using standard algorithms from the SF-12 developer. If data at any month are missing, the outcome variable will be coded as missing for that month. All longitudinal analyses or time-specific analyses will use all available data. \\\\\n\\hline PFIQ-SF Urinary Impact Questionnaire (UIQ-7) at 6month post-operative intervals & Continuous & The PFIQ-SF Urinary Impact Questionnaire (UIQ-7) score will be computed at 6 month post-operative intervals using standard scoring algorithms described by Barber (2006) to create a measure scaled 0 to 100 at each time point. If data at any month are missing, the outcome variable will be coded as missing. 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All longitudinal analyses or","confidence":1,"confidence_rate":1},{"cnt":[[1169,519],[1922,519],[1922,565],[1169,565]],"region":{"top_left_x":1168,"top_left_y":519,"width":755,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"126bca93aebd4e6796c2c3a29d73cd01","type":"text","conversion_output":false,"parent_id":"565a2444fd3f4ff187dda98e6eea9480","text":"time-specific analyses will use all available data.","text_display":" time-specific analyses will use all available data.","confidence":1,"confidence_rate":1},{"cnt":[[305,1895],[690,1895],[690,1931],[305,1931]],"region":{"top_left_x":305,"top_left_y":1894,"width":385,"height":38},"line":26,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a778c66e25d540f6917f909964614ee1","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 27","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999864334115239}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-29","page":29,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d6fa95d3a8504e888ce420d4f5313bfe","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4020527511264c90858a3f36259be560","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,314],[920,314],[920,367],[370,367]],"region":{"top_left_x":369,"top_left_y":313,"width":551,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec29786e3440473ea3334836cf282ff5","type":"section_header","conversion_output":false,"children_ids":["43d869e10ad9420f9f93908ee2e7b8db"],"text":"","text_display":""},{"cnt":[[374,318],[917,318],[917,363],[374,363]],"region":{"top_left_x":373,"top_left_y":317,"width":545,"height":47},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43d869e10ad9420f9f93908ee2e7b8db","type":"text","conversion_output":true,"parent_id":"ec29786e3440473ea3334836cf282ff5","text":"9.3 Primary Analysis Methods","text_display":"\n\n\\subsection*{9.3 Primary Analysis Methods}","confidence":1,"confidence_rate":1},{"cnt":[[309,382],[1876,382],[1876,428],[309,428]],"region":{"top_left_x":309,"top_left_y":382,"width":1567,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28fb7763e5d04ba383c1d166ed310a04","type":"text","conversion_output":true,"text":"The primary efficacy outcome measure is a binary measure of treatment failure/success as determined","text_display":"\n\nThe primary efficacy outcome measure is a binary measure of treatment failure/success as determined","confidence":0.99951171875,"confidence_rate":0.9999953038523913},{"cnt":[[309,425],[1777,425],[1777,473],[309,473]],"region":{"top_left_x":309,"top_left_y":425,"width":1468,"height":48},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c9beba6054f40b9ba21a4739d9e9b2b","type":"text","conversion_output":true,"text":"at 6 -month time intervals post-intervention. Surgical failure rates will be compared graphically","text_display":" at 6 -month time intervals post-intervention. Surgical failure rates will be compared graphically","confidence":0.99365234375,"confidence_rate":0.9999393552838918},{"cnt":[[309,473],[1871,473],[1871,518],[309,518]],"region":{"top_left_x":309,"top_left_y":472,"width":1563,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06111ccd964a40a2b6bc9240723732a8","type":"text","conversion_output":true,"text":"across the two treatment arms with Kaplan-Meier type plots, with survival curves computed using the","text_display":" across the two treatment arms with Kaplan-Meier type plots, with survival curves computed using the","confidence":1,"confidence_rate":1},{"cnt":[[309,516],[1824,516],[1824,561],[309,561]],"region":{"top_left_x":309,"top_left_y":515,"width":1516,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e82b50cfef5c443793e45d5a0fb0e0b9","type":"text","conversion_output":true,"text":"product-limit estimator appropriately extended for interval estimation. While the original protocol","text_display":" product-limit estimator appropriately extended for interval estimation. While the original protocol","confidence":0.99658203125,"confidence_rate":0.9999670791635416},{"cnt":[[309,559],[1863,559],[1863,604],[309,604]],"region":{"top_left_x":309,"top_left_y":558,"width":1554,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1edf6a87d4f4b3197ca35b309f3af1a","type":"text","conversion_output":true,"text":"indicated that a log-rank test would be use for the primary analysis, additional data that have come to","text_display":" indicated that a log-rank test would be use for the primary analysis, additional data that have come to","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[309,604],[1835,604],[1835,647],[309,647]],"region":{"top_left_x":309,"top_left_y":603,"width":1526,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09123f1a03c7447098668a0eeffd96f5","type":"text","conversion_output":true,"text":"light since the development of the protocol led to a masked decision to modify the primary analysis","text_display":" light since the development of the protocol led to a masked decision to modify the primary analysis","confidence":1,"confidence_rate":1},{"cnt":[[309,649],[889,649],[889,694],[309,694]],"region":{"top_left_x":309,"top_left_y":648,"width":581,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92b790f6e4aa4e618c073314abaffc57","type":"text","conversion_output":true,"text":"approach as specified in detail below.","text_display":" approach as specified in detail below.","confidence":1,"confidence_rate":1},{"cnt":[[309,713],[1880,713],[1880,758],[309,758]],"region":{"top_left_x":309,"top_left_y":713,"width":1571,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94ec58dac904492b97f9feb2b52b61dd","type":"text","conversion_output":true,"text":"This analysis contained several limitations that became apparent upon the studies initiation that makes","text_display":"\n\nThis analysis contained several limitations that became apparent upon the studies initiation that makes","confidence":1,"confidence_rate":1},{"cnt":[[309,756],[1824,756],[1824,801],[309,801]],"region":{"top_left_x":309,"top_left_y":756,"width":1516,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e768a85c087247f38dcbd2056eb1584e","type":"text","conversion_output":true,"text":"revision necessary. First, the survival analysis methods initially proposed were developed for right","text_display":" revision necessary. First, the survival analysis methods initially proposed were developed for right","confidence":1,"confidence_rate":1},{"cnt":[[309,799],[1871,799],[1871,844],[309,844]],"region":{"top_left_x":309,"top_left_y":799,"width":1563,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"301153b2887b4808adb2512a62326671","type":"text","conversion_output":true,"text":"censored data, while the outcome data for the bulge symptoms and anatomic failure is collected at the","text_display":" censored data, while the outcome data for the bulge symptoms and anatomic failure is collected at the","confidence":1,"confidence_rate":1},{"cnt":[[309,842],[1854,842],[1854,887],[309,887]],"region":{"top_left_x":309,"top_left_y":842,"width":1546,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9aa5db9577b4b639a038a3a9ca1f342","type":"text","conversion_output":true,"text":"six 6-month follow-up visits, making the data a combination of interval censored and right censored.","text_display":" six 6-month follow-up visits, making the data a combination of interval censored and right censored.","confidence":0.957233190536499,"confidence_rate":0.9995838175904184},{"cnt":[[309,887],[1871,887],[1871,935],[309,935]],"region":{"top_left_x":309,"top_left_y":887,"width":1563,"height":48},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17cea7679bb5480c82cfecd8c50593fc","type":"text","conversion_output":true,"text":"Second, results from long term follow-up of the OPTIMAL trial showed that the proportional hazards","text_display":" Second, results from long term follow-up of the OPTIMAL trial showed that the proportional hazards","confidence":1,"confidence_rate":1},{"cnt":[[309,932],[1880,932],[1880,975],[309,975]],"region":{"top_left_x":309,"top_left_y":932,"width":1571,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29f989a91f814747b90b4a6d20bc75fe","type":"text","conversion_output":true,"text":"assumption is not likely hold over the 60 -month follow-up time. Third, recent research has shown that","text_display":" assumption is not likely hold over the 60 -month follow-up time. Third, recent research has shown that","confidence":0.8740234375,"confidence_rate":0.9987766753512703},{"cnt":[[309,975],[1775,975],[1775,1021],[309,1021]],"region":{"top_left_x":309,"top_left_y":975,"width":1466,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"845e54a33227408bad74300817a9a6a1","type":"text","conversion_output":true,"text":"it's possible for patients with uterovaginal prolapse to move in and out of \"treatment failure\" as","text_display":" it's possible for patients with uterovaginal prolapse to move in and out of \"treatment failure\" as","confidence":1,"confidence_rate":1},{"cnt":[[309,1018],[1785,1018],[1785,1063],[309,1063]],"region":{"top_left_x":309,"top_left_y":1018,"width":1477,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f42615ef55044f9ab092b12bfcd6268b","type":"text","conversion_output":true,"text":"defined above, such that these repeated failures are ignored in the defined analysis. The analysis","text_display":" defined above, such that these repeated failures are ignored in the defined analysis. The analysis","confidence":1,"confidence_rate":1},{"cnt":[[309,1061],[1079,1061],[1079,1111],[309,1111]],"region":{"top_left_x":309,"top_left_y":1061,"width":770,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6d37dc568b54b1d93e36a18c6936cae","type":"text","conversion_output":true,"text":"proposed are selected to address these limitations.","text_display":" proposed are selected to address these limitations.","confidence":1,"confidence_rate":1},{"cnt":[[309,1128],[1863,1128],[1863,1173],[309,1173]],"region":{"top_left_x":309,"top_left_y":1127,"width":1554,"height":47},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e96fa13fc4c4065a6930045641706f7","type":"text","conversion_output":true,"text":"The first two sections below describe a modified analytic approach that treat participants in a manner","text_display":"\n\nThe first two sections below describe a modified analytic approach that treat participants in a manner","confidence":0.9970722198486328,"confidence_rate":0.9999725978101793},{"cnt":[[309,1173],[1738,1173],[1738,1218],[309,1218]],"region":{"top_left_x":309,"top_left_y":1173,"width":1430,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f74f03e7f644442b4d48a9d298b7bc2","type":"text","conversion_output":true,"text":"consistent with the original analysis design in that study participants that meet the criteria for","text_display":" consistent with the original analysis design in that study participants that meet the criteria for","confidence":1,"confidence_rate":1},{"cnt":[[309,1216],[1813,1216],[1813,1261],[309,1261]],"region":{"top_left_x":309,"top_left_y":1216,"width":1505,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d669a24f8f1d4fbfb3fd5b2c630dc10c","type":"text","conversion_output":true,"text":"treatment failure a remain treatment failures until they are lost to follow-up or the study ends. The","text_display":" treatment failure a remain treatment failures until they are lost to follow-up or the study ends. The","confidence":1,"confidence_rate":1},{"cnt":[[309,1259],[1779,1259],[1779,1304],[309,1304]],"region":{"top_left_x":309,"top_left_y":1258,"width":1470,"height":47},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d1bb05514d640ea9832ee9dfc76d945","type":"text","conversion_output":true,"text":"proposed model-based and nonparametric analytic methods address interval censoring and non-","text_display":" proposed model-based and nonparametric analytic methods address interval censoring and non","confidence":1,"confidence_rate":1},{"cnt":[[309,1302],[1863,1302],[1863,1349],[309,1349]],"region":{"top_left_x":309,"top_left_y":1301,"width":1554,"height":49},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2215c2c211934172a789c50c0b81f7b5","type":"text","conversion_output":true,"text":"proportional hazards in the assessment of the study's primary hypothesis. The model-based approach","text_display":"proportional hazards in the assessment of the study's primary hypothesis. The model-based approach","confidence":1,"confidence_rate":1},{"cnt":[[309,1349],[1876,1349],[1876,1394],[309,1394]],"region":{"top_left_x":309,"top_left_y":1349,"width":1567,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0acc5788b984b01a37d70f5152e9396","type":"text","conversion_output":true,"text":"will serve as the primary analytic method for testing the efficacy of the two strategies for uterovaginal","text_display":" will serve as the primary analytic method for testing the efficacy of the two strategies for uterovaginal","confidence":1,"confidence_rate":1},{"cnt":[[309,1392],[1704,1392],[1704,1437],[309,1437]],"region":{"top_left_x":309,"top_left_y":1392,"width":1395,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c481307e44f4ed6a9913f0159706a0e","type":"text","conversion_output":true,"text":"prolapse as it can control for study design and potentially confounding variables, while the","text_display":" prolapse as it can control for study design and potentially confounding variables, while the","confidence":0.994140625,"confidence_rate":0.9999394182424789},{"cnt":[[309,1435],[1848,1435],[1848,1480],[309,1480]],"region":{"top_left_x":309,"top_left_y":1435,"width":1539,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de8781c1552e452a99e46f85d700f41c","type":"text","conversion_output":true,"text":"nonparametric method will serve a confirmatory role, particularly in the masked analysis as detailed","text_display":" nonparametric method will serve a confirmatory role, particularly in the masked analysis as detailed","confidence":1,"confidence_rate":1},{"cnt":[[309,1478],[1850,1478],[1850,1523],[309,1523]],"region":{"top_left_x":309,"top_left_y":1478,"width":1541,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6e649ee3fea4f16be0f9c85bc9bd0fa","type":"text","conversion_output":true,"text":"below. The third section focuses on modeling recurrent events to better understand the impact of the","text_display":" below. The third section focuses on modeling recurrent events to better understand the impact of the","confidence":1,"confidence_rate":1},{"cnt":[[309,1521],[1876,1521],[1876,1568],[309,1568]],"region":{"top_left_x":309,"top_left_y":1521,"width":1567,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e660ba4b78cf4304b5be7c703e51069f","type":"text","conversion_output":true,"text":"interventions over time. The analytic methods for estimating survival curves will first be conducted in","text_display":" interventions over time. The analytic methods for estimating survival curves will first be conducted in","confidence":1,"confidence_rate":1},{"cnt":[[309,1566],[1841,1566],[1841,1611],[309,1611]],"region":{"top_left_x":309,"top_left_y":1566,"width":1533,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e190b27861a4898af39f1af62eb0163","type":"text","conversion_output":true,"text":"a blinded fashion on all subjects, ignoring treatment assignment as a part of a masked analysis, then","text_display":" a blinded fashion on all subjects, ignoring treatment assignment as a part of a masked analysis, then","confidence":1,"confidence_rate":1},{"cnt":[[309,1611],[1480,1611],[1480,1656],[309,1656]],"region":{"top_left_x":309,"top_left_y":1611,"width":1172,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14cb9a08a1134db9aa5dfc9799e705bc","type":"text","conversion_output":true,"text":"comparing subjects randomized their interventions in an unmasked analysis.","text_display":" comparing subjects randomized their interventions in an unmasked analysis.","confidence":1,"confidence_rate":1},{"cnt":[[305,1676],[679,1676],[679,1723],[305,1723]],"region":{"top_left_x":305,"top_left_y":1675,"width":374,"height":49},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc74c43637684207802195b700fd9928","type":"section_header","conversion_output":false,"children_ids":["86af02ef8d5b4ec2a6faa1c064de4fcc"],"text":"","text_display":""},{"cnt":[[309,1676],[677,1676],[677,1721],[309,1721]],"region":{"top_left_x":309,"top_left_y":1675,"width":368,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86af02ef8d5b4ec2a6faa1c064de4fcc","type":"text","conversion_output":true,"parent_id":"bc74c43637684207802195b700fd9928","text":"Model-based analysis:","text_display":"\n\n\\section*{Model-based analysis:}","confidence":1,"confidence_rate":1},{"cnt":[[309,1740],[1687,1740],[1687,1785],[309,1785]],"region":{"top_left_x":309,"top_left_y":1740,"width":1378,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c654d9527c1f41aaa963f926c9cf6292","type":"text","conversion_output":true,"text":"To appropriately account for the interval censored nature of the follow-up data, where the","text_display":"\n\nTo appropriately account for the interval censored nature of the follow-up data, where the","confidence":1,"confidence_rate":1},{"cnt":[[309,1783],[1790,1783],[1790,1828],[309,1828]],"region":{"top_left_x":309,"top_left_y":1783,"width":1481,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6832c557f6d34302862b51812d87bc4e","type":"text","conversion_output":true,"text":"proportional hazards assumption is unlikely to hold, and control for study design and potentially","text_display":" proportional hazards assumption is unlikely to hold, and control for study design and potentially","confidence":1,"confidence_rate":1},{"cnt":[[309,1828],[1790,1828],[1790,1876],[309,1876]],"region":{"top_left_x":309,"top_left_y":1828,"width":1481,"height":48},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39a18c86f33744aebf5d7e709e9d5ed5","type":"text","conversion_output":true,"text":"confounding variables in assessing intervention effects, a piecewise exponential (PWE) survival","text_display":" confounding variables in assessing intervention effects, a piecewise exponential (PWE) survival","confidence":1,"confidence_rate":1},{"cnt":[[309,1869],[1830,1869],[1830,1916],[309,1916]],"region":{"top_left_x":309,"top_left_y":1869,"width":1522,"height":48},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a03147e257e4fd09037d448aeeadbf5","type":"text","conversion_output":true,"text":"model with mixed effects will be employed. The PWE survival model is a model in which the time","text_display":" model with mixed effects will be employed. The PWE survival model is a model in which the time","confidence":1,"confidence_rate":1},{"cnt":[[309,1914],[1871,1914],[1871,1962],[309,1962]],"region":{"top_left_x":309,"top_left_y":1914,"width":1563,"height":48},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c1588099a3d45248e3e10405695d3b8","type":"text","conversion_output":true,"text":"scale is divided into \\(K\\) periods and the baseline hazard function, \\(h(t)\\), is assumed to be constant within","text_display":" scale is divided into \\(K\\) periods and the baseline hazard function, \\(h(t)\\), is assumed to be constant within","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[309,1959],[1794,1959],[1794,2004],[309,2004]],"region":{"top_left_x":309,"top_left_y":1959,"width":1485,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62c260ee67b346af915f1d1f4367ba28","type":"text","conversion_output":true,"text":"each period such that \\(h(t)=\\lambda_{k} \\exp (\\beta X )\\), where \\(\\lambda_{k}\\) is the hazard function for period \\(k, X\\) matrix of","text_display":" each period such that \\(h(t)=\\lambda_{k} \\exp (\\beta X )\\), where \\(\\lambda_{k}\\) is the hazard function for period \\(k, X\\) matrix of","confidence":0.9990236759185791,"confidence_rate":0.9999926000198329},{"cnt":[[309,2002],[1863,2002],[1863,2050],[309,2050]],"region":{"top_left_x":309,"top_left_y":2002,"width":1554,"height":48},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5377cccff05b44b88ec6921c48bdc1af","type":"text","conversion_output":true,"text":"explanatory variables with vector \\(\\beta\\) coefficients (Breslow 1974). This piecewise approach effectively","text_display":" explanatory variables with vector \\(\\beta\\) coefficients (Breslow 1974). This piecewise approach effectively","confidence":1,"confidence_rate":1},{"cnt":[[309,2047],[1811,2047],[1811,2093],[309,2093]],"region":{"top_left_x":309,"top_left_y":2047,"width":1503,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee2df059c99441219990c34a104bbd0a","type":"text","conversion_output":true,"text":"eliminates the need to specify the distribution of the hazard function and satisfies the proportional","text_display":" eliminates the need to specify the distribution of the hazard function and satisfies the proportional","confidence":1,"confidence_rate":1},{"cnt":[[309,2093],[1824,2093],[1824,2138],[309,2138]],"region":{"top_left_x":309,"top_left_y":2092,"width":1516,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d408485b88e24abbba3716780ac70e2f","type":"text","conversion_output":true,"text":"hazards assumption if the baseline hazard is constant within each period. The PWE survival model","text_display":" hazards assumption if the baseline hazard is constant within each period. The PWE survival model","confidence":1,"confidence_rate":1},{"cnt":[[309,2136],[1785,2136],[1785,2181],[309,2181]],"region":{"top_left_x":309,"top_left_y":2135,"width":1477,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2808c15a8e574fb1aa3801ca0b75d73b","type":"text","conversion_output":true,"text":"has been shown to be equivalent to a Poisson regression model if the baseline hazard function is","text_display":" has been shown to be equivalent to a Poisson regression model if the baseline hazard function is","confidence":1,"confidence_rate":1},{"cnt":[[309,2179],[1846,2179],[1846,2224],[309,2224]],"region":{"top_left_x":309,"top_left_y":2178,"width":1537,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af23d94551ff40b79ecec0cb50ec163a","type":"text","conversion_output":true,"text":"constant as a function of time [i.e. \\(h(t)=\\lambda(t)=\\lambda\\) ] (Laird \\& Olivier, 1981). This means that the PWE","text_display":" constant as a function of time [i.e. \\(h(t)=\\lambda(t)=\\lambda\\) ] (Laird \\& Olivier, 1981). This means that the PWE","confidence":0.9951210021972656,"confidence_rate":0.9999542913346826},{"cnt":[[309,2221],[1852,2221],[1852,2269],[309,2269]],"region":{"top_left_x":309,"top_left_y":2221,"width":1543,"height":48},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c1f77a03521421e97faec1ff2e3c107","type":"text","conversion_output":true,"text":"survival model can be fitted with a generalized linear mixed model (GLMM) by taking survival data","text_display":" survival model can be fitted with a generalized linear mixed model (GLMM) by taking survival data","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[309,2269],[1846,2269],[1846,2314],[309,2314]],"region":{"top_left_x":309,"top_left_y":2268,"width":1537,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"486a75f5a0bb49029ec93b7429936296","type":"text","conversion_output":true,"text":"consisting of observed survival time \\(t_{i}\\) for the \\(i\\)-th subject with a treatment failure indicator \\(d_{i}\\) within","text_display":" consisting of observed survival time \\(t_{i}\\) for the \\(i\\)-th subject with a treatment failure indicator \\(d_{i}\\) within","confidence":1,"confidence_rate":1},{"cnt":[[309,2312],[1854,2312],[1854,2357],[309,2357]],"region":{"top_left_x":309,"top_left_y":2311,"width":1546,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f13acf3880084583b96ef089bad3639c","type":"text","conversion_output":true,"text":"the \\(k\\)-th period, so that \\(t_{i k}\\) denotes survival time and \\(d_{i k}\\) the occurrence of treatment failure for the \\(i\\)-th","text_display":" the \\(k\\)-th period, so that \\(t_{i k}\\) denotes survival time and \\(d_{i k}\\) the occurrence of treatment failure for the \\(i\\)-th","confidence":0.9975595474243164,"confidence_rate":0.9999825470427767},{"cnt":[[309,2355],[1828,2355],[1828,2400],[309,2400]],"region":{"top_left_x":309,"top_left_y":2354,"width":1520,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"677850ea2ea545b6b8c68fc7b802d7bc","type":"text","conversion_output":true,"text":"subject in period \\(k\\), creating a number of pseudo-observations, one for each combination of subject","text_display":" subject in period \\(k\\), creating a number of pseudo-observations, one for each combination of subject","confidence":1,"confidence_rate":1},{"cnt":[[309,2398],[1843,2398],[1843,2445],[309,2445]],"region":{"top_left_x":309,"top_left_y":2397,"width":1535,"height":48},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34dc72b694f84f259c83ef1aa2b65360","type":"text","conversion_output":true,"text":"and period. A PWE survival model can then be fit by handling treatment failure indicators as if they","text_display":" and period. A PWE survival model can then be fit by handling treatment failure indicators as if they","confidence":1,"confidence_rate":1},{"cnt":[[309,2445],[1858,2445],[1858,2490],[309,2490]],"region":{"top_left_x":309,"top_left_y":2444,"width":1550,"height":47},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42becc489a4c49bcb029d51f0c3cb295","type":"text","conversion_output":true,"text":"were Poisson observations with means \\(\\mu_{i k}=\\lambda_{i k} t_{i k}\\), where \\(\\lambda_{i k}\\) is the hazard for the \\(i\\)-th subject in period","text_display":" were Poisson observations with means \\(\\mu_{i k}=\\lambda_{i k} t_{i k}\\), where \\(\\lambda_{i k}\\) is the hazard for the \\(i\\)-th subject in period","confidence":0.99951171875,"confidence_rate":0.9999966775531512},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":52,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bae582db59294457812b81e45f2ca137","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 28","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-30","page":30,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1101bdb11dbe46f0af1f0ab365ae1579","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"09fd6ee89f2e4995b6765c0e80bec9d9","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[307,314],[1755,314],[1755,359],[307,359]],"region":{"top_left_x":307,"top_left_y":313,"width":1449,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2bb4759977e04d6a915f442a680a42d3","type":"text","conversion_output":true,"text":"\\(k\\). Also needed is an offset variable denoting a logarithm of the time at risk during each period","text_display":"\n\\(k\\). Also needed is an offset variable denoting a logarithm of the time at risk during each period","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[305,357],[1824,357],[1824,404],[305,404]],"region":{"top_left_x":305,"top_left_y":356,"width":1520,"height":48},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d834a9c77b54151bc25f0b5440f3d51","type":"text","conversion_output":true,"text":"(Crowther et al., 2012). It is important to note that PWE survival models do not assume that the \\(d_{i k}\\)","text_display":" (Crowther et al., 2012). It is important to note that PWE survival models do not assume that the \\(d_{i k}\\)","confidence":1,"confidence_rate":1},{"cnt":[[305,404],[1803,404],[1803,449],[305,449]],"region":{"top_left_x":305,"top_left_y":403,"width":1498,"height":47},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0b79654c69924ff5a608f2531a4d3f8c","type":"text","conversion_output":true,"text":"have independent Poisson distributions as a subject who has treatment failure in period \\(k(i)\\), must","text_display":" have independent Poisson distributions as a subject who has treatment failure in period \\(k(i)\\), must","confidence":0.9990236759185791,"confidence_rate":0.999990871060396},{"cnt":[[305,447],[1858,447],[1858,492],[305,492]],"region":{"top_left_x":305,"top_left_y":446,"width":1554,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91ab770422e3413ca2ea939786e21a08","type":"text","conversion_output":true,"text":"have had no failure in all prior periods. Rather, each \\(i\\)-th subject across period covariance is modeled","text_display":" have had no failure in all prior periods. Rather, each \\(i\\)-th subject across period covariance is modeled","confidence":1,"confidence_rate":1},{"cnt":[[305,492],[827,492],[827,531],[305,531]],"region":{"top_left_x":305,"top_left_y":491,"width":523,"height":40},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"233ffdce327f43d3b06b75845334f9a7","type":"text","conversion_output":true,"text":"as a random effect in the GLMM.","text_display":" as a random effect in the GLMM.","confidence":1,"confidence_rate":1},{"cnt":[[305,554],[1809,554],[1809,602],[305,602]],"region":{"top_left_x":305,"top_left_y":554,"width":1504,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b0f684c75b641979ac2d73e049eb7e1","type":"text","conversion_output":true,"text":"The GLMM of the PWE survival model will be is specified with (1) a Poisson distribution, (2) an","text_display":"\n\nThe GLMM of the PWE survival model will be is specified with (1) a Poisson distribution, (2) an","confidence":1,"confidence_rate":1},{"cnt":[[305,602],[1811,602],[1811,647],[305,647]],"region":{"top_left_x":305,"top_left_y":601,"width":1507,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8edc65e8094f447b9a741edefb741d2f","type":"text","conversion_output":true,"text":"offset variable denoting the logarithm of the exposure time during a given period, and (3) subject-","text_display":" offset variable denoting the logarithm of the exposure time during a given period, and (3) subject","confidence":0.56201171875,"confidence_rate":0.994474623496349},{"cnt":[[305,645],[1798,645],[1798,690],[305,690]],"region":{"top_left_x":305,"top_left_y":644,"width":1494,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8733260e2cca4103ac4c5c3feb0cdb65","type":"text","conversion_output":true,"text":"specific random intercepts to incorporate within-subject homogeneity, using the SAS GLIMMIX","text_display":"specific random intercepts to incorporate within-subject homogeneity, using the SAS GLIMMIX","confidence":1,"confidence_rate":1},{"cnt":[[305,688],[1837,688],[1837,733],[305,733]],"region":{"top_left_x":305,"top_left_y":687,"width":1532,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"027b4b92d6444fa9813b9c22f6ad8a6b","type":"text","conversion_output":true,"text":"procedure in SAS STAT version 14.2 (SAS Institute Inc. 2016). The study's follow-up time will be","text_display":" procedure in SAS STAT version 14.2 (SAS Institute Inc. 2016). The study's follow-up time will be","confidence":1,"confidence_rate":1},{"cnt":[[305,730],[1820,730],[1820,776],[305,776]],"region":{"top_left_x":305,"top_left_y":730,"width":1515,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56750309fe4147df94ae4575b88bc9af","type":"text","conversion_output":true,"text":"divided into three periods: first, before and up to 12 -months; second, 13 months to 30 months; and","text_display":" divided into three periods: first, before and up to 12 -months; second, 13 months to 30 months; and","confidence":0.99560546875,"confidence_rate":0.9999610254003707},{"cnt":[[305,776],[1871,776],[1871,819],[305,819]],"region":{"top_left_x":305,"top_left_y":775,"width":1567,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9de7170e87a74553b29f7cc37baab0c7","type":"text","conversion_output":true,"text":"third, 31 months and beyond. The choice cut points will be evaluated during the masked analysis with","text_display":" third, 31 months and beyond. The choice cut points will be evaluated during the masked analysis with","confidence":1,"confidence_rate":1},{"cnt":[[305,819],[1846,819],[1846,864],[305,864]],"region":{"top_left_x":305,"top_left_y":818,"width":1541,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7eebf6ed5dc7434988d60102ba009ab5","type":"text","conversion_output":true,"text":"a plot of the NPMLE survival function (described below) and adjusted if necessary. As it is possible","text_display":" a plot of the NPMLE survival function (described below) and adjusted if necessary. As it is possible","confidence":1,"confidence_rate":1},{"cnt":[[305,864],[1798,864],[1798,909],[305,909]],"region":{"top_left_x":305,"top_left_y":863,"width":1494,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a4d3a506a654b79a0126043997b61c6","type":"text","conversion_output":true,"text":"for subjects to have a right censored treatment failure at the beginning of a period, resulting in an","text_display":" for subjects to have a right censored treatment failure at the beginning of a period, resulting in an","confidence":1,"confidence_rate":1},{"cnt":[[305,907],[1871,907],[1871,952],[305,952]],"region":{"top_left_x":305,"top_left_y":906,"width":1567,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cbca29b4c0d44e08cb6ba96e2961431","type":"text","conversion_output":true,"text":"exposure time of zero and a offset variable that is undefined, subjects experiencing a treatment failure","text_display":" exposure time of zero and a offset variable that is undefined, subjects experiencing a treatment failure","confidence":1,"confidence_rate":1},{"cnt":[[305,950],[1785,950],[1785,995],[305,995]],"region":{"top_left_x":305,"top_left_y":949,"width":1481,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f4c9bffcf9e407cbacfc92ea8e49450","type":"text","conversion_output":true,"text":"at the beginning of a given period will be assigned an exposure time of 0.5 months and an offset","text_display":" at the beginning of a given period will be assigned an exposure time of 0.5 months and an offset","confidence":1,"confidence_rate":1},{"cnt":[[305,993],[1775,993],[1775,1040],[305,1040]],"region":{"top_left_x":305,"top_left_y":992,"width":1470,"height":48},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"045b47794b184b15aaf73c246eb0bea4","type":"text","conversion_output":true,"text":"variable of \\(\\log (0.5)\\). The unmasked analysis will use the GLMM specified above to generate an","text_display":" variable of \\(\\log (0.5)\\). The unmasked analysis will use the GLMM specified above to generate an","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1835,1040],[1835,1085],[305,1085]],"region":{"top_left_x":305,"top_left_y":1039,"width":1530,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b1a6d8e5df349fe8afdb5961e5192a5","type":"text","conversion_output":true,"text":"overall test of the failure hazard ratio across the two interventions using a two-sided hypothesis test","text_display":" overall test of the failure hazard ratio across the two interventions using a two-sided hypothesis test","confidence":1,"confidence_rate":1},{"cnt":[[305,1083],[1811,1083],[1811,1128],[305,1128]],"region":{"top_left_x":305,"top_left_y":1082,"width":1507,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"03dcd7f2ff7d4212828788a4dd141ee5","type":"text","conversion_output":true,"text":"with an overall type I error rate of 0.05 , controlling for the design variables of site the subject was","text_display":" with an overall type I error rate of 0.05 , controlling for the design variables of site the subject was","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[305,1126],[1846,1126],[1846,1171],[305,1171]],"region":{"top_left_x":305,"top_left_y":1125,"width":1541,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4293bdc6c3ec4a3088f43da4906b6d36","type":"text","conversion_output":true,"text":"recruited into. Also, the point and interval estimates of 12-, 24- and 36-month treatment failure rates","text_display":" recruited into. Also, the point and interval estimates of 12-, 24- and 36-month treatment failure rates","confidence":0.9412307739257812,"confidence_rate":0.9994393523495799},{"cnt":[[305,1171],[1846,1171],[1846,1214],[305,1214]],"region":{"top_left_x":305,"top_left_y":1170,"width":1541,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17973383ab504f0ab72cf673f55d1290","type":"text","conversion_output":true,"text":"on each intervention arm as well as hazard ratios between the two arms will be provided. Additional","text_display":" on each intervention arm as well as hazard ratios between the two arms will be provided. Additional","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1828,1216],[1828,1261],[305,1261]],"region":{"top_left_x":305,"top_left_y":1216,"width":1524,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fbdd12da67cb4c069a672b4a90a8b3b7","type":"text","conversion_output":true,"text":"models will be used to evaluate potentially confounding variables of subject age and prior prolapse","text_display":" models will be used to evaluate potentially confounding variables of subject age and prior prolapse","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[305,1263],[438,1263],[438,1304],[305,1304]],"region":{"top_left_x":305,"top_left_y":1263,"width":134,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"199ac523ef534c06ba6a538a19c75d75","type":"text","conversion_output":true,"text":"surgery.","text_display":" surgery.","confidence":1,"confidence_rate":1},{"cnt":[[305,1319],[720,1319],[720,1373],[305,1373]],"region":{"top_left_x":305,"top_left_y":1319,"width":415,"height":54},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77b23abdb47b49718e45326f0259e1ff","type":"section_header","conversion_output":false,"children_ids":["68d54d652470490f8ab684457082b44e"],"text":"","text_display":""},{"cnt":[[305,1323],[715,1323],[715,1369],[305,1369]],"region":{"top_left_x":305,"top_left_y":1323,"width":411,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68d54d652470490f8ab684457082b44e","type":"text","conversion_output":true,"parent_id":"77b23abdb47b49718e45326f0259e1ff","text":"Nonparametric analysis:","text_display":"\n\n\\section*{Nonparametric analysis:}","confidence":1,"confidence_rate":1},{"cnt":[[305,1388],[1777,1388],[1777,1433],[305,1433]],"region":{"top_left_x":305,"top_left_y":1387,"width":1472,"height":47},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0a4e5ea85b743c7b280340586cb7f51","type":"text","conversion_output":true,"text":"This analysis will employ nonparametric maximum likelihood estimation (NPMLE) to estimate","text_display":"\n\nThis analysis will employ nonparametric maximum likelihood estimation (NPMLE) to estimate","confidence":1,"confidence_rate":1},{"cnt":[[305,1431],[1863,1431],[1863,1476],[305,1476]],"region":{"top_left_x":305,"top_left_y":1430,"width":1558,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d970449871344db3ba4428eda8d6925d","type":"text","conversion_output":true,"text":"survival functions in a similar manner as the Kaplan-Meier estimator for right censored data, but also","text_display":" survival functions in a similar manner as the Kaplan-Meier estimator for right censored data, but also","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[305,1474],[1815,1474],[1815,1521],[305,1521]],"region":{"top_left_x":305,"top_left_y":1473,"width":1511,"height":49},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"782fb141850d492f9bff869a453edc65","type":"text","conversion_output":true,"text":"employs a combination of the EM and iterative convex minorant (ICM) algorithms to estimate the","text_display":" employs a combination of the EM and iterative convex minorant (ICM) algorithms to estimate the","confidence":1,"confidence_rate":1},{"cnt":[[305,1521],[1777,1521],[1777,1566],[305,1566]],"region":{"top_left_x":305,"top_left_y":1521,"width":1472,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"680c0bc292a444e5a28460b8a8f1f2fd","type":"text","conversion_output":true,"text":"survival function in non-overlapping intervals (Wellner and Zhan, 1997). Standard errors of the","text_display":" survival function in non-overlapping intervals (Wellner and Zhan, 1997). Standard errors of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1564],[1858,1564],[1858,1609],[305,1609]],"region":{"top_left_x":305,"top_left_y":1564,"width":1554,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49d4b2b2aa5642d1939dffb57636f7a2","type":"text","conversion_output":true,"text":"survival curves and the covariance matrix for the generalized rank statistic will be generated with the","text_display":" survival curves and the covariance matrix for the generalized rank statistic will be generated with the","confidence":1,"confidence_rate":1},{"cnt":[[305,1607],[1830,1607],[1830,1652],[305,1652]],"region":{"top_left_x":305,"top_left_y":1607,"width":1526,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1898722575fe416da195af4b7c47b1bc","type":"text","conversion_output":true,"text":"multiple imputation method developed by Sun (2001). The overall test for the difference in the two","text_display":" multiple imputation method developed by Sun (2001). The overall test for the difference in the two","confidence":0.67578125,"confidence_rate":0.9962025117748654},{"cnt":[[305,1650],[1833,1650],[1833,1695],[305,1695]],"region":{"top_left_x":305,"top_left_y":1649,"width":1528,"height":47},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fcf9e2b08714249ad0c05d3df1e96e3","type":"text","conversion_output":true,"text":"interventions survival curves will be conducted with the generalized log-rank test (Huang, Lee, and","text_display":" interventions survival curves will be conducted with the generalized log-rank test (Huang, Lee, and","confidence":1,"confidence_rate":1},{"cnt":[[305,1695],[1828,1695],[1828,1740],[305,1740]],"region":{"top_left_x":305,"top_left_y":1695,"width":1524,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ebcda5ca1cf4022b375a08714a734c3","type":"text","conversion_output":true,"text":"Yu, 2008). In addition, point estimates and \\(95 \\%\\) confidence limits will be estimated at \\(12-\\), 24 - and","text_display":" Yu, 2008). In addition, point estimates and \\(95 \\%\\) confidence limits will be estimated at \\(12-\\), 24 - and","confidence":0.676984602516775,"confidence_rate":0.9966135145117545},{"cnt":[[305,1740],[1837,1740],[1837,1785],[305,1785]],"region":{"top_left_x":305,"top_left_y":1740,"width":1532,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bcbf8a3ff1eb4ea583d32ef0b174c791","type":"text","conversion_output":true,"text":"36-month intervals. The nonparametric survival analysis methods detailed above will be carried out","text_display":" 36-month intervals. The nonparametric survival analysis methods detailed above will be carried out","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[305,1783],[1824,1783],[1824,1828],[305,1828]],"region":{"top_left_x":305,"top_left_y":1783,"width":1520,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5b4a2084e694375bf8820b58bcc8c0a","type":"text","conversion_output":true,"text":"using the ICLIFETEST procedure. The advantage of this approach is that it makes no assumptions","text_display":" using the ICLIFETEST procedure. The advantage of this approach is that it makes no assumptions","confidence":1,"confidence_rate":1},{"cnt":[[305,1826],[1828,1826],[1828,1871],[305,1871]],"region":{"top_left_x":305,"top_left_y":1826,"width":1524,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc5dca371ac544e191d0e001fe56d0f3","type":"text","conversion_output":true,"text":"about the distribution of the interval centered data and permits estimated survival curves to be non-","text_display":" about the distribution of the interval centered data and permits estimated survival curves to be non","confidence":1,"confidence_rate":1},{"cnt":[[305,1869],[1850,1869],[1850,1914],[305,1914]],"region":{"top_left_x":305,"top_left_y":1869,"width":1545,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39e07ed2685547f8b8215374aaed7ec5","type":"text","conversion_output":true,"text":"monotonic (no proportional hazards assumption), although it is unable to adjust for study design and","text_display":"monotonic (no proportional hazards assumption), although it is unable to adjust for study design and","confidence":1,"confidence_rate":1},{"cnt":[[305,1914],[1850,1914],[1850,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1914,"width":1545,"height":48},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9109408021d441328f9f57095fd6cbd7","type":"text","conversion_output":true,"text":"potential confounders. This analysis will primarily be used to confirm the results of the model-based","text_display":" potential confounders. This analysis will primarily be used to confirm the results of the model-based","confidence":1,"confidence_rate":1},{"cnt":[[305,1959],[1783,1959],[1783,2004],[305,2004]],"region":{"top_left_x":305,"top_left_y":1959,"width":1479,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a436eb2d7a84eeeb69ff99426d52fc5","type":"text","conversion_output":true,"text":"analysis, particularly the specification of the piecewise survival function in the masked analysis.","text_display":" analysis, particularly the specification of the piecewise survival function in the masked analysis.","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[305,2022],[958,2022],[958,2073],[305,2073]],"region":{"top_left_x":305,"top_left_y":2021,"width":654,"height":53},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aadb3542a18c44edb98be6d1bb800e02","type":"section_header","conversion_output":false,"children_ids":["de15fed801314dacb1748553b2ef903d"],"text":"","text_display":""},{"cnt":[[305,2024],[956,2024],[956,2069],[305,2069]],"region":{"top_left_x":305,"top_left_y":2023,"width":652,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de15fed801314dacb1748553b2ef903d","type":"text","conversion_output":true,"parent_id":"aadb3542a18c44edb98be6d1bb800e02","text":"Analysis of multiple treatment failures:","text_display":"\n\n\\section*{Analysis of multiple treatment failures:}","confidence":1,"confidence_rate":1},{"cnt":[[305,2088],[1768,2088],[1768,2133],[305,2133]],"region":{"top_left_x":305,"top_left_y":2088,"width":1464,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdf3ccc9df324037b17fb19f04c0f639","type":"text","conversion_output":true,"text":"Data from other trials that emerged after this study was designed have shown that patients with","text_display":"\n\nData from other trials that emerged after this study was designed have shown that patients with","confidence":1,"confidence_rate":1},{"cnt":[[305,2133],[1863,2133],[1863,2176],[305,2176]],"region":{"top_left_x":305,"top_left_y":2133,"width":1558,"height":44},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8af4dd8d380e4cc3b247640c44ee1b8f","type":"text","conversion_output":true,"text":"uterovaginal prolapse can move in and out of the state of \"treatment failure\" after surgical repair, and","text_display":" uterovaginal prolapse can move in and out of the state of \"treatment failure\" after surgical repair, and","confidence":1,"confidence_rate":1},{"cnt":[[305,2176],[1863,2176],[1863,2221],[305,2221]],"region":{"top_left_x":305,"top_left_y":2176,"width":1558,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0e1dfbbee76418cb7e0279d27b82c8f","type":"text","conversion_output":true,"text":"that the standard survival methods employed above ignore these repeated events; as such the survival","text_display":" that the standard survival methods employed above ignore these repeated events; as such the survival","confidence":1,"confidence_rate":1},{"cnt":[[305,2221],[1867,2221],[1867,2267],[305,2267]],"region":{"top_left_x":305,"top_left_y":2221,"width":1562,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a0a419d0ad845f6bcb3e8184d357418","type":"text","conversion_output":true,"text":"approach may underestimate the impact of the interventions in the treatment of uterovaginal prolapse.","text_display":" approach may underestimate the impact of the interventions in the treatment of uterovaginal prolapse.","confidence":1,"confidence_rate":1},{"cnt":[[305,2264],[1820,2264],[1820,2310],[305,2310]],"region":{"top_left_x":305,"top_left_y":2264,"width":1515,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d9e08fb9cf7455cbe6ee3dd99fe446e","type":"text","conversion_output":true,"text":"This concern is specifically relevant for the treatment failure criteria anatomic failure and reported","text_display":" This concern is specifically relevant for the treatment failure criteria anatomic failure and reported","confidence":1,"confidence_rate":1},{"cnt":[[305,2307],[1854,2307],[1854,2353],[305,2353]],"region":{"top_left_x":305,"top_left_y":2307,"width":1550,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff7ce5b339ad47a58f628e4966271490","type":"text","conversion_output":true,"text":"bothersome vaginal bulge symptoms, which are measured repeatedly at each of the follow-ups while","text_display":" bothersome vaginal bulge symptoms, which are measured repeatedly at each of the follow-ups while","confidence":1,"confidence_rate":1},{"cnt":[[305,2350],[1850,2350],[1850,2396],[305,2396]],"region":{"top_left_x":305,"top_left_y":2350,"width":1545,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc715ebf823d4f858054bfd445f08d90","type":"text","conversion_output":true,"text":"retreatment with surgery or pessary result in a permanent failure. Below are two analytic approaches","text_display":" retreatment with surgery or pessary result in a permanent failure. Below are two analytic approaches","confidence":1,"confidence_rate":1},{"cnt":[[305,2396],[1800,2396],[1800,2443],[305,2443]],"region":{"top_left_x":305,"top_left_y":2395,"width":1496,"height":48},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44ecb7551dba40eca3820f3c4a0fbbb8","type":"text","conversion_output":true,"text":"that focus on answering two questions that may be of practical interest to clinicians: (1) is there a","text_display":" that focus on answering two questions that may be of practical interest to clinicians: (1) is there a","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[305,2441],[1742,2441],[1742,2486],[305,2486]],"region":{"top_left_x":305,"top_left_y":2440,"width":1438,"height":46},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15bb3ca0c7454261a4e10641192a6e39","type":"text","conversion_output":true,"text":"difference in the prevalence of subjects meeting failure criteria (anatomic failure, bothersome","text_display":" difference in the prevalence of subjects meeting failure criteria (anatomic failure, bothersome","confidence":1,"confidence_rate":1},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":52,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9b7a2481f5764f67824e2149c337921d","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 29","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-31","page":31,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"69327aa139c341a0bb8fc60ed97939d7","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4781e000755e4e519b016840610a1bb5","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,316],[1841,316],[1841,359],[309,359]],"region":{"top_left_x":309,"top_left_y":315,"width":1533,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"338cb60cdb484d80b88520efe476a2ed","type":"text","conversion_output":true,"text":"symptoms or retreatment) at 12-, 24- and 36- month follow-up times between the interventions; and","text_display":"\nsymptoms or retreatment) at 12-, 24- and 36- month follow-up times between the interventions; and","confidence":0.7975787760119601,"confidence_rate":0.9977850578820442},{"cnt":[[309,357],[1863,357],[1863,402],[309,402]],"region":{"top_left_x":309,"top_left_y":356,"width":1554,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3a7ec60ebe84f629fbfac063c1cb451","type":"text","conversion_output":true,"text":"(2) is there a difference in the rates of anatomic failure and bothersome bulge symptoms over follow-","text_display":" (2) is there a difference in the rates of anatomic failure and bothersome bulge symptoms over follow","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[309,404],[909,404],[909,449],[309,449]],"region":{"top_left_x":309,"top_left_y":403,"width":600,"height":47},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2829d43a0b594113be46872194ebd2d2","type":"text","conversion_output":true,"text":"up time between the two interventions.","text_display":"up time between the two interventions.","confidence":1,"confidence_rate":1},{"cnt":[[309,468],[1833,468],[1833,513],[309,513]],"region":{"top_left_x":309,"top_left_y":468,"width":1524,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20cbc9ea110e4018a1f02d22021c8ee3","type":"text","conversion_output":true,"text":"For the first question, at 12-, 24- and 36-month follow-up times, the proportion of subjects meeting","text_display":"\n\nFor the first question, at 12-, 24- and 36-month follow-up times, the proportion of subjects meeting","confidence":0.9410028182901442,"confidence_rate":0.9994210329575043},{"cnt":[[309,511],[1878,511],[1878,556],[309,556]],"region":{"top_left_x":309,"top_left_y":511,"width":1569,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25cd7891a94d4835b52173ae8d71663c","type":"text","conversion_output":true,"text":"specific failure criteria (anatomic failure, bothersome bulge symptoms, retreatment, no failure) will be","text_display":" specific failure criteria (anatomic failure, bothersome bulge symptoms, retreatment, no failure) will be","confidence":1,"confidence_rate":1},{"cnt":[[309,556],[1841,556],[1841,599],[309,599]],"region":{"top_left_x":309,"top_left_y":556,"width":1533,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b6455d7ce7848a4ac0cb3ccc93ac9cd","type":"text","conversion_output":true,"text":"compared across intervention groups using the Fisher-Freeman-Halton's exact test for r c tables as","text_display":" compared across intervention groups using the Fisher-Freeman-Halton's exact test for r c tables as","confidence":0.4577424901071936,"confidence_rate":0.9929846466956798},{"cnt":[[309,602],[1828,602],[1828,647],[309,647]],"region":{"top_left_x":309,"top_left_y":601,"width":1520,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aafcf46a5e7e48ff9bd28bc68ef97c8a","type":"text","conversion_output":true,"text":"proportion of subjects receiving retreatment will likely be small (Lydersen et al. 2007). If a subject","text_display":" proportion of subjects receiving retreatment will likely be small (Lydersen et al. 2007). If a subject","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[309,645],[1687,645],[1687,690],[309,690]],"region":{"top_left_x":309,"top_left_y":644,"width":1378,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb2c7414ce174867a66043d4288c865b","type":"text","conversion_output":true,"text":"meets more than one failure criteria, she will be classified as follows: retreatment and any","text_display":" meets more than one failure criteria, she will be classified as follows: retreatment and any","confidence":1,"confidence_rate":1},{"cnt":[[309,688],[1871,688],[1871,733],[309,733]],"region":{"top_left_x":309,"top_left_y":687,"width":1563,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f61bdefd9b9f4b6097cefef802d91dc6","type":"text","conversion_output":true,"text":"combination of anatomic failure and bothersome bulge symptoms will be classified as retreatment; no","text_display":" combination of anatomic failure and bothersome bulge symptoms will be classified as retreatment; no","confidence":1,"confidence_rate":1},{"cnt":[[309,733],[1858,733],[1858,776],[309,776]],"region":{"top_left_x":309,"top_left_y":732,"width":1550,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e5d3f723e6a4f2fbdebb2c062527d60","type":"text","conversion_output":true,"text":"retreatment but both anatomic failure and bothersome bulge symptoms will be classified as anatomic","text_display":" retreatment but both anatomic failure and bothersome bulge symptoms will be classified as anatomic","confidence":1,"confidence_rate":1},{"cnt":[[309,776],[1828,776],[1828,819],[309,819]],"region":{"top_left_x":309,"top_left_y":775,"width":1520,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f08fa674df874243a4c4019f3daa7b52","type":"text","conversion_output":true,"text":"failure. Additionally, within each follow-up time, the odds of subjects being classified as treatment","text_display":" failure. Additionally, within each follow-up time, the odds of subjects being classified as treatment","confidence":1,"confidence_rate":1},{"cnt":[[309,821],[1828,821],[1828,862],[309,862]],"region":{"top_left_x":309,"top_left_y":820,"width":1520,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35aa280edfb34b7eb2d16d56beb90441","type":"text","conversion_output":true,"text":"failures at that follow-up time (not being retained as failures if they met failure criteria at an earlier","text_display":" failures at that follow-up time (not being retained as failures if they met failure criteria at an earlier","confidence":1,"confidence_rate":1},{"cnt":[[309,864],[1867,864],[1867,907],[309,907]],"region":{"top_left_x":309,"top_left_y":863,"width":1558,"height":44},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4f2c30f40954f319582a743de4c3ba4","type":"text","conversion_output":true,"text":"follow-up) will be compared across treatment groups with logistic regression models that will control","text_display":" follow-up) will be compared across treatment groups with logistic regression models that will control","confidence":1,"confidence_rate":1},{"cnt":[[309,907],[913,907],[913,952],[309,952]],"region":{"top_left_x":309,"top_left_y":906,"width":605,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00f4b431f3a741598354e91821e07c9a","type":"text","conversion_output":true,"text":"for site, age and prior prolapse surgery.","text_display":" for site, age and prior prolapse surgery.","confidence":1,"confidence_rate":1},{"cnt":[[309,971],[1841,971],[1841,1016],[309,1016]],"region":{"top_left_x":309,"top_left_y":971,"width":1533,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"234e7830889e4556a8a6e37b50d6b6fc","type":"text","conversion_output":true,"text":"Rates of anatomic failure and bothersome bulge symptoms over the follow-up time will be modeled","text_display":"\n\nRates of anatomic failure and bothersome bulge symptoms over the follow-up time will be modeled","confidence":1,"confidence_rate":1},{"cnt":[[309,1018],[1869,1018],[1869,1059],[309,1059]],"region":{"top_left_x":309,"top_left_y":1018,"width":1561,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58ba31fd93ce465f8c1a0160a7630c62","type":"text","conversion_output":true,"text":"using a GLMM (a shared frailty model), fitted by Gaussian quadrature in SAS NLMIXED procedure,","text_display":" using a GLMM (a shared frailty model), fitted by Gaussian quadrature in SAS NLMIXED procedure,","confidence":1,"confidence_rate":1},{"cnt":[[309,1061],[1828,1061],[1828,1104],[309,1104]],"region":{"top_left_x":309,"top_left_y":1061,"width":1520,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"660ee863c24640d6a30088134a83d8c2","type":"text","conversion_output":true,"text":"where a piecewise baseline hazard function will again be employed to generate a parametric model","text_display":" where a piecewise baseline hazard function will again be employed to generate a parametric model","confidence":1,"confidence_rate":1},{"cnt":[[309,1104],[1876,1104],[1876,1149],[309,1149]],"region":{"top_left_x":309,"top_left_y":1104,"width":1567,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dada0a9522e14abeae4bf6949e0f7e12","type":"text","conversion_output":true,"text":"that eliminates the need to specify the distribution of the hazard function and satisfies the proportional","text_display":" that eliminates the need to specify the distribution of the hazard function and satisfies the proportional","confidence":1,"confidence_rate":1},{"cnt":[[309,1147],[1828,1147],[1828,1192],[309,1192]],"region":{"top_left_x":309,"top_left_y":1147,"width":1520,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2753503f0026430fa85871a602e6a50c","type":"text","conversion_output":true,"text":"hazards assumption if the baseline hazard is constant within each period (Liu \\& Huang, 2008). The","text_display":" hazards assumption if the baseline hazard is constant within each period (Liu \\& Huang, 2008). The","confidence":1,"confidence_rate":1},{"cnt":[[309,1192],[1824,1192],[1824,1235],[309,1235]],"region":{"top_left_x":309,"top_left_y":1192,"width":1516,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1360d823761423ba605b68f7e4b42a7","type":"text","conversion_output":true,"text":"model will be specified with a period indicator variable for each follow-up; variables for treatment","text_display":" model will be specified with a period indicator variable for each follow-up; variables for treatment","confidence":1,"confidence_rate":1},{"cnt":[[309,1238],[1850,1238],[1850,1280],[309,1280]],"region":{"top_left_x":309,"top_left_y":1237,"width":1541,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"32929ddb4b0d45fdb27d832ae4cacbca","type":"text","conversion_output":true,"text":"failure and for the length of time in each follow-up period; study design (site) indicator variables; an","text_display":" failure and for the length of time in each follow-up period; study design (site) indicator variables; an","confidence":0.9990234375,"confidence_rate":0.9999910363736797},{"cnt":[[309,1280],[1712,1280],[1712,1326],[309,1326]],"region":{"top_left_x":309,"top_left_y":1280,"width":1404,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72960276989a4d488cae395a8b6275e3","type":"text","conversion_output":true,"text":"intervention indicator; and as having a normal distribution for the subject random intercept.","text_display":" intervention indicator; and as having a normal distribution for the subject random intercept.","confidence":1,"confidence_rate":1},{"cnt":[[309,1345],[1863,1345],[1863,1390],[309,1390]],"region":{"top_left_x":309,"top_left_y":1344,"width":1554,"height":47},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d42089b777614302928d97f30b747678","type":"text","conversion_output":true,"text":"Note that this model uses each 6-month follow-up interval as a period in the piecewise model. This is","text_display":"\n\nNote that this model uses each 6-month follow-up interval as a period in the piecewise model. This is","confidence":0.9951171875,"confidence_rate":0.999953823968252},{"cnt":[[309,1388],[1846,1388],[1846,1433],[309,1433]],"region":{"top_left_x":309,"top_left_y":1387,"width":1537,"height":47},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0b38dff8c40452c9ebecea8507e3a5d","type":"text","conversion_output":true,"text":"primarily to assure that within each period, there is only one treatment failure/success indicator. It is","text_display":" primarily to assure that within each period, there is only one treatment failure/success indicator. It is","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[309,1433],[1876,1433],[1876,1476],[309,1476]],"region":{"top_left_x":309,"top_left_y":1433,"width":1567,"height":43},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e932f30756ff4929ad983216966118a1","type":"text","conversion_output":true,"text":"possible to combine multiple intervals into periods when treatment failure become sparse. This can be","text_display":" possible to combine multiple intervals into periods when treatment failure become sparse. This can be","confidence":1,"confidence_rate":1},{"cnt":[[309,1478],[1871,1478],[1871,1519],[309,1519]],"region":{"top_left_x":309,"top_left_y":1478,"width":1563,"height":41},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9b1a16e6de5427294cd7ef05ab3fbd8","type":"text","conversion_output":true,"text":"done in the masked analysis. The unmasked analysis will generate an overall test of the failure hazard","text_display":" done in the masked analysis. The unmasked analysis will generate an overall test of the failure hazard","confidence":1,"confidence_rate":1},{"cnt":[[309,1521],[1871,1521],[1871,1564],[309,1564]],"region":{"top_left_x":309,"top_left_y":1521,"width":1563,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a208dc9b941c43f4b0ee2618b7ab7c55","type":"text","conversion_output":true,"text":"ratio across the two interventions using a two-sided hypothesis test with an overall type I error rate of","text_display":" ratio across the two interventions using a two-sided hypothesis test with an overall type I error rate of","confidence":1,"confidence_rate":1},{"cnt":[[309,1564],[1809,1564],[1809,1609],[309,1609]],"region":{"top_left_x":309,"top_left_y":1564,"width":1500,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3d8a7e78bbd45a1aca628b4239c50a3","type":"text","conversion_output":true,"text":"0.05 , controlling for the design variables of site the subject was recruited into. Also, the point and","text_display":" 0.05 , controlling for the design variables of site the subject was recruited into. Also, the point and","confidence":0.9912109375,"confidence_rate":0.999917499533037},{"cnt":[[309,1607],[1871,1607],[1871,1648],[309,1648]],"region":{"top_left_x":309,"top_left_y":1607,"width":1563,"height":41},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c8afe0416494bd59ba504837f688350","type":"text","conversion_output":true,"text":"interval estimates of 12-, 24 - and 36-month treatment failure rates on each intervention arm as well as","text_display":" interval estimates of 12-, 24 - and 36-month treatment failure rates on each intervention arm as well as","confidence":0.5656416416168213,"confidence_rate":0.9949254678828169},{"cnt":[[309,1654],[1790,1654],[1790,1695],[309,1695]],"region":{"top_left_x":309,"top_left_y":1654,"width":1481,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9c2749a75504ad6ac9b5c3bf6ff1f5f","type":"text","conversion_output":true,"text":"hazard ratios between the two arms will be provided. Additional models will be used to evaluate","text_display":" hazard ratios between the two arms will be provided. Additional models will be used to evaluate","confidence":1,"confidence_rate":1},{"cnt":[[309,1697],[1472,1697],[1472,1742],[309,1742]],"region":{"top_left_x":309,"top_left_y":1697,"width":1163,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"079c7d735af54337b954375ceab5607c","type":"text","conversion_output":true,"text":"potentially confounding variables of subject age and prior prolapse surgery.","text_display":" potentially confounding variables of subject age and prior prolapse surgery.","confidence":1,"confidence_rate":1},{"cnt":[[309,1826],[1313,1826],[1313,1871],[309,1871]],"region":{"top_left_x":309,"top_left_y":1826,"width":1004,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fc3ca98eeb54ff79d7a3a9c0219f000","type":"text","conversion_output":true,"text":"All analyses will be implemented using SAS Version 9.3 or later.","text_display":"\n\nAll analyses will be implemented using SAS Version 9.3 or later.","confidence":1,"confidence_rate":1},{"cnt":[[370,1891],[1130,1891],[1130,1940],[370,1940]],"region":{"top_left_x":369,"top_left_y":1890,"width":762,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c856bbf6cfe45deb1053ab2bb60b379","type":"section_header","conversion_output":false,"children_ids":["ff35ef629cb544499d9ea111357113b9"],"text":"","text_display":""},{"cnt":[[374,1895],[1128,1895],[1128,1936],[374,1936]],"region":{"top_left_x":373,"top_left_y":1894,"width":755,"height":42},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff35ef629cb544499d9ea111357113b9","type":"text","conversion_output":true,"parent_id":"7c856bbf6cfe45deb1053ab2bb60b379","text":"9.4 Secondary Efficacy Analysis Methods","text_display":"\n\n\\subsection*{9.4 Secondary Efficacy Analysis Methods}","confidence":0.9912109375,"confidence_rate":0.9997993857138384},{"cnt":[[455,1959],[924,1959],[924,2009],[455,2009]],"region":{"top_left_x":455,"top_left_y":1959,"width":469,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11e40d6127ab43b5bb5330d7339c6bc0","type":"section_header","conversion_output":false,"children_ids":["df06188ecff34d67abde95018cf6edbe"],"text":"","text_display":""},{"cnt":[[460,1964],[922,1964],[922,2004],[460,2004]],"region":{"top_left_x":459,"top_left_y":1963,"width":463,"height":42},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df06188ecff34d67abde95018cf6edbe","type":"text","conversion_output":true,"parent_id":"11e40d6127ab43b5bb5330d7339c6bc0","text":"9.4.1 General Approach","text_display":"\n\n\\subsection*{9.4.1 General Approach}","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[309,2050],[1876,2050],[1876,2090],[309,2090]],"region":{"top_left_x":309,"top_left_y":2049,"width":1567,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4e9ad773d2246a380029d5cd2e14483","type":"text","conversion_output":true,"text":"As outlined in the above sections, the secondary outcome variables comprise a combination of binary,","text_display":"\n\nAs outlined in the above sections, the secondary outcome variables comprise a combination of binary,","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[309,2093],[1772,2093],[1772,2133],[309,2133]],"region":{"top_left_x":309,"top_left_y":2092,"width":1464,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31cbafa53656492187a324443bcfd7fb","type":"text","conversion_output":true,"text":"ordinal, and continuous measures that are collected at 6 -month intervals through post-operative","text_display":" ordinal, and continuous measures that are collected at 6 -month intervals through post-operative","confidence":0.89013671875,"confidence_rate":0.9988815853973196},{"cnt":[[309,2136],[1729,2136],[1729,2172],[309,2172]],"region":{"top_left_x":309,"top_left_y":2135,"width":1421,"height":38},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79856f0655884e869d8f4584f1536663","type":"text","conversion_output":true,"text":"Month 24 and at either 6- or 12-month intervals thereafter. These outcome measures will be","text_display":" Month 24 and at either 6- or 12-month intervals thereafter. These outcome measures will be","confidence":0.9990236759185791,"confidence_rate":0.9999900326925697},{"cnt":[[309,2179],[1815,2179],[1815,2224],[309,2224]],"region":{"top_left_x":309,"top_left_y":2178,"width":1507,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e77e266a9e9948cbac443b98cb74fa7c","type":"text","conversion_output":true,"text":"summarized in both tabular and graphical fashion by treatment arm over the full follow-up period,","text_display":" summarized in both tabular and graphical fashion by treatment arm over the full follow-up period,","confidence":1,"confidence_rate":1},{"cnt":[[309,2226],[1871,2226],[1871,2267],[309,2267]],"region":{"top_left_x":309,"top_left_y":2225,"width":1563,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b5360556b5249eebcf4632d14b7c2e5","type":"text","conversion_output":true,"text":"although the focus of the analysis will be on the first 36 months of the post-operative period. We will","text_display":" although the focus of the analysis will be on the first 36 months of the post-operative period. We will","confidence":1,"confidence_rate":1},{"cnt":[[309,2269],[1721,2269],[1721,2310],[309,2310]],"region":{"top_left_x":309,"top_left_y":2268,"width":1412,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e278ba2b1804951b61d7c977af11548","type":"text","conversion_output":true,"text":"then use model-based approaches appropriate for the variable type (linear mixed models for","text_display":" then use model-based approaches appropriate for the variable type (linear mixed models for","confidence":1,"confidence_rate":1},{"cnt":[[309,2312],[1841,2312],[1841,2357],[309,2357]],"region":{"top_left_x":309,"top_left_y":2311,"width":1533,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3732797d229a4a1da00f917aec6bd724","type":"text","conversion_output":true,"text":"continuous variables and GEE extensions of robust Poisson regression models for binary outcomes)","text_display":" continuous variables and GEE extensions of robust Poisson regression models for binary outcomes)","confidence":1,"confidence_rate":1},{"cnt":[[309,2357],[1304,2357],[1304,2400],[309,2400]],"region":{"top_left_x":309,"top_left_y":2356,"width":996,"height":44},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d5aa5529df34086a909dde65105a5bb","type":"text","conversion_output":true,"text":"to compare the outcomes for the two treatment arms across time.","text_display":" to compare the outcomes for the two treatment arms across time.","confidence":1,"confidence_rate":1},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":47,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f5bf84509f5e4a0483d847662e595831","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 30","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-32","page":32,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e660a86e887c4b739647119aa05ba366","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"47543fcc5b9d49268d8744eb9b192133","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,318],[1790,318],[1790,359],[309,359]],"region":{"top_left_x":309,"top_left_y":317,"width":1481,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41da3f175af94b74acc91e2e07d89cb9","type":"text","conversion_output":true,"text":"Because the primary scientific interest for the study is in the trajectories of various the outcomes","text_display":"\n\nBecause the primary scientific interest for the study is in the trajectories of various the outcomes","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[309,361],[1846,361],[1846,402],[309,402]],"region":{"top_left_x":309,"top_left_y":360,"width":1537,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54bec870a4d241dfaf7bb1fbc2a64d93","type":"text","conversion_output":true,"text":"across time and because information about the patterns of these trajectories is limited, a longitudinal","text_display":" across time and because information about the patterns of these trajectories is limited, a longitudinal","confidence":1,"confidence_rate":1},{"cnt":[[309,404],[1835,404],[1835,449],[309,449]],"region":{"top_left_x":309,"top_left_y":403,"width":1526,"height":47},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2b25d6f91ef40d1b820272ff9938773","type":"text","conversion_output":true,"text":"approach incorporating all time points will generally be employed. Specifically, the unit of analysis","text_display":" approach incorporating all time points will generally be employed. 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as","text_display":" operatively, and the models will incorporate treatment group, time, and treatment group by time, as","confidence":1,"confidence_rate":1},{"cnt":[[309,537],[1863,537],[1863,578],[309,578]],"region":{"top_left_x":309,"top_left_y":537,"width":1554,"height":41},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6029f9fba79c4a42a7c0ebbb68df2f63","type":"text","conversion_output":true,"text":"well as site, the randomization stratification variable, as fixed effects in the model with time (or visit)","text_display":" well as site, the randomization stratification variable, as fixed effects in the model with time (or 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compound","text_display":" Participant will be included as a random effect in the linear mixed model with an assumed compound","confidence":1,"confidence_rate":1},{"cnt":[[309,666],[1867,666],[1867,711],[309,711]],"region":{"top_left_x":309,"top_left_y":666,"width":1558,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6c6b667d2464b6785afa33f04b95d45","type":"text","conversion_output":true,"text":"symmetric covariance structure across the post-operative observation period and this same compound","text_display":" symmetric covariance structure across the post-operative observation period and this same compound","confidence":1,"confidence_rate":1},{"cnt":[[309,713],[1876,713],[1876,754],[309,754]],"region":{"top_left_x":309,"top_left_y":713,"width":1567,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0120e6dfb384e0eacdf9845165c139f","type":"text","conversion_output":true,"text":"symmetric structure will be assumed in the GEE model with observations clustered within participant.","text_display":" symmetric structure will be assumed in the GEE model with observations clustered within participant.","confidence":1,"confidence_rate":1},{"cnt":[[309,756],[1833,756],[1833,799],[309,799]],"region":{"top_left_x":309,"top_left_y":756,"width":1524,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33538205f7f94731b33b89a25342847c","type":"text","conversion_output":true,"text":"The general structure of the SAS code that will be used for the mixed model (using the POPDI-6 as","text_display":" The general structure of the SAS code that will be used for the mixed model (using the POPDI-6 as","confidence":1,"confidence_rate":1},{"cnt":[[309,799],[844,799],[844,844],[309,844]],"region":{"top_left_x":309,"top_left_y":799,"width":536,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06bc46822fbb4b29b9682caa3821f06c","type":"text","conversion_output":true,"text":"an example) is summarized below.","text_display":" an example) is summarized below.","confidence":1,"confidence_rate":1},{"cnt":[[309,864],[595,864],[595,896],[309,896]],"region":{"top_left_x":309,"top_left_y":863,"width":287,"height":33},"line":15,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bf60752b762249d1a57790ccf1f9316b","type":"text","conversion_output":true,"text":"Proc Mixed data=SUPeR;","text_display":"\n\nProc Mixed 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participant;","confidence":1,"confidence_rate":1},{"cnt":[[309,986],[1038,986],[1038,1016],[309,1016]],"region":{"top_left_x":309,"top_left_y":986,"width":729,"height":31},"line":18,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6037f6e3b18e4cd1b6ff74a899cf8175","type":"text","conversion_output":true,"text":"Model POPDI-6=treatment visit treatment*visit center/solution;","text_display":"\nModel POPDI-6=treatment visit treatment*visit center/solution;","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[309,1027],[544,1027],[544,1059],[309,1059]],"region":{"top_left_x":309,"top_left_y":1026,"width":235,"height":34},"line":19,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e465e567ea8642c0bb6a1fc6583687e3","type":"text","conversion_output":true,"text":"Random participant;","text_display":"\nRandom participant;","confidence":1,"confidence_rate":1},{"cnt":[[309,1070],[698,1070],[698,1102],[309,1102]],"region":{"top_left_x":309,"top_left_y":1069,"width":390,"height":34},"line":20,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"43273a57f445449a8adc1b21c6a5a6bc","type":"text","conversion_output":true,"text":"Lsmeans treatment*visit/ pdiff Cl;","text_display":"\nLsmeans treatment*visit/ pdiff Cl;","confidence":0.9697265625,"confidence_rate":0.9992120761762987},{"cnt":[[309,1109],[1347,1109],[1347,1139],[309,1139]],"region":{"top_left_x":309,"top_left_y":1108,"width":1039,"height":31},"line":21,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c248b936f81841b0abd347618550f71d","type":"text","conversion_output":true,"text":"Contrast 'POPDI Outcome' treatment 7-7 treatment*month 11111 11-1-1-1-1-1-1-1;","text_display":"\nContrast 'POPDI Outcome' treatment 7-7 treatment*month 11111 11-1-1-1-1-1-1-1;","confidence":0.34979379446645337,"confidence_rate":0.9878602024843915},{"cnt":[[309,1152],[1751,1152],[1751,1192],[309,1192]],"region":{"top_left_x":309,"top_left_y":1151,"width":1442,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"374d7c3668464cacade7d79d7c18666a","type":"text","conversion_output":true,"text":"As suggested by the SAS code, the primary hypothesis will be tested using the F-test from the","text_display":"\nAs suggested by the SAS code, the primary hypothesis will be tested using the F-test from the","confidence":1,"confidence_rate":1},{"cnt":[[309,1195],[1850,1195],[1850,1235],[309,1235]],"region":{"top_left_x":309,"top_left_y":1194,"width":1541,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5427ac7816e94ed3b53058d34ce1de41","type":"text","conversion_output":true,"text":"Contrast statement, which tests whether mean POPDI across 36 months differs for the two treatment","text_display":" Contrast statement, which tests whether mean POPDI across 36 months differs for the two treatment","confidence":1,"confidence_rate":1},{"cnt":[[309,1240],[1755,1240],[1755,1283],[309,1283]],"region":{"top_left_x":309,"top_left_y":1239,"width":1447,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59d8c98fd0d641068c37e5d3b6484183","type":"text","conversion_output":true,"text":"arms. Note that the LSMEANS statement will provide by visit estimates of the post-operative","text_display":" arms. Note that the LSMEANS statement will provide by visit estimates of the post-operative","confidence":1,"confidence_rate":1},{"cnt":[[309,1283],[1863,1283],[1863,1326],[309,1326]],"region":{"top_left_x":309,"top_left_y":1282,"width":1554,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e26d58121a944147aa93f9fe920d28df","type":"text","conversion_output":true,"text":"POPDI6 score for each treatment arm from Month 6 through Month 36. These estimates will allow a","text_display":" POPDI6 score for each treatment arm from Month 6 through Month 36. These estimates will allow a","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[309,1328],[1738,1328],[1738,1369],[309,1369]],"region":{"top_left_x":309,"top_left_y":1327,"width":1430,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"070fb2f8c9634801b3ffbad6171a522c","type":"text","conversion_output":true,"text":"description of the difference in trajectory of treatment effect in the two arms and will provide","text_display":" description of the difference in trajectory of treatment effect in the two arms and will provide","confidence":1,"confidence_rate":1},{"cnt":[[309,1371],[1876,1371],[1876,1412],[309,1412]],"region":{"top_left_x":309,"top_left_y":1370,"width":1567,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3360425a62094302a117c67ce15200fa","type":"text","conversion_output":true,"text":"descriptive measures of differences between the two arms at each study visit. If the outcome is binary","text_display":" descriptive measures of differences between the two arms at each study visit. If the outcome is binary","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[309,1414],[1781,1414],[1781,1457],[309,1457]],"region":{"top_left_x":309,"top_left_y":1413,"width":1473,"height":44},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20c008aebec547bca4e0038172b4c5ef","type":"text","conversion_output":true,"text":"rather than continuous, the SAS procedure GENMOD will be used with a Poisson distributional","text_display":" rather than continuous, the SAS procedure GENMOD will be used with a Poisson distributional","confidence":1,"confidence_rate":1},{"cnt":[[309,1457],[1852,1457],[1852,1502],[309,1502]],"region":{"top_left_x":309,"top_left_y":1456,"width":1543,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"950db844347a464286839756baeb39f2","type":"text","conversion_output":true,"text":"assumption to generate comparable comparisons between the treatment arms in which the difference","text_display":" assumption to generate comparable comparisons between the treatment arms in which the difference","confidence":1,"confidence_rate":1},{"cnt":[[309,1504],[1334,1504],[1334,1545],[309,1545]],"region":{"top_left_x":309,"top_left_y":1503,"width":1026,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1ffcdc0c1784e9db01be6a84d84aa7d","type":"text","conversion_output":true,"text":"is assessed using a relative risk rather than mean difference metric.","text_display":" is assessed using a relative risk rather than mean difference metric.","confidence":1,"confidence_rate":1},{"cnt":[[455,1564],[1665,1564],[1665,1618],[455,1618]],"region":{"top_left_x":455,"top_left_y":1564,"width":1211,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eb5c4713d0d4823968246158e591bb2","type":"section_header","conversion_output":false,"children_ids":["697b1d1987e843d2b827643d126978bc"],"text":"","text_display":""},{"cnt":[[460,1568],[1661,1568],[1661,1613],[460,1613]],"region":{"top_left_x":459,"top_left_y":1568,"width":1202,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"697b1d1987e843d2b827643d126978bc","type":"text","conversion_output":true,"parent_id":"5eb5c4713d0d4823968246158e591bb2","text":"9.4.2 Comparison of Anatomical Measures of Treatment Efficacy","text_display":"\n\n\\subsection*{9.4.2 Comparison of Anatomical Measures of Treatment Efficacy}","confidence":0.9990236759185791,"confidence_rate":0.9999852000944255},{"cnt":[[309,1654],[1830,1654],[1830,1699],[309,1699]],"region":{"top_left_x":309,"top_left_y":1654,"width":1522,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dba89fde13b040cebddb24a262e85fbe","type":"text","conversion_output":true,"text":"One component of the first secondary efficacy aim is to compare anatomical measures of treatment","text_display":"\n\nOne component of the first secondary efficacy aim is to compare anatomical measures of treatment","confidence":1,"confidence_rate":1},{"cnt":[[309,1702],[1764,1702],[1764,1742],[309,1742]],"region":{"top_left_x":309,"top_left_y":1701,"width":1455,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d61e21ba5644c26ba3240c4f79cb47a","type":"text","conversion_output":true,"text":"efficacy across the two arms. For the 3 continuous measures ( \\(Ba , Bp\\), and C ), the linear model","text_display":" efficacy across the two arms. For the 3 continuous measures ( \\(Ba , Bp\\), and C ), the linear model","confidence":0.9801020787949352,"confidence_rate":0.9998296878038676},{"cnt":[[309,1745],[1755,1745],[1755,1785],[309,1785]],"region":{"top_left_x":309,"top_left_y":1744,"width":1447,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"300b4b9f07d54e8980e5155bf5a63692","type":"text","conversion_output":true,"text":"described above will be used to generate mean estimates of each of these 3 metrics for the two","text_display":" described above will be used to generate mean estimates of each of these 3 metrics for the two","confidence":1,"confidence_rate":1},{"cnt":[[309,1788],[1794,1788],[1794,1830],[309,1830]],"region":{"top_left_x":309,"top_left_y":1787,"width":1485,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b70f001b2c7747cc8bc5131d4aa1e258","type":"text","conversion_output":true,"text":"treatment arms at each of the post-operative visits. For the binary measure of \\(C >1 / 2\\) TLV, large-","text_display":" treatment arms at each of the post-operative visits. For the binary measure of \\(C >1 / 2\\) TLV, large","confidence":0.9277190524153411,"confidence_rate":0.9992990650475635},{"cnt":[[309,1830],[1566,1830],[1566,1876],[309,1876]],"region":{"top_left_x":309,"top_left_y":1830,"width":1258,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"485f22668fd8454cb64b321e32b338e9","type":"text","conversion_output":true,"text":"sample chi-square tests will be used to compare incidence at different time points.","text_display":"sample chi-square tests will be used to compare incidence at different time points.","confidence":1,"confidence_rate":1},{"cnt":[[455,1895],[1652,1895],[1652,1944],[455,1944]],"region":{"top_left_x":455,"top_left_y":1894,"width":1198,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9d9f03020764316a451afff4e3e8ff4","type":"section_header","conversion_output":false,"children_ids":["a90e7c06f5e14eec8461ebc67e3e8c9d"],"text":"","text_display":""},{"cnt":[[460,1899],[1650,1899],[1650,1944],[460,1944]],"region":{"top_left_x":459,"top_left_y":1899,"width":1191,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a90e7c06f5e14eec8461ebc67e3e8c9d","type":"text","conversion_output":true,"parent_id":"a9d9f03020764316a451afff4e3e8ff4","text":"9.4.3 Comparison of Functional Measures of Treatment Efficacy","text_display":"\n\n\\subsection*{9.4.3 Comparison of Functional Measures of Treatment Efficacy}","confidence":0.9980475902557373,"confidence_rate":0.9999703895568735},{"cnt":[[309,1985],[1826,1985],[1826,2030],[309,2030]],"region":{"top_left_x":309,"top_left_y":1985,"width":1518,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"209ca77e5d7b47c29a3dcbdcbedb8d5b","type":"text","conversion_output":true,"text":"A second component of the secondary efficacy aim for this study is to compare multiple functional","text_display":"\n\nA second component of the secondary efficacy aim for this study is to compare multiple functional","confidence":1,"confidence_rate":1},{"cnt":[[309,2030],[1798,2030],[1798,2073],[309,2073]],"region":{"top_left_x":309,"top_left_y":2030,"width":1490,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdfdd827c69a4dd1badd86c389181d2e","type":"text","conversion_output":true,"text":"and quality of life for the two treatment regimens. As outlined in Sections 3.2 and 9.2, outcomes","text_display":" and quality of life for the two treatment regimens. As outlined in Sections 3.2 and 9.2, outcomes","confidence":1,"confidence_rate":1},{"cnt":[[309,2073],[1833,2073],[1833,2116],[309,2116]],"region":{"top_left_x":309,"top_left_y":2073,"width":1524,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29e1f4c81d0a4af096aba5d7d5418d1c","type":"text","conversion_output":true,"text":"associated with this aim will include a number of continuous (e.g., scales from the PFDI-SF, PFIQ-","text_display":" associated with this aim will include a number of continuous (e.g., scales from the PFDI-SF, PFIQ","confidence":1,"confidence_rate":1},{"cnt":[[309,2118],[1876,2118],[1876,2159],[309,2159]],"region":{"top_left_x":309,"top_left_y":2118,"width":1567,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44bc0929f21a4c018ab52af94d306ac2","type":"text","conversion_output":true,"text":"SF, PISQ-R and SF-12 scales) and binary indicators (global improvement and de novo risk of voiding","text_display":"SF, PISQ-R and SF-12 scales) and binary indicators (global improvement and de novo risk of voiding","confidence":1,"confidence_rate":1},{"cnt":[[309,2161],[1775,2161],[1775,2202],[309,2202]],"region":{"top_left_x":309,"top_left_y":2161,"width":1466,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5ff1688adea4f3497e74300e0ef3100","type":"text","conversion_output":true,"text":"dysfunction, incontinence, dyspareunia). While the analyses for these secondary outcomes will","text_display":" dysfunction, incontinence, dyspareunia). While the analyses for these secondary outcomes will","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[309,2204],[1858,2204],[1858,2247],[309,2247]],"region":{"top_left_x":309,"top_left_y":2204,"width":1550,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49810ab7c1d24ac1bdd477ed51d333eb","type":"text","conversion_output":true,"text":"produce point and interval estimates as well as p -values from hypotheses, all analyses are considered","text_display":" produce point and interval estimates as well as p -values from hypotheses, all analyses are considered","confidence":0.98779296875,"confidence_rate":0.9998913143227193},{"cnt":[[309,2247],[1815,2247],[1815,2292],[309,2292]],"region":{"top_left_x":309,"top_left_y":2247,"width":1507,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37acfb6b124f45a78f2d3c28c8510e74","type":"text","conversion_output":true,"text":"to be descriptive rather than inferential, so p -values will be interpreted as measures of evidence of","text_display":" to be descriptive rather than inferential, so p -values will be interpreted as measures of evidence of","confidence":0.8233480453491211,"confidence_rate":0.9982813346232421},{"cnt":[[309,2295],[1347,2295],[1347,2335],[309,2335]],"region":{"top_left_x":309,"top_left_y":2294,"width":1039,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9fae46798194d77be173721d1bb28a6","type":"text","conversion_output":true,"text":"descriptive differences in the treatment arms, not formal inferences.","text_display":" descriptive differences in the treatment arms, not formal inferences.","confidence":1,"confidence_rate":1},{"cnt":[[309,2359],[1858,2359],[1858,2400],[309,2400]],"region":{"top_left_x":309,"top_left_y":2358,"width":1550,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"429b5ba216864141afdaa3139ea76000","type":"text","conversion_output":true,"text":"Analyses for the continuous outcome measures associated with this efficacy aim will be analogous to","text_display":"\n\nAnalyses for the continuous outcome measures associated with this efficacy aim will be analogous to","confidence":1,"confidence_rate":1},{"cnt":[[309,2402],[1852,2402],[1852,2443],[309,2443]],"region":{"top_left_x":309,"top_left_y":2401,"width":1543,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d796e2f8234f4798b7195e306347b17e","type":"text","conversion_output":true,"text":"those described above. For these continuous secondary outcomes, additional models that account for","text_display":" those described above. For these continuous secondary outcomes, additional models that account for","confidence":1,"confidence_rate":1},{"cnt":[[309,2445],[1841,2445],[1841,2488],[309,2488]],"region":{"top_left_x":309,"top_left_y":2444,"width":1533,"height":44},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"057bb3521bed4a339a28843893f8d118","type":"text","conversion_output":true,"text":"covariates found to be potentially confounded with treatment in the preliminary descriptive analysis","text_display":" covariates found to be potentially confounded with treatment in the preliminary descriptive analysis","confidence":1,"confidence_rate":1},{"cnt":[[309,2522],[685,2522],[685,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":377,"height":33},"line":51,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1d4baed0fc564296be74fc4bfa836913","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 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Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,316],[1824,316],[1824,359],[309,359]],"region":{"top_left_x":309,"top_left_y":315,"width":1516,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d00c5e3738b4ae9ac87c1170de26825","type":"text","conversion_output":true,"text":"(specifically any baseline or clinical values found to be associated with treatment at the 0.10 level)","text_display":"\n(specifically any baseline or clinical values found to be associated with treatment at the 0.10 level)","confidence":1,"confidence_rate":1},{"cnt":[[309,361],[1712,361],[1712,402],[309,402]],"region":{"top_left_x":309,"top_left_y":360,"width":1404,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81d605f66a6a43aa816383b1a5a69c03","type":"text","conversion_output":true,"text":"will be fit to ensure that these potentially confounding effects don't change treatment effect","text_display":" will be fit to ensure that these potentially confounding effects don't change treatment effect","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[309,404],[505,404],[505,440],[309,440]],"region":{"top_left_x":309,"top_left_y":403,"width":196,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f686ccec8744be9a0d5b1ca9c5d702b","type":"text","conversion_output":true,"text":"conclusions.","text_display":" conclusions.","confidence":1,"confidence_rate":1},{"cnt":[[309,468],[1863,468],[1863,511],[309,511]],"region":{"top_left_x":309,"top_left_y":468,"width":1554,"height":44},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0656d72a8564c1ea3330ce2e724c680","type":"text","conversion_output":true,"text":"Analyses for the binary outcome measures associated with this efficacy aim will also be analogous to","text_display":"\n\nAnalyses for the binary outcome measures associated with this efficacy aim will also be analogous to","confidence":1,"confidence_rate":1},{"cnt":[[309,511],[1867,511],[1867,556],[309,556]],"region":{"top_left_x":309,"top_left_y":511,"width":1558,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e2b65f6010a4c2f84665c43fe1b1c9c","type":"text","conversion_output":true,"text":"those described for the primary analyses in that they account for the longitudinal structure of the data,","text_display":" those described for the primary analyses in that they account for the longitudinal structure of the data,","confidence":1,"confidence_rate":1},{"cnt":[[309,559],[1751,559],[1751,599],[309,599]],"region":{"top_left_x":309,"top_left_y":558,"width":1442,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"532261be801447398bcb1bd90f837bad","type":"text","conversion_output":true,"text":"but they will be modified to account for the binary nature of the outcome measure and for any","text_display":" but they will be modified to account for the binary nature of the outcome measure and for any","confidence":1,"confidence_rate":1},{"cnt":[[309,602],[1850,602],[1850,642],[309,642]],"region":{"top_left_x":309,"top_left_y":601,"width":1541,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8c79c8e0bc944a786887369918c403f","type":"text","conversion_output":true,"text":"differences in outcome timing. Analyses will be conducted using a robust Poisson regression model","text_display":" differences in outcome timing. Analyses will be conducted using a robust Poisson regression model","confidence":1,"confidence_rate":1},{"cnt":[[309,645],[1876,645],[1876,690],[309,690]],"region":{"top_left_x":309,"top_left_y":644,"width":1567,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e87814f72776462191fee465afdaad7e","type":"text","conversion_output":true,"text":"as implemented through a generalized linear model with an assumed Poisson distribution and log link.","text_display":" as implemented through a generalized linear model with an assumed Poisson distribution and log link.","confidence":1,"confidence_rate":1},{"cnt":[[309,690],[1794,690],[1794,733],[309,733]],"region":{"top_left_x":309,"top_left_y":689,"width":1485,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d615843f7144f67bbba2aa90434fd50","type":"text","conversion_output":true,"text":"The model structure will be comparable to that described above with each model including fixed","text_display":" The model structure will be comparable to that described above with each model including fixed","confidence":1,"confidence_rate":1},{"cnt":[[309,733],[1766,733],[1766,776],[309,776]],"region":{"top_left_x":309,"top_left_y":732,"width":1458,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d04c7ea7af94919bca990dfa564aec6","type":"text","conversion_output":true,"text":"effects treatment group, visit (as a categorical measure), treatment by visit interaction and, site.","text_display":" effects treatment group, visit (as a categorical measure), treatment by visit interaction and, site.","confidence":1,"confidence_rate":1},{"cnt":[[309,778],[1867,778],[1867,819],[309,819]],"region":{"top_left_x":309,"top_left_y":777,"width":1558,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a582cc039b784e42be8539be39bfcff5","type":"text","conversion_output":true,"text":"Participant will be handled as a clustering variable with an assumed compound symmetric covariance","text_display":" Participant will be handled as a clustering variable with an assumed compound symmetric covariance","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[309,821],[1858,821],[1858,862],[309,862]],"region":{"top_left_x":309,"top_left_y":820,"width":1550,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09057a279c6a4b5fbcadc05e4c48676b","type":"text","conversion_output":true,"text":"structure within participant. However, p-values and interval estimates of effect sizes will be obtained","text_display":" structure within participant. However, p-values and interval estimates of effect sizes will be obtained","confidence":0.98828125,"confidence_rate":0.9998908582179529},{"cnt":[[309,864],[1863,864],[1863,907],[309,907]],"region":{"top_left_x":309,"top_left_y":863,"width":1554,"height":44},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"065178cac1464110b13881fd452604aa","type":"text","conversion_output":true,"text":"using GEE extensions of the generalized linear model using the Liang and Zeger sandwich estimator.","text_display":" using GEE extensions of the generalized linear model using the Liang and Zeger sandwich estimator.","confidence":1,"confidence_rate":1},{"cnt":[[309,907],[1865,907],[1865,952],[309,952]],"region":{"top_left_x":309,"top_left_y":906,"width":1556,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3870941c95e545e68ea39ab143188a87","type":"text","conversion_output":true,"text":"For these outcomes, additional models that account for covariates found to be potentially confounded","text_display":" For these outcomes, additional models that account for covariates found to be potentially confounded","confidence":1,"confidence_rate":1},{"cnt":[[309,952],[1798,952],[1798,995],[309,995]],"region":{"top_left_x":309,"top_left_y":951,"width":1490,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc2c9442353e4e1abca37b871962fc29","type":"text","conversion_output":true,"text":"with treatment in the preliminary descriptive analysis (specifically any baseline or clinical values","text_display":" with treatment in the preliminary descriptive analysis (specifically any baseline or clinical values","confidence":1,"confidence_rate":1},{"cnt":[[309,997],[1790,997],[1790,1038],[309,1038]],"region":{"top_left_x":309,"top_left_y":996,"width":1481,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d62765ac7644f52a5fad91be019d25e","type":"text","conversion_output":true,"text":"found to be associated with treatment at the 0.10 level) will be fit to ensure that these potentially","text_display":" found to be associated with treatment at the 0.10 level) will be fit to ensure that these potentially","confidence":0.99853515625,"confidence_rate":0.9999865513043565},{"cnt":[[309,1040],[1274,1040],[1274,1085],[309,1085]],"region":{"top_left_x":309,"top_left_y":1039,"width":966,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d45b8f808f974204915398ed0dfc8f4c","type":"text","conversion_output":true,"text":"confounding effects don't change treatment effect conclusions.","text_display":" confounding effects don't change treatment effect conclusions.","confidence":1,"confidence_rate":1},{"cnt":[[455,1104],[1240,1104],[1240,1149],[455,1149]],"region":{"top_left_x":455,"top_left_y":1104,"width":785,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0d89994d90f416b9f61ea56f4be140f","type":"section_header","conversion_output":false,"children_ids":["3279b7baa4b34942b16d03129b96cb45"],"text":"","text_display":""},{"cnt":[[460,1109],[1238,1109],[1238,1145],[460,1145]],"region":{"top_left_x":459,"top_left_y":1108,"width":779,"height":38},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3279b7baa4b34942b16d03129b96cb45","type":"text","conversion_output":true,"parent_id":"d0d89994d90f416b9f61ea56f4be140f","text":"9.4.4 Predictors of Poor Treatment Effect","text_display":"\n\n\\subsection*{9.4.4 Predictors of Poor Treatment Effect}","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[309,1195],[1747,1195],[1747,1240],[309,1240]],"region":{"top_left_x":309,"top_left_y":1194,"width":1438,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4dce56f21f34a9da40fc9fd97313035","type":"text","conversion_output":true,"text":"Two approaches will be utilized to evaluate predictors of poor treatment effect. First a binary","text_display":"\n\nTwo approaches will be utilized to evaluate predictors of poor treatment effect. First a binary","confidence":1,"confidence_rate":1},{"cnt":[[309,1238],[1807,1238],[1807,1283],[309,1283]],"region":{"top_left_x":309,"top_left_y":1237,"width":1498,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8ed288cf00e4ccc87a55e02c7e6b285","type":"text","conversion_output":true,"text":"outcome of treatment failure over a 36 -month post-operative period will be created. Contingency","text_display":" outcome of treatment failure over a 36 -month post-operative period will be created. Contingency","confidence":0.9716796875,"confidence_rate":0.9997237971083432},{"cnt":[[309,1283],[1740,1283],[1740,1326],[309,1326]],"region":{"top_left_x":309,"top_left_y":1282,"width":1432,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4be93540769d44e390ce854de380013d","type":"text","conversion_output":true,"text":"tables and univariate logistic regression models will be used to determine whether this binary","text_display":" tables and univariate logistic regression models will be used to determine whether this binary","confidence":1,"confidence_rate":1},{"cnt":[[309,1326],[1691,1326],[1691,1369],[309,1369]],"region":{"top_left_x":309,"top_left_y":1325,"width":1382,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d18beb67c5c8473786a2e488ffb249c4","type":"text","conversion_output":true,"text":"outcome is related to the potential predictors of advanced prolapse, age, obesity, smoking,","text_display":" outcome is related to the potential predictors of advanced prolapse, age, obesity, smoking,","confidence":1,"confidence_rate":1},{"cnt":[[309,1371],[1809,1371],[1809,1414],[309,1414]],"region":{"top_left_x":309,"top_left_y":1370,"width":1500,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"345f63307b32412d9d08b24836e0923a","type":"text","conversion_output":true,"text":"menopausal status, estrogens, primary vs. recurrent prolapse, and physical and functional activity.","text_display":" menopausal status, estrogens, primary vs. recurrent prolapse, and physical and functional activity.","confidence":1,"confidence_rate":1},{"cnt":[[309,1414],[1766,1414],[1766,1454],[309,1454]],"region":{"top_left_x":309,"top_left_y":1413,"width":1458,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c81dc3366b1b4fae9380f2aaff045da2","type":"text","conversion_output":true,"text":"Any covariates that are related to the outcome measure at a p -value of 0.10 will be utilized in a","text_display":" Any covariates that are related to the outcome measure at a p -value of 0.10 will be utilized in a","confidence":0.8701803684234619,"confidence_rate":0.9987592099816208},{"cnt":[[309,1457],[1835,1457],[1835,1502],[309,1502]],"region":{"top_left_x":309,"top_left_y":1456,"width":1526,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"329090e0701e4c49a9cc36c86202ead6","type":"text","conversion_output":true,"text":"multivariable logistic regression model to develop an overall predictive model for treatment failure.","text_display":" multivariable logistic regression model to develop an overall predictive model for treatment failure.","confidence":1,"confidence_rate":1},{"cnt":[[309,1521],[1876,1521],[1876,1566],[309,1566]],"region":{"top_left_x":309,"top_left_y":1521,"width":1567,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d28fe62703b419ba413f899191b3b7f","type":"text","conversion_output":true,"text":"The second approach will involve fitting a multivariable complementary log-log model comparable to","text_display":"\n\nThe second approach will involve fitting a multivariable complementary log-log model comparable to","confidence":1,"confidence_rate":1},{"cnt":[[309,1566],[1721,1566],[1721,1609],[309,1609]],"region":{"top_left_x":309,"top_left_y":1566,"width":1412,"height":44},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"201c816a6fa4479dadd25c67add743a1","type":"text","conversion_output":true,"text":"the model described in the Section 9.3 that includes the covariates described above with any","text_display":" the model described in the Section 9.3 that includes the covariates described above with any","confidence":1,"confidence_rate":1},{"cnt":[[309,1611],[1394,1611],[1394,1652],[309,1652]],"region":{"top_left_x":309,"top_left_y":1611,"width":1086,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8849ae9aaf8745088c99533b752706ea","type":"text","conversion_output":true,"text":"covariates with a p-value of 0.10 or greater retained in the final model.","text_display":" covariates with a p-value of 0.10 or greater retained in the final model.","confidence":0.7603707313537598,"confidence_rate":0.9966236244208695},{"cnt":[[455,1671],[1369,1671],[1369,1725],[455,1725]],"region":{"top_left_x":455,"top_left_y":1671,"width":914,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"004e6fdf61674afb9585067c9831876b","type":"section_header","conversion_output":false,"children_ids":["abe21e9291144e5fb28324779cd8a99a"],"text":"","text_display":""},{"cnt":[[460,1676],[1364,1676],[1364,1721],[460,1721]],"region":{"top_left_x":459,"top_left_y":1675,"width":906,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abe21e9291144e5fb28324779cd8a99a","type":"text","conversion_output":true,"parent_id":"004e6fdf61674afb9585067c9831876b","text":"9.4.5 Cost-effectiveness of Treatment Regimens","text_display":"\n\n\\subsection*{9.4.5 Cost-effectiveness of Treatment Regimens}","confidence":1,"confidence_rate":1},{"cnt":[[309,1762],[1841,1762],[1841,1807],[309,1807]],"region":{"top_left_x":309,"top_left_y":1761,"width":1533,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"933c0f85c9b64b43981851b72b445f2f","type":"text","conversion_output":true,"text":"The cost-effectiveness analysis will be conducted from a payer perspective and will be expressed as","text_display":"\n\nThe cost-effectiveness analysis will be conducted from a payer perspective and will be expressed as","confidence":1,"confidence_rate":1},{"cnt":[[309,1807],[1837,1807],[1837,1850],[309,1850]],"region":{"top_left_x":309,"top_left_y":1806,"width":1528,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88083f7ff2c74c2ebb84ed52f92cf3ef","type":"text","conversion_output":true,"text":"incremental cost required to produce one additional unit of quality-adjusted life year (QALY). Data","text_display":" incremental cost required to produce one additional unit of quality-adjusted life year (QALY). Data","confidence":1,"confidence_rate":1},{"cnt":[[309,1852],[1811,1852],[1811,1893],[309,1893]],"region":{"top_left_x":309,"top_left_y":1851,"width":1503,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e12e7007e2e544fc92a25bac78785f06","type":"text","conversion_output":true,"text":"on each participant's use of medical and non-medical resources related to urologic or gynecologic","text_display":" on each participant's use of medical and non-medical resources related to urologic or gynecologic","confidence":1,"confidence_rate":1},{"cnt":[[309,1895],[1854,1895],[1854,1938],[309,1938]],"region":{"top_left_x":309,"top_left_y":1894,"width":1546,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6de8a81dc6041b0843cda412a137f89","type":"text","conversion_output":true,"text":"conditions will be collected during the follow up period. Direct and indirect costs of the treatment of","text_display":" conditions will be collected during the follow up period. Direct and indirect costs of the treatment of","confidence":1,"confidence_rate":1},{"cnt":[[309,1938],[1742,1938],[1742,1983],[309,1983]],"region":{"top_left_x":309,"top_left_y":1937,"width":1434,"height":47},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89e2c9be2d20491eb6b61f0bbfe2b8ff","type":"text","conversion_output":true,"text":"apical pelvic organ prolapse with native tissue surgical repair or transvaginal mesh repair and","text_display":" apical pelvic organ prolapse with native tissue surgical repair or transvaginal mesh repair and","confidence":1,"confidence_rate":1},{"cnt":[[309,1983],[1803,1983],[1803,2026],[309,2026]],"region":{"top_left_x":309,"top_left_y":1983,"width":1494,"height":43},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea815b665825431b860c5abc1477573e","type":"text","conversion_output":true,"text":"women's preference for health states for improvement in pelvic organ prolapse will be estimated.","text_display":" women's preference for health states for improvement in pelvic organ prolapse will be estimated.","confidence":1,"confidence_rate":1},{"cnt":[[309,2050],[1689,2050],[1689,2090],[309,2090]],"region":{"top_left_x":309,"top_left_y":2049,"width":1380,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0af213e0cd374a0caebf6a3ea98a2aa4","type":"text","conversion_output":true,"text":"We plan to capture incremental health care resource use related to study interventions and","text_display":"\n\nWe plan to capture incremental health care resource use related to study interventions and","confidence":1,"confidence_rate":1},{"cnt":[[309,2093],[1858,2093],[1858,2136],[309,2136]],"region":{"top_left_x":309,"top_left_y":2092,"width":1550,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d244de9eb10a493a8b655c988d118ce1","type":"text","conversion_output":true,"text":"complications and other prolapse management (such as pessary use or additional surgery). Costs will","text_display":" complications and other prolapse management (such as pessary use or additional surgery). 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reimbursement","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[305,1096],[1835,1096],[1835,1141],[305,1141]],"region":{"top_left_x":305,"top_left_y":1095,"width":1530,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18c139e8b9c249138a3c238beb2d6cf0","type":"text","conversion_output":true,"text":"The SF-6D preference-based utility index algorithm derived from the SF-12 instrument53 will be","text_display":"\n\nThe SF-6D preference-based utility index algorithm derived from the SF-12 instrument53 will be","confidence":1,"confidence_rate":1},{"cnt":[[305,1139],[1841,1139],[1841,1188],[305,1188]],"region":{"top_left_x":305,"top_left_y":1138,"width":1537,"height":51},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7fa42f2043da4ec382101e2f7d8827f4","type":"text","conversion_output":true,"text":"used to calculate each participant's utility index at baseline and various follow up time points based","text_display":" used to calculate each participant's utility index at baseline and various follow up time points based","confidence":1,"confidence_rate":1},{"cnt":[[305,1182],[1880,1182],[1880,1231],[305,1231]],"region":{"top_left_x":305,"top_left_y":1181,"width":1575,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"322e0a16c2a0477eb044503c85951330","type":"text","conversion_output":true,"text":"on her responses to the SF-12 questionnaire. The SF-6D focuses on seven of the eight health domains","text_display":" on her responses to the SF-12 questionnaire. The SF-6D focuses on seven of the eight health domains","confidence":1,"confidence_rate":1},{"cnt":[[305,1229],[1790,1229],[1790,1274],[305,1274]],"region":{"top_left_x":305,"top_left_y":1228,"width":1485,"height":47},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37e4d7e645bd403e8a01d54ab6bca51b","type":"text","conversion_output":true,"text":"covered by the SF-12: physical functioning, role participation (combined role-physical and role-","text_display":" covered by the SF-12: physical functioning, role participation (combined role-physical and role","confidence":1,"confidence_rate":1},{"cnt":[[305,1272],[1820,1272],[1820,1317],[305,1317]],"region":{"top_left_x":305,"top_left_y":1271,"width":1515,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f086c28f854b40a28fc1282856ee6193","type":"text","conversion_output":true,"text":"emotional), social functioning, bodily pain, mental health, and vitality.). This instrument has been","text_display":"emotional), social functioning, bodily pain, mental health, and vitality.). This instrument has been","confidence":0.9638671875,"confidence_rate":0.9996495684043954},{"cnt":[[305,1315],[1876,1315],[1876,1362],[305,1362]],"region":{"top_left_x":305,"top_left_y":1314,"width":1571,"height":49},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0232145d32934712a13fcc092a0297b9","type":"text","conversion_output":true,"text":"previously used in women with urinary incontinence54. These data will be used to compare change in","text_display":" previously used in women with urinary incontinence54. These data will be used to compare change in","confidence":0.87060546875,"confidence_rate":0.9986555999699337},{"cnt":[[305,1358],[1876,1358],[1876,1405],[305,1405]],"region":{"top_left_x":305,"top_left_y":1357,"width":1571,"height":49},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ef81b89eb8f4ef1ab58dacc28c2f2b7","type":"text","conversion_output":true,"text":"QALYs between the two treatment groups. We are choosing to use a general scale to calculate change","text_display":" QALYs between the two treatment groups. We are choosing to use a general scale to calculate change","confidence":0.94921875,"confidence_rate":0.9994941473930107},{"cnt":[[305,1403],[1846,1403],[1846,1450],[305,1450]],"region":{"top_left_x":305,"top_left_y":1402,"width":1541,"height":49},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18dc2304ebc54e389c70f41d1d969630","type":"text","conversion_output":true,"text":"in utilities (rather than condition-specific) to allow for comparison of cost-effectiveness results with","text_display":" in utilities (rather than condition-specific) to allow for comparison of cost-effectiveness results with","confidence":1,"confidence_rate":1},{"cnt":[[305,1448],[1811,1448],[1811,1493],[305,1493]],"region":{"top_left_x":305,"top_left_y":1448,"width":1507,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b26d75222f294d49a90c032cf5299ed5","type":"text","conversion_output":true,"text":"other interventions and diseases. Because the follow up period for participants spans at least three","text_display":" other interventions and diseases. Because the follow up period for participants spans at least three","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1863,1491],[1863,1536],[305,1536]],"region":{"top_left_x":305,"top_left_y":1491,"width":1558,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39ba789618284eeebf7a048f4d92cbbf","type":"text","conversion_output":true,"text":"years, costs and QALYs in the second year and third year of follow up will be discounted using a \\(3 \\%\\)","text_display":" years, costs and QALYs in the second year and third year of follow up will be discounted using a \\(3 \\%\\)","confidence":0.9980475902557373,"confidence_rate":0.999981026217086},{"cnt":[[305,1534],[597,1534],[597,1583],[305,1583]],"region":{"top_left_x":305,"top_left_y":1533,"width":293,"height":51},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f4887030e054ea3b6d61066ec0e3c06","type":"text","conversion_output":true,"text":"discount rate/year.","text_display":" discount rate/year.","confidence":1,"confidence_rate":1},{"cnt":[[305,1598],[1783,1598],[1783,1646],[305,1646]],"region":{"top_left_x":305,"top_left_y":1598,"width":1479,"height":48},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ab563ff700e4571b4425a15e9a5847a","type":"text","conversion_output":true,"text":"Differential mean costs and differential mean QALYs between the two treatment groups will be","text_display":"\n\nDifferential mean costs and differential mean QALYs between the two treatment groups will be","confidence":1,"confidence_rate":1},{"cnt":[[305,1644],[1876,1644],[1876,1691],[305,1691]],"region":{"top_left_x":305,"top_left_y":1643,"width":1571,"height":48},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc762bf7f4a242daab76160efb6a7414","type":"text","conversion_output":true,"text":"estimated using multiple regression analysis. Specifically, a generalized linear model with appropriate","text_display":" estimated using multiple regression analysis. Specifically, a generalized linear model with appropriate","confidence":1,"confidence_rate":1},{"cnt":[[305,1689],[1837,1689],[1837,1734],[305,1734]],"region":{"top_left_x":305,"top_left_y":1688,"width":1532,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34309aabee984f07b4b48cfa48aa1933","type":"text","conversion_output":true,"text":"link function (e.g., log-link) and response probability distribution (e.g., gamma distribution) will be","text_display":" link function (e.g., log-link) and response probability distribution (e.g., gamma distribution) will be","confidence":1,"confidence_rate":1},{"cnt":[[305,1732],[1807,1732],[1807,1777],[305,1777]],"region":{"top_left_x":305,"top_left_y":1731,"width":1502,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f890ce40f8e4ee8bb6e2935006a605f","type":"text","conversion_output":true,"text":"used to analyze costs due to the potential skewness and heteroscedasticity of medical expenditure","text_display":" used to analyze costs due to the potential skewness and heteroscedasticity of medical expenditure","confidence":1,"confidence_rate":1},{"cnt":[[305,1775],[1835,1775],[1835,1822],[305,1822]],"region":{"top_left_x":305,"top_left_y":1774,"width":1530,"height":48},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53cc65a490834ec2a892cafd53034cbc","type":"text","conversion_output":true,"text":"data, while an ordinary least squares regression will be used for analyzing QALY data. The models","text_display":" data, while an ordinary least squares regression will be used for analyzing QALY data. The models","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1818],[1841,1818],[1841,1865],[305,1865]],"region":{"top_left_x":305,"top_left_y":1817,"width":1537,"height":48},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59acc224f2fe402f9b42cdf247b545b4","type":"text","conversion_output":true,"text":"will account for treatment group, study site and stratification factors, as well as other characteristics","text_display":" will account for treatment group, study site and stratification factors, as well as other characteristics","confidence":1,"confidence_rate":1},{"cnt":[[305,1863],[1846,1863],[1846,1910],[305,1910]],"region":{"top_left_x":305,"top_left_y":1862,"width":1541,"height":48},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2305557770074870898fbc36cd01e217","type":"text","conversion_output":true,"text":"of the participants that are found to differ significantly between the traditional vaginal hysterectomy","text_display":" of the participants that are found to differ significantly between the traditional vaginal hysterectomy","confidence":1,"confidence_rate":1},{"cnt":[[305,1908],[1768,1908],[1768,1953],[305,1953]],"region":{"top_left_x":305,"top_left_y":1907,"width":1464,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c5a730038d14a7898a901c9c1c13fd7","type":"text","conversion_output":true,"text":"with native tissue vault suspension and mesh hysteropexy suspension groups. When estimating","text_display":" with native tissue vault suspension and mesh hysteropexy suspension groups. When estimating","confidence":1,"confidence_rate":1},{"cnt":[[305,1951],[1869,1951],[1869,1996],[305,1996]],"region":{"top_left_x":305,"top_left_y":1950,"width":1565,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5602d6b8e8d4c569458eaf790b8392d","type":"text","conversion_output":true,"text":"QALYs, we will also adjust for participants' baseline utility scores to account for potential imbalance","text_display":" QALYs, we will also adjust for participants' baseline utility scores to account for potential imbalance","confidence":1,"confidence_rate":1},{"cnt":[[305,1994],[1156,1994],[1156,2043],[305,2043]],"region":{"top_left_x":305,"top_left_y":1993,"width":851,"height":51},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07d05fcbe5df4032afbfbe17345aada5","type":"text","conversion_output":true,"text":"in baseline utility between the two treatment groups. 55","text_display":" in baseline utility between the two treatment groups. 55","confidence":1,"confidence_rate":1},{"cnt":[[305,2058],[1876,2058],[1876,2103],[305,2103]],"region":{"top_left_x":305,"top_left_y":2058,"width":1571,"height":46},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d5255d91327428ab70579687b08f9dc","type":"text","conversion_output":true,"text":"We will calculate the incremental cost-effectiveness ratio (ICER), which is the differential mean costs","text_display":"\n\nWe will calculate the incremental cost-effectiveness ratio (ICER), which is the differential mean costs","confidence":1,"confidence_rate":1},{"cnt":[[305,2103],[1766,2103],[1766,2151],[305,2151]],"region":{"top_left_x":305,"top_left_y":2103,"width":1462,"height":48},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ba402f411c24f268255980c1f17e815","type":"text","conversion_output":true,"text":"divided by the differential mean QALYs between the two groups, to assess the additional costs","text_display":" divided by the differential mean QALYs between the two groups, to assess the additional costs","confidence":1,"confidence_rate":1},{"cnt":[[305,2148],[1811,2148],[1811,2194],[305,2194]],"region":{"top_left_x":305,"top_left_y":2148,"width":1507,"height":46},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d4f761c606bd4b36b2e1cbde93c48ee8","type":"text","conversion_output":true,"text":"associated with each additional QALY gained. Our base case analysis will be conducted based on","text_display":" associated with each additional QALY gained. Our base case analysis will be conducted based on","confidence":1,"confidence_rate":1},{"cnt":[[305,2191],[1818,2191],[1818,2237],[305,2237]],"region":{"top_left_x":305,"top_left_y":2191,"width":1513,"height":46},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0d93850ebb24345a20a5a9ef8787539","type":"text","conversion_output":true,"text":"participants with complete data. Sensitivity analysis will be conducted to include participants with","text_display":" participants with complete data. Sensitivity analysis will be conducted to include participants with","confidence":1,"confidence_rate":1},{"cnt":[[305,2234],[1815,2234],[1815,2282],[305,2282]],"region":{"top_left_x":305,"top_left_y":2234,"width":1511,"height":48},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"03f0af9c631a4fbe95c3c2e867136f73","type":"text","conversion_output":true,"text":"incomplete data using the multiple imputation method. Non-parametric bootstrapping resampling","text_display":" incomplete data using the multiple imputation method. Non-parametric bootstrapping resampling","confidence":1,"confidence_rate":1},{"cnt":[[305,2282],[1738,2282],[1738,2327],[305,2327]],"region":{"top_left_x":305,"top_left_y":2281,"width":1434,"height":46},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6510d793a3cb4d16b7553567108d328c","type":"text","conversion_output":true,"text":"technique will be used to derive the \\(95 \\%\\) confidence interval for the ICER. In addition, cost-","text_display":" technique will be used to derive the \\(95 \\%\\) confidence interval for the ICER. In addition, cost","confidence":1,"confidence_rate":1},{"cnt":[[305,2325],[1760,2325],[1760,2370],[305,2370]],"region":{"top_left_x":305,"top_left_y":2324,"width":1455,"height":46},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58bb1134b8cb41cb815d60832b460e09","type":"text","conversion_output":true,"text":"effectiveness acceptability curve (CEAC) will be generated to illustrate the likelihood that one","text_display":"effectiveness acceptability curve (CEAC) will be generated to illustrate the likelihood that one","confidence":1,"confidence_rate":1},{"cnt":[[305,2368],[1721,2368],[1721,2413],[305,2413]],"region":{"top_left_x":305,"top_left_y":2367,"width":1416,"height":46},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"206007efa36b4db98c51904973d88761","type":"text","conversion_output":true,"text":"treatment is more cost-effective than the other with various ceiling cost-effectiveness ratios.","text_display":" treatment is more cost-effective than the other with various ceiling cost-effectiveness ratios.","confidence":1,"confidence_rate":1},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":64,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a4e06b61fb4d4ab986ad944bffa94972","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 33","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-35","page":35,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"15508ecda3234e6d90b5a1b9c7c24884","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"71c9a7391c004ec689943faab2f5fa16","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,316],[1807,316],[1807,359],[309,359]],"region":{"top_left_x":309,"top_left_y":315,"width":1498,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65a046b8bcf04b908f2365c327d324e4","type":"text","conversion_output":true,"text":"In the case that a statistically significant difference in changes in utilities (as measured by SF-6D)","text_display":"\n\nIn the case that a statistically significant difference in changes in utilities (as measured by SF-6D)","confidence":1,"confidence_rate":1},{"cnt":[[309,361],[1749,361],[1749,402],[309,402]],"region":{"top_left_x":309,"top_left_y":360,"width":1440,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b68b694e805241a6aaf80eb6645dac72","type":"text","conversion_output":true,"text":"between the treatment groups is not detected, we plan to conduct supplemental analyses using","text_display":" between the treatment groups is not detected, we plan to conduct supplemental analyses using","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[309,404],[1826,404],[1826,449],[309,449]],"region":{"top_left_x":309,"top_left_y":403,"width":1518,"height":47},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d1850df12a24cac8c00f49f4dd414ce","type":"text","conversion_output":true,"text":"alternative outcome measures, such as incremental cost per treatment success, incremental cost per","text_display":" alternative outcome measures, such as incremental cost per treatment success, incremental cost per","confidence":1,"confidence_rate":1},{"cnt":[[309,449],[1089,449],[1089,492],[309,492]],"region":{"top_left_x":309,"top_left_y":449,"width":781,"height":43},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59d3e5860ae64085b1e4945b8c3f4234","type":"text","conversion_output":true,"text":"POP HRQOL, or incremental cost per satisfaction.","text_display":" POP HRQOL, or incremental cost per satisfaction.","confidence":1,"confidence_rate":1},{"cnt":[[309,511],[1863,511],[1863,556],[309,556]],"region":{"top_left_x":309,"top_left_y":511,"width":1554,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7e913e7c1ba4b14a63fb1405d9e8e5c","type":"text","conversion_output":true,"text":"The cost-effectiveness evaluations will be conducted as within-trial comparisons. A decision analytic","text_display":"\n\nThe cost-effectiveness evaluations will be conducted as within-trial comparisons. A decision analytic","confidence":0.998046875,"confidence_rate":0.9999815564452184},{"cnt":[[309,559],[1841,559],[1841,599],[309,599]],"region":{"top_left_x":309,"top_left_y":558,"width":1533,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cbeac9e77144c3b8758ee4dc6bf3b85","type":"text","conversion_output":true,"text":"model will also be developed from trial data to evaluate the trajectory of the cost-effectiveness ratio","text_display":" model will also be developed from trial data to evaluate the trajectory of the cost-effectiveness ratio","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[309,602],[1869,602],[1869,645],[309,645]],"region":{"top_left_x":309,"top_left_y":601,"width":1561,"height":44},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7482b24272434c57b6ce32cb82f8b957","type":"text","conversion_output":true,"text":"over a lifetime; assuming an average life expectancy, given the average age of participants at the time","text_display":" over a lifetime; assuming an average life expectancy, given the average age of participants at the time","confidence":1,"confidence_rate":1},{"cnt":[[309,645],[604,645],[604,681],[309,681]],"region":{"top_left_x":309,"top_left_y":644,"width":295,"height":38},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22137f33817a4d618f1f481bf57185c6","type":"text","conversion_output":true,"text":"of the intervention.","text_display":" of the intervention.","confidence":1,"confidence_rate":1},{"cnt":[[455,709],[1025,709],[1025,758],[455,758]],"region":{"top_left_x":455,"top_left_y":708,"width":570,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19b8b0a4830141139fe8b4be7edab768","type":"section_header","conversion_output":false,"children_ids":["507ea93f91de4e20bb6f66e258305ce3"],"text":"","text_display":""},{"cnt":[[460,711],[1023,711],[1023,756],[460,756]],"region":{"top_left_x":459,"top_left_y":711,"width":564,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"507ea93f91de4e20bb6f66e258305ce3","type":"text","conversion_output":true,"parent_id":"19b8b0a4830141139fe8b4be7edab768","text":"9.4.6 Changes in Body Image","text_display":"\n\n\\subsection*{9.4.6 Changes in Body Image}","confidence":0.9902532030828297,"confidence_rate":0.999693965342382},{"cnt":[[309,799],[1865,799],[1865,840],[309,840]],"region":{"top_left_x":309,"top_left_y":799,"width":1556,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2aa8bea0ea44799978f22004a9f0ead","type":"text","conversion_output":true,"text":"Total BIS scores will be calculated as described by Hopwood et al, and changes in BIS scores will be","text_display":"\n\nTotal BIS scores will be calculated as described by Hopwood et al, and changes in BIS scores will be","confidence":0.99853515625,"confidence_rate":0.9999860389766703},{"cnt":[[309,842],[1792,842],[1792,885],[309,885]],"region":{"top_left_x":309,"top_left_y":842,"width":1483,"height":44},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7593f782d7574d2d9b6c1bb60c56215c","type":"text","conversion_output":true,"text":"correlated with changes in PISQ R scores, the leading edge of prolapse, and POPDI scores using","text_display":" correlated with changes in PISQ R scores, the leading edge of prolapse, and POPDI scores using","confidence":1,"confidence_rate":1},{"cnt":[[309,885],[1858,885],[1858,930],[309,930]],"region":{"top_left_x":309,"top_left_y":885,"width":1550,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d21848cb23442a0914c1b8890edc034","type":"text","conversion_output":true,"text":"Pearson's and Spearman correlation coefficients. If measures are correlated, we will further describe","text_display":" Pearson's and Spearman correlation coefficients. If measures are correlated, we will further describe","confidence":1,"confidence_rate":1},{"cnt":[[309,930],[1796,930],[1796,973],[309,973]],"region":{"top_left_x":309,"top_left_y":930,"width":1488,"height":44},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"165b594e181349d4ab5c71703a045d9a","type":"text","conversion_output":true,"text":"changes in individual items of the BIS scale before and after treatment for prolapse, to determine","text_display":" changes in individual items of the BIS scale before and after treatment for prolapse, to determine","confidence":1,"confidence_rate":1},{"cnt":[[309,975],[1687,975],[1687,1016],[309,1016]],"region":{"top_left_x":309,"top_left_y":975,"width":1378,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07c2140d08434dd8b8c0fb4de126da45","type":"text","conversion_output":true,"text":"which portions of the BIS scale explain the overall change in BIS scores, and evaluate the","text_display":" which portions of the BIS scale explain the overall change in BIS scores, and evaluate the","confidence":1,"confidence_rate":1},{"cnt":[[309,1018],[1871,1018],[1871,1059],[309,1059]],"region":{"top_left_x":309,"top_left_y":1018,"width":1563,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97cf0318b4384b7b9d3f94ceef1b0abb","type":"text","conversion_output":true,"text":"associations between BIS item scores and PISQ IR item scores. General linear model analyses will be","text_display":" associations between BIS item scores and PISQ IR item scores. General linear model analyses will be","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[309,1061],[1824,1061],[1824,1106],[309,1106]],"region":{"top_left_x":309,"top_left_y":1061,"width":1516,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"63cae2fcf5a844d4911db02f1c8b63ee","type":"text","conversion_output":true,"text":"used to evaluate how well the combination of BIS scores, demographic and experimental variables","text_display":" used to evaluate how well the combination of BIS scores, demographic and experimental variables","confidence":1,"confidence_rate":1},{"cnt":[[309,1109],[840,1109],[840,1149],[309,1149]],"region":{"top_left_x":309,"top_left_y":1108,"width":532,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab306aee708747a2a95c79344ec87b60","type":"text","conversion_output":true,"text":"explain changes in PISQ R scores.","text_display":" explain changes in PISQ R scores.","confidence":1,"confidence_rate":1},{"cnt":[[309,1173],[1841,1173],[1841,1214],[309,1214]],"region":{"top_left_x":309,"top_left_y":1173,"width":1533,"height":41},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fba7e1a0946e424fa8f6124d3b0490c6","type":"text","conversion_output":true,"text":"Between randomization group comparisons will also be made using linear models for total and item","text_display":"\n\nBetween randomization group comparisons will also be made using linear models for total and item","confidence":1,"confidence_rate":1},{"cnt":[[309,1216],[1850,1216],[1850,1257],[309,1257]],"region":{"top_left_x":309,"top_left_y":1216,"width":1541,"height":41},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"599c012351714699964b608a818b0089","type":"text","conversion_output":true,"text":"scores controlling for randomization strata. We will also utilize extensions of this model to evaluate","text_display":" scores controlling for randomization strata. We will also utilize extensions of this model to evaluate","confidence":1,"confidence_rate":1},{"cnt":[[309,1259],[1768,1259],[1768,1302],[309,1302]],"region":{"top_left_x":309,"top_left_y":1258,"width":1460,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1e03f61ce824feea82c409711688e64","type":"text","conversion_output":true,"text":"if any differences in BIS scores are either modified by or confounded with differences in either","text_display":" if any differences in BIS scores are either modified by or confounded with differences in either","confidence":1,"confidence_rate":1},{"cnt":[[309,1302],[668,1302],[668,1347],[309,1347]],"region":{"top_left_x":309,"top_left_y":1301,"width":360,"height":47},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26eaf9bbadb24ae39d73d6f3b3d4f8f2","type":"text","conversion_output":true,"text":"efficacy or side effects.","text_display":" efficacy or side effects.","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[309,1388],[750,1388],[750,1429],[309,1429]],"region":{"top_left_x":309,"top_left_y":1387,"width":441,"height":42},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50aee676c480433092d7933486249a5e","type":"section_header","conversion_output":false,"children_ids":["ad5c8f0226c349aebadefb2ffbd01845"],"text":"","text_display":""},{"cnt":[[312,1388],[748,1388],[748,1429],[312,1429]],"region":{"top_left_x":311,"top_left_y":1387,"width":437,"height":42},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad5c8f0226c349aebadefb2ffbd01845","type":"text","conversion_output":true,"parent_id":"50aee676c480433092d7933486249a5e","text":"10 SAFETY ANALYSES","text_display":"\n\n\\section*{10 SAFETY ANALYSES}","confidence":1,"confidence_rate":1},{"cnt":[[374,1474],[1244,1474],[1244,1528],[374,1528]],"region":{"top_left_x":373,"top_left_y":1473,"width":871,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bb78fd7d5bb4f60991e647e7468a32a","type":"section_header","conversion_output":false,"children_ids":["f65ace556d7442f38a50ae1b792144d6"],"text":"","text_display":""},{"cnt":[[374,1478],[1240,1478],[1240,1523],[374,1523]],"region":{"top_left_x":373,"top_left_y":1478,"width":867,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f65ace556d7442f38a50ae1b792144d6","type":"text","conversion_output":true,"parent_id":"1bb78fd7d5bb4f60991e647e7468a32a","text":"10.1 Overview of Safety Analysis Methods","text_display":"\n\n\\subsection*{10.1 Overview of Safety Analysis Methods}","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[309,1545],[1876,1545],[1876,1588],[309,1588]],"region":{"top_left_x":309,"top_left_y":1544,"width":1567,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c33b8a51fa04c208c5fa39c07d2c4ae","type":"text","conversion_output":true,"text":"All safety analyses will be performed using the SAF population unless otherwise specified. Study arm","text_display":"\n\nAll safety analyses will be performed using the SAF population unless otherwise specified. Study arm","confidence":1,"confidence_rate":1},{"cnt":[[309,1590],[1841,1590],[1841,1633],[309,1633]],"region":{"top_left_x":309,"top_left_y":1589,"width":1533,"height":44},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33114519485649179b34cd47324e745e","type":"text","conversion_output":true,"text":"summaries will be constructed across all study sites. Descriptive p-values comparing the study arms","text_display":" summaries will be constructed across all study sites. Descriptive p-values comparing the study arms","confidence":0.6298828125,"confidence_rate":0.995565424503921},{"cnt":[[309,1633],[1833,1633],[1833,1678],[309,1678]],"region":{"top_left_x":309,"top_left_y":1632,"width":1524,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f770e628921434ea694129b4bbd9bb6","type":"text","conversion_output":true,"text":"will be provided on most safety table summaries and will be obtained using Fisher exact tests if the","text_display":" will be provided on most safety table summaries and will be obtained using Fisher exact tests if the","confidence":1,"confidence_rate":1},{"cnt":[[309,1678],[1790,1678],[1790,1717],[309,1717]],"region":{"top_left_x":309,"top_left_y":1677,"width":1481,"height":40},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff00107c5d8b49b4b08dbe2f4d901e3a","type":"text","conversion_output":true,"text":"occurrence of such events is rare and Cochrane-Mantel-Haenszel tests for more common events.","text_display":" occurrence of such events is rare and Cochrane-Mantel-Haenszel tests for more common events.","confidence":0.99072265625,"confidence_rate":0.9999039154789536},{"cnt":[[374,1740],[853,1740],[853,1783],[374,1783]],"region":{"top_left_x":373,"top_left_y":1740,"width":480,"height":44},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5db39d63081647199f79e53a51f8fd16","type":"section_header","conversion_output":false,"children_ids":["deeaf38ce014418f80aab2a0eb4f7cc9"],"text":"","text_display":""},{"cnt":[[374,1745],[851,1745],[851,1781],[374,1781]],"region":{"top_left_x":373,"top_left_y":1744,"width":478,"height":38},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"deeaf38ce014418f80aab2a0eb4f7cc9","type":"text","conversion_output":true,"parent_id":"5db39d63081647199f79e53a51f8fd16","text":"10.2 Adverse Events","text_display":"\n\n\\subsection*{10.2 Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[309,1809],[1846,1809],[1846,1854],[309,1854]],"region":{"top_left_x":309,"top_left_y":1808,"width":1537,"height":47},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58b16116395e41c9ae31e0488f7c97fc","type":"text","conversion_output":true,"text":"As described in Section 3.2, four types of measures will be utilized to characterize participant safety","text_display":"\n\nAs described in Section 3.2, four types of measures will be utilized to characterize participant safety","confidence":1,"confidence_rate":1},{"cnt":[[309,1852],[1798,1852],[1798,1897],[309,1897]],"region":{"top_left_x":309,"top_left_y":1851,"width":1490,"height":47},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e42ea1130c144b1c92b7b51ac52439a7","type":"text","conversion_output":true,"text":"and tolerability measures. First, as a part of the inter-operative and peri-operative data collection","text_display":" and tolerability measures. First, as a part of the inter-operative and peri-operative data collection","confidence":1,"confidence_rate":1},{"cnt":[[309,1897],[1717,1897],[1717,1940],[309,1940]],"region":{"top_left_x":309,"top_left_y":1897,"width":1408,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc52780de67441f88ac307c50a80864a","type":"text","conversion_output":true,"text":"forms, information will be collected on surgical complications that characterize the risk and","text_display":" forms, information will be collected on surgical complications that characterize the risk and","confidence":1,"confidence_rate":1},{"cnt":[[309,1942],[1734,1942],[1734,1983],[309,1983]],"region":{"top_left_x":309,"top_left_y":1942,"width":1425,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3db9e54b47641e3b1c75b7562152466","type":"text","conversion_output":true,"text":"tolerability of the procedure itself. Second, participants will be asked about specific targeted","text_display":" tolerability of the procedure itself. Second, participants will be asked about specific targeted","confidence":1,"confidence_rate":1},{"cnt":[[309,1985],[1830,1985],[1830,2028],[309,2028]],"region":{"top_left_x":309,"top_left_y":1985,"width":1522,"height":44},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21c68e94456f4a3c9822ec32b2bbac32","type":"text","conversion_output":true,"text":"complications on both the post-operative visit and a standard study evaluation collected at 6-month","text_display":" complications on both the post-operative visit and a standard study evaluation collected at 6-month","confidence":0.9907452900695262,"confidence_rate":0.9999106020652049},{"cnt":[[309,2028],[1867,2028],[1867,2073],[309,2073]],"region":{"top_left_x":309,"top_left_y":2028,"width":1558,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2660fb849df4001951bf1ab590b9b3a","type":"text","conversion_output":true,"text":"intervals (with those complications automatically populating the AE form. Third, participants will be","text_display":" intervals (with those complications automatically populating the AE form. Third, participants will be","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[309,2075],[1815,2075],[1815,2116],[309,2116]],"region":{"top_left_x":309,"top_left_y":2075,"width":1507,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6fec4b8334e44626b4483328dc06ca77","type":"text","conversion_output":true,"text":"asked through a response to open-ended questions to report any post-surgery adverse events to the","text_display":" asked through a response to open-ended questions to report any post-surgery adverse events to the","confidence":1,"confidence_rate":1},{"cnt":[[309,2118],[1837,2118],[1837,2159],[309,2159]],"region":{"top_left_x":309,"top_left_y":2118,"width":1528,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74d4a1021c804c029d729fa0948a3b69","type":"text","conversion_output":true,"text":"study coordinator or physician at the 6-week visit and at the subsequent follow-up visits at 6-month","text_display":" study coordinator or physician at the 6-week visit and at the subsequent follow-up visits at 6-month","confidence":0.9578317170962691,"confidence_rate":0.9995897681957769},{"cnt":[[309,2161],[1807,2161],[1807,2204],[309,2204]],"region":{"top_left_x":309,"top_left_y":2161,"width":1498,"height":44},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d19092cc3ac343589bd53dd3c84ada11","type":"text","conversion_output":true,"text":"intervals. If a serious adverse event, particularly a hospitalization, occurs, the participants will be","text_display":" intervals. If a serious adverse event, particularly a hospitalization, occurs, the participants will be","confidence":1,"confidence_rate":1},{"cnt":[[309,2204],[1747,2204],[1747,2249],[309,2249]],"region":{"top_left_x":309,"top_left_y":2204,"width":1438,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc7b4cdca5a142ad9b305da4d6219355","type":"text","conversion_output":true,"text":"asked to report that immediately to the study coordinator or physician. All adverse events are","text_display":" asked to report that immediately to the study coordinator or physician. All adverse events are","confidence":1,"confidence_rate":1},{"cnt":[[309,2249],[1790,2249],[1790,2292],[309,2292]],"region":{"top_left_x":309,"top_left_y":2249,"width":1481,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c53c13e08c8f44ae9b620cbd1298a527","type":"text","conversion_output":true,"text":"captured by the study coordinator on the adverse event logs. Finally, specific pain information is","text_display":" captured by the study coordinator on the adverse event logs. Finally, specific pain information is","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[309,2295],[1781,2295],[1781,2335],[309,2335]],"region":{"top_left_x":309,"top_left_y":2294,"width":1473,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9aebbc58ddf5496d984788257bd5b79f","type":"text","conversion_output":true,"text":"being collected as a part of all follow-up visits to characterize differences in post-operative pain","text_display":" being collected as a part of all follow-up visits to characterize differences in post-operative pain","confidence":1,"confidence_rate":1},{"cnt":[[309,2338],[569,2338],[569,2378],[309,2378]],"region":{"top_left_x":309,"top_left_y":2337,"width":261,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48b8bcb933cd475f9c77663e9ae947ef","type":"text","conversion_output":true,"text":"beyond 6 weeks.","text_display":" beyond 6 weeks.","confidence":0.99853515625,"confidence_rate":0.9999362664796542},{"cnt":[[309,2402],[1803,2402],[1803,2443],[309,2443]],"region":{"top_left_x":309,"top_left_y":2401,"width":1494,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f40250040e024cef898df94ca5d38898","type":"text","conversion_output":true,"text":"The group of measures collected inter-operatively and peri-operatively includes those in the table","text_display":"\n\nThe group of measures collected inter-operatively and peri-operatively includes those in the table","confidence":1,"confidence_rate":1},{"cnt":[[309,2445],[1828,2445],[1828,2488],[309,2488]],"region":{"top_left_x":309,"top_left_y":2444,"width":1520,"height":44},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"845ee9987c5444ffba5fbace72ef106f","type":"text","conversion_output":true,"text":"below. These measures include continuous measures as well binary and ordinal measures. For the","text_display":" below. These measures include continuous measures as well binary and ordinal measures. For the","confidence":1,"confidence_rate":1},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":50,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e3812398abb74c27baf1764163694397","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 34","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"81e64422-79d2-483d-ba68-619ad30346b2-36","page":36,"lines":[{"cnt":[[309,129],[569,129],[569,157],[309,157]],"region":{"top_left_x":309,"top_left_y":128,"width":261,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"36418a679bf744bfb9d975907393cc17","type":"page_info","conversion_output":false,"text":"Pelvic Floor Disorder","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[664,180],[664,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":355,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"46de8a37676d429686df0d512c17abfe","type":"page_info","conversion_output":false,"text":"17P01 Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,316],[1807,316],[1807,359],[309,359]],"region":{"top_left_x":309,"top_left_y":315,"width":1498,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5f26035972d4a41867b91d77db46187","type":"text","conversion_output":true,"text":"continuous measures, summaries will be presented by treatment arm that include mean levels and","text_display":"\ncontinuous measures, summaries will be presented by treatment arm that include mean levels and","confidence":1,"confidence_rate":1},{"cnt":[[309,361],[1871,361],[1871,402],[309,402]],"region":{"top_left_x":309,"top_left_y":360,"width":1563,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2adb18a495bc427ead41ba8be3347a28","type":"text","conversion_output":true,"text":"standard deviations and linear models with treatment as the primary predictor, controlling for site will","text_display":" standard deviations and linear models with treatment as the primary predictor, controlling for site will","confidence":1,"confidence_rate":1},{"cnt":[[309,404],[1871,404],[1871,447],[309,447]],"region":{"top_left_x":309,"top_left_y":403,"width":1563,"height":44},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b888f6018754d949e64baa28324ae5c","type":"text","conversion_output":true,"text":"be used to test for differences by treatment arm. For the binary and ordinal measures, summaries will","text_display":" be used to test for differences by treatment arm. For the binary and ordinal measures, summaries will","confidence":1,"confidence_rate":1},{"cnt":[[309,447],[1783,447],[1783,492],[309,492]],"region":{"top_left_x":309,"top_left_y":446,"width":1475,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4f59e61015b44e3b52c4e4b3fea9f69","type":"text","conversion_output":true,"text":"included counts and percentages associated with each level of the binary or ordinal measure and","text_display":" included counts and percentages associated with each level of the binary or ordinal measure and","confidence":1,"confidence_rate":1},{"cnt":[[309,492],[1803,492],[1803,535],[309,535]],"region":{"top_left_x":309,"top_left_y":491,"width":1494,"height":44},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2e6dfde6fa64b6796f570e115422e5e","type":"text","conversion_output":true,"text":"Cochran-Mantel-Haenszel statistics and associated p-value with analyses stratified by site will be","text_display":" Cochran-Mantel-Haenszel statistics and associated p-value with analyses stratified by site will be","confidence":0.9507074356079102,"confidence_rate":0.999509354362704},{"cnt":[[309,537],[1137,537],[1137,574],[309,574]],"region":{"top_left_x":309,"top_left_y":537,"width":828,"height":37},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae9a0924ed4d4e5780dbbe44bca8b779","type":"text","conversion_output":true,"text":"used to characterize differences in the treatment arms.","text_display":" used to characterize differences in the treatment arms.","confidence":1,"confidence_rate":1},{"cnt":[[309,602],[1803,602],[1803,642],[309,642]],"region":{"top_left_x":309,"top_left_y":601,"width":1494,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5163855242a4c7fb5050d85ab2006b3","type":"text","conversion_output":true,"text":"The AEs collected through the standard AE form will be summarized using standard contingency","text_display":"\n\nThe AEs collected through the standard AE form will be summarized using standard contingency","confidence":1,"confidence_rate":1},{"cnt":[[309,645],[1833,645],[1833,690],[309,690]],"region":{"top_left_x":309,"top_left_y":644,"width":1524,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d04605912c5b47acabe3bb92f841f915","type":"text","conversion_output":true,"text":"tables by treatment arm. These summaries will be provided by individual treatment-emergent AEs,","text_display":" tables by treatment arm. These summaries will be provided by individual treatment-emergent AEs,","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[309,690],[1721,690],[1721,733],[309,733]],"region":{"top_left_x":309,"top_left_y":689,"width":1412,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bea52ef2f0a14241b4740c7e620bf5ad","type":"text","conversion_output":true,"text":"AEs by body system, and AEs by subject. In addition to these general descriptions, specific","text_display":" AEs by body system, and AEs by subject. In addition to these general descriptions, specific","confidence":0.994140625,"confidence_rate":0.9999387872018195},{"cnt":[[309,733],[1876,733],[1876,776],[309,776]],"region":{"top_left_x":309,"top_left_y":732,"width":1567,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1036bf567364994945b9efa02da9384","type":"text","conversion_output":true,"text":"comparison of risk and differences across the treatment arms will be evaluated for the outcomes listed","text_display":" comparison of risk and differences across the treatment arms will be evaluated for the outcomes listed","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[309,778],[595,778],[595,814],[309,814]],"region":{"top_left_x":309,"top_left_y":777,"width":287,"height":38},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2adee597f06d477e8b2f94831c8a56f4","type":"text","conversion_output":true,"text":"in the table below.","text_display":" in the table below.","confidence":1,"confidence_rate":1},{"cnt":[[288,834],[1897,834],[1897,2481],[288,2481]],"region":{"top_left_x":287,"top_left_y":833,"width":1611,"height":1649},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a226db02836042c3bd642e7c776f9494","type":"table","conversion_output":true,"children_ids":["d0dd494323e34af69bfa33f930c5567f","1cac105fdfdb4d6ca1b6afefea1c7a27","405f68a0bafd4f608c31d8ce626c8dca","d98590ce7e134b30ae46ed86a0b545f8","37ad8077437a4b4b98e9cf3fdd999259","9b61fd8e3d1c4c5e93d82d9f6329c6a7","b5516548f3854267876330e08017cb64","983df4b53de1415492e639814964d3a2","92edefe3077f4447b7f0fad177607a55","60a883d454e645a1ad386e3690e0938d","fdd7b32ed15449f4abc24b3d69e144f0","c9499d2335f943f9951f3620c30c68a9","8f8268a58a794a5ab57d2dab6de36a01","a8ce64eb1d9c4a59bbbea46a59ff8007","fe98982aa88f487998942ea6530d4064","8cc506d32bbc4208a1e3931dc8ecc889","ebd00f96673c435dbe9f0dd35f1b4f15","3df782ccdaf646b1b321352a0770f1fa","93271120afb24687a695163cf1fcd241","810a1239ae3b461ba0f7f77cb698233a","496ec91ea9e54035943a40079c816775","cfc1645d80244e70ae385b46c4fec550","896313edb8ee4ef38f2ac7494c6dc7e8","fdfd061494dd4a56b9415e667561fdd9","884ab1d107aa4f93a6f6d83f8e575420","fc075759eb1d4127929045a60760f4a7","2df19904171a477db983775148cc8b4b","2f05c649f39b4eb18ebd4917300b5b4d","ae8cf6d12ef2453780fbeb85dad1aba6","01065a79eabf425d80ce39c5e54efcf4","e508fa9a5ca644ae82e956a74a81f459","5eaf3ef56d3f4033928a3733e4fc130d","2983a68c2919461b92378395d35a5964","dc89628cffe74349b837463f3f7a5b5f","694e82d617214787b6811d63c9b9c628","f1b18a29e60e48dfb442dc1bbc70de4b","eec9fa6babe64028a397def80065473e","d686c1286294439f81f5343ad8937d54","569ee35ec890450cbc6d091c37c263e1","d1d5f727459a48b998d20c59c9c9e5bb","c5541bab38034704bd62cafdd73fc0b0"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|l|}{Summary of Safety Variables} \\\\\n\\hline \\multicolumn{3}{|l|}{Inter-operative and peri-operative measures} \\\\\n\\hline Variable & Type & Definition \\\\\n\\hline Operative time & Continuous & Obtained directly from peri-operative form \\\\\n\\hline Blood loss & Continuous & Obtained directly from peri-operative form \\\\\n\\hline Blood transfusion & Binary & Obtained directly from peri-operative form \\\\\n\\hline Complications & Ordinal & All complications will be collected and scored on a fivepoint ordinal scale using the Dindo classification scheme (Dindo, 2004). Each participant will then be classified according to the most severe complication \\\\\n\\hline \\multicolumn{3}{|l|}{Routinely Collected Adverse Events} \\\\\n\\hline Mesh-related Complications & Ordinal & \\begin{tabular}{l}\nMesh related complications: mesh exposure in the vagina or mesh erosion into another organ; note that level of complication will be characterized into based on the following response classification schema: \\\\\n(a) None or non-surgical medical intervention only; \\\\\n(b) Minor or intra-office surgical intervention; \\\\\n(c) Outpatient surgery; \\\\\n(d) Inpatient surgery\n\\end{tabular} \\\\\n\\hline Pelvic infection & Binary & Any incident of pelvic infection will be captured as a Yes response (AE or SAE) to Question 13 in the complications section of the Hospitalization form or Question 14 of the follow-up evaluation form. It will also be captured based on open-ended AE responses with comments indicative of pelvic infection. \\\\\n\\hline Perioperative infection & Binary & A perioperative infection will be captured as a Yes response (AE or SAE) to one or more of Questions 13, 14, 22, 23, 24, or 25 of the Hospitalization form or Questions 15, 16, 17, 18, 19, or 10 of the Post-operative visit form. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|l|}{Summary of Safety Variables} \\\\\n\\hline \\multicolumn{3}{|l|}{Inter-operative and peri-operative measures} \\\\\n\\hline Variable & Type & Definition \\\\\n\\hline Operative time & Continuous & Obtained directly from peri-operative form \\\\\n\\hline Blood loss & Continuous & Obtained directly from peri-operative form \\\\\n\\hline Blood transfusion & Binary & Obtained directly from peri-operative form \\\\\n\\hline Complications & Ordinal & All complications will be collected and scored on a fivepoint ordinal scale using the Dindo classification scheme (Dindo, 2004). Each participant will then be classified according to the most severe complication \\\\\n\\hline \\multicolumn{3}{|l|}{Routinely Collected Adverse Events} \\\\\n\\hline Mesh-related Complications & Ordinal & \\begin{tabular}{l}\nMesh related complications: mesh exposure in the vagina or mesh erosion into another organ; note that level of complication will be characterized into based on the following response classification schema: \\\\\n(a) None or non-surgical medical intervention only; \\\\\n(b) Minor or intra-office surgical intervention; \\\\\n(c) Outpatient surgery; \\\\\n(d) Inpatient surgery\n\\end{tabular} \\\\\n\\hline Pelvic infection & Binary & Any incident of pelvic infection will be captured as a Yes response (AE or SAE) to Question 13 in the complications section of the Hospitalization form or Question 14 of the follow-up evaluation form. It will also be captured based on open-ended AE responses with comments indicative of pelvic infection. \\\\\n\\hline Perioperative infection & Binary & A perioperative infection will be captured as a Yes response (AE or SAE) to one or more of Questions 13, 14, 22, 23, 24, or 25 of the Hospitalization form or Questions 15, 16, 17, 18, 19, or 10 of the Post-operative visit form. 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It will also be captured based on open-ended AE responses with comments indicative of pelvic infection.","text_display":"Any incident of pelvic infection will be captured as a Yes response (AE or SAE) to Question 13 in the complications section of the Hospitalization form or Question 14 of the follow-up evaluation form. It will also be captured based on open-ended AE responses with comments indicative of pelvic infection.","cell_row":9,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[954,1985],[1840,1985],[1840,2031],[954,2031]],"region":{"top_left_x":953,"top_left_y":1985,"width":887,"height":46},"line":70,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d2a74c8ea33415188c9a80edbd1e8ab","type":"text","conversion_output":false,"parent_id":"d686c1286294439f81f5343ad8937d54","text":"Any incident of pelvic infection will be captured as a Yes","text_display":"Any incident of pelvic infection will be captured as a Yes","confidence":1,"confidence_rate":1},{"cnt":[[954,2031],[1857,2031],[1857,2074],[954,2074]],"region":{"top_left_x":953,"top_left_y":2030,"width":904,"height":44},"line":71,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb78d50323ef47569d12ebcac0256cd3","type":"text","conversion_output":false,"parent_id":"d686c1286294439f81f5343ad8937d54","text":"response (AE or SAE) to Question 13 in the complications","text_display":" response (AE or SAE) to Question 13 in the complications","confidence":1,"confidence_rate":1},{"cnt":[[954,2076],[1827,2076],[1827,2117],[954,2117]],"region":{"top_left_x":953,"top_left_y":2075,"width":874,"height":43},"line":72,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0aea46eb108441887fca6f8bee691ee","type":"text","conversion_output":false,"parent_id":"d686c1286294439f81f5343ad8937d54","text":"section of the Hospitalization form or Question 14 of the","text_display":" section of the Hospitalization form or Question 14 of the","confidence":1,"confidence_rate":1},{"cnt":[[954,2119],[1840,2119],[1840,2163],[954,2163]],"region":{"top_left_x":953,"top_left_y":2119,"width":887,"height":44},"line":73,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5330f7b4b6704cb8b86c176f6ca93656","type":"text","conversion_output":false,"parent_id":"d686c1286294439f81f5343ad8937d54","text":"follow-up evaluation form. It will also be captured based","text_display":" follow-up evaluation form. It will also be captured based","confidence":1,"confidence_rate":1},{"cnt":[[954,2163],[1855,2163],[1855,2206],[954,2206]],"region":{"top_left_x":953,"top_left_y":2162,"width":902,"height":44},"line":74,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"721b2f8941544399aad162a41ad74b1d","type":"text","conversion_output":false,"parent_id":"d686c1286294439f81f5343ad8937d54","text":"on open-ended AE responses with comments indicative of","text_display":" on open-ended AE responses with comments indicative of","confidence":1,"confidence_rate":1},{"cnt":[[954,2206],[1207,2206],[1207,2251],[954,2251]],"region":{"top_left_x":953,"top_left_y":2205,"width":255,"height":47},"line":75,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4a2fac464514469bac8dde336b18984","type":"text","conversion_output":false,"parent_id":"d686c1286294439f81f5343ad8937d54","text":"pelvic infection.","text_display":" pelvic infection.","confidence":1,"confidence_rate":1},{"cnt":[[306,2280],[523,2280],[523,2368],[306,2368]],"region":{"top_left_x":306,"top_left_y":2279,"width":218,"height":90},"line":76,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"569ee35ec890450cbc6d091c37c263e1","type":"complex_cell","conversion_output":false,"parent_id":"a226db02836042c3bd642e7c776f9494","children_ids":["6b32b5f491b34e879e244d9dc51702e3","7caef8106f654f8c9590cc3ffd6f15d3"],"text":"Perioperative infection","text_display":"Perioperative infection","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,2284],[519,2284],[519,2325],[309,2325]],"region":{"top_left_x":308,"top_left_y":2283,"width":211,"height":43},"line":77,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b32b5f491b34e879e244d9dc51702e3","type":"text","conversion_output":false,"parent_id":"569ee35ec890450cbc6d091c37c263e1","text":"Perioperative","text_display":"Perioperative","confidence":1,"confidence_rate":1},{"cnt":[[309,2327],[454,2327],[454,2364],[309,2364]],"region":{"top_left_x":308,"top_left_y":2327,"width":146,"height":38},"line":78,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7caef8106f654f8c9590cc3ffd6f15d3","type":"text","conversion_output":false,"parent_id":"569ee35ec890450cbc6d091c37c263e1","text":"infection","text_display":" infection","confidence":1,"confidence_rate":1},{"cnt":[[672,2284],[783,2284],[783,2325],[672,2325]],"region":{"top_left_x":672,"top_left_y":2283,"width":111,"height":43},"line":79,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1d5f727459a48b998d20c59c9c9e5bb","type":"simple_cell","conversion_output":false,"parent_id":"a226db02836042c3bd642e7c776f9494","text":"Binary","text_display":"Binary","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[950,2280],[1857,2280],[1857,2464],[950,2464]],"region":{"top_left_x":949,"top_left_y":2279,"width":908,"height":185},"line":80,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5541bab38034704bd62cafdd73fc0b0","type":"complex_cell","conversion_output":false,"parent_id":"a226db02836042c3bd642e7c776f9494","children_ids":["e89d1a1bd73b4b9abf5f55f01b124718","eb3e0062a64645c5a7aa29be97b2879d","5682291e75f54b33b6b4c416c53cbeb5","1af8f4a85d50461c8dd5f83bc25e256d"],"text":"A perioperative infection will be captured as a Yes response (AE or SAE) to one or more of Questions 13, 14, 22, 23, 24, or 25 of the Hospitalization form or Questions 15, 16, 17, 18, 19, or 10 of the Post-operative visit form.","text_display":"A perioperative infection will be captured as a Yes response (AE or SAE) to one or more of Questions 13, 14, 22, 23, 24, or 25 of the Hospitalization form or Questions 15, 16, 17, 18, 19, or 10 of the Post-operative visit form.","cell_row":10,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9912109375,"confidence_rate":0.9999670605644421},{"cnt":[[954,2284],[1736,2284],[1736,2325],[954,2325]],"region":{"top_left_x":953,"top_left_y":2283,"width":783,"height":43},"line":81,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e89d1a1bd73b4b9abf5f55f01b124718","type":"text","conversion_output":false,"parent_id":"c5541bab38034704bd62cafdd73fc0b0","text":"A perioperative infection will be captured as a Yes","text_display":"A perioperative infection will be captured as a Yes","confidence":1,"confidence_rate":1},{"cnt":[[954,2327],[1853,2327],[1853,2370],[954,2370]],"region":{"top_left_x":953,"top_left_y":2327,"width":900,"height":44},"line":82,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb3e0062a64645c5a7aa29be97b2879d","type":"text","conversion_output":false,"parent_id":"c5541bab38034704bd62cafdd73fc0b0","text":"response (AE or SAE) to one or more of Questions 13, 14,","text_display":" response (AE or SAE) to one or more of Questions 13, 14,","confidence":1,"confidence_rate":1},{"cnt":[[954,2370],[1842,2370],[1842,2416],[954,2416]],"region":{"top_left_x":953,"top_left_y":2370,"width":889,"height":46},"line":83,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5682291e75f54b33b6b4c416c53cbeb5","type":"text","conversion_output":false,"parent_id":"c5541bab38034704bd62cafdd73fc0b0","text":"22, 23, 24, or 25 of the Hospitalization form or Questions","text_display":" 22, 23, 24, or 25 of the Hospitalization form or Questions","confidence":1,"confidence_rate":1},{"cnt":[[954,2414],[1822,2414],[1822,2459],[954,2459]],"region":{"top_left_x":953,"top_left_y":2413,"width":870,"height":47},"line":84,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1af8f4a85d50461c8dd5f83bc25e256d","type":"text","conversion_output":false,"parent_id":"c5541bab38034704bd62cafdd73fc0b0","text":"15, 16, 17, 18, 19, or 10 of the Post-operative visit form.","text_display":" 15, 16, 17, 18, 19, or 10 of the Post-operative visit form.","confidence":0.9912109375,"confidence_rate":0.999868248767664},{"cnt":[[309,2522],[690,2522],[690,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2522,"width":381,"height":33},"line":85,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c66e709941bb49739889de405f7fce65","type":"page_info","conversion_output":false,"text":"Version 1.0, 12/15/2018; Page 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Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,305],[1901,305],[1901,2499],[288,2499]],"region":{"top_left_x":287,"top_left_y":305,"width":1615,"height":2194},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4ddfe87a08141949d60281b4cee3d7b","type":"table","conversion_output":true,"children_ids":["6296bc22c84448dba494a0f18d2833fa","2c64efb2387943959673ba57fbae4e7f","1d48387b83ac43248694930e3708e034","52f4650ef60b44879bb351bcf712e633","0cf856c511a740ae8ec4f580429e3bb7","48f896773df34241b5d814b922e1d5d8","e4f08939d87f46b6b7b1e844697dda24","7ffe143549924ad892cbfd4287d73554","3c44d332f863402fa39d20efedcb9bf1","2f18b4b11c5f4914a3b24d999ab16744","8e975ffd16d04fa096160344d354a4ac","6651839ebf6941158a5850bd897b1936","7b73adfc6e5f4ea9a8236d27bb1cbd7d","a219f35f48c446ef8a10af045a3d0989","95bd7a0beb5a44db93079b2832632602","a97228c207924387bc5db76dc4bf3746","19ce6fb6f5994c39ae0910fa4eab1ce7","e2584e344096480d846e864594b23446","fa3f962d7dd74ddba07bf8c3c9a0f015","de14af5eaec6467783501def7ded46bc","81364a5b91534bf1ae4220ebd139996e","ee451366729943aaa325531733ba219d","c2211aa5626b48b7b1c5c7bcd03fb10c","b074a308961940b4b87af699d9182413","438180a1b4904ca28822e3801472ff53","e7ded1ab3f3042138f2c1884643fea03","dee945387c8e4b76a894faaf24e415bc","e3799f7774d7435786465e97e3709614","3f5cd129c5fe4b0e94a52d584bc76d1e","e371162484ef4e9cbd26be5b69a66080","1e0d76b77a9444e0b16cb7f40b76fffd","3c7710a125a04c73b8125efa8fc166f6","6c24c49ddc1345eebb2b3af172886db5","2d92c19b33d542ddbf95d1d6da018144","a5bfd39ca0a74573a90e09823ce79404"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline UTI & Binary & A UTI will be captured as a Yes response (AE or SAE) to Question 23 of the Hospitalization form, Question 18 of the Post-operative visit form, or Question 20 or the 6- to 60Month Study follow-up form or by an event classified as a Urinary Tract Infection based on Preferred terms in the AE form. \\\\\n\\hline Vaginal infections & Binary & A Vaginal Infection will be captured as a Yes response (AE or SAE) to Question 22 of the Hospitalization form, Question 17 of the Post-operative visit form, or Question 19 or the 6- to 60- Month Study follow-up form or by an event classified as a vaginal infection based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline Vaginal shortening & Binary & Vaginal shortening will be determined by an event classified as a vaginal shortening based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline De novo vaginal bleeding & Binary & Based on masked data review this event was modified from De novo vaginal bleeding to any incident of vaginal bleeding because of the small number of events. It will be captured as a Yes response (AE or SAE) to Question 17 on the 6- to 60- Month Study follow-up form or by an event classified as a vaginal bleeding based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline Atypical vaginal discharge & Binary & Atypical vaginal discharge will be captured as a Yes response (AE or SAE) to Question 16 on the 6- to 60Month Study follow-up form or by an event classified as atypical vaginal discharge based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline Fistula formation & Binary & Fistula formation will be captured as a Yes response (AE or SAE) to Question 16 of the Hospitalization form, Question 8 of the Post-operative visit form, or Question 7 or the 6- to 60- Month Study follow-up form or by an event classified as a fistula based on either the preferred term or comments for an event on the AE form \\\\\n\\hline Neuromuscular problems & Binary & A neuromuscular problem will be captured as a Yes response (AE or SAE) to Question 12 of the Hospitalization form, Question 14 of the Post-operative visit form, or Question 13 or the 6- to 60- Month Study follow-up form or by an event classified as a neuromuscular disorder based on either the preferred term or comments for an event on the AE form \\\\\n\\hline Need for subsequent procedures & Binary & Need for subsequent procedures will be classified as Yes if the responses on Section E of the Post-operative visit form or Section D of the 6-to-60 Month Evaluation form indicated that the participant had a procedure performed in \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline UTI & Binary & A UTI will be captured as a Yes response (AE or SAE) to Question 23 of the Hospitalization form, Question 18 of the Post-operative visit form, or Question 20 or the 6- to 60Month Study follow-up form or by an event classified as a Urinary Tract Infection based on Preferred terms in the AE form. \\\\\n\\hline Vaginal infections & Binary & A Vaginal Infection will be captured as a Yes response (AE or SAE) to Question 22 of the Hospitalization form, Question 17 of the Post-operative visit form, or Question 19 or the 6- to 60- Month Study follow-up form or by an event classified as a vaginal infection based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline Vaginal shortening & Binary & Vaginal shortening will be determined by an event classified as a vaginal shortening based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline De novo vaginal bleeding & Binary & Based on masked data review this event was modified from De novo vaginal bleeding to any incident of vaginal bleeding because of the small number of events. It will be captured as a Yes response (AE or SAE) to Question 17 on the 6- to 60- Month Study follow-up form or by an event classified as a vaginal bleeding based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline Atypical vaginal discharge & Binary & Atypical vaginal discharge will be captured as a Yes response (AE or SAE) to Question 16 on the 6- to 60Month Study follow-up form or by an event classified as atypical vaginal discharge based on either the preferred term or comments for an event on the AE form. \\\\\n\\hline Fistula formation & Binary & Fistula formation will be captured as a Yes response (AE or SAE) to Question 16 of the Hospitalization form, Question 8 of the Post-operative visit form, or Question 7 or the 6- to 60- Month Study follow-up form or by an event classified as a fistula based on either the preferred term or comments for an event on the AE form \\\\\n\\hline Neuromuscular problems & Binary & A neuromuscular problem will be captured as a Yes response (AE or SAE) to Question 12 of the Hospitalization form, Question 14 of the Post-operative visit form, or Question 13 or the 6- to 60- Month Study follow-up form or by an event classified as a neuromuscular disorder based on either the preferred term or comments for an event on the AE form \\\\\n\\hline Need for subsequent procedures & Binary & Need for subsequent procedures will be classified as Yes if the responses on Section E of the Post-operative visit form or Section D of the 6-to-60 Month Evaluation form indicated that the participant had a procedure performed in 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on masked data review this event was modified from De novo vaginal bleeding to any incident of vaginal bleeding because of the small number of events. 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preferred term or comments for an event on the AE form.","confidence":0.9970715045928955,"confidence_rate":0.9999511213306029},{"cnt":[[306,1422],[571,1422],[571,1516],[306,1516]],"region":{"top_left_x":306,"top_left_y":1422,"width":265,"height":94},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b074a308961940b4b87af699d9182413","type":"complex_cell","conversion_output":false,"parent_id":"c4ddfe87a08141949d60281b4cee3d7b","children_ids":["0d53499712d347e3843e8905e62ef110","9d271b27f97e471088bc096fbee3738a"],"text":"Atypical vaginal discharge","text_display":"Atypical vaginal 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vaginal discharge will be captured as a Yes response (AE or SAE) to Question 16 on the 6- to 60Month Study follow-up form or by an event classified as atypical vaginal discharge based on either the preferred term or comments for an event on the AE form.","text_display":"Atypical vaginal discharge will be captured as a Yes response (AE or SAE) to Question 16 on the 6- to 60Month Study follow-up form or by an event classified as atypical vaginal discharge based on either the preferred term or comments for an event on the AE form.","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9965834617614746,"confidence_rate":0.9999863105419698},{"cnt":[[954,1427],[1762,1427],[1762,1470],[954,1470]],"region":{"top_left_x":953,"top_left_y":1426,"width":809,"height":45},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4b5f394384849df8ef659f6f1a30ded","type":"text","conversion_output":false,"parent_id":"e7ded1ab3f3042138f2c1884643fea03","text":"Atypical vaginal discharge will be captured as a Yes","text_display":"Atypical vaginal discharge will be captured as a Yes","confidence":1,"confidence_rate":1},{"cnt":[[954,1470],[1783,1470],[1783,1513],[954,1513]],"region":{"top_left_x":953,"top_left_y":1470,"width":831,"height":44},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c67babb639d34bb88b31e09a83bc4660","type":"text","conversion_output":false,"parent_id":"e7ded1ab3f3042138f2c1884643fea03","text":"response (AE or SAE) to Question 16 on the 6- to 60-","text_display":" response (AE or SAE) to Question 16 on the 6- to 60","confidence":1,"confidence_rate":1},{"cnt":[[954,1513],[1827,1513],[1827,1559],[954,1559]],"region":{"top_left_x":953,"top_left_y":1513,"width":874,"height":46},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b75d192cd5fb4b8bb9a231e01dd66b18","type":"text","conversion_output":false,"parent_id":"e7ded1ab3f3042138f2c1884643fea03","text":"Month Study follow-up form or by an event classified as","text_display":"Month Study follow-up form or by an event classified as","confidence":1,"confidence_rate":1},{"cnt":[[954,1559],[1805,1559],[1805,1602],[954,1602]],"region":{"top_left_x":953,"top_left_y":1558,"width":853,"height":45},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20c5fa4011294135bf10d362dc90e22c","type":"text","conversion_output":false,"parent_id":"e7ded1ab3f3042138f2c1884643fea03","text":"atypical vaginal 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formation","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[672,1680],[783,1680],[783,1721],[672,1721]],"region":{"top_left_x":672,"top_left_y":1680,"width":111,"height":42},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3799f7774d7435786465e97e3709614","type":"simple_cell","conversion_output":false,"parent_id":"c4ddfe87a08141949d60281b4cee3d7b","text":"Binary","text_display":"Binary","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[950,1676],[1883,1676],[1883,1942],[950,1942]],"region":{"top_left_x":949,"top_left_y":1675,"width":934,"height":268},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f5cd129c5fe4b0e94a52d584bc76d1e","type":"complex_cell","conversion_output":false,"parent_id":"c4ddfe87a08141949d60281b4cee3d7b","children_ids":["1a415d246ee84bf3b4f160d583294d87","e9e0c6e9a5944767b311a8a1acc58283","f19095c5b1ac44538820ae6763121ea0","d4a1c1d8624546e6b9aaacea03339519","82829952e35248f8bf0e40259d8c8f47","d72941740f494973ae7de1eee0fa8325"],"text":"Fistula formation will be captured as a Yes response (AE or SAE) to Question 16 of the Hospitalization form, Question 8 of the Post-operative visit form, or Question 7 or the 6- to 60- Month Study follow-up form or by an event classified as a fistula based on either the preferred term or comments for an event on the AE form","text_display":"Fistula formation will be captured as a Yes response (AE or SAE) to Question 16 of the Hospitalization form, Question 8 of the Post-operative visit form, or Question 7 or the 6- to 60- Month Study follow-up form or by an event classified as a fistula based on either the preferred term or comments for an event on the AE form","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9853813648223877,"confidence_rate":0.9999474481746994},{"cnt":[[954,1678],[1876,1678],[1876,1721],[954,1721]],"region":{"top_left_x":953,"top_left_y":1677,"width":924,"height":45},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a415d246ee84bf3b4f160d583294d87","type":"text","conversion_output":false,"parent_id":"3f5cd129c5fe4b0e94a52d584bc76d1e","text":"Fistula formation will be captured as a Yes response (AE or","text_display":"Fistula formation will be captured as a Yes response (AE or","confidence":1,"confidence_rate":1},{"cnt":[[954,1721],[1861,1721],[1861,1767],[954,1767]],"region":{"top_left_x":953,"top_left_y":1721,"width":909,"height":46},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9e0c6e9a5944767b311a8a1acc58283","type":"text","conversion_output":false,"parent_id":"3f5cd129c5fe4b0e94a52d584bc76d1e","text":"SAE) to Question 16 of the Hospitalization form, Question","text_display":" SAE) to Question 16 of the Hospitalization form, Question","confidence":1,"confidence_rate":1},{"cnt":[[954,1767],[1870,1767],[1870,1810],[954,1810]],"region":{"top_left_x":953,"top_left_y":1766,"width":917,"height":45},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f19095c5b1ac44538820ae6763121ea0","type":"text","conversion_output":false,"parent_id":"3f5cd129c5fe4b0e94a52d584bc76d1e","text":"8 of the Post-operative visit form, or Question 7 or the 6- to","text_display":" 8 of the Post-operative visit form, or Question 7 or the 6- 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or comments","text_display":" as a fistula based on either the preferred term or comments","confidence":1,"confidence_rate":1},{"cnt":[[954,1899],[1389,1899],[1389,1936],[954,1936]],"region":{"top_left_x":953,"top_left_y":1898,"width":437,"height":38},"line":69,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d72941740f494973ae7de1eee0fa8325","type":"text","conversion_output":false,"parent_id":"3f5cd129c5fe4b0e94a52d584bc76d1e","text":"for an event on the AE form","text_display":" for an event on the AE form","confidence":0.99853515625,"confidence_rate":0.9999541911216807},{"cnt":[[306,1972],[558,1972],[558,2066],[306,2066]],"region":{"top_left_x":306,"top_left_y":1972,"width":252,"height":94},"line":70,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e371162484ef4e9cbd26be5b69a66080","type":"complex_cell","conversion_output":false,"parent_id":"c4ddfe87a08141949d60281b4cee3d7b","children_ids":["9079717aa341472399d6192d22de7d2d","1406ccff57be4b5a886d9a2ab7d8672e"],"text":"Neuromuscular problems","text_display":"Neuromuscular 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via two different mechanisms: (a) as an event of dyspareunia as listed on AE form or the 6-month complication evaluation form; or (b) assessed via reporting on the PISQ-IR instrument. Note that because on masked review women moved in and out of the dyspareunia category after surgery, the decision was made to evaluate all incidents of dyspareunia irrespective of de novo status.","text_display":"Defined via two different mechanisms: (a) as an event of dyspareunia as listed on AE form or the 6-month complication evaluation form; or (b) assessed via reporting on the PISQ-IR instrument. Note that because on masked review women moved in and out of the dyspareunia category after surgery, the decision was made to evaluate all incidents of dyspareunia irrespective of de novo status.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970715045928955,"confidence_rate":0.9999919429120192},{"cnt":[[954,855],[1835,855],[1835,900],[954,900]],"region":{"top_left_x":953,"top_left_y":854,"width":883,"height":47},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a01071e241be4447a7cde19efccba699","type":"text","conversion_output":false,"parent_id":"e7288a0c041d475b8e1bd4d75229b4a6","text":"Defined via two different mechanisms: (a) as an event of","text_display":"Defined via two different mechanisms: (a) as an event of","confidence":1,"confidence_rate":1},{"cnt":[[954,898],[1710,898],[1710,943],[954,943]],"region":{"top_left_x":953,"top_left_y":898,"width":757,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00aa1bf26e314d7fa8a2fd2d4902d831","type":"text","conversion_output":false,"parent_id":"e7288a0c041d475b8e1bd4d75229b4a6","text":"dyspareunia as listed on AE form or the 6-month","text_display":" dyspareunia as listed on AE form or the 6-month","confidence":0.9970715045928955,"confidence_rate":0.9999436017473665},{"cnt":[[954,943],[1866,943],[1866,987],[954,987]],"region":{"top_left_x":953,"top_left_y":943,"width":913,"height":44},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce77954f0fb347cc9dfdb016e5c9acd1","type":"text","conversion_output":false,"parent_id":"e7288a0c041d475b8e1bd4d75229b4a6","text":"complication evaluation form; or (b) assessed via reporting","text_display":" complication evaluation form; or (b) assessed via reporting","confidence":1,"confidence_rate":1},{"cnt":[[954,987],[1837,987],[1837,1030],[954,1030]],"region":{"top_left_x":953,"top_left_y":986,"width":885,"height":45},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbe80fa59fab4f548204258bd1da17ce","type":"text","conversion_output":false,"parent_id":"e7288a0c041d475b8e1bd4d75229b4a6","text":"on the PISQ-IR instrument. Note that because on masked","text_display":" on the PISQ-IR instrument. Note that because on masked","confidence":1,"confidence_rate":1},{"cnt":[[954,1030],[1755,1030],[1755,1076],[954,1076]],"region":{"top_left_x":953,"top_left_y":1030,"width":803,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9ba2a05b9dc4db79a8b445587ab5496","type":"text","conversion_output":false,"parent_id":"e7288a0c041d475b8e1bd4d75229b4a6","text":"review women moved in and out of the dyspareunia","text_display":" review women moved in and out of the dyspareunia","confidence":1,"confidence_rate":1},{"cnt":[[954,1076],[1837,1076],[1837,1119],[954,1119]],"region":{"top_left_x":953,"top_left_y":1075,"width":885,"height":44},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8975a763e554a47b5ac2bf92a723881","type":"text","conversion_output":false,"parent_id":"e7288a0c041d475b8e1bd4d75229b4a6","text":"category after surgery, the decision was made to evaluate","text_display":" category after surgery, the decision was made to evaluate","confidence":1,"confidence_rate":1},{"cnt":[[954,1119],[1848,1119],[1848,1162],[954,1162]],"region":{"top_left_x":953,"top_left_y":1118,"width":896,"height":45},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72550557fcaa4867a2f70e48efdae346","type":"text","conversion_output":false,"parent_id":"e7288a0c041d475b8e1bd4d75229b4a6","text":"all incidents of dyspareunia irrespective of de novo status.","text_display":" all incidents of dyspareunia irrespective of de novo 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or the follow-up periods, and either: (1) results in death, or (2) requires inpatient","confidence":1,"confidence_rate":1},{"cnt":[[309,1362],[1779,1362],[1779,1407],[309,1407]],"region":{"top_left_x":309,"top_left_y":1362,"width":1470,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b18e760fb2ba4cebafbacd838c2ebcd7","type":"text","conversion_output":true,"text":"hospitalization or a prolongation of existing hospitalization, or (3) is a congenital anomaly/birth","text_display":" hospitalization or a prolongation of existing hospitalization, or (3) is a congenital anomaly/birth","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[309,1405],[1858,1405],[1858,1450],[309,1450]],"region":{"top_left_x":309,"top_left_y":1405,"width":1550,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"964550c61c7243fe88a841cf95efa0ca","type":"text","conversion_output":true,"text":"defect, or (4) results in persistent or significant disability / incapacity, or (5) is life-threatening, or (6)","text_display":" defect, or (4) results in persistent or significant disability / incapacity, or (5) is life-threatening, or (6)","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[309,1452],[1222,1452],[1222,1497],[309,1497]],"region":{"top_left_x":309,"top_left_y":1452,"width":914,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce0a04a08d9c44698f47976f4f83905f","type":"text","conversion_output":true,"text":"requires intervention to prevent one of the above outcomes.","text_display":" requires intervention to prevent one of the above outcomes.","confidence":1,"confidence_rate":1},{"cnt":[[309,1517],[1824,1517],[1824,1558],[309,1558]],"region":{"top_left_x":309,"top_left_y":1516,"width":1516,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"677c58e5df2843c9ad557964aff21270","type":"text","conversion_output":true,"text":"SAEs will be listed and SAEs, treatment-related SAEs and SAEs with an outcome of death will be","text_display":"\n\nSAEs will be listed and SAEs, treatment-related SAEs and SAEs with an outcome of death will be","confidence":1,"confidence_rate":1},{"cnt":[[309,1560],[1807,1560],[1807,1605],[309,1605]],"region":{"top_left_x":309,"top_left_y":1559,"width":1498,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f69e8b081d8d42748bf67937ce56fb6c","type":"text","conversion_output":true,"text":"summarized by treatment arm and site if there are enough events to summarize. Separate displays","text_display":" summarized by treatment arm and site if there are enough events to summarize. Separate displays","confidence":1,"confidence_rate":1},{"cnt":[[309,1603],[1091,1603],[1091,1648],[309,1648]],"region":{"top_left_x":309,"top_left_y":1602,"width":783,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a04abd1bf799463485d8bd935bb735cc","type":"text","conversion_output":true,"text":"listing and summarizing death will also be created.","text_display":" listing and summarizing death will also be created.","confidence":1,"confidence_rate":1},{"cnt":[[370,1663],[995,1663],[995,1721],[370,1721]],"region":{"top_left_x":369,"top_left_y":1662,"width":626,"height":59},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9280e4cce7d1469fa155f403d62b3fe0","type":"section_header","conversion_output":false,"children_ids":["b6411ae5d69143ba9a0745719e503d83"],"text":"","text_display":""},{"cnt":[[374,1667],[990,1667],[990,1717],[374,1717]],"region":{"top_left_x":373,"top_left_y":1667,"width":618,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6411ae5d69143ba9a0745719e503d83","type":"text","conversion_output":true,"parent_id":"9280e4cce7d1469fa155f403d62b3fe0","text":"10.4 Other Safety Outcomes","text_display":"\n\n\\subsection*{10.4 Other Safety Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[309,1736],[1852,1736],[1852,1781],[309,1781]],"region":{"top_left_x":309,"top_left_y":1735,"width":1543,"height":47},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5d22f92601548239b9795afd7add828","type":"text","conversion_output":true,"text":"All AEs identified on the AE forms will be summarized by treatment arm using MedDRA-classified","text_display":"\n\nAll AEs identified on the AE forms will be summarized by treatment arm using MedDRA-classified","confidence":1,"confidence_rate":1},{"cnt":[[309,1781],[1854,1781],[1854,1824],[309,1824]],"region":{"top_left_x":309,"top_left_y":1781,"width":1546,"height":44},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8fb1c465580b498bbd33728545f7e8d8","type":"text","conversion_output":true,"text":"verbatim terms and system organ class with numbers and percentages summarized by treatment arm.","text_display":" verbatim terms and system organ class with numbers and percentages summarized by treatment arm.","confidence":1,"confidence_rate":1},{"cnt":[[370,1843],[1033,1843],[1033,1893],[370,1893]],"region":{"top_left_x":369,"top_left_y":1843,"width":665,"height":50},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5f864b2cb16499f99002494b57644c1","type":"section_header","conversion_output":false,"children_ids":["377e70b3934c4fe3a074f5b6e2a34a65"],"text":"","text_display":""},{"cnt":[[374,1848],[1029,1848],[1029,1886],[374,1886]],"region":{"top_left_x":373,"top_left_y":1847,"width":657,"height":40},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"377e70b3934c4fe3a074f5b6e2a34a65","type":"text","conversion_output":true,"parent_id":"c5f864b2cb16499f99002494b57644c1","text":"10.5 Concomitant Medications","text_display":"\n\n\\subsection*{10.5 Concomitant Medications}","confidence":0.9970724582672119,"confidence_rate":0.9999111604505576},{"cnt":[[309,1912],[1751,1912],[1751,1957],[309,1957]],"region":{"top_left_x":309,"top_left_y":1912,"width":1442,"height":46},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0dc212499084485795437a58a1c2464a","type":"text","conversion_output":true,"text":"Limited data on concomitant medications related to pelvic floor disorders as well as antibiotic","text_display":"\n\nLimited data on concomitant medications related to pelvic floor disorders as well as antibiotic","confidence":1,"confidence_rate":1},{"cnt":[[309,1955],[1779,1955],[1779,2000],[309,2000]],"region":{"top_left_x":309,"top_left_y":1955,"width":1470,"height":46},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5bc5ed056f304ed39df8be000e6294cc","type":"text","conversion_output":true,"text":"information will be collected as a part of this protocol. These medications will be listed and the","text_display":" information will be collected as a part of this protocol. 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Measure & TVH & Hysteropexy & P value \\\\\n\\hline Age in years & & & \\\\\n\\hline Gravity & & & \\\\\n\\hline Parity & & & \\\\\n\\hline BMI ( \\(Kg / m ^{2}\\) ) & & & \\\\\n\\hline Menopausal status ( almost everyone will be postmenopausal so we can just report \\% postmenopausal) & & & \\\\\n\\hline Marital status & & & \\\\\n\\hline Education & & & \\\\\n\\hline Health Insurance & & & \\\\\n\\hline History of smoking & & & \\\\\n\\hline Current smoker & & & \\\\\n\\hline Past history of surgery for SUI & & & \\\\\n\\hline Past History of POP surgery & & & \\\\\n\\hline Other Pelvic surgery & & & \\\\\n\\hline Duration of POP symptoms & & & \\\\\n\\hline History of recurrent UTI & & & \\\\\n\\hline Yes to any PMH question e3 * & & & \\\\\n\\hline POPQ Ba & & & \\\\\n\\hline POPQ C & & & \\\\\n\\hline POPQ Bp & & & \\\\\n\\hline PVR ( mean, median, IQR, usually has a right tail skewed distribution) & & & \\\\\n\\hline PFDI -20 & & & \\\\\n\\hline POPDI-6 & & & \\\\\n\\hline UDI 6 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\\multirow[b]{2}{*}{Characteristic} & \\multirow[b]{2}{*}{Statistic/ Category} & \\multicolumn{2}{|c|}{\\multirow{2}{*}{Treatment Group Vaginal UPHOLD hysterectom Procedure \\(y\\) and USLS ( \\(N=88\\) ) ( \\(N=87\\) )}} & \\multirow[b]{2}{*}{Total ( \\(N=175\\) )} & \\multirow[b]{2}{*}{\\begin{tabular}{l}\n\\(P_{-} P\\)\nvalue \\\\\n\\(P-\\) value\n\\end{tabular}} \\\\\n\\hline & & & & & \\\\\n\\hline 12 Month Visit Outcome & Not Failure & \\multicolumn{2}{|c|}{\\multirow{18}{*}{}} & \\multirow{18}{*}{} & \\multirow{18}{*}{} \\\\\n\\hline \\multirow{5}{*}{} & Anatomic Failure & & & & \\\\\n\\hline & Anatomic and sympt. & & & & \\\\\n\\hline & Failure & & & & \\\\\n\\hline & Retreatment Failure & & & & \\\\\n\\hline & Symptomatic Failure & & & & \\\\\n\\hline \\multirow[t]{6}{*}{24 Month Visit Outcome} & Not Failure & & & & \\\\\n\\hline & Anatomic Failure & & & & \\\\\n\\hline & Anatomic and symp. & & & & \\\\\n\\hline & Failure & & & & \\\\\n\\hline & Retreatment Failure & & & & 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\\multicolumn{2}{|c|}{\\multirow{2}{*}{}} & & & \\multirow[b]{2}{*}{Total ( \\(N=175\\) )} & \\multirow[b]{2}{*}{\\(P-\\) value} \\\\\n\\hline Characteristic & Statistic/ Category & & \\begin{tabular}{l}\nTreatment Group \\\\\nVaginal UPHOLD hysterectom Procedure \\(y\\) and USLS ( \\(N=88\\) ) ( \\(N=87\\) )\n\\end{tabular} & & \\\\\n\\hline \\multirow[t]{5}{*}{Operative time in minutes} & N & \\multicolumn{2}{|c|}{\\multirow{12}{*}{}} & \\multirow{18}{*}{} & \\multirow{18}{*}{} \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & Quartiles 1 \\& 3 & & & & \\\\\n\\hline & Range & & & & \\\\\n\\hline \\multirow[t]{5}{*}{Estimated blood loss in ml} & N & & & & \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & & & & & \\\\\n\\hline & \\begin{tabular}{l}\nQuartiles 1 \\& 3 \\\\\nRange\n\\end{tabular} & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Blood transfusion rate} & No & & & & \\\\\n\\hline & Yes & & & & \\\\\n\\hline \\multirow[t]{4}{*}{Number of postoperative tests} & N & \\multicolumn{2}{|c|}{\\multirow{7}{*}{}} & & \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & \\begin{tabular}{l}\nQuartiles 1 \\& 3 \\\\\nRange\n\\end{tabular} & & & & \\\\\n\\hline \\multirow{2}{*}{Voiding spontaneously at discharge} & No & & & & \\\\\n\\hline & & & & & \\\\\n\\hline & Yes & \\multicolumn{2}{|c|}{\\multirow{6}{*}{}} & \\multicolumn{2}{|c|}{\\multirow{6}{*}{}} \\\\\n\\hline \\multirow[t]{5}{*}{Days in hospital} & N & & & & \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & & & & & \\\\\n\\hline & \\begin{tabular}{l}\nQuartiles 1 \\& 3 \\\\\nRange\n\\end{tabular} & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Return to OR} & No & \\multicolumn{2}{|c|}{\\multirow{2}{*}{}} & & \\\\\n\\hline & Yes & & & & \\\\\n\\hline \\multirow[t]{2}{*}{ICU admission rate} & No & \\multicolumn{2}{|c|}{\\multirow{10}{*}{}} & & \\\\\n\\hline & Yes & & & & \\\\\n\\hline \\multirow[t]{8}{*}{DIndo complications (hospital)} & None & & & & \\\\\n\\hline & & & & & \\\\\n\\hline & I & & & & \\\\\n\\hline & Ila & & & & \\\\\n\\hline & llb & & & & \\\\\n\\hline & lllb & & & & \\\\\n\\hline & IIIo & & & & \\\\\n\\hline & IVa & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Hemolytic agent use} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Urethral kink} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{3}{*}{Device malfunction} & SAE & & & & \\\\\n\\hline & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Bladder injury} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vaginal laceration} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline Postoperative thrombosis & AE & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4: Perioperative Outcomes by treatment}\n\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline \\multicolumn{2}{|c|}{\\multirow{2}{*}{}} & & & \\multirow[b]{2}{*}{Total ( \\(N=175\\) )} & \\multirow[b]{2}{*}{\\(P-\\) value} \\\\\n\\hline Characteristic & Statistic/ Category & & \\begin{tabular}{l}\nTreatment Group \\\\\nVaginal UPHOLD hysterectom Procedure \\(y\\) and USLS ( \\(N=88\\) ) ( \\(N=87\\) )\n\\end{tabular} & & \\\\\n\\hline \\multirow[t]{5}{*}{Operative time in minutes} & N & \\multicolumn{2}{|c|}{\\multirow{12}{*}{}} & \\multirow{18}{*}{} & \\multirow{18}{*}{} \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & Quartiles 1 \\& 3 & & & & \\\\\n\\hline & Range & & & & \\\\\n\\hline \\multirow[t]{5}{*}{Estimated blood loss in ml} & N & & & & \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & & & & & \\\\\n\\hline & \\begin{tabular}{l}\nQuartiles 1 \\& 3 \\\\\nRange\n\\end{tabular} & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Blood transfusion rate} & No & & & & \\\\\n\\hline & Yes & & & & \\\\\n\\hline \\multirow[t]{4}{*}{Number of postoperative tests} & N & \\multicolumn{2}{|c|}{\\multirow{7}{*}{}} & & \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & \\begin{tabular}{l}\nQuartiles 1 \\& 3 \\\\\nRange\n\\end{tabular} & & & & \\\\\n\\hline \\multirow{2}{*}{Voiding spontaneously at discharge} & No & & & & \\\\\n\\hline & & & & & \\\\\n\\hline & Yes & \\multicolumn{2}{|c|}{\\multirow{6}{*}{}} & \\multicolumn{2}{|c|}{\\multirow{6}{*}{}} \\\\\n\\hline \\multirow[t]{5}{*}{Days in hospital} & N & & & & \\\\\n\\hline & Mean (SD) & & & & \\\\\n\\hline & Median & & & & \\\\\n\\hline & & & & & \\\\\n\\hline & \\begin{tabular}{l}\nQuartiles 1 \\& 3 \\\\\nRange\n\\end{tabular} & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Return to OR} & No & \\multicolumn{2}{|c|}{\\multirow{2}{*}{}} & & \\\\\n\\hline & Yes & & & & \\\\\n\\hline \\multirow[t]{2}{*}{ICU admission rate} & No & \\multicolumn{2}{|c|}{\\multirow{10}{*}{}} & & \\\\\n\\hline & Yes & & & & \\\\\n\\hline 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\\multicolumn{2}{|c|}{\\multirow{2}{*}{}} & \\multicolumn{3}{|c|}{Treatment Group} & \\multirow[b]{2}{*}{\\(P-\\) value} \\\\\n\\hline Characteristic & Statistic/ Category & UPHOLD Procedure ( \\(N=88\\) ) & Vaginal hysterectom \\(y\\) and USLS ( \\(N=87\\) ) & Total ( \\(N=175\\) ) & \\\\\n\\hline Excessive granulation tissue & AE & & & & \\\\\n\\hline Stress urinary incontinence & AE & & & & \\\\\n\\hline Urinary tract infection & AE & & & & \\\\\n\\hline Constipation & AE & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Urge incontinence} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Faecal incontinence} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Urinary incontinence} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vulvovaginal adhesion} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline Hypoaesthesia & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{cPain in extremity} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Dysuria} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vulvovagina Ipain} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Lichensclerosus} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline Colitis & \\begin{tabular}{l}\nSAE \\\\\nNo\n\\end{tabular} & & & & \\\\\n\\hline & & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vulvovaginal injury} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Bartholin scyst} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Suture related complication} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Urinary retention} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vaginal hematoma} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Valval hemorrhage} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Colitis, ischemic} & 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Excessive granulation tissue & AE & & & & \\\\\n\\hline Stress urinary incontinence & AE & & & & \\\\\n\\hline Urinary tract infection & AE & & & & \\\\\n\\hline Constipation & AE & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Urge incontinence} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Faecal incontinence} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Urinary incontinence} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vulvovaginal adhesion} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline Hypoaesthesia & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{cPain in extremity} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Dysuria} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vulvovagina Ipain} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Lichensclerosus} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline Colitis & \\begin{tabular}{l}\nSAE \\\\\nNo\n\\end{tabular} & & & & \\\\\n\\hline & & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vulvovaginal injury} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Bartholin scyst} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Suture related complication} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Urinary retention} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vaginal hematoma} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Valval hemorrhage} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Colitis, ischemic} & SAE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Phlebitis} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Rash} & AE & & & & \\\\\n\\hline & No & & & & \\\\\n\\hline \\multirow[t]{2}{*}{Vaginal infection} & AE & & & & \\\\\n\\hline & No & & & & 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