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ABC & Anticholinergic versus Botox Comparison trial \\\\\n\\hline ATLAS & Ambulatory Treatments for Leakage Associated with Stress Incontinence trial \\\\\n\\hline BBUSQ & Birmingham Bowel Urinary Symptom Questionnaire \\\\\n\\hline BD & Bladder diary \\\\\n\\hline BE- DRI & Behavior Enhances Drug Reduction of Incontinence trial \\\\\n\\hline BPTx & Behavioral/pelvic floor therapy \\\\\n\\hline CDF & Cumulative distribution function \\\\\n\\hline CST & Cough stress test \\\\\n\\hline DCC & Data Coordinating Center \\\\\n\\hline DO & Detrusor overactivity \\\\\n\\hline DSMB & Data and Safety Monitoring Board \\\\\n\\hline EQ-5D & European Quality of Life-5 Dimensions \\\\\n\\hline HRQOL & Health related quality of life \\\\\n\\hline IE & Incontinence episode \\\\\n\\hline ICI & International Consultation on Incontinence \\\\\n\\hline ICS & International Continence Society \\\\\n\\hline IIQ & Incontinence Impact Questionnaire \\\\\n\\hline IRB & Institutional Review Board \\\\\n\\hline 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Describe rates of reoperation (sling revision) for worsening OAB symptoms after MUS","text_display":"\n5. Describe rates of reoperation (sling revision) for worsening OAB symptoms after MUS","confidence":0.99560546875,"confidence_rate":0.9999516031977022},{"cnt":[[494,799],[1867,799],[1867,844],[494,844]],"region":{"top_left_x":494,"top_left_y":799,"width":1373,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba8146e651c3415a9602eca5cdb276a5","type":"text","conversion_output":true,"text":"and to compare the proportion of women in each group initiating additional treatment for","text_display":" and to compare the proportion of women in each group initiating additional treatment for","confidence":1,"confidence_rate":1},{"cnt":[[494,842],[1764,842],[1764,887],[494,887]],"region":{"top_left_x":494,"top_left_y":842,"width":1270,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e4d938a332d4930ab252a8ff39314d9","type":"text","conversion_output":true,"text":"SUI and/or OAB, and the types of additional treatment (BPTx, medications, other)","text_display":" SUI and/or OAB, and the types of additional treatment (BPTx, medications, other)","confidence":1,"confidence_rate":1},{"cnt":[[434,885],[1764,885],[1764,930],[434,930]],"region":{"top_left_x":433,"top_left_y":885,"width":1331,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33845bebbd994b53bdd65257d3a78ec4","type":"text","conversion_output":true,"text":"6. 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Compare pelvic floor muscle strength changes between women randomized to combined","text_display":"\n7. 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Presence of both SUI and UUI on bladder diary; and \\(>2\\) IEs \\(/ 3\\) days","text_display":"\n1. 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Reporting at least \"moderate bother\" from UUI item on UDI: \"Do you usually","text_display":"\n2. Reporting at least \"moderate bother\" from UUI item on UDI: \"Do you usually","confidence":1,"confidence_rate":1},{"cnt":[[559,791],[1747,791],[1747,836],[559,836]],"region":{"top_left_x":558,"top_left_y":790,"width":1189,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a15b9f4d5ae346729c89d90b2b71c2cd","type":"text","conversion_output":true,"text":"experience urine leakage associated with a feeling of urgency, that is a strong","text_display":" experience urine leakage associated with a feeling of urgency, that is a strong","confidence":1,"confidence_rate":1},{"cnt":[[559,836],[1250,836],[1250,879],[559,879]],"region":{"top_left_x":558,"top_left_y":835,"width":693,"height":44},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1af7b422575149438e960abfdb13f0f9","type":"text","conversion_output":true,"text":"sensation of needing to go to the bathroom?\"","text_display":" sensation of needing to go to the bathroom?\"","confidence":1,"confidence_rate":1},{"cnt":[[494,881],[1757,881],[1757,922],[494,922]],"region":{"top_left_x":494,"top_left_y":880,"width":1264,"height":42},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b430d49828b04e398d1f6becded6a1ea","type":"text","conversion_output":true,"text":"3. 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Participation in other trial that may influence results of this study","confidence":1,"confidence_rate":1},{"cnt":[[498,2032],[922,2032],[922,2069],[498,2069]],"region":{"top_left_x":498,"top_left_y":2032,"width":424,"height":37},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b433eb524c249f0998725c45dbe21bc","type":"text","conversion_output":true,"text":"9. Unevaluated hematuria","text_display":"\n9. Unevaluated hematuria","confidence":1,"confidence_rate":1},{"cnt":[[501,2075],[1858,2075],[1858,2121],[501,2121]],"region":{"top_left_x":500,"top_left_y":2075,"width":1359,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9f0f46cf357457ebde8efa212a50191","type":"text","conversion_output":true,"text":"10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence","text_display":"\n10. 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Diagnosis of and/or history of bladder pain or chronic pelvic pain","text_display":"\n17. Diagnosis of and/or history of bladder pain or chronic pelvic pain","confidence":1,"confidence_rate":1},{"cnt":[[498,447],[1663,447],[1663,492],[498,492]],"region":{"top_left_x":498,"top_left_y":446,"width":1165,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"893aa8f3c9f44ab1b4d118917e285e03","type":"text","conversion_output":true,"text":"18. Women who had intravesical Botox injection within the past 12 months","text_display":"\n18. Women who had intravesical Botox injection within the past 12 months","confidence":1,"confidence_rate":1},{"cnt":[[498,490],[1828,490],[1828,535],[498,535]],"region":{"top_left_x":498,"top_left_y":489,"width":1331,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"afccd69b344e46ce91c33a8abfa7335b","type":"text","conversion_output":true,"text":"19. 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All patient","confidence":1,"confidence_rate":1},{"cnt":[[434,1285],[1738,1285],[1738,1330],[434,1330]],"region":{"top_left_x":433,"top_left_y":1284,"width":1306,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca90b91325ce4996974e3e80cdc84e96","type":"text","conversion_output":true,"text":"reported outcomes (PROs) will be administered prior to other clinical assessments or","text_display":"reported outcomes (PROs) will be administered prior to other clinical assessments or","confidence":1,"confidence_rate":1},{"cnt":[[434,1328],[617,1328],[617,1377],[434,1377]],"region":{"top_left_x":433,"top_left_y":1327,"width":184,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"843168f5901b43428c477685d55e1e46","type":"text","conversion_output":true,"text":"procedures.","text_display":" procedures.","confidence":1,"confidence_rate":1},{"cnt":[[434,1439],[1835,1439],[1835,1485],[434,1485]],"region":{"top_left_x":433,"top_left_y":1439,"width":1402,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a01d304dcde1458eb888d249035fbbc9","type":"text","conversion_output":true,"text":"It is not feasible to mask the patients or interventionists to the BPTx intervention due to the","text_display":"\n\nIt is not feasible to mask the patients or interventionists to the BPTx intervention due to the","confidence":1,"confidence_rate":1},{"cnt":[[434,1482],[1010,1482],[1010,1528],[434,1528]],"region":{"top_left_x":433,"top_left_y":1482,"width":577,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d62066ba81ca4a9391fc181e20f3c31b","type":"text","conversion_output":true,"text":"nature of the treatment being studied.","text_display":" nature of the treatment being studied.","confidence":1,"confidence_rate":1},{"cnt":[[447,1573],[1134,1573],[1134,2013],[447,2013]],"region":{"top_left_x":446,"top_left_y":1572,"width":689,"height":442},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"643a8a5d886b43f4be0f708dc4605f11","type":"table","conversion_output":true,"text":"\\begin{tabular}{|l|l|}\n\\hline Study individual & Masking \\\\\n\\hline Study participant & No \\\\\n\\hline Interventionist & No \\\\\n\\hline \\begin{tabular}{l} \nOutcome assessors \\\\\n(includes clinical staff \\\\\nperforming PFM \\\\\nmeasurement)\n\\end{tabular} & Yes \\\\\n\\hline Study surgeon & Yes \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Study individual & Masking \\\\\n\\hline Study participant & No \\\\\n\\hline Interventionist & No \\\\\n\\hline \\begin{tabular}{l} \nOutcome assessors \\\\\n(includes clinical staff \\\\\nperforming PFM \\\\\nmeasurement)\n\\end{tabular} & Yes \\\\\n\\hline Study surgeon & Yes \\\\\n\\hline\n\\end{tabular}","confidence":1,"confidence_rate":1},{"cnt":[[434,2067],[1863,2067],[1863,2112],[434,2112]],"region":{"top_left_x":433,"top_left_y":2066,"width":1430,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f16e20e16152460ca110423f7850f709","type":"text","conversion_output":true,"text":"Efforts will be made by unmasked research assistant/staff members to remind the patient that","text_display":"\n\nEfforts will be made by unmasked research assistant/staff members to remind the patient that","confidence":1,"confidence_rate":1},{"cnt":[[434,2110],[1824,2110],[1824,2155],[434,2155]],"region":{"top_left_x":433,"top_left_y":2109,"width":1392,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b4e1cd7f84d45cbab3033925e3a0229","type":"text","conversion_output":true,"text":"the surgeon is masked to her treatment assignment. If she desires additional treatment, it is","text_display":" the surgeon is masked to her treatment assignment. 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& Baseline & Randomization visit (T0-5 wks) & 2 wk preop (range 1-4 wks preop) & Surg MUS (T0) & Call (3-5d postop) & 2 wk postClinic & 4 \\& 6 wks post & 8 wk post- & 3 mo postClinic and QoL & 6 mo postClinic and QoL & 12 mo postClinic and QoL \\\\\n\\hline Window of time & & \\(\\pm 7 d\\) & 7-28d preop & & & \\(\\pm 7 d\\) & \\(\\pm 7 d\\) for each visit & \\(\\pm 7 d\\) & \\(\\pm 30 d\\) & \\(\\pm 30 d\\) & \\(\\pm 60 d\\) \\\\\n\\hline \\multirow[t]{2}{*}{Estimated duration of clinic and/or BPTx visit for each group} & \\multirow{2}{*}{} & \\multirow[t]{2}{*}{Both: 1.52hr} & Control: N/A & \\multirow{2}{*}{} & Contr: N/A & Control: 1.5hr & Control: N/A & Control: 1 hr & \\multirow[t]{2}{*}{Both: 1.5hr} & Control: 1.5hr & \\multirow[t]{2}{*}{Both: 1.52 hr} \\\\\n\\hline & & & Interv: 1.5 hr & & Interv: 15 min & Interv: 2.5hr & Interv: 1hr & Interv: 2 hr & & Interv: 2.5 hr & \\\\\n\\hline \\multicolumn{12}{|l|}{All subjects} \\\\\n\\hline Consent & X & & & & & & & & & & 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\\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Baseline & Randomization visit (T0-5 wks) & 2 wk preop (range 1-4 wks preop) & Surg MUS (T0) & Call (3-5d postop) & 2 wk postClinic & 4 \\& 6 wks post & 8 wk post- & 3 mo postClinic and QoL & 6 mo postClinic and QoL & 12 mo postClinic and QoL \\\\\n\\hline Window of time & & \\(\\pm 7 d\\) & 7-28d preop & & & \\(\\pm 7 d\\) & \\(\\pm 7 d\\) for each visit & \\(\\pm 7 d\\) & \\(\\pm 30 d\\) & \\(\\pm 30 d\\) & \\(\\pm 60 d\\) \\\\\n\\hline \\multirow[t]{2}{*}{Estimated duration of clinic and/or BPTx visit for each group} & \\multirow{2}{*}{} & \\multirow[t]{2}{*}{Both: 1.52hr} & Control: N/A & \\multirow{2}{*}{} & Contr: N/A & Control: 1.5hr & Control: N/A & Control: 1 hr & \\multirow[t]{2}{*}{Both: 1.5hr} & Control: 1.5hr & \\multirow[t]{2}{*}{Both: 1.52 hr} \\\\\n\\hline & & & Interv: 1.5 hr & & Interv: 15 min & Interv: 2.5hr & Interv: 1hr & Interv: 2 hr & & Interv: 2.5 hr & 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It is also possible that women randomized to BPTx may cancel their","confidence":1,"confidence_rate":1},{"cnt":[[370,868],[1803,868],[1803,913],[370,913]],"region":{"top_left_x":369,"top_left_y":867,"width":1434,"height":47},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5b47ad6e17e49deac6b4c01e20b7cb2","type":"text","conversion_output":true,"text":"surgical procedure if they receive preoperative BPTx treatment and experience improvement.","text_display":" surgical procedure if they receive preoperative BPTx treatment and experience improvement.","confidence":1,"confidence_rate":1},{"cnt":[[370,911],[1304,911],[1304,956],[370,956]],"region":{"top_left_x":369,"top_left_y":910,"width":936,"height":47},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea4e00acc61f463d8ce08d312708f67f","type":"text","conversion_output":true,"text":"These women will still be included from an ITT perspective.","text_display":" These women will still be included from an ITT perspective.","confidence":1,"confidence_rate":1},{"cnt":[[365,971],[956,971],[956,1029],[365,1029]],"region":{"top_left_x":365,"top_left_y":971,"width":592,"height":59},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"143c0112a6dd401fa61af16c045f9924","type":"section_header","conversion_output":false,"children_ids":["3c59767ff22449258558ad5855ab2712"],"text":"","text_display":""},{"cnt":[[372,975],[952,975],[952,1021],[372,1021]],"region":{"top_left_x":371,"top_left_y":975,"width":581,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c59767ff22449258558ad5855ab2712","type":"text","conversion_output":true,"parent_id":"143c0112a6dd401fa61af16c045f9924","text":"5.2 Per-Protocol (PP) Population","text_display":"\n\n\\subsection*{5.2 Per-Protocol (PP) Population}","confidence":1,"confidence_rate":1},{"cnt":[[370,1031],[1794,1031],[1794,1076],[370,1076]],"region":{"top_left_x":369,"top_left_y":1031,"width":1425,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5953bbfe5d684e86949ad64e9ab80a3b","type":"text","conversion_output":true,"text":"Per-protocol analyses (in which participants are analyzed according to the treatment actually","text_display":"\n\nPer-protocol analyses (in which participants are analyzed according to the treatment actually","confidence":1,"confidence_rate":1},{"cnt":[[370,1076],[1815,1076],[1815,1121],[370,1121]],"region":{"top_left_x":369,"top_left_y":1076,"width":1447,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"852943b8560b4670a0d059d3520540dc","type":"text","conversion_output":true,"text":"received and their degree of compliance with those treatments) will be considered exploratory","text_display":" received and their degree of compliance with those treatments) will be considered exploratory","confidence":1,"confidence_rate":1},{"cnt":[[370,1121],[1695,1121],[1695,1167],[370,1167]],"region":{"top_left_x":369,"top_left_y":1121,"width":1327,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c741de2bb18f455cb48d8ae7b5bf4f81","type":"text","conversion_output":true,"text":"secondary analyses. The per-protocol population will be defined in the following way:","text_display":" secondary analyses. The per-protocol population will be defined in the following way:","confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[434,1173],[1830,1173],[1830,1218],[434,1218]],"region":{"top_left_x":433,"top_left_y":1173,"width":1398,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cff4c68ec8114577af32fb061ebca8e0","type":"text","conversion_output":true,"text":"1. Participants randomized to the MUS only treatment arm are considered adherent to the","text_display":"\n1. Participants randomized to the MUS only treatment arm are considered adherent to the","confidence":1,"confidence_rate":1},{"cnt":[[494,1220],[1098,1220],[1098,1263],[494,1263]],"region":{"top_left_x":494,"top_left_y":1220,"width":604,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ca3d761043c469dadd00acfedbcdbbb","type":"text","conversion_output":true,"text":"protocol if they undergo MUS surgery.","text_display":" protocol if they undergo MUS surgery.","confidence":1,"confidence_rate":1},{"cnt":[[432,1263],[1766,1263],[1766,1308],[432,1308]],"region":{"top_left_x":431,"top_left_y":1263,"width":1336,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2241f35f40654b03bbd331a8b447cc12","type":"text","conversion_output":true,"text":"2. Participants randomized to the MUS plus behavioral therapy treatment arm will be","text_display":"\n2. Participants randomized to the MUS plus behavioral therapy treatment arm will be","confidence":1,"confidence_rate":1},{"cnt":[[494,1306],[1472,1306],[1472,1351],[494,1351]],"region":{"top_left_x":494,"top_left_y":1306,"width":978,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8b08f7a16d84e2a9834d862c9d14953","type":"text","conversion_output":true,"text":"considered adherent to the protocol if all the following are true:","text_display":" considered adherent to the protocol if all the following are true:","confidence":1,"confidence_rate":1},{"cnt":[[559,1351],[1253,1351],[1253,1394],[559,1394]],"region":{"top_left_x":558,"top_left_y":1351,"width":695,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c5b439eab6149f49c61efa6e74a585a","type":"text","conversion_output":true,"text":"a. The participant undergoes MUS surgery.","text_display":"\na. The participant undergoes MUS surgery.","confidence":1,"confidence_rate":1},{"cnt":[[559,1394],[1781,1394],[1781,1439],[559,1439]],"region":{"top_left_x":558,"top_left_y":1394,"width":1224,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac855922771c4f3ca32e21f2167d6fed","type":"text","conversion_output":true,"text":"b. The participant attends at least 4 out of 5 of the behavioral therapy sessions","text_display":"\nb. The participant attends at least 4 out of 5 of the behavioral therapy sessions","confidence":1,"confidence_rate":1},{"cnt":[[621,1439],[1313,1439],[1313,1485],[621,1485]],"region":{"top_left_x":620,"top_left_y":1439,"width":693,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f8faee71ca74a89b90f5ede317ce2bf","type":"text","conversion_output":true,"text":"between 2-weeks and 6-months post-surgery","text_display":" between 2-weeks and 6-months post-surgery","confidence":0.8848216533660889,"confidence_rate":0.9973433357190121},{"cnt":[[559,1482],[1858,1482],[1858,1528],[559,1528]],"region":{"top_left_x":558,"top_left_y":1482,"width":1301,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62a13ce13299469280c6c5704fe82cd4","type":"text","conversion_output":true,"text":"c. The participant reports performing exercises at least \\(4-5\\) times/week for weeks 2","text_display":"\nc. The participant reports performing exercises at least \\(4-5\\) times/week for weeks 2","confidence":0.7998046875,"confidence_rate":0.9975209920307659},{"cnt":[[621,1525],[1871,1525],[1871,1568],[621,1568]],"region":{"top_left_x":620,"top_left_y":1525,"width":1252,"height":44},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e46e85b93e24feb81fe9931b9519541","type":"text","conversion_output":true,"text":"and 6 or at least \\(2-3\\) times/week for week 8 at \\(\\geq 75 \\%\\) of attended visits between 2","text_display":" and 6 or at least \\(2-3\\) times/week for week 8 at \\(\\geq 75 \\%\\) of attended visits between 2","confidence":0.9809975624084473,"confidence_rate":0.9998001730490792},{"cnt":[[621,1568],[1175,1568],[1175,1616],[621,1616]],"region":{"top_left_x":620,"top_left_y":1568,"width":556,"height":48},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40305f8d97b841c4a715f90a4f019d96","type":"text","conversion_output":true,"text":"and 8 weeks post-surgery, inclusive","text_display":" and 8 weeks post-surgery, inclusive","confidence":1,"confidence_rate":1},{"cnt":[[559,1616],[1846,1616],[1846,1661],[559,1661]],"region":{"top_left_x":558,"top_left_y":1615,"width":1288,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"32e383b9743e428caa6955dc0eff739f","type":"text","conversion_output":true,"text":"d. The participant reports performing at least 30 contractions at \\(\\geq 75 \\%\\) of attended","text_display":"\nd. The participant reports performing at least 30 contractions at \\(\\geq 75 \\%\\) of attended","confidence":1,"confidence_rate":1},{"cnt":[[621,1659],[1433,1659],[1433,1704],[621,1704]],"region":{"top_left_x":620,"top_left_y":1658,"width":814,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"170b0fb07e954ae4bb9bcbd787da8693","type":"text","conversion_output":true,"text":"visits between 2 and 8 weeks post-surgery, inclusive","text_display":" visits between 2 and 8 weeks post-surgery, inclusive","confidence":1,"confidence_rate":1},{"cnt":[[559,1702],[1779,1702],[1779,1747],[559,1747]],"region":{"top_left_x":558,"top_left_y":1701,"width":1221,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"101ea9f8d40a4de8874dbc94a202847c","type":"text","conversion_output":true,"text":"e. The participant reports no problems or, if participant reports problems with","text_display":"\ne. The participant reports no problems or, if participant reports problems with","confidence":1,"confidence_rate":1},{"cnt":[[621,1745],[1830,1745],[1830,1790],[621,1790]],"region":{"top_left_x":620,"top_left_y":1744,"width":1211,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b27633543717408980a5de674c60bbbd","type":"text","conversion_output":true,"text":"leakage, they also report using the \"Knack\" at \\(\\geq 75 \\%\\) percent of attended visits","text_display":" leakage, they also report using the \"Knack\" at \\(\\geq 75 \\%\\) percent of attended visits","confidence":1,"confidence_rate":1},{"cnt":[[621,1835],[621,1787],[1463,1790],[1463,1837]],"region":{"top_left_x":620,"top_left_y":1787,"width":844,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4e75d5bd4694bbb8a63b5dfad56f9dc","type":"text","conversion_output":true,"text":"between 2 weeks and 6 months post-surgery, inclusive","text_display":" between 2 weeks and 6 months post-surgery, inclusive","confidence":0.9970703125,"confidence_rate":0.9999534298552992},{"cnt":[[559,1835],[1779,1835],[1779,1880],[559,1880]],"region":{"top_left_x":558,"top_left_y":1834,"width":1221,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e7c867ac6024723a495ed2bb90f3397","type":"text","conversion_output":true,"text":"f. The participant reports no problems or, if participant reports problems with","text_display":"\nf. The participant reports no problems or, if participant reports problems with","confidence":1,"confidence_rate":1},{"cnt":[[621,1878],[1760,1878],[1760,1923],[621,1923]],"region":{"top_left_x":620,"top_left_y":1877,"width":1140,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb1cfa057e164c1bb0ccb1e15f66c655","type":"text","conversion_output":true,"text":"urgency, they also report using the urgency suppression strategy at \\(\\geq 75 \\%\\)","text_display":" urgency, they also report using the urgency suppression strategy at \\(\\geq 75 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[619,1921],[1858,1921],[1858,1966],[619,1966]],"region":{"top_left_x":618,"top_left_y":1920,"width":1241,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"244c0b3af6bf42ca8481184ec0d8059c","type":"text","conversion_output":true,"text":"percent of attended visits between 2 weeks and 6 months post-surgery, inclusive","text_display":" percent of attended visits between 2 weeks and 6 months post-surgery, inclusive","confidence":1,"confidence_rate":1},{"cnt":[[559,1966],[1777,1966],[1777,2013],[559,2013]],"region":{"top_left_x":558,"top_left_y":1965,"width":1219,"height":49},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf93ffd4a30b424ea3bf834123d989d9","type":"text","conversion_output":true,"text":"g. The participant reports no problems or, if participant reports problems with","text_display":"\ng. 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Page 14","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-16","page":16,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d1fb3707b10e4cc3a0afc7c03b311b02","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fd2e182689104769b3248fa12b648e10","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,312],[982,312],[982,363],[305,363]],"region":{"top_left_x":305,"top_left_y":311,"width":677,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad72d72b48df443d87459a3b07e79a3e","type":"section_header","conversion_output":false,"children_ids":["1ecc8e9d239f49ac962ace9afa3f9007"],"text":"","text_display":""},{"cnt":[[309,318],[978,318],[978,359],[309,359]],"region":{"top_left_x":309,"top_left_y":317,"width":669,"height":42},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ecc8e9d239f49ac962ace9afa3f9007","type":"text","conversion_output":true,"parent_id":"ad72d72b48df443d87459a3b07e79a3e","text":"6 SAMPLE SIZE DETERMINATION","text_display":"\n\n\\section*{6 SAMPLE SIZE DETERMINATION}","confidence":1,"confidence_rate":1},{"cnt":[[309,406],[1863,406],[1863,449],[309,449]],"region":{"top_left_x":309,"top_left_y":406,"width":1554,"height":44},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24a78fcca0bf49a190eb3e0e1e76f4dd","type":"text","conversion_output":true,"text":"This study is designed to compare the relative effectiveness of MUS and MUS combined with BPTx.","text_display":"\n\nThis study is designed to compare the relative effectiveness of MUS and MUS combined with BPTx.","confidence":1,"confidence_rate":1},{"cnt":[[309,449],[1818,449],[1818,492],[309,492]],"region":{"top_left_x":309,"top_left_y":449,"width":1509,"height":43},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1d28f63cab84479bfc4f730b1d880f2","type":"text","conversion_output":true,"text":"Power and sample size calculations were generated to determine the sample size needed to test for","text_display":" Power and sample size calculations were generated to determine the sample size needed to test for","confidence":1,"confidence_rate":1},{"cnt":[[309,492],[1772,492],[1772,535],[309,535]],"region":{"top_left_x":309,"top_left_y":491,"width":1464,"height":44},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c6e2fa1df25436bb5a73719f64f010d","type":"text","conversion_output":true,"text":"treatment difference favoring MUS combined with BPTx across the study arms for a variety of","text_display":" treatment difference favoring MUS combined with BPTx across the study arms for a variety of","confidence":1,"confidence_rate":1},{"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":"c30e390fac4845918771df6c710e303d","type":"text","conversion_output":true,"text":"assumptions about effective size and follow-up time. Sample size estimates are based on simulations","text_display":" assumptions about effective size and follow-up time. Sample size estimates are based on simulations","confidence":1,"confidence_rate":1},{"cnt":[[309,580],[1850,580],[1850,625],[309,625]],"region":{"top_left_x":309,"top_left_y":580,"width":1541,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5cfbe6306e1d4184a833db7a2a5f68f9","type":"text","conversion_output":true,"text":"using analysis methods accounting for both the rate of additional treatment in the two groups as well","text_display":" using analysis methods accounting for both the rate of additional treatment in the two groups as well","confidence":1,"confidence_rate":1},{"cnt":[[309,625],[1854,625],[1854,668],[309,668]],"region":{"top_left_x":309,"top_left_y":625,"width":1546,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd7330b2782e4fe6b804f11b6f828a14","type":"text","conversion_output":true,"text":"as UDI total score or subscore values over the 12 month follow up. We assumed that \\(30 \\%\\) of women","text_display":" as UDI total score or subscore values over the 12 month follow up. We assumed that \\(30 \\%\\) of women","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[309,666],[1762,666],[1762,711],[309,711]],"region":{"top_left_x":309,"top_left_y":666,"width":1453,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"431a5f8972714e9cba2e29cbf1841233","type":"text","conversion_output":true,"text":"in the MUS only group and \\(20 \\%\\) of women in the MUS+BPTx group would request additional","text_display":" in the MUS only group and \\(20 \\%\\) of women in the MUS+BPTx group would request additional","confidence":1,"confidence_rate":1},{"cnt":[[309,713],[1858,713],[1858,758],[309,758]],"region":{"top_left_x":309,"top_left_y":713,"width":1550,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e7987130c9e54037bb5b53a18ffb772d","type":"text","conversion_output":true,"text":"treatment. In TOMUS, 10-12\\% of women who had baseline MUI had persistent UUI postoperatively","text_display":" treatment. In TOMUS, 10-12\\% of women who had baseline MUI had persistent UUI postoperatively","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[309,752],[1841,752],[1841,801],[309,801]],"region":{"top_left_x":309,"top_left_y":751,"width":1533,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ada2395a781c439a93b654442cc8a0af","type":"text","conversion_output":true,"text":"based on MESA responses and/or initiation of anticholinergic treatment. \\({ }^{24}\\) In Barber's TVT vs TOT","text_display":" based on MESA responses and/or initiation of anticholinergic treatment. \\({ }^{24}\\) In Barber's TVT vs TOT","confidence":0.99755859375,"confidence_rate":0.9999781753154675},{"cnt":[[309,799],[1762,799],[1762,844],[309,844]],"region":{"top_left_x":309,"top_left_y":799,"width":1453,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4180af520aaa488db4b39d53be2e56d1","type":"text","conversion_output":true,"text":"equivalence trial, 70\\% reported baseline MUI and postoperatively, 30\\% of all women reported","text_display":" equivalence trial, 70\\% reported baseline MUI and postoperatively, 30\\% of all women reported","confidence":0.9062390327453613,"confidence_rate":0.9989749822037008},{"cnt":[[309,842],[1777,842],[1777,887],[309,887]],"region":{"top_left_x":309,"top_left_y":842,"width":1468,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d33d66804b9944b4ad47d54cb53ea8f2","type":"text","conversion_output":true,"text":"bothersome UUI with \\(16 \\%\\) of subjects on anticholinergic treatment postoperatively. \\({ }^{31}\\) In Abdel-","text_display":" bothersome UUI with \\(16 \\%\\) of subjects on anticholinergic treatment postoperatively. \\({ }^{31}\\) In Abdel","confidence":0.9111328125,"confidence_rate":0.9991693933167203},{"cnt":[[309,889],[1869,889],[1869,930],[309,930]],"region":{"top_left_x":309,"top_left_y":889,"width":1561,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7707e0c1e43f45ba8b215718a3063d07","type":"text","conversion_output":true,"text":"Fattah's transobturator MUS trial, 25\\% reported worsening OAB and almost all of these women were","text_display":"Fattah's transobturator MUS trial, 25\\% reported worsening OAB and almost all of these women were","confidence":0.56982421875,"confidence_rate":0.9944468881826432},{"cnt":[[309,930],[1846,930],[1846,978],[309,978]],"region":{"top_left_x":309,"top_left_y":930,"width":1537,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0df54120820a46b0abd3576fec56f2b8","type":"text","conversion_output":true,"text":"on anticholinergic treatment postoperatively. \\({ }^{34}\\) In Palva's TVT vs TVT-O trial, 174 women reported","text_display":" on anticholinergic treatment postoperatively. \\({ }^{34}\\) In Palva's TVT vs TVT-O trial, 174 women reported","confidence":0.8310546875,"confidence_rate":0.9984059298383373},{"cnt":[[309,975],[1871,975],[1871,1021],[309,1021]],"region":{"top_left_x":309,"top_left_y":975,"width":1563,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87d34d090a4e43e5a384d575965007ed","type":"text","conversion_output":true,"text":"preoperative UUI and of these, 7 women ( \\(4 \\%\\) ) had tried anticholinergics postoperatively after 3 years.","text_display":" preoperative UUI and of these, 7 women ( \\(4 \\%\\) ) had tried anticholinergics postoperatively after 3 years.","confidence":0.9990236759185791,"confidence_rate":0.9999916513083871},{"cnt":[[309,1018],[1876,1018],[1876,1063],[309,1063]],"region":{"top_left_x":309,"top_left_y":1018,"width":1567,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d24daf6d7c6467e920a435ea742d3f8","type":"text","conversion_output":true,"text":"Therefore, based on existing MUS trials, the rate of additional treatment for OAB ranges from \\(4-25 \\%\\),","text_display":" Therefore, based on existing MUS trials, the rate of additional treatment for OAB ranges from \\(4-25 \\%\\),","confidence":0.9980475902557373,"confidence_rate":0.9999830060732627},{"cnt":[[309,1063],[1835,1063],[1835,1109],[309,1109]],"region":{"top_left_x":309,"top_left_y":1063,"width":1526,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"504220c9f40242f78be42c4728c56286","type":"text","conversion_output":true,"text":"supporting our conservative assumption that \\(30 \\%\\) of women will request additional treatment in the","text_display":" supporting our conservative assumption that \\(30 \\%\\) of women will request additional treatment in the","confidence":1,"confidence_rate":1},{"cnt":[[309,1109],[582,1109],[582,1154],[309,1154]],"region":{"top_left_x":309,"top_left_y":1108,"width":274,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8faddea0340f46ca9a9935d76b73ef40","type":"text","conversion_output":true,"text":"MUS only group.","text_display":" MUS only group.","confidence":1,"confidence_rate":1},{"cnt":[[370,1169],[771,1169],[771,1222],[370,1222]],"region":{"top_left_x":369,"top_left_y":1168,"width":403,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69deb96c264b4c57a8864e2f2b98a9c5","type":"section_header","conversion_output":false,"children_ids":["056563cdff29494e9832cb3fa2c5af58"],"text":"","text_display":""},{"cnt":[[374,1173],[767,1173],[767,1218],[374,1218]],"region":{"top_left_x":373,"top_left_y":1173,"width":394,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"056563cdff29494e9832cb3fa2c5af58","type":"text","conversion_output":true,"parent_id":"69deb96c264b4c57a8864e2f2b98a9c5","text":"6.1 Primary Outcome","text_display":"\n\n\\subsection*{6.1 Primary Outcome}","confidence":1,"confidence_rate":1},{"cnt":[[372,1227],[1717,1227],[1717,1274],[372,1274]],"region":{"top_left_x":371,"top_left_y":1226,"width":1346,"height":49},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4153b67b799c420891512db1620776f3","type":"text","conversion_output":true,"text":"The MID for the UDI-total score published by Dyer et al. is estimated to be 35 points. \\({ }^{50}\\)","text_display":"\n\nThe MID for the UDI-total score published by Dyer et al. is estimated to be 35 points. \\({ }^{50}\\)","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[370,1276],[1871,1276],[1871,1317],[370,1317]],"region":{"top_left_x":369,"top_left_y":1276,"width":1503,"height":41},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f685b04c721420db130bee298ae084a","type":"text","conversion_output":true,"text":"Assuming a two-sided alpha of .05 , SD of 50.4, and true difference in mean change from baseline","text_display":" Assuming a two-sided alpha of .05 , SD of 50.4, and true difference in mean change from baseline","confidence":0.9001466174424877,"confidence_rate":0.9989889958262045},{"cnt":[[372,1319],[1871,1319],[1871,1362],[372,1362]],"region":{"top_left_x":371,"top_left_y":1319,"width":1501,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb6c334f62ef402b8b14776c43aa3979","type":"text","conversion_output":true,"text":"in UDI-total scores at 1 year between treatment groups of 35 , 75 women per group would provide","text_display":" in UDI-total scores at 1 year between treatment groups of 35 , 75 women per group would provide","confidence":0.6129202659012662,"confidence_rate":0.995519056460264},{"cnt":[[372,1362],[1497,1362],[1497,1405],[372,1405]],"region":{"top_left_x":371,"top_left_y":1362,"width":1127,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73e4322e08a64c0b9eefd8514acba05f","type":"text","conversion_output":true,"text":"90\\% power to detect a statistically significant difference between groups.","text_display":" 90\\% power to detect a statistically significant difference between groups.","confidence":0.6325035095214844,"confidence_rate":0.9942184297525952},{"cnt":[[370,1422],[821,1422],[821,1476],[370,1476]],"region":{"top_left_x":369,"top_left_y":1422,"width":452,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9f8a38ca0d8408fac3c04c516c96015","type":"section_header","conversion_output":false,"children_ids":["2754f428a2d44545b3972cecfba14e86"],"text":"","text_display":""},{"cnt":[[374,1427],[816,1427],[816,1472],[374,1472]],"region":{"top_left_x":373,"top_left_y":1426,"width":444,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2754f428a2d44545b3972cecfba14e86","type":"text","conversion_output":true,"parent_id":"f9f8a38ca0d8408fac3c04c516c96015","text":"6.2 Secondary Outcomes","text_display":"\n\n\\subsection*{6.2 Secondary Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[372,1482],[1863,1482],[1863,1528],[372,1528]],"region":{"top_left_x":371,"top_left_y":1482,"width":1492,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e91983d8ac543a5b57d25d54ed9598b","type":"text","conversion_output":true,"text":"For the UDI-irritative subscale, the published MID estimate is 15 points. \\({ }^{50}\\) Assuming a two-sided","text_display":"\n\nFor the UDI-irritative subscale, the published MID estimate is 15 points. \\({ }^{50}\\) Assuming a two-sided","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[372,1530],[1800,1530],[1800,1571],[372,1571]],"region":{"top_left_x":371,"top_left_y":1529,"width":1430,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88f28fe2dce9432b9ded388069e0b6d1","type":"text","conversion_output":true,"text":"alpha of 0.05 , SD of 25.6, and true difference in mean change from baseline in UDI-irritative","text_display":" alpha of 0.05 , SD of 25.6, and true difference in mean change from baseline in UDI-irritative","confidence":0.5684437483159854,"confidence_rate":0.9944775314952982},{"cnt":[[372,1573],[1867,1573],[1867,1616],[372,1616]],"region":{"top_left_x":371,"top_left_y":1572,"width":1496,"height":44},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0b369157753743b992d855cdad91f93c","type":"text","conversion_output":true,"text":"scores at 1 year between treatment groups of 15, 92 women per group would provide \\(90 \\%\\) power.","text_display":" scores at 1 year between treatment groups of 15, 92 women per group would provide \\(90 \\%\\) power.","confidence":0.7022936344146729,"confidence_rate":0.9966715546175818},{"cnt":[[372,1660],[372,1611],[1798,1613],[1798,1662]],"region":{"top_left_x":371,"top_left_y":1611,"width":1428,"height":52},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ed5ab9ec00d41b884b131e90ae28052","type":"text","conversion_output":true,"text":"For the UDI-stress subscale, the published MID is 8 points. \\({ }^{51}\\) Assuming a two-sided alpha of","text_display":" For the UDI-stress subscale, the published MID is 8 points. \\({ }^{51}\\) Assuming a two-sided alpha of","confidence":1,"confidence_rate":1},{"cnt":[[372,1661],[1867,1661],[1867,1704],[372,1704]],"region":{"top_left_x":371,"top_left_y":1660,"width":1496,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0745e8af0209452299e8026e99eecd59","type":"text","conversion_output":true,"text":"0.05, SD of 21.5, and true difference in mean change from baseline in UDI-stress scores at 1 year","text_display":" 0.05, SD of 21.5, and true difference in mean change from baseline in UDI-stress scores at 1 year","confidence":0.9132518768310547,"confidence_rate":0.9991361489705401},{"cnt":[[372,1706],[1781,1706],[1781,1747],[372,1747]],"region":{"top_left_x":371,"top_left_y":1705,"width":1411,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cbdec74032aa4b8cafd5e2b703a6d446","type":"text","conversion_output":true,"text":"between treatment groups of 8, 200 women per group would provide \\(90 \\%\\) power to detect a","text_display":" between treatment groups of 8, 200 women per group would provide \\(90 \\%\\) power to detect a","confidence":0.8674558565269308,"confidence_rate":0.9985351908476828},{"cnt":[[372,1749],[1145,1749],[1145,1794],[372,1794]],"region":{"top_left_x":371,"top_left_y":1748,"width":775,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1426ddc261b4453db2e7da7239131895","type":"text","conversion_output":true,"text":"statistically significant difference between groups.","text_display":" statistically significant difference between groups.","confidence":1,"confidence_rate":1},{"cnt":[[370,1809],[767,1809],[767,1863],[370,1863]],"region":{"top_left_x":369,"top_left_y":1808,"width":398,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b18053509f74d4caefeefdc64ada90c","type":"section_header","conversion_output":false,"children_ids":["27bfea0af9e540a68a1292b274501cf8"],"text":"","text_display":""},{"cnt":[[374,1813],[763,1813],[763,1858],[374,1858]],"region":{"top_left_x":373,"top_left_y":1813,"width":390,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27bfea0af9e540a68a1292b274501cf8","type":"text","conversion_output":true,"parent_id":"0b18053509f74d4caefeefdc64ada90c","text":"6.3 Final Sample Size","text_display":"\n\n\\subsection*{6.3 Final Sample Size}","confidence":1,"confidence_rate":1},{"cnt":[[372,1869],[1854,1869],[1854,1914],[372,1914]],"region":{"top_left_x":371,"top_left_y":1869,"width":1484,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0dd61d6ddda47adbd4377d8727fda1e","type":"text","conversion_output":true,"text":"Using 200 per group as our base estimate and adjusting for \\(15 \\%\\) dropout post-operatively results","text_display":"\n\nUsing 200 per group as our base estimate and adjusting for \\(15 \\%\\) dropout post-operatively results","confidence":0.9970703125,"confidence_rate":0.9999723212563202},{"cnt":[[374,1914],[1858,1914],[1858,1957],[374,1957]],"region":{"top_left_x":373,"top_left_y":1914,"width":1486,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21096d4281694767acb866d059f69299","type":"text","conversion_output":true,"text":"in a total sample size of 472 randomized to treatment. Additionally, this sample size will provide","text_display":" in a total sample size of 472 randomized to treatment. Additionally, this sample size will provide","confidence":1,"confidence_rate":1},{"cnt":[[372,1959],[1852,1959],[1852,2002],[372,2002]],"region":{"top_left_x":371,"top_left_y":1959,"width":1481,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"877ef53eb0a345f99abfd75fb9ebe2e5","type":"text","conversion_output":true,"text":"approximately \\(90 \\%\\) power to detect a difference as small as 19 between treatment groups for the","text_display":" approximately \\(90 \\%\\) power to detect a difference as small as 19 between treatment groups for the","confidence":0.9814846515655518,"confidence_rate":0.9998220262856733},{"cnt":[[372,2002],[1506,2002],[1506,2047],[372,2047]],"region":{"top_left_x":371,"top_left_y":2002,"width":1136,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06b6ce2f91b04ddf9be1c893119ca6d0","type":"text","conversion_output":true,"text":"UDI-total score, and a difference as small as 16.5 points with \\(80 \\%\\) power.","text_display":" UDI-total score, and a difference as small as 16.5 points with \\(80 \\%\\) power.","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[305,2086],[1137,2086],[1137,2133],[305,2133]],"region":{"top_left_x":305,"top_left_y":2086,"width":832,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f725706216a498da562a085c94503e1","type":"section_header","conversion_output":false,"children_ids":["1000deb79320423e941183e0dee0b0d8"],"text":"","text_display":""},{"cnt":[[309,2088],[1137,2088],[1137,2129],[309,2129]],"region":{"top_left_x":309,"top_left_y":2088,"width":828,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1000deb79320423e941183e0dee0b0d8","type":"text","conversion_output":true,"parent_id":"0f725706216a498da562a085c94503e1","text":"7 STATISTICAL AND ANALYTICAL ISSUES","text_display":"\n\n\\section*{7 STATISTICAL AND ANALYTICAL ISSUES}","confidence":0.99755859375,"confidence_rate":0.9999373252630722},{"cnt":[[370,2174],[707,2174],[707,2219],[370,2219]],"region":{"top_left_x":369,"top_left_y":2174,"width":338,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57b8581f0126445cb85af3489457c679","type":"section_header","conversion_output":false,"children_ids":["df37308572d34b2eb03df0d8b744462f"],"text":"","text_display":""},{"cnt":[[374,2179],[703,2179],[703,2219],[374,2219]],"region":{"top_left_x":373,"top_left_y":2178,"width":330,"height":42},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df37308572d34b2eb03df0d8b744462f","type":"text","conversion_output":true,"parent_id":"57b8581f0126445cb85af3489457c679","text":"7.1 General Rules","text_display":"\n\n\\subsection*{7.1 General Rules}","confidence":1,"confidence_rate":1},{"cnt":[[372,2234],[1858,2234],[1858,2279],[372,2279]],"region":{"top_left_x":371,"top_left_y":2234,"width":1488,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01b9c7be465a46949567b3516e85934f","type":"text","conversion_output":true,"text":"All statistical computations will be performed and data summaries will be created using SAS 9.4","text_display":"\n\nAll statistical computations will be performed and data summaries will be created using SAS 9.4","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[374,2277],[1777,2277],[1777,2322],[374,2322]],"region":{"top_left_x":373,"top_left_y":2277,"width":1404,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f669bc74a6a240c28d1576090ca11d3b","type":"text","conversion_output":true,"text":"or higher. If additional statistical packages are required, these will be discussed in the study","text_display":" or higher. If additional statistical packages are required, these will be discussed in the study","confidence":1,"confidence_rate":1},{"cnt":[[372,2322],[1871,2322],[1871,2365],[372,2365]],"region":{"top_left_x":371,"top_left_y":2322,"width":1501,"height":44},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"397fb969190f4fc4855871287486b66b","type":"text","conversion_output":true,"text":"report. For summaries of study data, categorical measures will be summarized in tables listing the","text_display":" report. For summaries of study data, categorical measures will be summarized in tables listing the","confidence":1,"confidence_rate":1},{"cnt":[[374,2368],[1854,2368],[1854,2411],[374,2411]],"region":{"top_left_x":373,"top_left_y":2367,"width":1482,"height":44},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9065f770bba34854886d3efb1047ef1e","type":"text","conversion_output":true,"text":"frequency and the percentage of subjects in each study arm; continuous data will be summarized","text_display":" frequency and the percentage of subjects in each study arm; continuous data will be summarized","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[372,2411],[1852,2411],[1852,2456],[372,2456]],"region":{"top_left_x":371,"top_left_y":2410,"width":1481,"height":46},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d0198b4773c479bb8cd2abd3d17615f","type":"text","conversion_output":true,"text":"by presenting mean, standard deviation, median, minimum, and maximum; and ordinal data will","text_display":" by presenting mean, standard deviation, median, minimum, and maximum; and ordinal data will","confidence":1,"confidence_rate":1},{"cnt":[[372,2454],[1442,2454],[1442,2499],[372,2499]],"region":{"top_left_x":371,"top_left_y":2453,"width":1071,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78fab3fec7044ee4a7a5015d2328b197","type":"text","conversion_output":true,"text":"be summarized by only presenting median, minimum, and maximum.","text_display":" be summarized by only presenting median, minimum, and maximum.","confidence":1,"confidence_rate":1},{"cnt":[[309,2552],[681,2552],[681,2585],[309,2585]],"region":{"top_left_x":309,"top_left_y":2552,"width":373,"height":33},"line":53,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9ecb3d0592874afb848a83bb8b78078c","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 15","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-17","page":17,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e289d219d5144df38058c55f298a963d","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"77e4e4790ea841db891ed8437d144072","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,314],[926,314],[926,365],[370,365]],"region":{"top_left_x":369,"top_left_y":313,"width":557,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92a036659cc244f18328403f91456384","type":"section_header","conversion_output":false,"children_ids":["2956a6ac5c2d4a69a7c31bd8ec910fac"],"text":"","text_display":""},{"cnt":[[374,318],[922,318],[922,363],[374,363]],"region":{"top_left_x":373,"top_left_y":317,"width":549,"height":47},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2956a6ac5c2d4a69a7c31bd8ec910fac","type":"text","conversion_output":true,"parent_id":"92a036659cc244f18328403f91456384","text":"7.2 Adjustments for Covariates","text_display":"\n\n\\subsection*{7.2 Adjustments for Covariates}","confidence":1,"confidence_rate":1},{"cnt":[[372,374],[1850,374],[1850,417],[372,417]],"region":{"top_left_x":371,"top_left_y":373,"width":1479,"height":44},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09c1e9350256477aa9901eada90ae514","type":"text","conversion_output":true,"text":"Indicator variables for the study stratification factors of site and severity of baseline UUI (with a","text_display":"\n\nIndicator variables for the study stratification factors of site and severity of baseline UUI (with a","confidence":1,"confidence_rate":1},{"cnt":[[374,417],[1826,417],[1826,462],[374,462]],"region":{"top_left_x":373,"top_left_y":416,"width":1454,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0504e6c13f241a784710db073a55031","type":"text","conversion_output":true,"text":"cut-off of \\(\\geq 4\\) urge incontinence episodes on 3-day diary) will be included as covariates in most","text_display":" cut-off of \\(\\geq 4\\) urge incontinence episodes on 3-day diary) will be included as covariates in most","confidence":1,"confidence_rate":1},{"cnt":[[374,460],[1837,460],[1837,505],[374,505]],"region":{"top_left_x":373,"top_left_y":459,"width":1464,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9fd8aa9cb1dc4b4ba32c8d9518b38cb8","type":"text","conversion_output":true,"text":"efficacy analyses performed for this study (details in section 9). 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If sample sizes allow, these analyses","text_display":"square tests for general association for categorical measures. If sample sizes allow, these analyses","confidence":1,"confidence_rate":1},{"cnt":[[372,681],[1708,681],[1708,724],[372,724]],"region":{"top_left_x":371,"top_left_y":681,"width":1338,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffe8f40ef9f94f04af1497f769417182","type":"text","conversion_output":true,"text":"will control for the study stratification factors. If these analyses suggest that substantial","text_display":" will control for the study stratification factors. If these analyses suggest that substantial","confidence":1,"confidence_rate":1},{"cnt":[[372,726],[1850,726],[1850,769],[372,769]],"region":{"top_left_x":371,"top_left_y":726,"width":1479,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f5301a268eb4bd8b8f9330db0ce1d4e","type":"text","conversion_output":true,"text":"differences exist among arms, the use as covariates of these parameters on which the arms differ","text_display":" differences exist among arms, the use as covariates of these parameters on which the arms differ","confidence":1,"confidence_rate":1},{"cnt":[[372,769],[1463,769],[1463,812],[372,812]],"region":{"top_left_x":371,"top_left_y":769,"width":1093,"height":44},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"382f507112544ee392a900de96b6e953","type":"text","conversion_output":true,"text":"will be explored in secondary exploratory analyses of the efficacy data.","text_display":" will be explored in secondary exploratory analyses of the efficacy data.","confidence":1,"confidence_rate":1},{"cnt":[[370,834],[1128,834],[1128,883],[370,883]],"region":{"top_left_x":369,"top_left_y":833,"width":759,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e725fa33562d4498a405abc7ed7f3053","type":"section_header","conversion_output":false,"children_ids":["ca0b39036c8846d9b93e6c12fcad8f09"],"text":"","text_display":""},{"cnt":[[374,838],[1124,838],[1124,883],[374,883]],"region":{"top_left_x":373,"top_left_y":837,"width":751,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca0b39036c8846d9b93e6c12fcad8f09","type":"text","conversion_output":true,"parent_id":"e725fa33562d4498a405abc7ed7f3053","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":[[372,889],[1869,889],[1869,935],[372,935]],"region":{"top_left_x":371,"top_left_y":889,"width":1499,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c55322fe3c14c9a8fd3078a19726389","type":"text","conversion_output":true,"text":"Missing data mechanisms will be explored, and sensitivity analyses will be conducted on primary","text_display":"\n\nMissing data mechanisms will be explored, and sensitivity analyses will be conducted on primary","confidence":1,"confidence_rate":1},{"cnt":[[374,937],[1818,937],[1818,978],[374,978]],"region":{"top_left_x":373,"top_left_y":936,"width":1445,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"122121b9e6144805897254acd0df23ac","type":"text","conversion_output":true,"text":"outcomes to assess the robustness of the described analyses. Methods employed for sensitivity","text_display":" outcomes to assess the robustness of the described analyses. 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For further details on sensitivity analyses","text_display":" Imputation is not planned for secondary analyses. For further details on sensitivity analyses","confidence":1,"confidence_rate":1},{"cnt":[[374,1068],[1055,1068],[1055,1111],[374,1111]],"region":{"top_left_x":373,"top_left_y":1067,"width":682,"height":44},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b20326ff7b945758030d2c8412ed5d7","type":"text","conversion_output":true,"text":"involving missing data see Attachment 16.2.","text_display":" involving missing data see Attachment 16.2.","confidence":1,"confidence_rate":1},{"cnt":[[370,1130],[1111,1130],[1111,1182],[370,1182]],"region":{"top_left_x":369,"top_left_y":1130,"width":742,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29045dd8e3004096b2c729176aa07800","type":"section_header","conversion_output":false,"children_ids":["a46ff5f9327843399efcb9ea558964cf"],"text":"","text_display":""},{"cnt":[[374,1134],[1106,1134],[1106,1179],[374,1179]],"region":{"top_left_x":373,"top_left_y":1134,"width":734,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a46ff5f9327843399efcb9ea558964cf","type":"text","conversion_output":true,"parent_id":"29045dd8e3004096b2c729176aa07800","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":[[372,1190],[1807,1190],[1807,1233],[372,1233]],"region":{"top_left_x":371,"top_left_y":1190,"width":1436,"height":44},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a319c409c5049f48f8d324bd3132811","type":"text","conversion_output":true,"text":"Safety outcomes will be assessed at each DSMB meeting. This will include the need for sling","text_display":"\n\nSafety outcomes will be assessed at each DSMB meeting. This will include the need for sling","confidence":1,"confidence_rate":1},{"cnt":[[372,1233],[1871,1233],[1871,1278],[372,1278]],"region":{"top_left_x":371,"top_left_y":1233,"width":1501,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7699fc0f3a58419f97848c3ccf3fea25","type":"text","conversion_output":true,"text":"revision due to worsening OAB symptoms. Rates of sling revision and other safety outcomes will","text_display":" revision due to worsening OAB symptoms. Rates of sling revision and other safety outcomes will","confidence":0.9970715045928955,"confidence_rate":0.9999703762787923},{"cnt":[[372,1278],[1803,1278],[1803,1321],[372,1321]],"region":{"top_left_x":371,"top_left_y":1278,"width":1432,"height":44},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97bb31e7f73d4e32904470c96bd311d5","type":"text","conversion_output":true,"text":"be compared between treatment groups using Fisher's exact tests and provided to the DSMB.","text_display":" be compared between treatment groups using Fisher's exact tests and provided to the DSMB.","confidence":1,"confidence_rate":1},{"cnt":[[372,1323],[1876,1323],[1876,1364],[372,1364]],"region":{"top_left_x":371,"top_left_y":1323,"width":1505,"height":42},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baa74b97bfb1444bb307bdc0809f5920","type":"text","conversion_output":true,"text":"There is no established guidance regarding what sling revision rate is \"appropriate\" for worsening","text_display":" There is no established guidance regarding what sling revision rate is \"appropriate\" for worsening","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[372,1366],[1648,1366],[1648,1412],[372,1412]],"region":{"top_left_x":371,"top_left_y":1366,"width":1277,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a26640d472a4f309c7ae746bf9e2342","type":"text","conversion_output":true,"text":"OAB symptoms in this population: this is one of the exploratory aims of this study.","text_display":" OAB symptoms in this population: this is one of the exploratory aims of this study.","confidence":0.994140625,"confidence_rate":0.9999347064818369},{"cnt":[[374,1420],[1841,1420],[1841,1463],[374,1463]],"region":{"top_left_x":373,"top_left_y":1420,"width":1469,"height":44},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6184f1179ea44f37af578f04446147bf","type":"text","conversion_output":true,"text":"Since we expect to enroll ESTEEM within 2 years, and since the primary outcome is attained at","text_display":"\nSince we expect to enroll ESTEEM within 2 years, and since the primary outcome is attained at","confidence":1,"confidence_rate":1},{"cnt":[[374,1465],[1876,1465],[1876,1506],[374,1506]],"region":{"top_left_x":373,"top_left_y":1465,"width":1503,"height":42},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02b3b213d5274ce5a98a6f52287fa603","type":"text","conversion_output":true,"text":"12 months following surgery, we propose that no interim analyses of outcomes will be performed.","text_display":" 12 months following surgery, we propose that no interim analyses of outcomes will be performed.","confidence":0.9560546875,"confidence_rate":0.9995461619745457},{"cnt":[[374,1508],[1785,1508],[1785,1551],[374,1551]],"region":{"top_left_x":373,"top_left_y":1508,"width":1413,"height":44},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c767f91360f4425a6fd0b992fda8166","type":"text","conversion_output":true,"text":"Thus, reports to the DSMB will not include outcome data until primary outcomes have been","text_display":" Thus, reports to the DSMB will not include outcome data until primary outcomes have been","confidence":1,"confidence_rate":1},{"cnt":[[372,1551],[1876,1551],[1876,1596],[372,1596]],"region":{"top_left_x":371,"top_left_y":1551,"width":1505,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80f78aec5bfa4273a99f1b336414e531","type":"text","conversion_output":true,"text":"attained for all participants. At each meeting, the DSMB will be presented with information about","text_display":" attained for all participants. At each meeting, the DSMB will be presented with information about","confidence":1,"confidence_rate":1},{"cnt":[[372,1594],[1824,1594],[1824,1639],[372,1639]],"region":{"top_left_x":371,"top_left_y":1594,"width":1454,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2d265ea0c4d4df18cac2b38395df10c","type":"text","conversion_output":true,"text":"enrollment and outcome data attainment (for example, the percent of expected clinic visits that","text_display":" enrollment and outcome data attainment (for example, the percent of expected clinic visits that","confidence":1,"confidence_rate":1},{"cnt":[[370,1641],[1828,1641],[1828,1684],[370,1684]],"region":{"top_left_x":369,"top_left_y":1641,"width":1460,"height":44},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5682935f21dd453089f6abda32452b16","type":"text","conversion_output":true,"text":"have been completed) to allow them to determine that the study is making reasonable progress.","text_display":" have been completed) to allow them to determine that the study is making reasonable progress.","confidence":1,"confidence_rate":1},{"cnt":[[370,1702],[819,1702],[819,1747],[370,1747]],"region":{"top_left_x":369,"top_left_y":1701,"width":450,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d98364a620cf458794280e03a24e9f28","type":"section_header","conversion_output":false,"children_ids":["e1b289bdabcb41cfad846181025d497e"],"text":"","text_display":""},{"cnt":[[374,1706],[819,1706],[819,1745],[374,1745]],"region":{"top_left_x":373,"top_left_y":1705,"width":446,"height":40},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1b289bdabcb41cfad846181025d497e","type":"text","conversion_output":true,"parent_id":"d98364a620cf458794280e03a24e9f28","text":"7.5 Masked Data Review","text_display":"\n\n\\subsection*{7.5 Masked Data Review}","confidence":1,"confidence_rate":1},{"cnt":[[370,1762],[1798,1762],[1798,1807],[370,1807]],"region":{"top_left_x":369,"top_left_y":1761,"width":1430,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3113b71966294359a0c09fe23f317419","type":"text","conversion_output":true,"text":"A masked data review of the primary outcome and secondary outcomes for this study will be","text_display":"\n\nA masked data review of the primary outcome and secondary outcomes for this study will be","confidence":1,"confidence_rate":1},{"cnt":[[370,1807],[1841,1807],[1841,1850],[370,1850]],"region":{"top_left_x":369,"top_left_y":1806,"width":1473,"height":44},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e62e2ca05aeb4145a0dff7dcad2aeb22","type":"text","conversion_output":true,"text":"performed by the protocol team. This review will occur prior to data lock and completion of the","text_display":" performed by the protocol team. This review will occur prior to data lock and completion of the","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[374,1850],[1818,1850],[1818,1893],[374,1893]],"region":{"top_left_x":373,"top_left_y":1849,"width":1445,"height":44},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"403b00aacf0e44f3be297fda2132ba75","type":"text","conversion_output":true,"text":"1 -year analyses. This will include a presentation of descriptive statistics (e.g. means, standard","text_display":" 1 -year analyses. This will include a presentation of descriptive statistics (e.g. means, standard","confidence":0.767578125,"confidence_rate":0.9974100752144454},{"cnt":[[372,1895],[1747,1895],[1747,1936],[372,1936]],"region":{"top_left_x":371,"top_left_y":1894,"width":1376,"height":42},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0038b653b37443c69ab4702f0ac4b2fc","type":"text","conversion_output":true,"text":"deviations, percentiles for continuous variables and counts and percentages of categorical","text_display":" deviations, percentiles for continuous variables and counts and percentages of categorical","confidence":1,"confidence_rate":1},{"cnt":[[372,1938],[1858,1938],[1858,1981],[372,1981]],"region":{"top_left_x":371,"top_left_y":1937,"width":1488,"height":44},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b071d41cf2344a98a10b6f71a965c3f","type":"text","conversion_output":true,"text":"variables) of the selected outcomes and model predictor variables. In the masked review, all data","text_display":" variables) of the selected outcomes and model predictor variables. 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Specifically, the instructions are to sum the Stress, Irritative, and Obstructive subscales of the UDI (see below). If any subscale scores are missing, then no Total score will be calculated. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline \\multicolumn{3}{|l|}{Secondary Outcomes} \\\\\n\\hline Change from baseline in UDI Stress Score at 12 months & Continuous & The Urogenital Distress Inventory-Stress Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions D and F and their respective subquestions \\((0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly; \\(2=\\) Yes and Moderately; \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in UDI Irritative Score at 12 months & Continuous & The Urogenital Distress Inventory-Irritative Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions A, B, C, G, H, and I and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1= Yes\\) and Slightly; \\(2= Yes\\) and Moderately; \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. \\\\\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 Outcomes} \\\\\n\\hline Change from baseline in UDI Total Score at 12 months & Continuous & The Urogenital Distress Inventory-Total Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to sum the Stress, Irritative, and Obstructive subscales of the UDI (see below). If any subscale scores are missing, then no Total score will be calculated. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline \\multicolumn{3}{|l|}{Secondary Outcomes} \\\\\n\\hline Change from baseline in UDI Stress Score at 12 months & Continuous & The Urogenital Distress Inventory-Stress Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions D and F and their respective subquestions \\((0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly; \\(2=\\) Yes and Moderately; \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in UDI Irritative Score at 12 months & Continuous & The Urogenital Distress Inventory-Irritative Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions A, B, C, G, H, and I and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1= Yes\\) and Slightly; \\(2= Yes\\) and Moderately; \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. 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If data for an assessment time point are missing,","text_display":" months) and the Total score at baseline. If data for an assessment time point are missing,","confidence":1,"confidence_rate":1},{"cnt":[[1189,856],[1910,856],[1910,899],[1189,899]],"region":{"top_left_x":1188,"top_left_y":855,"width":722,"height":45},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dca352d582a41deb8935ca98abb3803","type":"text","conversion_output":false,"parent_id":"c39e663892454f5aa9d0f5c4efd59bb3","text":"the outcome variable will be coded as missing.","text_display":" the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[322,940],[2568,940],[2568,995],[322,995]],"region":{"top_left_x":322,"top_left_y":940,"width":2246,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"565e9b11f26649258ea6f750b43bad88","type":"table_spanning_cell","conversion_output":false,"parent_id":"55379cf8eadb407a9246ab08686053e2","children_ids":["4bc73ac41dd442328df3ab258fda5774"],"text":"","text_display":"Secondary Outcomes","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":3},{"cnt":[[327,945],[658,945],[658,990],[327,990]],"region":{"top_left_x":326,"top_left_y":944,"width":332,"height":47},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bc73ac41dd442328df3ab258fda5774","type":"simple_cell","conversion_output":false,"parent_id":"565e9b11f26649258ea6f750b43bad88","text":"Secondary Outcomes","text_display":"Secondary Outcomes","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":3,"confidence":1,"confidence_rate":1},{"cnt":[[324,1031],[712,1031],[712,1163],[324,1163]],"region":{"top_left_x":324,"top_left_y":1031,"width":389,"height":133},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85053447d2474c7690d3dd4662513653","type":"complex_cell","conversion_output":false,"parent_id":"55379cf8eadb407a9246ab08686053e2","children_ids":["4924df6a13af4bb08b76c090efe89d77","c71d6f6703a84bd59a76480a6dd16ded","b2de60b9e48b4c92abb3d8410cb61175"],"text":"Change from baseline in UDI Stress Score at 12 months","text_display":"Change from baseline in UDI Stress Score at 12 months","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1036],[710,1036],[710,1077],[327,1077]],"region":{"top_left_x":326,"top_left_y":1035,"width":384,"height":42},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4924df6a13af4bb08b76c090efe89d77","type":"text","conversion_output":false,"parent_id":"85053447d2474c7690d3dd4662513653","text":"Change from baseline in","text_display":"Change from baseline in","confidence":1,"confidence_rate":1},{"cnt":[[327,1079],[684,1079],[684,1116],[327,1116]],"region":{"top_left_x":326,"top_left_y":1078,"width":358,"height":38},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c71d6f6703a84bd59a76480a6dd16ded","type":"text","conversion_output":false,"parent_id":"85053447d2474c7690d3dd4662513653","text":"UDI Stress Score at 12","text_display":" UDI Stress Score at 12","confidence":1,"confidence_rate":1},{"cnt":[[327,1122],[446,1122],[446,1159],[327,1159]],"region":{"top_left_x":326,"top_left_y":1122,"width":120,"height":38},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2de60b9e48b4c92abb3d8410cb61175","type":"text","conversion_output":false,"parent_id":"85053447d2474c7690d3dd4662513653","text":"months","text_display":" months","confidence":1,"confidence_rate":1},{"cnt":[[816,1036],[996,1036],[996,1072],[816,1072]],"region":{"top_left_x":816,"top_left_y":1035,"width":180,"height":38},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45890cc114c8427fbdec06d4e3f3820d","type":"simple_cell","conversion_output":false,"parent_id":"55379cf8eadb407a9246ab08686053e2","text":"Continuous","text_display":"Continuous","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,1031],[2548,1031],[2548,1432],[1184,1432]],"region":{"top_left_x":1184,"top_left_y":1031,"width":1365,"height":401},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea313ef336534162a8016614e0485f73","type":"complex_cell","conversion_output":false,"parent_id":"55379cf8eadb407a9246ab08686053e2","children_ids":["71ba85fa57d049f2b6ac69d369adb77e","25e8f6843cf44bdf805f86ad6abc6e19","ae69c50d875d4261a48c412926c05603","b42ab9f57bc14d9695edba5aff8b5029","fd8da77cbb1940a1a974947a03de6357","a5b21c580fb8438fb0855f46fb8fa270","872532c841154fb680a84e8f23fadc5d","b3d8bdabd0b4411ca047331d40cdc692","53800f4be7ee4008abe6f82d3822c44f"],"text":"The Urogenital Distress Inventory-Stress Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions D and F and their respective subquestions \\((0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly; \\(2=\\) Yes and Moderately; \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The Urogenital Distress Inventory-Stress Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. 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If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.5286318857688457,"confidence_rate":0.9991469939854012},{"cnt":[[1191,1036],[2477,1036],[2477,1079],[1191,1079]],"region":{"top_left_x":1190,"top_left_y":1035,"width":1287,"height":44},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71ba85fa57d049f2b6ac69d369adb77e","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"The Urogenital Distress Inventory-Stress Score will be computed at baseline and 12","text_display":"The Urogenital Distress Inventory-Stress Score will be computed at baseline and 12","confidence":1,"confidence_rate":1},{"cnt":[[1189,1079],[2477,1079],[2477,1122],[1189,1122]],"region":{"top_left_x":1188,"top_left_y":1078,"width":1289,"height":45},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25e8f6843cf44bdf805f86ad6abc6e19","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the","text_display":" months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the","confidence":1,"confidence_rate":1},{"cnt":[[1189,1122],[2533,1122],[2533,1168],[1189,1168]],"region":{"top_left_x":1188,"top_left_y":1122,"width":1346,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae69c50d875d4261a48c412926c05603","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"instructions are to average responses across questions D and F and their respective sub-","text_display":" instructions are to average responses across questions D and F and their respective sub","confidence":0.95263671875,"confidence_rate":0.9995379958469319},{"cnt":[[1189,1166],[2473,1166],[2473,1211],[1189,1211]],"region":{"top_left_x":1188,"top_left_y":1165,"width":1285,"height":47},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b42ab9f57bc14d9695edba5aff8b5029","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"questions \\((0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly; \\(2=\\) Yes and Moderately;","text_display":"questions \\((0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly; \\(2=\\) Yes and Moderately;","confidence":0.5286318857688457,"confidence_rate":0.9934497638732528},{"cnt":[[1189,1209],[2525,1209],[2525,1254],[1189,1254]],"region":{"top_left_x":1188,"top_left_y":1208,"width":1337,"height":47},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd8da77cbb1940a1a974947a03de6357","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"\\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the","text_display":" \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the","confidence":0.94287109375,"confidence_rate":0.9993537725901982},{"cnt":[[1191,1252],[2525,1252],[2525,1298],[1191,1298]],"region":{"top_left_x":1190,"top_left_y":1252,"width":1335,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5b21c580fb8438fb0855f46fb8fa270","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"score will be calculated as the average of the non-missing responses. The outcome will","text_display":" score will be calculated as the average of the non-missing responses. The outcome will","confidence":1,"confidence_rate":1},{"cnt":[[1189,1296],[2520,1296],[2520,1341],[1189,1341]],"region":{"top_left_x":1188,"top_left_y":1295,"width":1333,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"872532c841154fb680a84e8f23fadc5d","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"then be computed as the difference in score at 12 months (and 3 and 6 months) and the","text_display":" then be computed as the difference in score at 12 months (and 3 and 6 months) and the","confidence":1,"confidence_rate":1},{"cnt":[[1191,1343],[2542,1343],[2542,1384],[1191,1384]],"region":{"top_left_x":1190,"top_left_y":1343,"width":1352,"height":42},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3d8bdabd0b4411ca047331d40cdc692","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"score at baseline. If data for an assessment time point are missing, the outcome variable","text_display":" score at baseline. If data for an assessment time point are missing, the outcome variable","confidence":1,"confidence_rate":1},{"cnt":[[1189,1386],[1580,1386],[1580,1428],[1189,1428]],"region":{"top_left_x":1188,"top_left_y":1386,"width":393,"height":42},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53800f4be7ee4008abe6f82d3822c44f","type":"text","conversion_output":false,"parent_id":"ea313ef336534162a8016614e0485f73","text":"will be coded as missing.","text_display":" will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[322,1464],[729,1464],[729,1597],[322,1597]],"region":{"top_left_x":322,"top_left_y":1464,"width":408,"height":133},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf4ab607978c4a0ba6f2959a17d07ade","type":"complex_cell","conversion_output":false,"parent_id":"55379cf8eadb407a9246ab08686053e2","children_ids":["b9ebad12ed1e4861ab03ff3fc7c89277","93477dcfd90e4eed9ebf177934c58f91","61dca3baee0d4904991456123c15de99"],"text":"Change from baseline in UDI Irritative Score at 12 months","text_display":"Change from baseline in UDI Irritative Score at 12 months","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1469],[710,1469],[710,1512],[327,1512]],"region":{"top_left_x":326,"top_left_y":1468,"width":384,"height":45},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9ebad12ed1e4861ab03ff3fc7c89277","type":"text","conversion_output":false,"parent_id":"cf4ab607978c4a0ba6f2959a17d07ade","text":"Change from baseline in","text_display":"Change from baseline in","confidence":1,"confidence_rate":1},{"cnt":[[327,1512],[727,1512],[727,1549],[327,1549]],"region":{"top_left_x":326,"top_left_y":1512,"width":402,"height":37},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93477dcfd90e4eed9ebf177934c58f91","type":"text","conversion_output":false,"parent_id":"cf4ab607978c4a0ba6f2959a17d07ade","text":"UDI Irritative Score at 12","text_display":" UDI Irritative Score at 12","confidence":1,"confidence_rate":1},{"cnt":[[327,1560],[446,1560],[446,1597],[327,1597]],"region":{"top_left_x":326,"top_left_y":1559,"width":120,"height":38},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61dca3baee0d4904991456123c15de99","type":"text","conversion_output":false,"parent_id":"cf4ab607978c4a0ba6f2959a17d07ade","text":"months","text_display":" months","confidence":1,"confidence_rate":1},{"cnt":[[816,1469],[996,1469],[996,1506],[816,1506]],"region":{"top_left_x":816,"top_left_y":1468,"width":180,"height":38},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6088681e64c64b3fa8359a168e3582b6","type":"simple_cell","conversion_output":false,"parent_id":"55379cf8eadb407a9246ab08686053e2","text":"Continuous","text_display":"Continuous","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,1464],[2533,1464],[2533,1735],[1184,1735]],"region":{"top_left_x":1184,"top_left_y":1464,"width":1350,"height":272},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1d12b48f6cf4c3d893aa74f864f09ce","type":"complex_cell","conversion_output":false,"parent_id":"55379cf8eadb407a9246ab08686053e2","children_ids":["f84d5e81b9f342e9b5abc28028ef3db9","c63eded0cb484c4c953763d5ac5b889e","f9731b11ab0c46bdb1e6ff59c449c974","64d443e59397434bbf951461e137271a","a10e8e77c3dd42c29d9027b476d8807d","96d84f442eb84dcfa5e8d83c0d0baf95"],"text":"The Urogenital Distress Inventory-Irritative Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions A, B, C, G, H, and I and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1= Yes\\) and Slightly; \\(2= Yes\\) and Moderately; \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses.","text_display":"The Urogenital Distress Inventory-Irritative Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions A, B, C, G, H, and I and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1= Yes\\) and Slightly; \\(2= Yes\\) and Moderately; \\(3=\\) Yes and Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses.","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8155999272096718,"confidence_rate":0.9994470524339455},{"cnt":[[1191,1469],[2520,1469],[2520,1512],[1191,1512]],"region":{"top_left_x":1190,"top_left_y":1468,"width":1331,"height":45},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f84d5e81b9f342e9b5abc28028ef3db9","type":"text","conversion_output":false,"parent_id":"f1d12b48f6cf4c3d893aa74f864f09ce","text":"The Urogenital Distress Inventory-Irritative Score will be computed at baseline and 12","text_display":"The Urogenital Distress Inventory-Irritative Score will be computed at baseline and 12","confidence":1,"confidence_rate":1},{"cnt":[[1189,1512],[2477,1512],[2477,1558],[1189,1558]],"region":{"top_left_x":1188,"top_left_y":1512,"width":1289,"height":46},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c63eded0cb484c4c953763d5ac5b889e","type":"text","conversion_output":false,"parent_id":"f1d12b48f6cf4c3d893aa74f864f09ce","text":"months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the","text_display":" months (and 3 and 6 months) using the standard scoring algorithm. 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If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in UDI Obstructive Score at 12 months & Continuous & The Urogenital Distress Inventory-Obstructive Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions \\(E , J , K , L , M , N , O , P , Q , R\\), and S and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly; \\(2=\\) Yes and Moderately; \\(3=\\) Yes and Greatly), and then multiply by \\(100 / 3\\). If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline \\multicolumn{3}{|l|}{Exploratory Outcomes} \\\\\n\\hline Change from baseline in Urge Incontinence Episodes at 12 months & Continuous & The daily frequency of urge incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of urge incontinence episodes at 12 months (and 6 months) and the daily frequency of urge incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Stress Incontinence Episodes at 12 months & Continuous & The daily frequency of stress incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of stress incontinence episodes at 12 months (and 6 months) and the daily frequency of stress incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Total Incontinence Episodes at 12 months & Continuous & The daily frequency of total incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of total incontinence episodes at 12 months (and 6 months) and the daily frequency of total \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline & & The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in UDI Obstructive Score at 12 months & Continuous & The Urogenital Distress Inventory-Obstructive Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the instructions are to average responses across questions \\(E , J , K , L , M , N , O , P , Q , R\\), and S and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly; \\(2=\\) Yes and Moderately; \\(3=\\) Yes and Greatly), and then multiply by \\(100 / 3\\). If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline \\multicolumn{3}{|l|}{Exploratory Outcomes} \\\\\n\\hline Change from baseline in Urge Incontinence Episodes at 12 months & Continuous & The daily frequency of urge incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of urge incontinence episodes at 12 months (and 6 months) and the daily frequency of urge incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Stress Incontinence Episodes at 12 months & Continuous & The daily frequency of stress incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of stress incontinence episodes at 12 months (and 6 months) and the daily frequency of stress incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Total Incontinence Episodes at 12 months & Continuous & The daily frequency of total incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of total incontinence episodes at 12 months (and 6 months) and the daily frequency of total 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If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.5772851381658484,"confidence_rate":0.9986882334958237},{"cnt":[[1191,532],[2566,532],[2566,575],[1191,575]],"region":{"top_left_x":1190,"top_left_y":532,"width":1376,"height":44},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef84a1944d6843fa889bd1a5274b464e","type":"text","conversion_output":false,"parent_id":"9ea04d17c06e4657994cd7987e0f2504","text":"The Urogenital Distress Inventory-Obstructive Score will be computed at baseline and 12","text_display":"The Urogenital Distress Inventory-Obstructive Score will be computed at baseline and 12","confidence":1,"confidence_rate":1},{"cnt":[[1189,575],[2477,575],[2477,619],[1189,619]],"region":{"top_left_x":1188,"top_left_y":575,"width":1289,"height":44},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62dbee5470c344d28502d933776dcee0","type":"text","conversion_output":false,"parent_id":"9ea04d17c06e4657994cd7987e0f2504","text":"months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the","text_display":" months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the","confidence":1,"confidence_rate":1},{"cnt":[[1191,619],[2553,619],[2553,662],[1191,662]],"region":{"top_left_x":1190,"top_left_y":618,"width":1363,"height":45},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a9f4875bb23450abf87e59e8e7cfb84","type":"text","conversion_output":false,"parent_id":"9ea04d17c06e4657994cd7987e0f2504","text":"instructions are to average responses across questions \\(E , J , K , L , M , N , O , P , Q , R\\), and S","text_display":" instructions are to average responses across questions \\(E , J , K , L , M , N , O , P , Q , R\\), and S","confidence":0.6085753440856934,"confidence_rate":0.9959374993334373},{"cnt":[[1191,662],[2475,662],[2475,708],[1191,708]],"region":{"top_left_x":1190,"top_left_y":662,"width":1285,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d908d4b7db54d669180ef3f368daf80","type":"text","conversion_output":false,"parent_id":"9ea04d17c06e4657994cd7987e0f2504","text":"and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly;","text_display":" and their respective sub-questions ( \\(0=\\) No or Yes and Not at all; \\(1=\\) Yes and Slightly;","confidence":0.5772851381658484,"confidence_rate":0.9943518978453132},{"cnt":[[1189,705],[2410,705],[2410,751],[1189,751]],"region":{"top_left_x":1188,"top_left_y":705,"width":1222,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"969bde8460914bf0b5f1d09c10946e88","type":"text","conversion_output":false,"parent_id":"9ea04d17c06e4657994cd7987e0f2504","text":"\\(2=\\) Yes and Moderately; \\(3=\\) Yes and Greatly), and then multiply by \\(100 / 3\\). If any","text_display":" \\(2=\\) Yes and Moderately; \\(3=\\) Yes and Greatly), and then multiply by \\(100 / 3\\). 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The outcome will then be computed as the difference in score at 12 months","text_display":" responses. The outcome will then be computed as the difference in score at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[1191,840],[2533,840],[2533,885],[1191,885]],"region":{"top_left_x":1190,"top_left_y":839,"width":1344,"height":47},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc306ae3bcd041a89ae6be6fdb1b2fc4","type":"text","conversion_output":false,"parent_id":"9ea04d17c06e4657994cd7987e0f2504","text":"(and 3 and 6 months) and the score at baseline. If data for an assessment time point are","text_display":" (and 3 and 6 months) and the score at baseline. If data for an assessment time point are","confidence":1,"confidence_rate":1},{"cnt":[[1189,883],[2048,883],[2048,928],[1189,928]],"region":{"top_left_x":1188,"top_left_y":882,"width":861,"height":47},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6dff31a93064369a1ef36dc0d8f0fb6","type":"text","conversion_output":false,"parent_id":"9ea04d17c06e4657994cd7987e0f2504","text":"missing, the outcome variable will be coded as missing.","text_display":" missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[324,972],[2585,972],[2585,1019],[324,1019]],"region":{"top_left_x":324,"top_left_y":971,"width":2262,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82223a1d7cb14305a24774148ed061b2","type":"table_spanning_cell","conversion_output":false,"parent_id":"f8ff8d515f3b44ceb9ea36adfddf1eec","children_ids":["78c7552537f34dcfa6eaac84771d98ce"],"text":"","text_display":"Exploratory Outcomes","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":3},{"cnt":[[327,974],[680,974],[680,1015],[327,1015]],"region":{"top_left_x":326,"top_left_y":973,"width":354,"height":43},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78c7552537f34dcfa6eaac84771d98ce","type":"simple_cell","conversion_output":false,"parent_id":"82223a1d7cb14305a24774148ed061b2","text":"Exploratory Outcomes","text_display":"Exploratory Outcomes","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":3,"confidence":1,"confidence_rate":1},{"cnt":[[324,1061],[766,1061],[766,1190],[324,1190]],"region":{"top_left_x":324,"top_left_y":1060,"width":443,"height":131},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b41b520fdc548f18fa5a39f76d31b2b","type":"complex_cell","conversion_output":false,"parent_id":"f8ff8d515f3b44ceb9ea36adfddf1eec","children_ids":["160eb3177c9a46849016fdf75b7bb211","ca8b9feaafb146c18fb939bf95ac8828","695e47bd21df45aaaa5c9b367c4a74de"],"text":"Change from baseline in Urge Incontinence Episodes at 12 months","text_display":"Change from baseline in Urge Incontinence Episodes at 12 months","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1065],[710,1065],[710,1106],[327,1106]],"region":{"top_left_x":326,"top_left_y":1064,"width":384,"height":43},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"160eb3177c9a46849016fdf75b7bb211","type":"text","conversion_output":false,"parent_id":"7b41b520fdc548f18fa5a39f76d31b2b","text":"Change from baseline in","text_display":"Change from baseline in","confidence":1,"confidence_rate":1},{"cnt":[[327,1108],[762,1108],[762,1149],[327,1149]],"region":{"top_left_x":326,"top_left_y":1108,"width":436,"height":42},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca8b9feaafb146c18fb939bf95ac8828","type":"text","conversion_output":false,"parent_id":"7b41b520fdc548f18fa5a39f76d31b2b","text":"Urge Incontinence Episodes","text_display":" Urge Incontinence Episodes","confidence":1,"confidence_rate":1},{"cnt":[[327,1152],[532,1152],[532,1188],[327,1188]],"region":{"top_left_x":326,"top_left_y":1151,"width":207,"height":38},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"695e47bd21df45aaaa5c9b367c4a74de","type":"text","conversion_output":false,"parent_id":"7b41b520fdc548f18fa5a39f76d31b2b","text":"at 12 months","text_display":" at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[816,1065],[996,1065],[996,1100],[816,1100]],"region":{"top_left_x":816,"top_left_y":1064,"width":180,"height":36},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86708607be984991a528267b8d47df3a","type":"simple_cell","conversion_output":false,"parent_id":"f8ff8d515f3b44ceb9ea36adfddf1eec","text":"Continuous","text_display":"Continuous","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,1061],[2544,1061],[2544,1288],[1184,1288]],"region":{"top_left_x":1184,"top_left_y":1060,"width":1361,"height":228},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a59ed80f9408443eaa6781922e16ca5a","type":"complex_cell","conversion_output":false,"parent_id":"f8ff8d515f3b44ceb9ea36adfddf1eec","children_ids":["453475b43f084cb98c86ec77f8677747","a50a6c770f1d4f1d9b137b950290e20d","0543f92e42b742d0b40a8325edd37677","a52acb6f2a0c4893b202811bdf0d94fa","581fbb68432b46f886580b559adb0a04"],"text":"The daily frequency of urge incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of urge incontinence episodes at 12 months (and 6 months) and the daily frequency of urge incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The daily frequency of urge incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of urge incontinence episodes at 12 months (and 6 months) and the daily frequency of urge incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999968132275071},{"cnt":[[1191,1063],[2535,1063],[2535,1106],[1191,1106]],"region":{"top_left_x":1190,"top_left_y":1062,"width":1346,"height":45},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"453475b43f084cb98c86ec77f8677747","type":"text","conversion_output":false,"parent_id":"a59ed80f9408443eaa6781922e16ca5a","text":"The daily frequency of urge incontinence episodes will be taken from the bladder diary.","text_display":"The daily frequency of urge incontinence episodes will be taken from the bladder diary.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1108],[2416,1108],[2416,1149],[1189,1149]],"region":{"top_left_x":1188,"top_left_y":1108,"width":1229,"height":42},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a50a6c770f1d4f1d9b137b950290e20d","type":"text","conversion_output":false,"parent_id":"a59ed80f9408443eaa6781922e16ca5a","text":"The outcome will then be computed as the difference in daily frequency of urge","text_display":" The outcome will then be computed as the difference in daily frequency of urge","confidence":1,"confidence_rate":1},{"cnt":[[1191,1152],[2468,1152],[2468,1197],[1191,1197]],"region":{"top_left_x":1190,"top_left_y":1151,"width":1279,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0543f92e42b742d0b40a8325edd37677","type":"text","conversion_output":false,"parent_id":"a59ed80f9408443eaa6781922e16ca5a","text":"incontinence episodes at 12 months (and 6 months) and the daily frequency of urge","text_display":" incontinence episodes at 12 months (and 6 months) and the daily frequency of urge","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[1189,1195],[2538,1195],[2538,1238],[1189,1238]],"region":{"top_left_x":1188,"top_left_y":1194,"width":1350,"height":45},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a52acb6f2a0c4893b202811bdf0d94fa","type":"text","conversion_output":false,"parent_id":"a59ed80f9408443eaa6781922e16ca5a","text":"incontinence episodes at baseline. If data for the assessment time point are missing, the","text_display":" incontinence episodes at baseline. If data for the assessment time point are missing, the","confidence":1,"confidence_rate":1},{"cnt":[[1191,1238],[1853,1238],[1853,1284],[1191,1284]],"region":{"top_left_x":1190,"top_left_y":1238,"width":664,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"581fbb68432b46f886580b559adb0a04","type":"text","conversion_output":false,"parent_id":"a59ed80f9408443eaa6781922e16ca5a","text":"outcome variable will be coded as missing.","text_display":" outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[324,1325],[781,1325],[781,1457],[324,1457]],"region":{"top_left_x":324,"top_left_y":1324,"width":458,"height":133},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ac67927551e48988e622c5ec11bc3ff","type":"complex_cell","conversion_output":false,"parent_id":"f8ff8d515f3b44ceb9ea36adfddf1eec","children_ids":["9335e6294ea945f3b92da7af26a925de","178bec10f45c4f80aa95baa135f6b461","00a4ce68492844d9a9417f3218f946db"],"text":"Change from baseline in Stress Incontinence Episodes at 12 months","text_display":"Change from baseline in Stress Incontinence Episodes at 12 months","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1329],[710,1329],[710,1370],[327,1370]],"region":{"top_left_x":326,"top_left_y":1329,"width":384,"height":42},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9335e6294ea945f3b92da7af26a925de","type":"text","conversion_output":false,"parent_id":"9ac67927551e48988e622c5ec11bc3ff","text":"Change from baseline in","text_display":"Change from baseline in","confidence":1,"confidence_rate":1},{"cnt":[[327,1372],[779,1372],[779,1418],[327,1418]],"region":{"top_left_x":326,"top_left_y":1372,"width":454,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"178bec10f45c4f80aa95baa135f6b461","type":"text","conversion_output":false,"parent_id":"9ac67927551e48988e622c5ec11bc3ff","text":"Stress Incontinence Episodes","text_display":" Stress Incontinence Episodes","confidence":1,"confidence_rate":1},{"cnt":[[327,1416],[532,1416],[532,1453],[327,1453]],"region":{"top_left_x":326,"top_left_y":1415,"width":207,"height":38},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00a4ce68492844d9a9417f3218f946db","type":"text","conversion_output":false,"parent_id":"9ac67927551e48988e622c5ec11bc3ff","text":"at 12 months","text_display":" at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[816,1329],[996,1329],[996,1366],[816,1366]],"region":{"top_left_x":816,"top_left_y":1329,"width":180,"height":37},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ede19431929243b58e4793c972d561a0","type":"simple_cell","conversion_output":false,"parent_id":"f8ff8d515f3b44ceb9ea36adfddf1eec","text":"Continuous","text_display":"Continuous","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,1325],[2555,1325],[2555,1552],[1184,1552]],"region":{"top_left_x":1184,"top_left_y":1324,"width":1371,"height":229},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11cdfd10eac745acb4818060e87b1548","type":"complex_cell","conversion_output":false,"parent_id":"f8ff8d515f3b44ceb9ea36adfddf1eec","children_ids":["4d0ae4b76adb4835a64971e4f09ec807","74e54263a2d940c0b86cb193cdeaf5c2","6f66d2c2a402408d9b4d815cbe2c0669","ba8d03888d2847db8fe846ddacaa3493","bec9d8a766bd466b94364f2ccdc4951e"],"text":"The daily frequency of stress incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of stress incontinence episodes at 12 months (and 6 months) and the daily frequency of stress incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The daily frequency of stress incontinence episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of stress incontinence episodes at 12 months (and 6 months) and the daily frequency of stress incontinence episodes at baseline. 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If data for the assessment time point are missing, the","text_display":" incontinence episodes at baseline. 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The outcome will then be computed as the difference in daily frequency of total incontinence episodes at 12 months (and 6 months) and the daily frequency of total","text_display":"The daily frequency of total incontinence episodes will be taken from the bladder diary. 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If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Urgency Episodes at 12 months & Continuous & The daily frequency of urgency episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of urgency episodes at 12 months (and 6 months) and the daily frequency of urgency episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Nocturia Episodes at 12 months & Continuous & The daily frequency of nighttime voids will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of nighttime voids at 12 months (and 6 months) and the daily frequency of nighttime voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Daytime voids at 12 months & Continuous & The daily frequency of daytime voids will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of daytime voids at 12 months (and 6 months) and the daily frequency of daytime voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in total voids at 12 months & Continuous & The daily frequency of total voids will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of total voids at 12 months (and 6 months) and the daily frequency of total voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in total voids without incontinence at 12 months & Continuous & The number of voids without incontinence will be taken from the bladder diary. The outcome will then be computed as the difference in number of voids without incontinence at 12 months (and 6 months) and the number of voids without incontinence at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline & & incontinence episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Urgency Episodes at 12 months & Continuous & The daily frequency of urgency episodes will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of urgency episodes at 12 months (and 6 months) and the daily frequency of urgency episodes at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Nocturia Episodes at 12 months & Continuous & The daily frequency of nighttime voids will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of nighttime voids at 12 months (and 6 months) and the daily frequency of nighttime voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Daytime voids at 12 months & Continuous & The daily frequency of daytime voids will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of daytime voids at 12 months (and 6 months) and the daily frequency of daytime voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in total voids at 12 months & Continuous & The daily frequency of total voids will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of total voids at 12 months (and 6 months) and the daily frequency of total voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in total voids without incontinence at 12 months & Continuous & The number of voids without incontinence will be taken from the bladder diary. The outcome will then be computed as the difference in number of voids without incontinence at 12 months (and 6 months) and the number of voids without incontinence at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. 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The outcome will then be computed as the difference in daily frequency of total voids at 12 months (and 6 months) and the daily frequency of total voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The daily frequency of total voids will be taken from the bladder diary. The outcome will then be computed as the difference in daily frequency of total voids at 12 months (and 6 months) and the daily frequency of total voids at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1191,1190],[2559,1190],[2559,1232],[1191,1232]],"region":{"top_left_x":1190,"top_left_y":1190,"width":1370,"height":42},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7981fd027daf40179c23b888f0e08720","type":"text","conversion_output":false,"parent_id":"1604f27c7c4448449d916abcd8ae3951","text":"The daily frequency of total voids will be taken from the bladder diary. The outcome will","text_display":"The daily frequency of total voids will be taken from the bladder diary. The outcome will","confidence":1,"confidence_rate":1},{"cnt":[[1191,1234],[2542,1234],[2542,1275],[1191,1275]],"region":{"top_left_x":1190,"top_left_y":1233,"width":1352,"height":42},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5500e6954d27470292e15f6cdd532369","type":"text","conversion_output":false,"parent_id":"1604f27c7c4448449d916abcd8ae3951","text":"then be computed as the difference in daily frequency of total voids at 12 months (and 6","text_display":" then be computed as the difference in daily frequency of total voids at 12 months (and 6","confidence":1,"confidence_rate":1},{"cnt":[[1191,1277],[2490,1277],[2490,1318],[1191,1318]],"region":{"top_left_x":1190,"top_left_y":1277,"width":1300,"height":42},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"981cf1ec33ac4f428ae353b94b4a6ab5","type":"text","conversion_output":false,"parent_id":"1604f27c7c4448449d916abcd8ae3951","text":"months) and the daily frequency of total voids at baseline. If data for the assessment","text_display":" months) and the daily frequency of total voids at baseline. If data for the assessment","confidence":1,"confidence_rate":1},{"cnt":[[1191,1320],[2269,1320],[2269,1364],[1191,1364]],"region":{"top_left_x":1190,"top_left_y":1320,"width":1080,"height":44},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be0496e54be542f09f5d53239b5251e2","type":"text","conversion_output":false,"parent_id":"1604f27c7c4448449d916abcd8ae3951","text":"time point are missing, the outcome variable will be coded as missing.","text_display":" time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[324,1407],[740,1407],[740,1537],[324,1537]],"region":{"top_left_x":324,"top_left_y":1407,"width":417,"height":130},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8649c62c49584f698307d192aca75056","type":"complex_cell","conversion_output":false,"parent_id":"69dea0f1c56d4fe882418e5903eae90e","children_ids":["a6b828b56eba4fdca50eba20b7db39f5","d589679fd8104caba1b7f8902b10a084","f97f252db2f6493087e07758bdfb30cb"],"text":"Change from baseline in total voids without incontinence at 12 months","text_display":"Change from baseline in total voids without incontinence at 12 months","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1411],[710,1411],[710,1453],[327,1453]],"region":{"top_left_x":326,"top_left_y":1411,"width":384,"height":42},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6b828b56eba4fdca50eba20b7db39f5","type":"text","conversion_output":false,"parent_id":"8649c62c49584f698307d192aca75056","text":"Change from baseline in","text_display":"Change from baseline in","confidence":1,"confidence_rate":1},{"cnt":[[327,1455],[621,1455],[621,1491],[327,1491]],"region":{"top_left_x":326,"top_left_y":1454,"width":296,"height":38},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d589679fd8104caba1b7f8902b10a084","type":"text","conversion_output":false,"parent_id":"8649c62c49584f698307d192aca75056","text":"total voids without","text_display":" total voids without","confidence":1,"confidence_rate":1},{"cnt":[[327,1498],[736,1498],[736,1535],[327,1535]],"region":{"top_left_x":326,"top_left_y":1497,"width":410,"height":38},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f97f252db2f6493087e07758bdfb30cb","type":"text","conversion_output":false,"parent_id":"8649c62c49584f698307d192aca75056","text":"incontinence at 12 months","text_display":" incontinence at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[816,1411],[996,1411],[996,1448],[816,1448]],"region":{"top_left_x":816,"top_left_y":1411,"width":180,"height":38},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09810987db6446e58c336672818ced88","type":"simple_cell","conversion_output":false,"parent_id":"69dea0f1c56d4fe882418e5903eae90e","text":"Continuous","text_display":"Continuous","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1189,1407],[2553,1407],[2553,1632],[1189,1632]],"region":{"top_left_x":1188,"top_left_y":1407,"width":1365,"height":226},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78b44d3544e04958b4161c1402ac3d41","type":"complex_cell","conversion_output":false,"parent_id":"69dea0f1c56d4fe882418e5903eae90e","children_ids":["46b2e83f8214456782fe0cc4b53edaf8","1d4a1dc18bb543a99411ba59e2f52f38","d31eb5d5c38049d2bf32d06a69c71025","2af1466b20114e0eb11c3afcd9fc3400","51a7e10aa104424db42e98c4d4e80328"],"text":"The number of voids without incontinence will be taken from the bladder diary. The outcome will then be computed as the difference in number of voids without incontinence at 12 months (and 6 months) and the number of voids without incontinence at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The number of voids without incontinence will be taken from the bladder diary. The outcome will then be computed as the difference in number of voids without incontinence at 12 months (and 6 months) and the number of voids without incontinence at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","cell_row":6,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1191,1411],[2486,1411],[2486,1457],[1191,1457]],"region":{"top_left_x":1190,"top_left_y":1411,"width":1296,"height":46},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46b2e83f8214456782fe0cc4b53edaf8","type":"text","conversion_output":false,"parent_id":"78b44d3544e04958b4161c1402ac3d41","text":"The number of voids without incontinence will be taken from the bladder diary. The","text_display":"The number of voids without incontinence will be taken from the bladder diary. The","confidence":1,"confidence_rate":1},{"cnt":[[1191,1455],[2369,1455],[2369,1498],[1191,1498]],"region":{"top_left_x":1190,"top_left_y":1454,"width":1179,"height":44},"line":67,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d4a1dc18bb543a99411ba59e2f52f38","type":"text","conversion_output":false,"parent_id":"78b44d3544e04958b4161c1402ac3d41","text":"outcome will then be computed as the difference in number of voids without","text_display":" outcome will then be computed as the difference in number of voids without","confidence":1,"confidence_rate":1},{"cnt":[[1191,1498],[2551,1498],[2551,1543],[1191,1543]],"region":{"top_left_x":1190,"top_left_y":1497,"width":1361,"height":47},"line":68,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d31eb5d5c38049d2bf32d06a69c71025","type":"text","conversion_output":false,"parent_id":"78b44d3544e04958b4161c1402ac3d41","text":"incontinence at 12 months (and 6 months) and the number of voids without incontinence","text_display":" incontinence at 12 months (and 6 months) and the number of voids without incontinence","confidence":1,"confidence_rate":1},{"cnt":[[1191,1541],[2533,1541],[2533,1587],[1191,1587]],"region":{"top_left_x":1190,"top_left_y":1541,"width":1344,"height":46},"line":69,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2af1466b20114e0eb11c3afcd9fc3400","type":"text","conversion_output":false,"parent_id":"78b44d3544e04958b4161c1402ac3d41","text":"at baseline. If data for the assessment time point are missing, the outcome variable will","text_display":" at baseline. If data for the assessment time point are missing, the outcome variable will","confidence":1,"confidence_rate":1},{"cnt":[[1191,1589],[1511,1589],[1511,1630],[1191,1630]],"region":{"top_left_x":1190,"top_left_y":1588,"width":322,"height":43},"line":70,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51a7e10aa104424db42e98c4d4e80328","type":"text","conversion_output":false,"parent_id":"78b44d3544e04958b4161c1402ac3d41","text":"be coded as missing.","text_display":" be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[681,1927],[681,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":377,"height":35},"line":71,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f966c60fe76f471c947d4eef1313a985","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 21","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-23","page":23,"lines":[{"cnt":[[305,133],[810,133],[810,217],[305,217]],"region":{"top_left_x":305,"top_left_y":133,"width":505,"height":84},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c8c9ce7ea8674805b79a80b6d4dae254","type":"figure_label","conversion_output":false,"children_ids":["2240965f1aab4ba5bbdb09338ffb0faa","4672e9f192844137bc44ce6ac24b7cba"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2240965f1aab4ba5bbdb09338ffb0faa","type":"text","conversion_output":false,"parent_id":"c8c9ce7ea8674805b79a80b6d4dae254","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4672e9f192844137bc44ce6ac24b7cba","type":"text","conversion_output":false,"parent_id":"c8c9ce7ea8674805b79a80b6d4dae254","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,243],[2587,243],[2587,1811],[305,1811]],"region":{"top_left_x":305,"top_left_y":242,"width":2282,"height":1570},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"044654e3cd62486ea7a3b2d5dfce7af5","type":"table","conversion_output":true,"children_ids":["788c12c2dd70431c88190b6c50aa0044","5acee486940c42a1b13277f295d42f81","b3a25b66b6224dd5ae671b7195a619c4","b528422dd9eb428ca23ded727c3d9d6b","96a94ca5952e4e4b8158a6482a133637","b53c6e01f68242baa3cb2993ab0da07b","9dd1d3ab428a47b0933c081ee19c467d","72144d39a1cd4f24b89770aa02ced2c6","daba9aed66a747f0b71d37d8aa7253a5","4664715972da4116a1c92a936214c6b6","766ce1f5c2244b9483a6aeff3708aa7e","25b071aff297415bad98f08c7b384177","f46b82a2c5524f56a8b4f8eed08cfcc3","c4fe3d6a4aa4448dbad0710a006aaec2","a7272c19a5f94c789a58c9ae74eeb9c5","0088f0ba59c14a2296c6dee43fad9884","eacc24c3b94448748988041a31ac094a","f3e4d8ae4d1a4c019acd624d6af415d7","1e96e21590834a72b02946bfd4f7c1de","764a779c877d43fb94f633fa0584e1ce","503dcd91122a4032842201f3ef9c2a6e","5eaa0f0720ce401c810efd783446d053","6a7396cef9ca443f828130c06f11bd9d"],"selected_labels":["c8c9ce7ea8674805b79a80b6d4dae254"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from baseline in Number of Pads per Day at 12 months & Continuous & The daily average number of pads will be taken from the bladder diary. The outcome will then be computed as the difference in daily average number of pads at 12 months (and 6 months) and the daily average number of pads at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Number of Wet Pads per Day at 12 months & Continuous & The daily average number of wet pads will be taken from the bladder diary. The outcome will then be computed as the difference in daily average number of wet pads at 12 months (and 6 months) and the daily average number of wet pads at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Normalization of Voiding Frequency at 12 months & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get a voiding frequency. The indicator for normalization at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at baseline: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : No \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at baseline: Missing \\\\\nIf data for the assessment time point are missing, the normalization indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Improvement in Voiding Frequency at 12 months & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days ( \\(<=3\\) ) to get a voiding frequency. If there has been at least a \\(50 \\%\\) reduction in the voiding frequency between baseline and the time point, the improvement indicator at 12 months (and 6 months) will be set to \"Yes\", otherwise it will be set to \"No\". If data for the assessment time point are missing, the improvement indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from baseline in Number of Pads per Day at 12 months & Continuous & The daily average number of pads will be taken from the bladder diary. The outcome will then be computed as the difference in daily average number of pads at 12 months (and 6 months) and the daily average number of pads at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from baseline in Number of Wet Pads per Day at 12 months & Continuous & The daily average number of wet pads will be taken from the bladder diary. The outcome will then be computed as the difference in daily average number of wet pads at 12 months (and 6 months) and the daily average number of wet pads at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Normalization of Voiding Frequency at 12 months & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get a voiding frequency. The indicator for normalization at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at baseline: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : No \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at baseline: Missing \\\\\nIf data for the assessment time point are missing, the normalization indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Improvement in Voiding Frequency at 12 months & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days ( \\(<=3\\) ) to get a voiding frequency. If there has been at least a \\(50 \\%\\) reduction in the voiding frequency between baseline and the time point, the improvement indicator at 12 months (and 6 months) will be set to \"Yes\", otherwise it will be set to \"No\". If data for the assessment time point are missing, the improvement indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} 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The outcome will then be computed as the difference in daily average number of pads at 12 months (and 6 months) and the daily average number of pads at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The daily average number of pads will be taken from the bladder diary. The outcome will then be computed as the difference in daily average number of pads at 12 months (and 6 months) and the daily average number of pads at baseline. 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The indicator for normalization at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at baseline: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : No \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at baseline: Missing \\\\\nIf data for the assessment time point are missing, the normalization indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get a voiding frequency. The indicator for normalization at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at baseline: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : No \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at baseline: Missing \\\\\nIf data for the assessment time point are missing, the normalization indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing 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Missing","text_display":"\nIf \\(\\leq 8\\) voids/ 24 hours at baseline: Missing","confidence":0.96875,"confidence_rate":0.9994011473402027},{"cnt":[[1189,1173],[2481,1173],[2481,1219],[1189,1219]],"region":{"top_left_x":1188,"top_left_y":1173,"width":1294,"height":46},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de55a727b5e84473a6e35e69036411d7","type":"text","conversion_output":false,"parent_id":"764a779c877d43fb94f633fa0584e1ce","text":"If data for the assessment time point are missing, the normalization indicator will be","text_display":"\nIf data for the assessment time point are missing, the normalization indicator will be","confidence":1,"confidence_rate":1},{"cnt":[[1189,1221],[1464,1221],[1464,1266],[1189,1266]],"region":{"top_left_x":1188,"top_left_y":1220,"width":276,"height":47},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a9e69b315e0409285d4f795a5baa483","type":"text","conversion_output":false,"parent_id":"764a779c877d43fb94f633fa0584e1ce","text":"coded as missing.","text_display":" coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1268],[2475,1268],[2475,1314],[1189,1314]],"region":{"top_left_x":1188,"top_left_y":1268,"width":1287,"height":46},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a74f0b35dd345579d7f925a43df1413","type":"text","conversion_output":false,"parent_id":"764a779c877d43fb94f633fa0584e1ce","text":"The variable is summarized as the percentage of participants with indicator equal to","text_display":"\nThe variable is summarized as the percentage of participants with indicator equal to","confidence":1,"confidence_rate":1},{"cnt":[[1189,1312],[1819,1312],[1819,1357],[1189,1357]],"region":{"top_left_x":1188,"top_left_y":1311,"width":631,"height":47},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d0fd844c190427f8caf8c8fce5f50a0","type":"text","conversion_output":false,"parent_id":"764a779c877d43fb94f633fa0584e1ce","text":"\"Yes\" among all non-missing indicators.","text_display":" \"Yes\" among all non-missing indicators.","confidence":1,"confidence_rate":1},{"cnt":[[324,1403],[719,1403],[719,1496],[324,1496]],"region":{"top_left_x":324,"top_left_y":1402,"width":395,"height":94},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"503dcd91122a4032842201f3ef9c2a6e","type":"complex_cell","conversion_output":false,"parent_id":"044654e3cd62486ea7a3b2d5dfce7af5","children_ids":["70bdd0b463e14587b956da148f7c5c25","42c35d9ffda742d3b4703c2a7a47d740"],"text":"Improvement in Voiding Frequency at 12 months","text_display":"Improvement in Voiding Frequency at 12 months","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1405],[714,1405],[714,1448],[327,1448]],"region":{"top_left_x":326,"top_left_y":1404,"width":389,"height":45},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70bdd0b463e14587b956da148f7c5c25","type":"text","conversion_output":false,"parent_id":"503dcd91122a4032842201f3ef9c2a6e","text":"Improvement in Voiding","text_display":"Improvement in Voiding","confidence":1,"confidence_rate":1},{"cnt":[[327,1450],[706,1450],[706,1491],[327,1491]],"region":{"top_left_x":326,"top_left_y":1450,"width":380,"height":42},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42c35d9ffda742d3b4703c2a7a47d740","type":"text","conversion_output":false,"parent_id":"503dcd91122a4032842201f3ef9c2a6e","text":"Frequency at 12 months","text_display":" Frequency at 12 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(Yes/No)","confidence":1,"confidence_rate":1},{"cnt":[[1184,1403],[2564,1403],[2564,1769],[1184,1769]],"region":{"top_left_x":1184,"top_left_y":1402,"width":1380,"height":367},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a7396cef9ca443f828130c06f11bd9d","type":"complex_cell","conversion_output":false,"parent_id":"044654e3cd62486ea7a3b2d5dfce7af5","children_ids":["9976ce4789d1499096a8c1833e01e77e","74492b809ce043fea6f58c033a17179b","58544c5795a14b6fbc98be4e0c2383e7","9c6888eb9a8343a0bf00a905050be0b1","9380cf920aa943bf88d8710b2843849f","1ccc75711c2e4c0d8db1933f3946f1f6","3ae35d67f281462e9afd8e136bdfcd0b","885013ba982244069c95ab1630387991"],"text":"\\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days ( \\(<=3\\) ) to get a voiding frequency. If there has been at least a \\(50 \\%\\) reduction in the voiding frequency between baseline and the time point, the improvement indicator at 12 months (and 6 months) will be set to \"Yes\", otherwise it will be set to \"No\". If data for the assessment time point are missing, the improvement indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days ( \\(<=3\\) ) to get a voiding frequency. If there has been at least a \\(50 \\%\\) reduction in the voiding frequency between baseline and the time point, the improvement indicator at 12 months (and 6 months) will be set to \"Yes\", otherwise it will be set to \"No\". If data for the assessment time point are missing, the improvement indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9926791191101074,"confidence_rate":0.9999864036349695},{"cnt":[[1191,1407],[2507,1407],[2507,1448],[1191,1448]],"region":{"top_left_x":1190,"top_left_y":1407,"width":1318,"height":42},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9976ce4789d1499096a8c1833e01e77e","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"The total number of daytime and nighttime voids will be taken from the bladder diary","text_display":"The total number of daytime and nighttime voids will be taken from the bladder diary","confidence":1,"confidence_rate":1},{"cnt":[[1189,1448],[2533,1448],[2533,1491],[1189,1491]],"region":{"top_left_x":1188,"top_left_y":1448,"width":1346,"height":44},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74492b809ce043fea6f58c033a17179b","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"and summed and divided by the number of diary days ( \\(<=3\\) ) to get a voiding frequency.","text_display":" and summed and divided by the number of diary days ( \\(<=3\\) ) to get a voiding frequency.","confidence":0.9926791191101074,"confidence_rate":0.9999218348630429},{"cnt":[[1189,1491],[2546,1491],[2546,1535],[1189,1535]],"region":{"top_left_x":1188,"top_left_y":1491,"width":1359,"height":44},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58544c5795a14b6fbc98be4e0c2383e7","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"If there has been at least a \\(50 \\%\\) reduction in the voiding frequency between baseline and","text_display":" If there has been at least a \\(50 \\%\\) reduction in the voiding frequency between baseline and","confidence":0.99755859375,"confidence_rate":0.9999745379143542},{"cnt":[[1189,1537],[2486,1537],[2486,1580],[1189,1580]],"region":{"top_left_x":1188,"top_left_y":1536,"width":1298,"height":45},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c6888eb9a8343a0bf00a905050be0b1","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"the time point, the improvement indicator at 12 months (and 6 months) will be set to","text_display":" the time point, the improvement indicator at 12 months (and 6 months) will be set to","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[1189,1580],[2559,1580],[2559,1626],[1189,1626]],"region":{"top_left_x":1188,"top_left_y":1580,"width":1372,"height":46},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9380cf920aa943bf88d8710b2843849f","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"\"Yes\", otherwise it will be set to \"No\". If data for the assessment time point are missing,","text_display":" \"Yes\", otherwise it will be set to \"No\". If data for the assessment time point are missing,","confidence":1,"confidence_rate":1},{"cnt":[[1189,1624],[1996,1624],[1996,1669],[1189,1669]],"region":{"top_left_x":1188,"top_left_y":1623,"width":809,"height":47},"line":67,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ccc75711c2e4c0d8db1933f3946f1f6","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"the improvement indicator will be coded as missing.","text_display":" the improvement indicator will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1676],[2475,1676],[2475,1721],[1189,1721]],"region":{"top_left_x":1188,"top_left_y":1675,"width":1287,"height":47},"line":68,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ae35d67f281462e9afd8e136bdfcd0b","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"The variable is summarized as the percentage of participants with indicator equal to","text_display":"\nThe variable is summarized as the percentage of participants with indicator equal to","confidence":1,"confidence_rate":1},{"cnt":[[1189,1719],[1819,1719],[1819,1764],[1189,1764]],"region":{"top_left_x":1188,"top_left_y":1718,"width":631,"height":47},"line":69,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"885013ba982244069c95ab1630387991","type":"text","conversion_output":false,"parent_id":"6a7396cef9ca443f828130c06f11bd9d","text":"\"Yes\" among all non-missing indicators.","text_display":" \"Yes\" among all non-missing indicators.","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[683,1927],[683,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":379,"height":35},"line":70,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"97a779bc819a41d18611f65870ae5be1","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 22","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-24","page":24,"lines":[{"cnt":[[305,133],[810,133],[810,219],[305,219]],"region":{"top_left_x":305,"top_left_y":133,"width":505,"height":87},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c056cea7b8c94aa49ea34d15da164f00","type":"figure_label","conversion_output":false,"children_ids":["624f05f6744341fca97aabd12c2470b5","86a9d2a69aa342fea65a2fe2c149845d"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"624f05f6744341fca97aabd12c2470b5","type":"text","conversion_output":false,"parent_id":"c056cea7b8c94aa49ea34d15da164f00","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"86a9d2a69aa342fea65a2fe2c149845d","type":"text","conversion_output":false,"parent_id":"c056cea7b8c94aa49ea34d15da164f00","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,243],[2589,243],[2589,1783],[305,1783]],"region":{"top_left_x":305,"top_left_y":242,"width":2284,"height":1542},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7fe5c746e5640869f9f4d19be00b2ae","type":"table","conversion_output":true,"children_ids":["f61e0d4e98424ed69fb61907d7538f72","223e1ccf435e46768b1fed75ba34da5b","ff861b86503044bea6811ee56147bb1b","e2bde3f4193645f4a3b97f35e3c15d90","e0d73bc0ebad4f5abf286eeba21274a1","197461b283b24b868520a507d34d0c9a","de3f64fdac37420fb666420cecf731ac","87a221ce6c8a4ddfab17d5417deae2aa","68454990938f4e3bb1c88606dd98bddc","ebf278e02b7942e483b05867613574b4","dbb2ad531eaf4a80a2bf8c621a675935","43d46a639f3a4c06bbaa457fc8f35efd","8918198f95a24561b21f0ac943a20640","f1dfc74c36f2425d8858300dac24b64f","f3b6c166eb8d4b9bb113d26c73e76359","4f7a594fef55416a91f372d17c637a60","6d5cc5b9d95348fc967bea155af21b7a","eedd2568b5274cb6b5f79f531e500118","3d9eb545e86d420094da5d7bcda94638"],"selected_labels":["c056cea7b8c94aa49ea34d15da164f00"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline High Voiding Frequency at 12 months & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get a voiding frequency. The indicator for high frequency at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the high frequency indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Dryness at 12 Months (Diary) & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of incontinence episodes will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get an average daily number of episodes. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf 0 episodes/ 24 hours at time x : Yes \\\\\nIf \\(>0\\) episodes/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Dryness at 12 Months (UDILF) & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe response to questions C (Do you experience urine leakage related to the feeling of urgency?) and D (Do you experience urine leakage related to physical activity, coughing, or sneezing?) will be taken from the UDI-LF. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf question \\(C =\\) No and question \\(D =\\) No at time x : Yes \\\\\nIf question \\(C =\\) Yes or question \\(D =\\) Yes at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline High Voiding Frequency at 12 months & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get a voiding frequency. The indicator for high frequency at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the high frequency indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Dryness at 12 Months (Diary) & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe total number of incontinence episodes will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get an average daily number of episodes. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf 0 episodes/ 24 hours at time x : Yes \\\\\nIf \\(>0\\) episodes/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Dryness at 12 Months (UDILF) & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe response to questions C (Do you experience urine leakage related to the feeling of urgency?) and D (Do you experience urine leakage related to physical activity, coughing, or sneezing?) will be taken from the UDI-LF. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf question \\(C =\\) No and question \\(D =\\) No at time x : Yes \\\\\nIf question \\(C =\\) Yes or question \\(D =\\) Yes at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} 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(Yes/No)","confidence":1,"confidence_rate":1},{"cnt":[[1184,342],[2538,342],[2538,816],[1184,816]],"region":{"top_left_x":1184,"top_left_y":341,"width":1354,"height":475},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8918198f95a24561b21f0ac943a20640","type":"complex_cell","conversion_output":false,"parent_id":"b7fe5c746e5640869f9f4d19be00b2ae","children_ids":["a4e3086ebc08457ca38e0e687f800099","2622e2a58afc4407abdad886b546ce82","d85345b659da48d298933abd61f13780","a9dc61dc74d64b1c95ac2754f2276876","7db5bccd327a4f38821d2f72fb74797a","5a9e9bc2974b4f92bcdef2faf5122679","cba2edb5ac214272a1f096f22e031c3b","3a6b0e8fabb048cd973cbcc2fbc37eb1","b5c1f3211a6b401295756a7bba961a58","dc5ec4a0b90542c0912b003354367d61"],"text":"\\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get a voiding frequency. The indicator for high frequency at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the high frequency indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe total number of daytime and nighttime voids will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get a voiding frequency. The indicator for high frequency at 12 months (and 6 months) will be defined for each subject as follows: \\\\\nIf \\(>8\\) voids/ 24 hours at time x : Yes \\\\\nIf \\(\\leq 8\\) voids/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the high frequency indicator will be coded as missing. \\\\\nThe variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.714540459215641,"confidence_rate":0.9996006509706258},{"cnt":[[1191,346],[2507,346],[2507,387],[1191,387]],"region":{"top_left_x":1190,"top_left_y":345,"width":1318,"height":43},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4e3086ebc08457ca38e0e687f800099","type":"text","conversion_output":false,"parent_id":"8918198f95a24561b21f0ac943a20640","text":"The total number of daytime and nighttime voids will be 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(Yes/No)","confidence":1,"confidence_rate":1},{"cnt":[[1184,855],[2538,855],[2538,1277],[1184,1277]],"region":{"top_left_x":1184,"top_left_y":854,"width":1354,"height":424},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f7a594fef55416a91f372d17c637a60","type":"complex_cell","conversion_output":false,"parent_id":"b7fe5c746e5640869f9f4d19be00b2ae","children_ids":["e64277c09162468999efffc3a6b5820c","262e00e7d4a04a458e9e34d4dc2eea09","9595339c6bb54575a1e669304bdbe695","9b6e126c84a84456859ca00638c8a3c3","25dc6acfb3a549148f2b085c705ebd95","28267c18945c4ec0a073fe9fc0218bc7","43b0158988684765a903e1a452186c5d","aa92641774ba40bd8e345f8a79ba7b8d","6423563d34624a28921c18c0de2b0472"],"text":"\\begin{tabular}{l}\nThe total number of incontinence episodes will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get an average daily number of episodes. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf 0 episodes/ 24 hours at time x : Yes \\\\\nIf \\(>0\\) episodes/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe total number of incontinence episodes will be taken from the bladder diary and summed and divided by the number of diary days (<=3) to get an average daily number of episodes. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf 0 episodes/ 24 hours at time x : Yes \\\\\nIf \\(>0\\) episodes/ 24 hours at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.7183961868286133,"confidence_rate":0.999547514682835},{"cnt":[[1191,859],[2473,859],[2473,902],[1191,902]],"region":{"top_left_x":1190,"top_left_y":859,"width":1283,"height":44},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e64277c09162468999efffc3a6b5820c","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"The total number of incontinence episodes will be taken from the bladder diary and","text_display":"The total number of incontinence episodes will be taken from the bladder diary and","confidence":1,"confidence_rate":1},{"cnt":[[1189,902],[2533,902],[2533,946],[1189,946]],"region":{"top_left_x":1188,"top_left_y":902,"width":1346,"height":44},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"262e00e7d4a04a458e9e34d4dc2eea09","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"summed and divided by the number of diary days (<=3) to get an average daily number","text_display":" summed and divided by the number of diary days (<=3) to get an average daily number","confidence":0.7183961868286133,"confidence_rate":0.9962487120235166},{"cnt":[[1191,948],[2520,948],[2520,989],[1191,989]],"region":{"top_left_x":1190,"top_left_y":947,"width":1331,"height":43},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9595339c6bb54575a1e669304bdbe695","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"of episodes. The indicator for dryness at 12 months will be defined for each subject as","text_display":" of episodes. The indicator for dryness at 12 months will be defined for each subject as","confidence":1,"confidence_rate":1},{"cnt":[[1191,991],[1321,991],[1321,1028],[1191,1028]],"region":{"top_left_x":1190,"top_left_y":991,"width":131,"height":38},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b6e126c84a84456859ca00638c8a3c3","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"follows:","text_display":" follows:","confidence":1,"confidence_rate":1},{"cnt":[[1251,1041],[1819,1041],[1819,1084],[1251,1084]],"region":{"top_left_x":1251,"top_left_y":1041,"width":568,"height":44},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25dc6acfb3a549148f2b085c705ebd95","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"If 0 episodes/ 24 hours at time x : Yes","text_display":"\nIf 0 episodes/ 24 hours at time x : Yes","confidence":0.9844391068909317,"confidence_rate":0.9997199814512996},{"cnt":[[1253,1093],[1838,1093],[1838,1136],[1253,1136]],"region":{"top_left_x":1253,"top_left_y":1093,"width":586,"height":44},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28267c18945c4ec0a073fe9fc0218bc7","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"If \\(>0\\) episodes/ 24 hours at time x : No","text_display":"\nIf \\(>0\\) episodes/ 24 hours at time x : No","confidence":0.9980480668600649,"confidence_rate":0.9999651105971485},{"cnt":[[1191,1143],[2529,1143],[2529,1184],[1191,1184]],"region":{"top_left_x":1190,"top_left_y":1142,"width":1339,"height":42},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43b0158988684765a903e1a452186c5d","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"If data for the assessment time point are missing, the dryness indicator will be coded as","text_display":"\nIf data for the assessment time point are missing, the dryness indicator will be coded as","confidence":1,"confidence_rate":1},{"cnt":[[1191,1186],[2481,1186],[2481,1232],[1191,1232]],"region":{"top_left_x":1190,"top_left_y":1186,"width":1292,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa92641774ba40bd8e345f8a79ba7b8d","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"missing. The variable is summarized as the percentage of participants with indicator","text_display":" missing. The variable is summarized as the percentage of participants with indicator","confidence":1,"confidence_rate":1},{"cnt":[[1189,1232],[1949,1232],[1949,1275],[1189,1275]],"region":{"top_left_x":1188,"top_left_y":1231,"width":761,"height":44},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6423563d34624a28921c18c0de2b0472","type":"text","conversion_output":false,"parent_id":"4f7a594fef55416a91f372d17c637a60","text":"equal to \"Yes\" among all non-missing indicators.","text_display":" equal to \"Yes\" among all non-missing indicators.","confidence":1,"confidence_rate":1},{"cnt":[[324,1316],[777,1316],[777,1414],[324,1414]],"region":{"top_left_x":324,"top_left_y":1316,"width":454,"height":98},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d5cc5b9d95348fc967bea155af21b7a","type":"complex_cell","conversion_output":false,"parent_id":"b7fe5c746e5640869f9f4d19be00b2ae","children_ids":["d0891302fccc4ae4868cd60e75f29905","a09a6fa2f4054a3bb63b5b011b61b646"],"text":"Dryness at 12 Months (UDILF)","text_display":"Dryness at 12 Months (UDILF)","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1320],[775,1320],[775,1364],[327,1364]],"region":{"top_left_x":326,"top_left_y":1320,"width":449,"height":44},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0891302fccc4ae4868cd60e75f29905","type":"text","conversion_output":false,"parent_id":"6d5cc5b9d95348fc967bea155af21b7a","text":"Dryness at 12 Months (UDI-","text_display":"Dryness at 12 Months (UDI","confidence":1,"confidence_rate":1},{"cnt":[[322,1362],[394,1362],[394,1414],[322,1414]],"region":{"top_left_x":322,"top_left_y":1361,"width":72,"height":53},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a09a6fa2f4054a3bb63b5b011b61b646","type":"text","conversion_output":false,"parent_id":"6d5cc5b9d95348fc967bea155af21b7a","text":"LF)","text_display":"LF)","confidence":1,"confidence_rate":1},{"cnt":[[812,1318],[1030,1318],[1030,1422],[812,1422]],"region":{"top_left_x":811,"top_left_y":1318,"width":220,"height":105},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eedd2568b5274cb6b5f79f531e500118","type":"complex_cell","conversion_output":false,"parent_id":"b7fe5c746e5640869f9f4d19be00b2ae","children_ids":["9a43ce31defa4e84841163e9103e7878","836d8d9c43e048ca96db734eed427c00"],"text":"Dichotomous (Yes/No)","text_display":"Dichotomous (Yes/No)","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[816,1320],[1026,1320],[1026,1357],[816,1357]],"region":{"top_left_x":816,"top_left_y":1320,"width":211,"height":38},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a43ce31defa4e84841163e9103e7878","type":"text","conversion_output":false,"parent_id":"eedd2568b5274cb6b5f79f531e500118","text":"Dichotomous","text_display":"Dichotomous","confidence":1,"confidence_rate":1},{"cnt":[[816,1372],[961,1372],[961,1416],[816,1416]],"region":{"top_left_x":816,"top_left_y":1372,"width":146,"height":44},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"836d8d9c43e048ca96db734eed427c00","type":"text","conversion_output":false,"parent_id":"eedd2568b5274cb6b5f79f531e500118","text":"(Yes/No)","text_display":" (Yes/No)","confidence":1,"confidence_rate":1},{"cnt":[[1184,1318],[2566,1318],[2566,1743],[1184,1743]],"region":{"top_left_x":1184,"top_left_y":1318,"width":1382,"height":425},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d9eb545e86d420094da5d7bcda94638","type":"complex_cell","conversion_output":false,"parent_id":"b7fe5c746e5640869f9f4d19be00b2ae","children_ids":["a7aef0f03dbc4fbaa2badbeddacfd914","b04a44c2af3a4c11abdc012ff330c465","26d87c1793e54ed48c92696d4e83e583","f6e3d01a014245ff99e512a7499151c3","e9d40f9deddf4696957f171f95178bca","270b68ac10244fe88d650fbf86aae110","ca9462f95a5f443e81ca7df398b3b5b3","cd78efbe8e2f4597ab716293fd631db7","1df7e70fca844c3fb9e58537b2e32d75"],"text":"\\begin{tabular}{l}\nThe response to questions C (Do you experience urine leakage related to the feeling of urgency?) and D (Do you experience urine leakage related to physical activity, coughing, or sneezing?) will be taken from the UDI-LF. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf question \\(C =\\) No and question \\(D =\\) No at time x : Yes \\\\\nIf question \\(C =\\) Yes or question \\(D =\\) Yes at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe response to questions C (Do you experience urine leakage related to the feeling of urgency?) and D (Do you experience urine leakage related to physical activity, coughing, or sneezing?) will be taken from the UDI-LF. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf question \\(C =\\) No and question \\(D =\\) No at time x : Yes \\\\\nIf question \\(C =\\) Yes or question \\(D =\\) Yes at time x : No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.5888671875,"confidence_rate":0.9993109420271699},{"cnt":[[1191,1320],[2525,1320],[2525,1364],[1191,1364]],"region":{"top_left_x":1190,"top_left_y":1320,"width":1335,"height":44},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7aef0f03dbc4fbaa2badbeddacfd914","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"The response to questions C (Do you experience urine leakage related to the feeling of","text_display":"The response to questions C (Do you experience urine leakage related to the feeling of","confidence":1,"confidence_rate":1},{"cnt":[[1189,1364],[2559,1364],[2559,1409],[1189,1409]],"region":{"top_left_x":1188,"top_left_y":1363,"width":1372,"height":47},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b04a44c2af3a4c11abdc012ff330c465","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"urgency?) and D (Do you experience urine leakage related to physical activity, coughing,","text_display":" urgency?) and D (Do you experience urine leakage related to physical activity, coughing,","confidence":0.5888671875,"confidence_rate":0.9943220452841481},{"cnt":[[1191,1407],[2564,1407],[2564,1453],[1191,1453]],"region":{"top_left_x":1190,"top_left_y":1407,"width":1374,"height":46},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26d87c1793e54ed48c92696d4e83e583","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"or sneezing?) will be taken from the UDI-LF. The indicator for dryness at 12 months will","text_display":" or sneezing?) will be taken from the UDI-LF. The indicator for dryness at 12 months will","confidence":1,"confidence_rate":1},{"cnt":[[1189,1455],[1782,1455],[1782,1498],[1189,1498]],"region":{"top_left_x":1188,"top_left_y":1454,"width":594,"height":44},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6e3d01a014245ff99e512a7499151c3","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"be defined for each subject as follows:","text_display":" be defined for each subject as follows:","confidence":1,"confidence_rate":1},{"cnt":[[1251,1502],[2096,1502],[2096,1548],[1251,1548]],"region":{"top_left_x":1251,"top_left_y":1502,"width":845,"height":46},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9d40f9deddf4696957f171f95178bca","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"If question \\(C =\\) No and question \\(D =\\) No at time x : Yes","text_display":"\nIf question \\(C =\\) No and question \\(D =\\) No at time x : Yes","confidence":0.9648606777191162,"confidence_rate":0.9995231595447385},{"cnt":[[1251,1554],[2087,1554],[2087,1600],[1251,1600]],"region":{"top_left_x":1251,"top_left_y":1554,"width":837,"height":46},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"270b68ac10244fe88d650fbf86aae110","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"If question \\(C =\\) Yes or question \\(D =\\) Yes at time x : No","text_display":"\nIf question \\(C =\\) Yes or question \\(D =\\) Yes at time x : No","confidence":0.9975602623308077,"confidence_rate":0.9999674309480002},{"cnt":[[1191,1606],[2529,1606],[2529,1647],[1191,1647]],"region":{"top_left_x":1190,"top_left_y":1606,"width":1339,"height":42},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca9462f95a5f443e81ca7df398b3b5b3","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"If data for the assessment time point are missing, the dryness indicator will be coded as","text_display":"\nIf data for the assessment time point are missing, the dryness indicator will be coded as","confidence":1,"confidence_rate":1},{"cnt":[[1189,1650],[2481,1650],[2481,1693],[1189,1693]],"region":{"top_left_x":1188,"top_left_y":1649,"width":1294,"height":44},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd78efbe8e2f4597ab716293fd631db7","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"missing. The variable is summarized as the percentage of participants with indicator","text_display":" missing. The variable is summarized as the percentage of participants with indicator","confidence":1,"confidence_rate":1},{"cnt":[[1191,1693],[1949,1693],[1949,1738],[1191,1738]],"region":{"top_left_x":1190,"top_left_y":1692,"width":759,"height":47},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1df7e70fca844c3fb9e58537b2e32d75","type":"text","conversion_output":false,"parent_id":"3d9eb545e86d420094da5d7bcda94638","text":"equal to \"Yes\" among all non-missing indicators.","text_display":" equal to \"Yes\" among all non-missing indicators.","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[681,1927],[681,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":377,"height":35},"line":64,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"378f0117e7234cb9a089c4402885d3d2","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-25","page":25,"lines":[{"cnt":[[305,133],[810,133],[810,219],[305,219]],"region":{"top_left_x":305,"top_left_y":133,"width":505,"height":87},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dc30c2336a3144d6b5caf0dcbcca8d90","type":"figure_label","conversion_output":false,"children_ids":["dd47f67c4c9040959073d83e882ab260","7ed0770926f74f1fa4841a707f9685ca"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dd47f67c4c9040959073d83e882ab260","type":"text","conversion_output":false,"parent_id":"dc30c2336a3144d6b5caf0dcbcca8d90","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7ed0770926f74f1fa4841a707f9685ca","type":"text","conversion_output":false,"parent_id":"dc30c2336a3144d6b5caf0dcbcca8d90","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,243],[2589,243],[2589,1736],[305,1736]],"region":{"top_left_x":305,"top_left_y":242,"width":2284,"height":1494},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf6ae9b412ce49649b0c3762699fd775","type":"table","conversion_output":true,"children_ids":["f4b8c9d24b1046eea7db758ba7cac24a","13e6925c39544cb38e5ee88cefa11a43","a671d9f1f0a04b9b8ce861d0ced4d593","7ccdf68881064b46b3e4e9d641def2bb","06d7daf20af74dbb9f3b7ab9a8487456","16c317ec61c445818ce0f50a5e41c89b","3c78d00892ea4c11b6d71b42285d1c62","365b8e9d145b4a63b762383b5ac2c208","97c20049b1c246fc90fe50a6d37a6aea","3fc636fc280d44cb94be419210f6e87e","c0e81c91eb84489686c72b0d7a027e24","6591f2c131394f7d8188f6dc500d724d","a314f7c00f2b4811bfee9cf094baebbf","374ed37ee91446a5a66f4f3951a2c7b3","c874398acdcf4bc48efb9a6f480036df","b3edd8a1d12b4b808ff85ca98ac985ce","8346548333a94432ae3fdf5054c4b4d9","61936e5ce73e47d19a93540aaaea8ee4","3069c4e0205b4d5e99020fa87ad802f2"],"selected_labels":["dc30c2336a3144d6b5caf0dcbcca8d90"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Dryness at 12 Months (UDILF and Diary) & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe responses to Dryness at 12 Months based on the UDI-LF and the diary will be combined. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf Dry (Diary) = Yes and Dry (UDI-LF) = Yes at time x : Yes \\\\\nIf Dry (Diary) = No or Dry (UDI-LF) = No at time x: No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Change from Baseline OABq Symptom Severity Score at 12 Months & Continuous & The OAB-q Symptom Severity Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1 through 8 ( \\(1=\\) Not at all, \\(2=\\) A little bit, \\(3=\\) Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract the minimum possible score (8) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline OABq HRQL Coping Score at 12 Months & Continuous & The OAB-q HRQL Coping Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions \\(9,11,16,21,22,26,32\\), and 33 ( \\(1=\\) Not at all, \\(2=\\) A little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 48 ) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Dryness at 12 Months (UDILF and Diary) & Dichotomous (Yes/No) & \\begin{tabular}{l}\nThe responses to Dryness at 12 Months based on the UDI-LF and the diary will be combined. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf Dry (Diary) = Yes and Dry (UDI-LF) = Yes at time x : Yes \\\\\nIf Dry (Diary) = No or Dry (UDI-LF) = No at time x: No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Change from Baseline OABq Symptom Severity Score at 12 Months & Continuous & The OAB-q Symptom Severity Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1 through 8 ( \\(1=\\) Not at all, \\(2=\\) A little bit, \\(3=\\) Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract the minimum possible score (8) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline OABq HRQL Coping Score at 12 Months & Continuous & The OAB-q HRQL Coping Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions \\(9,11,16,21,22,26,32\\), and 33 ( \\(1=\\) Not at all, \\(2=\\) A little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 48 ) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.4844191863776359,"confidence_rate":0.9997277784357386},{"cnt":[[309,242],[794,242],[794,1736],[309,1736]],"region":{"top_left_x":309,"top_left_y":242,"width":486,"height":1495},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f4b8c9d24b1046eea7db758ba7cac24a","type":"table_column","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"","text_display":""},{"cnt":[[801,242],[1039,242],[1039,1738],[801,1738]],"region":{"top_left_x":800,"top_left_y":242,"width":240,"height":1497},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13e6925c39544cb38e5ee88cefa11a43","type":"table_column","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"","text_display":""},{"cnt":[[1176,242],[2583,242],[2583,1738],[1176,1738]],"region":{"top_left_x":1175,"top_left_y":242,"width":1409,"height":1497},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a671d9f1f0a04b9b8ce861d0ced4d593","type":"table_column","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"","text_display":""},{"cnt":[[305,248],[2590,248],[2590,307],[305,307]],"region":{"top_left_x":305,"top_left_y":248,"width":2285,"height":59},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ccdf68881064b46b3e4e9d641def2bb","type":"table_row","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"","text_display":""},{"cnt":[[305,335],[2587,335],[2587,731],[305,731]],"region":{"top_left_x":305,"top_left_y":335,"width":2283,"height":397},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06d7daf20af74dbb9f3b7ab9a8487456","type":"table_row","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"","text_display":""},{"cnt":[[305,753],[2587,753],[2587,1216],[305,1216]],"region":{"top_left_x":305,"top_left_y":753,"width":2283,"height":464},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16c317ec61c445818ce0f50a5e41c89b","type":"table_row","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"","text_display":""},{"cnt":[[305,1240],[2587,1240],[2587,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1240,"width":2283,"height":464},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c78d00892ea4c11b6d71b42285d1c62","type":"table_row","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"","text_display":""},{"cnt":[[327,255],[480,255],[480,296],[327,296]],"region":{"top_left_x":326,"top_left_y":254,"width":155,"height":43},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"365b8e9d145b4a63b762383b5ac2c208","type":"simple_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"Variable","text_display":"Variable","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[812,255],[907,255],[907,300],[812,300]],"region":{"top_left_x":811,"top_left_y":254,"width":97,"height":47},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97c20049b1c246fc90fe50a6d37a6aea","type":"simple_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"Type","text_display":"Type","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1189,255],[1364,255],[1364,296],[1189,296]],"region":{"top_left_x":1188,"top_left_y":254,"width":176,"height":43},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fc636fc280d44cb94be419210f6e87e","type":"simple_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","text":"Definition","text_display":"Definition","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[322,342],[779,342],[779,439],[322,439]],"region":{"top_left_x":322,"top_left_y":341,"width":458,"height":99},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0e81c91eb84489686c72b0d7a027e24","type":"complex_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","children_ids":["e3d816eb5d4247d89caa3f48a4cb25c3","d07b9e7398694eafbabc12caf67217d4"],"text":"Dryness at 12 Months (UDILF and Diary)","text_display":"Dryness at 12 Months (UDILF and Diary)","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,346],[775,346],[775,389],[327,389]],"region":{"top_left_x":326,"top_left_y":345,"width":449,"height":45},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3d816eb5d4247d89caa3f48a4cb25c3","type":"text","conversion_output":false,"parent_id":"c0e81c91eb84489686c72b0d7a027e24","text":"Dryness at 12 Months (UDI-","text_display":"Dryness at 12 Months (UDI","confidence":1,"confidence_rate":1},{"cnt":[[327,389],[554,389],[554,435],[327,435]],"region":{"top_left_x":326,"top_left_y":389,"width":229,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d07b9e7398694eafbabc12caf67217d4","type":"text","conversion_output":false,"parent_id":"c0e81c91eb84489686c72b0d7a027e24","text":"LF and Diary)","text_display":"LF and 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(Yes/No)","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[812,342],[1030,342],[1030,387],[812,387]],"region":{"top_left_x":811,"top_left_y":341,"width":220,"height":47},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5830bc34dbf4e67938f3f397dcca51d","type":"text","conversion_output":false,"parent_id":"6591f2c131394f7d8188f6dc500d724d","text":"Dichotomous","text_display":"Dichotomous","confidence":1,"confidence_rate":1},{"cnt":[[816,394],[965,394],[965,441],[816,441]],"region":{"top_left_x":816,"top_left_y":393,"width":150,"height":49},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c29ff7d651294d09965df5f913b8ca45","type":"text","conversion_output":false,"parent_id":"6591f2c131394f7d8188f6dc500d724d","text":"(Yes/No)","text_display":" (Yes/No)","confidence":1,"confidence_rate":1},{"cnt":[[1184,339],[2535,339],[2535,725],[1184,725]],"region":{"top_left_x":1184,"top_left_y":339,"width":1352,"height":386},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a314f7c00f2b4811bfee9cf094baebbf","type":"complex_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","children_ids":["e6bbe8186c914007aac426c64a716b7f","77852f5bab624b7aa4892d7431263a34","312a394558f64147aa5a2433df4985dd","d62847d10b5b4de29272020e72bd835e","1f4269e3ea654b88a20d0ad2009fbadf","7e5401c41bbf4d6794f20f397517d4c7","1500da1d78c2425e8c524d31ac2e1ef2","88e8bf4e844a43938739d6e3d4d60336"],"text":"\\begin{tabular}{l}\nThe responses to Dryness at 12 Months based on the UDI-LF and the diary will be combined. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf Dry (Diary) = Yes and Dry (UDI-LF) = Yes at time x : Yes \\\\\nIf Dry (Diary) = No or Dry (UDI-LF) = No at time x: No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe responses to Dryness at 12 Months based on the UDI-LF and the diary will be combined. The indicator for dryness at 12 months will be defined for each subject as follows: \\\\\nIf Dry (Diary) = Yes and Dry (UDI-LF) = Yes at time x : Yes \\\\\nIf Dry (Diary) = No or Dry (UDI-LF) = No at time x: No \\\\\nIf data for the assessment time point are missing, the dryness indicator will be coded as missing. The variable is summarized as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.6363911016535528,"confidence_rate":0.9983509438241396},{"cnt":[[1189,342],[2462,342],[2462,391],[1189,391]],"region":{"top_left_x":1188,"top_left_y":341,"width":1274,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6bbe8186c914007aac426c64a716b7f","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"The responses to Dryness at 12 Months based on the UDI-LF and the diary will be","text_display":"The responses to Dryness at 12 Months based on the UDI-LF and the diary will be","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[1189,389],[2490,389],[2490,435],[1189,435]],"region":{"top_left_x":1188,"top_left_y":389,"width":1302,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77852f5bab624b7aa4892d7431263a34","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"combined. The indicator for dryness at 12 months will be defined for each subject as","text_display":" combined. The indicator for dryness at 12 months will be defined for each subject as","confidence":1,"confidence_rate":1},{"cnt":[[1189,433],[1321,433],[1321,474],[1189,474]],"region":{"top_left_x":1188,"top_left_y":432,"width":133,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"312a394558f64147aa5a2433df4985dd","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"follows:","text_display":" follows:","confidence":1,"confidence_rate":1},{"cnt":[[1249,485],[2195,485],[2195,530],[1249,530]],"region":{"top_left_x":1249,"top_left_y":484,"width":947,"height":47},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d62847d10b5b4de29272020e72bd835e","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"If Dry (Diary) = Yes and Dry (UDI-LF) = Yes at time x : Yes","text_display":"\nIf Dry (Diary) = Yes and Dry (UDI-LF) = Yes at time x : Yes","confidence":0.6789045572004145,"confidence_rate":0.9944827799993373},{"cnt":[[1249,532],[2135,532],[2135,582],[1249,582]],"region":{"top_left_x":1249,"top_left_y":532,"width":886,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f4269e3ea654b88a20d0ad2009fbadf","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"If Dry (Diary) = No or Dry (UDI-LF) = No at time x: No","text_display":"\nIf Dry (Diary) = No or Dry (UDI-LF) = No at time x: No","confidence":0.6363911016535528,"confidence_rate":0.992369229984232},{"cnt":[[1189,582],[2531,582],[2531,630],[1189,630]],"region":{"top_left_x":1188,"top_left_y":581,"width":1344,"height":49},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e5401c41bbf4d6794f20f397517d4c7","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"If data for the assessment time point are missing, the dryness indicator will be coded as","text_display":"\nIf data for the assessment time point are missing, the dryness indicator will be coded as","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[1189,627],[2486,627],[2486,677],[1189,677]],"region":{"top_left_x":1188,"top_left_y":627,"width":1298,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1500da1d78c2425e8c524d31ac2e1ef2","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"missing. The variable is summarized as the percentage of participants with indicator","text_display":" missing. The variable is summarized as the percentage of participants with indicator","confidence":1,"confidence_rate":1},{"cnt":[[1189,671],[1953,671],[1953,721],[1189,721]],"region":{"top_left_x":1188,"top_left_y":670,"width":765,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88e8bf4e844a43938739d6e3d4d60336","type":"text","conversion_output":false,"parent_id":"a314f7c00f2b4811bfee9cf094baebbf","text":"equal to \"Yes\" among all non-missing indicators.","text_display":" equal to \"Yes\" among all non-missing indicators.","confidence":1,"confidence_rate":1},{"cnt":[[322,757],[788,757],[788,896],[322,896]],"region":{"top_left_x":322,"top_left_y":757,"width":466,"height":139},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"374ed37ee91446a5a66f4f3951a2c7b3","type":"complex_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","children_ids":["d4d7d1816676491bbe1dd9ba20bc45e4","df99c792aa8c4b5698fb89f869657a96","073152eba5d349878bd2cebbfeefdf2b"],"text":"Change from Baseline OABq Symptom Severity Score at 12 Months","text_display":"Change from Baseline OABq Symptom Severity Score at 12 Months","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,762],[779,762],[779,809],[327,809]],"region":{"top_left_x":326,"top_left_y":761,"width":454,"height":49},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d4d7d1816676491bbe1dd9ba20bc45e4","type":"text","conversion_output":false,"parent_id":"374ed37ee91446a5a66f4f3951a2c7b3","text":"Change from Baseline OAB-","text_display":"Change from Baseline OAB","confidence":1,"confidence_rate":1},{"cnt":[[327,805],[784,805],[784,855],[327,855]],"region":{"top_left_x":326,"top_left_y":805,"width":458,"height":50},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df99c792aa8c4b5698fb89f869657a96","type":"text","conversion_output":false,"parent_id":"374ed37ee91446a5a66f4f3951a2c7b3","text":"q Symptom Severity Score at","text_display":"q Symptom Severity Score at","confidence":1,"confidence_rate":1},{"cnt":[[329,853],[502,853],[502,894],[329,894]],"region":{"top_left_x":328,"top_left_y":852,"width":175,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"073152eba5d349878bd2cebbfeefdf2b","type":"text","conversion_output":false,"parent_id":"374ed37ee91446a5a66f4f3951a2c7b3","text":"12 Months","text_display":" 12 Months","confidence":1,"confidence_rate":1},{"cnt":[[812,762],[1000,762],[1000,807],[812,807]],"region":{"top_left_x":811,"top_left_y":761,"width":190,"height":47},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c874398acdcf4bc48efb9a6f480036df","type":"simple_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","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":[[1182,757],[2566,757],[2566,1210],[1182,1210]],"region":{"top_left_x":1182,"top_left_y":757,"width":1384,"height":453},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3edd8a1d12b4b808ff85ca98ac985ce","type":"complex_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","children_ids":["302b2e78f46542dc8a17f3fb5ca0531f","313af865871b4015b67924d8f4989e99","b48680b5322141338c1e69503b4851e0","8f2f3428822042dc9312aeeb7e64c263","7180b7724af04162b711179691dc3538","0ebcf4109ed84ebb851ad9658946c207","bf91910a7f4649b38b3904e36055af2a","607e63a4d27d41e58f951f46d19b7e73","7d1a0137ac72495e8faee546b2cf9219","7f857d0b92c6439b9db3bc9511f9fce9"],"text":"The OAB-q Symptom Severity Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1 through 8 ( \\(1=\\) Not at all, \\(2=\\) A little bit, \\(3=\\) Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract the minimum possible score (8) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-q Symptom Severity Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1 through 8 ( \\(1=\\) Not at all, \\(2=\\) A little bit, \\(3=\\) Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract the minimum possible score (8) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.4844191863776359,"confidence_rate":0.9985465807954194},{"cnt":[[1189,762],[2559,762],[2559,809],[1189,809]],"region":{"top_left_x":1188,"top_left_y":761,"width":1372,"height":49},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"302b2e78f46542dc8a17f3fb5ca0531f","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"The OAB-q Symptom Severity Score will be computed at baseline and 12 months (and 3","text_display":"The OAB-q Symptom Severity Score will be computed at baseline and 12 months (and 3","confidence":1,"confidence_rate":1},{"cnt":[[1189,805],[2553,805],[2553,853],[1189,853]],"region":{"top_left_x":1188,"top_left_y":805,"width":1365,"height":48},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"313af865871b4015b67924d8f4989e99","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum","text_display":" and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum","confidence":1,"confidence_rate":1},{"cnt":[[1189,853],[2455,853],[2455,898],[1189,898]],"region":{"top_left_x":1188,"top_left_y":852,"width":1268,"height":47},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b48680b5322141338c1e69503b4851e0","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"responses across questions 1 through 8 ( \\(1=\\) Not at all, \\(2=\\) A little bit, \\(3=\\) Somewhat,","text_display":" responses across questions 1 through 8 ( \\(1=\\) Not at all, \\(2=\\) A little bit, \\(3=\\) Somewhat,","confidence":0.7402024051891658,"confidence_rate":0.9971390374268481},{"cnt":[[1189,894],[2551,894],[2551,941],[1189,941]],"region":{"top_left_x":1188,"top_left_y":893,"width":1363,"height":49},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f2f3428822042dc9312aeeb7e64c263","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract the minimum possible","text_display":" 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract the minimum possible","confidence":0.6607931451871991,"confidence_rate":0.9955067074595417},{"cnt":[[1189,939],[2525,939],[2525,985],[1189,985]],"region":{"top_left_x":1188,"top_left_y":939,"width":1337,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7180b7724af04162b711179691dc3538","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"score (8) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If","text_display":" score (8) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If","confidence":0.4844191863776359,"confidence_rate":0.9928494042814576},{"cnt":[[1189,983],[2399,983],[2399,1028],[1189,1028]],"region":{"top_left_x":1188,"top_left_y":982,"width":1212,"height":47},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ebcf4109ed84ebb851ad9658946c207","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"less than half of the responses are missing, then the score will be calculated by","text_display":" less than half of the responses are missing, then the score will be calculated by","confidence":1,"confidence_rate":1},{"cnt":[[1189,1026],[2447,1026],[2447,1076],[1189,1076]],"region":{"top_left_x":1188,"top_left_y":1025,"width":1259,"height":51},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf91910a7f4649b38b3904e36055af2a","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"substituting the missing responses with the average of the non-missing responses,","text_display":" substituting the missing responses with the average of the non-missing responses,","confidence":1,"confidence_rate":1},{"cnt":[[1189,1069],[2559,1069],[2559,1119],[1189,1119]],"region":{"top_left_x":1188,"top_left_y":1069,"width":1372,"height":51},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"607e63a4d27d41e58f951f46d19b7e73","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"otherwise no score is calculated. The outcome will then be computed as the difference in","text_display":" otherwise no score is calculated. The outcome will then be computed as the difference in","confidence":1,"confidence_rate":1},{"cnt":[[1189,1115],[2432,1115],[2432,1162],[1189,1162]],"region":{"top_left_x":1188,"top_left_y":1114,"width":1244,"height":49},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d1a0137ac72495e8faee546b2cf9219","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"score at 12 months (and 3 and 6 months) and the score at baseline. If data for an","text_display":" score at 12 months (and 3 and 6 months) and the score at baseline. If data for an","confidence":1,"confidence_rate":1},{"cnt":[[1189,1160],[2451,1160],[2451,1206],[1189,1206]],"region":{"top_left_x":1188,"top_left_y":1160,"width":1263,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f857d0b92c6439b9db3bc9511f9fce9","type":"text","conversion_output":false,"parent_id":"b3edd8a1d12b4b808ff85ca98ac985ce","text":"assessment time point are missing, the outcome variable will be coded as missing.","text_display":" assessment time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[318,1242],[784,1242],[784,1381],[318,1381]],"region":{"top_left_x":317,"top_left_y":1242,"width":467,"height":140},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8346548333a94432ae3fdf5054c4b4d9","type":"complex_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","children_ids":["506a01c580db4ae0a1d8c47a37afead0","64362231162448baa6dc44adfece6ec0","4f718b70697a41629a92a8fb5477dd16"],"text":"Change from Baseline OABq HRQL Coping Score at 12 Months","text_display":"Change from Baseline OABq HRQL Coping Score at 12 Months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,1249],[779,1249],[779,1294],[324,1294]],"region":{"top_left_x":324,"top_left_y":1248,"width":456,"height":47},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"506a01c580db4ae0a1d8c47a37afead0","type":"text","conversion_output":false,"parent_id":"8346548333a94432ae3fdf5054c4b4d9","text":"Change from Baseline OAB-","text_display":"Change from Baseline OAB","confidence":1,"confidence_rate":1},{"cnt":[[327,1292],[775,1292],[775,1340],[327,1340]],"region":{"top_left_x":326,"top_left_y":1292,"width":449,"height":48},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64362231162448baa6dc44adfece6ec0","type":"text","conversion_output":false,"parent_id":"8346548333a94432ae3fdf5054c4b4d9","text":"q HRQL Coping Score at 12","text_display":"q HRQL Coping Score at 12","confidence":1,"confidence_rate":1},{"cnt":[[327,1338],[454,1338],[454,1379],[327,1379]],"region":{"top_left_x":326,"top_left_y":1337,"width":129,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f718b70697a41629a92a8fb5477dd16","type":"text","conversion_output":false,"parent_id":"8346548333a94432ae3fdf5054c4b4d9","text":"Months","text_display":" Months","confidence":1,"confidence_rate":1},{"cnt":[[812,1247],[1000,1247],[1000,1292],[812,1292]],"region":{"top_left_x":811,"top_left_y":1246,"width":190,"height":47},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61936e5ce73e47d19a93540aaaea8ee4","type":"simple_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","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":[[1184,1242],[2568,1242],[2568,1695],[1184,1695]],"region":{"top_left_x":1184,"top_left_y":1242,"width":1384,"height":454},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3069c4e0205b4d5e99020fa87ad802f2","type":"complex_cell","conversion_output":false,"parent_id":"bf6ae9b412ce49649b0c3762699fd775","children_ids":["cfa728dfa8214ca3aa061cd7fe0e44c9","a56ebbf36d3f4222ac47ae35aed4cf6c","6d4a6510f997432e9d9cd483ca534cc9","d0ee4bd3ed2846be9d29f5a8cefd168b","acc801cecff3428eb031f716b7df31c1","f2186380653e424483da7403ca7a33b4","1ac87c313e654daf94f4b283c3c3b94d","d9c00e792d664d32b6c53aaa12164f43","e4b518232b0740af858664e63f0c0275","5ab7513dde764736893f2cd59b16740b"],"text":"The OAB-q HRQL Coping Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions \\(9,11,16,21,22,26,32\\), and 33 ( \\(1=\\) Not at all, \\(2=\\) A little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 48 ) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-q HRQL Coping Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions \\(9,11,16,21,22,26,32\\), and 33 ( \\(1=\\) Not at all, \\(2=\\) A little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 48 ) and divide by the range of possible score ( \\(48-8=40\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9055315836449154,"confidence_rate":0.9998378034844095},{"cnt":[[1189,1249],[2564,1249],[2564,1294],[1189,1294]],"region":{"top_left_x":1188,"top_left_y":1248,"width":1376,"height":47},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfa728dfa8214ca3aa061cd7fe0e44c9","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"The OAB-q HRQL Coping Score will be computed at baseline and 12 months (and 3 and","text_display":"The OAB-q HRQL Coping Score will be computed at baseline and 12 months (and 3 and","confidence":1,"confidence_rate":1},{"cnt":[[1189,1294],[2490,1294],[2490,1340],[1189,1340]],"region":{"top_left_x":1188,"top_left_y":1294,"width":1302,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a56ebbf36d3f4222ac47ae35aed4cf6c","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"6 months) using the standard scoring algorithm. Specifically, instructions are to sum","text_display":" 6 months) using the standard scoring algorithm. Specifically, instructions are to sum","confidence":1,"confidence_rate":1},{"cnt":[[1189,1338],[2542,1338],[2542,1381],[1189,1381]],"region":{"top_left_x":1188,"top_left_y":1337,"width":1354,"height":45},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d4a6510f997432e9d9cd483ca534cc9","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"responses across questions \\(9,11,16,21,22,26,32\\), and 33 ( \\(1=\\) Not at all, \\(2=\\) A little bit,","text_display":" responses across questions \\(9,11,16,21,22,26,32\\), and 33 ( \\(1=\\) Not at all, \\(2=\\) A little bit,","confidence":0.9055315836449154,"confidence_rate":0.9990642765296452},{"cnt":[[1189,1381],[2564,1381],[2564,1427],[1189,1427]],"region":{"top_left_x":1188,"top_left_y":1381,"width":1376,"height":46},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0ee4bd3ed2846be9d29f5a8cefd168b","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the","text_display":" 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the","confidence":0.9859005619073287,"confidence_rate":0.9998456664817541},{"cnt":[[1189,1424],[2542,1424],[2542,1470],[1189,1470]],"region":{"top_left_x":1188,"top_left_y":1424,"width":1354,"height":46},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"acc801cecff3428eb031f716b7df31c1","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"maximum possible score ( 48 ) and divide by the range of possible score ( \\(48-8=40\\) ), then","text_display":" maximum possible score ( 48 ) and divide by the range of possible score ( \\(48-8=40\\) ), then","confidence":0.9506467526935012,"confidence_rate":0.9994940007237091},{"cnt":[[1189,1468],[2486,1468],[2486,1515],[1189,1515]],"region":{"top_left_x":1188,"top_left_y":1467,"width":1298,"height":49},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f2186380653e424483da7403ca7a33b4","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"multiply by 100 . If less than half of the responses are missing, then the score will be","text_display":" multiply by 100 . If less than half of the responses are missing, then the score will be","confidence":0.99755859375,"confidence_rate":0.9999745379143542},{"cnt":[[1189,1511],[2492,1511],[2492,1561],[1189,1561]],"region":{"top_left_x":1188,"top_left_y":1510,"width":1305,"height":51},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ac87c313e654daf94f4b283c3c3b94d","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"calculated by substituting the missing responses with the average of the non-missing","text_display":" calculated by substituting the missing responses with the average of the non-missing","confidence":1,"confidence_rate":1},{"cnt":[[1189,1554],[2525,1554],[2525,1604],[1189,1604]],"region":{"top_left_x":1188,"top_left_y":1554,"width":1337,"height":51},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9c00e792d664d32b6c53aaa12164f43","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"responses, otherwise no score is calculated. The outcome will then be computed as the","text_display":" responses, otherwise no score is calculated. The outcome will then be computed as the","confidence":1,"confidence_rate":1},{"cnt":[[1189,1600],[2538,1600],[2538,1647],[1189,1647]],"region":{"top_left_x":1188,"top_left_y":1599,"width":1350,"height":49},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4b518232b0740af858664e63f0c0275","type":"text","conversion_output":false,"parent_id":"3069c4e0205b4d5e99020fa87ad802f2","text":"difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data","text_display":" difference in score at 12 months (and 3 and 6 months) and the score at baseline. 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Specifically, instructions are to sum responses across questions \\(12,13,14,19,23,25\\), and 29 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 35 ) and divide by the range of possible score ( \\(42-7=35\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline OABq HRQL Sleep Score at 12 Months & Continuous & The OAB-q HRQL Sleep Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions \\(10,15,17,24\\), and 30 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score (30) and divide by the range of possible score ( \\(30-5=25\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline OABq HRQL Social Score at 12 Months & Continuous & The OAB-q HRQL Social Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 18, 20, 27, 28, and 31 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 30 ) and divide by the range of possible score ( \\(30-5=25\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline OABq HRQL Concern Score at 12 Months & Continuous & The OAB-q HRQL Concern Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions \\(12,13,14,19,23,25\\), and 29 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 35 ) and divide by the range of possible score ( \\(42-7=35\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline OABq HRQL Sleep Score at 12 Months & Continuous & The OAB-q HRQL Sleep Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions \\(10,15,17,24\\), and 30 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score (30) and divide by the range of possible score ( \\(30-5=25\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline OABq HRQL Social Score at 12 Months & Continuous & The OAB-q HRQL Social Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 18, 20, 27, 28, and 31 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 30 ) and divide by the range of possible score ( \\(30-5=25\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. 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Specifically, instructions are to sum responses across questions \\(12,13,14,19,23,25\\), and 29 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 35 ) and divide by the range of possible score ( \\(42-7=35\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-q HRQL Concern Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. 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Specifically, instructions are to sum","text_display":" and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum","confidence":1,"confidence_rate":1},{"cnt":[[1189,435],[2499,435],[2499,478],[1189,478]],"region":{"top_left_x":1188,"top_left_y":434,"width":1311,"height":45},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd45c18d8a2f4b28be9c8c9e24276070","type":"text","conversion_output":false,"parent_id":"193b7e76aa6d41ed895efd5064cf3d16","text":"responses across questions \\(12,13,14,19,23,25\\), and 29 ( \\(1=\\) Not at all, \\(2= A\\) little bit,","text_display":" responses across questions \\(12,13,14,19,23,25\\), and 29 ( \\(1=\\) Not at all, \\(2= A\\) little bit,","confidence":0.47571743949751877,"confidence_rate":0.9930157192001993},{"cnt":[[1189,476],[2559,476],[2559,521],[1189,521]],"region":{"top_left_x":1188,"top_left_y":475,"width":1372,"height":47},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a93ec8e4f064e7387a59babfb5e0ba8","type":"text","conversion_output":false,"parent_id":"193b7e76aa6d41ed895efd5064cf3d16","text":"3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the","text_display":" 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the","confidence":0.9747287237778437,"confidence_rate":0.9997218204521431},{"cnt":[[1189,521],[2535,521],[2535,565],[1189,565]],"region":{"top_left_x":1188,"top_left_y":521,"width":1348,"height":44},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f77f9a8cbc5a4a2b8a0f56081cc07c71","type":"text","conversion_output":false,"parent_id":"193b7e76aa6d41ed895efd5064cf3d16","text":"maximum possible score ( 35 ) and divide by the range of possible score ( \\(42-7=35\\) ), then","text_display":" maximum possible score ( 35 ) and divide by the range of possible score ( \\(42-7=35\\) ), then","confidence":0.7416907894362867,"confidence_rate":0.9970162318258617},{"cnt":[[1189,562],[2481,562],[2481,608],[1189,608]],"region":{"top_left_x":1188,"top_left_y":562,"width":1294,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a47416647b14c29882ada001e7e2294","type":"text","conversion_output":false,"parent_id":"193b7e76aa6d41ed895efd5064cf3d16","text":"multiply by 100 . 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Specifically, instructions are to sum responses across questions 18, 20, 27, 28, and 31 ( \\(1=\\) Not at all, \\(2= A\\) little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal, 6=A very great deal), then subtract from the maximum possible score ( 30 ) and divide by the range of possible score ( \\(30-5=25\\) ), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-q HRQL Social Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. 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Specifically, instructions are to sum","text_display":" 6 months) using the standard scoring algorithm. 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Specifically, instructions are to sum the OAB-q HRQL Coping, Concern, Sleep, and Social prior to subtracting from the respective maximum possible scores, then subtract from the maximum possible sum score (150) and divide by the range of possible scores ( \\((18+42+30+10=150)\\) \\((8+7+5+5=25)=125)\\), then multiply by 100 . The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If any of the subscales are missing, the Total score will also be set to missing. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Satisfaction Score at 12 Months & Continuous & The OAB-SAT-q Satisfaction Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1, 2, and \\(3(1=\\) Extremely Dissatisfied, \\(\\ldots, 6=\\) Extremely Satisfied), then subtract from the maximum possible sum score (18) and divide by the range of possible scores \\((18-3=15)\\), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Side Effects Score at 12 Months & Continuous & The OAB-SAT-q Side Effects Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, if the response to question 5 is Never then the score is 100, regardless of the responses to questions 6 and 7. If the response to question 5 is not Never, then sum the responses across questions 5 (reverse coded: \\(1=\\) All of the time, \\(\\ldots, 5=\\) A little of the time \\(), 6(1=\\) Extremely bothersome, \\(\\ldots\\), \\(5=\\) Not at all bothersome), and \\(7(1= A\\) great deal, \\(\\ldots, 7=\\) Not at all), then subtract from the maximum possible sum score (15) and divide by the range of possible scores (15-3=12), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline OABq HRQL Total Score at 12 Months & Continuous & The OAB-q HRQL Total Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum the OAB-q HRQL Coping, Concern, Sleep, and Social prior to subtracting from the respective maximum possible scores, then subtract from the maximum possible sum score (150) and divide by the range of possible scores ( \\((18+42+30+10=150)\\) \\((8+7+5+5=25)=125)\\), then multiply by 100 . The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If any of the subscales are missing, the Total score will also be set to missing. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Satisfaction Score at 12 Months & Continuous & The OAB-SAT-q Satisfaction Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1, 2, and \\(3(1=\\) Extremely Dissatisfied, \\(\\ldots, 6=\\) Extremely Satisfied), then subtract from the maximum possible sum score (18) and divide by the range of possible scores \\((18-3=15)\\), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Side Effects Score at 12 Months & Continuous & The OAB-SAT-q Side Effects Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, if the response to question 5 is Never then the score is 100, regardless of the responses to questions 6 and 7. If the response to question 5 is not Never, then sum the responses across questions 5 (reverse coded: \\(1=\\) All of the time, \\(\\ldots, 5=\\) A little of the time \\(), 6(1=\\) Extremely bothersome, \\(\\ldots\\), \\(5=\\) Not at all bothersome), and \\(7(1= A\\) great deal, \\(\\ldots, 7=\\) Not at all), then subtract from the maximum possible sum score (15) and divide by the range of possible scores (15-3=12), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. 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Specifically, instructions are to sum the OAB-q HRQL Coping, Concern, Sleep, and Social prior to subtracting from the respective maximum possible scores, then subtract from the maximum possible sum score (150) and divide by the range of possible scores ( \\((18+42+30+10=150)\\) \\((8+7+5+5=25)=125)\\), then multiply by 100 . The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If any of the subscales are missing, the Total score will also be set to missing. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-q HRQL Total Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. 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If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.5728903168346733,"confidence_rate":0.998943669576408},{"cnt":[[1191,346],[2559,346],[2559,389],[1191,389]],"region":{"top_left_x":1190,"top_left_y":346,"width":1370,"height":44},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1c7765918ac4bf6bffd9300fec7666c","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"The OAB-q HRQL Total Score will be computed at baseline and 12 months (and 3 and 6","text_display":"The OAB-q HRQL Total Score will be computed at baseline and 12 months (and 3 and 6","confidence":1,"confidence_rate":1},{"cnt":[[1191,392],[2512,392],[2512,433],[1191,433]],"region":{"top_left_x":1190,"top_left_y":391,"width":1322,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"287aa453b3d745a19c803147d450a0a2","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"months) using the standard scoring algorithm. Specifically, instructions are to sum the","text_display":" months) using the standard scoring algorithm. Specifically, instructions are to sum the","confidence":1,"confidence_rate":1},{"cnt":[[1189,435],[2421,435],[2421,478],[1189,478]],"region":{"top_left_x":1188,"top_left_y":434,"width":1233,"height":45},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"208e012902784110ae46e06a7d7c78b2","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"OAB-q HRQL Coping, Concern, Sleep, and Social prior to subtracting from the","text_display":" OAB-q HRQL Coping, Concern, Sleep, and Social prior to subtracting from the","confidence":1,"confidence_rate":1},{"cnt":[[1189,478],[2483,478],[2483,522],[1189,522]],"region":{"top_left_x":1188,"top_left_y":478,"width":1296,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78b4373126044270afa6068c58f5cca6","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"respective maximum possible scores, then subtract from the maximum possible sum","text_display":" respective maximum possible scores, then subtract from the maximum possible sum","confidence":1,"confidence_rate":1},{"cnt":[[1189,522],[2377,522],[2377,563],[1189,563]],"region":{"top_left_x":1188,"top_left_y":521,"width":1190,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"745f05dda84f4d58878701d141172ff7","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"score (150) and divide by the range of possible scores ( \\((18+42+30+10=150)\\) -","text_display":" score (150) and divide by the range of possible scores ( \\((18+42+30+10=150)\\) ","confidence":0.5728903168346733,"confidence_rate":0.9933902624833437},{"cnt":[[1191,565],[2529,565],[2529,608],[1191,608]],"region":{"top_left_x":1190,"top_left_y":564,"width":1339,"height":45},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e1f733b3a5b48bb8a2a1c776fc6d517","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"\\((8+7+5+5=25)=125)\\), then multiply by 100 . The outcome will then be computed as the","text_display":"\\((8+7+5+5=25)=125)\\), then multiply by 100 . The outcome will then be computed as the","confidence":0.77197265625,"confidence_rate":0.9971285067687768},{"cnt":[[1189,608],[2570,608],[2570,651],[1189,651]],"region":{"top_left_x":1188,"top_left_y":608,"width":1383,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fd8398c3bac44e8905c251353898a58","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"difference in score at 12 months (and 3 and 6 months) and the score at baseline. If any of","text_display":" difference in score at 12 months (and 3 and 6 months) and the score at baseline. If any of","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[1189,651],[2451,651],[2451,697],[1189,697]],"region":{"top_left_x":1188,"top_left_y":651,"width":1263,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"627d98f7ba35488f8f596e0b0434e30c","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"the subscales are missing, the Total score will also be set to missing. If data for an","text_display":" the subscales are missing, the Total score will also be set to missing. If data for an","confidence":1,"confidence_rate":1},{"cnt":[[1189,699],[2449,699],[2449,740],[1189,740]],"region":{"top_left_x":1188,"top_left_y":699,"width":1261,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30166b8164c241839c94d9e1e26f970d","type":"text","conversion_output":false,"parent_id":"b33f157ce469427788a299d358c8dd76","text":"assessment time point are missing, the outcome variable will be coded as missing.","text_display":" assessment time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[324,786],[723,786],[723,870],[324,870]],"region":{"top_left_x":324,"top_left_y":785,"width":399,"height":86},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da1f57098cf149f0bdba168295a0af79","type":"complex_cell","conversion_output":false,"parent_id":"7b3a6eaf20f84985aa3df84c06f5cb09","children_ids":["6059db033b544af8b5c2bed235c5a671","0df27ce542de4984b6e1168cf5599e7c"],"text":"OAB-SAT-q Satisfaction Score at 12 Months","text_display":"OAB-SAT-q Satisfaction Score at 12 Months","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,788],[723,788],[723,831],[327,831]],"region":{"top_left_x":326,"top_left_y":787,"width":397,"height":45},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6059db033b544af8b5c2bed235c5a671","type":"text","conversion_output":false,"parent_id":"da1f57098cf149f0bdba168295a0af79","text":"OAB-SAT-q Satisfaction","text_display":"OAB-SAT-q Satisfaction","confidence":1,"confidence_rate":1},{"cnt":[[327,833],[632,833],[632,870],[327,870]],"region":{"top_left_x":326,"top_left_y":833,"width":306,"height":38},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0df27ce542de4984b6e1168cf5599e7c","type":"text","conversion_output":false,"parent_id":"da1f57098cf149f0bdba168295a0af79","text":"Score at 12 Months","text_display":" Score at 12 Months","confidence":1,"confidence_rate":1},{"cnt":[[816,788],[996,788],[996,825],[816,825]],"region":{"top_left_x":816,"top_left_y":787,"width":180,"height":38},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a211d5501c3422f8f6edcd3b2031d60","type":"simple_cell","conversion_output":false,"parent_id":"7b3a6eaf20f84985aa3df84c06f5cb09","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":[[1184,784],[2568,784],[2568,1143],[1184,1143]],"region":{"top_left_x":1184,"top_left_y":783,"width":1384,"height":361},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3274732343d468d9c28bcd431fec6e3","type":"complex_cell","conversion_output":false,"parent_id":"7b3a6eaf20f84985aa3df84c06f5cb09","children_ids":["ca2342f6500e466a908da02b94d047df","07f2842ac38f43f3802bd796a8b8c4fc","685dd4513e8247adb1c9b813c26a67ca","314302224dd343d7afd778cd7c16ee59","6f2298fd1bd24c1a9b43e4466e3b9253","85d5ee46bf1d4587abaa8d4fa58dab86","6ba16fa864a7459a9aca929c76a80cac","d1debeef5bc944cc918ade4d91dc7b0b"],"text":"The OAB-SAT-q Satisfaction Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1, 2, and \\(3(1=\\) Extremely Dissatisfied, \\(\\ldots, 6=\\) Extremely Satisfied), then subtract from the maximum possible sum score (18) and divide by the range of possible scores \\((18-3=15)\\), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-SAT-q Satisfaction Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 1, 2, and \\(3(1=\\) Extremely Dissatisfied, \\(\\ldots, 6=\\) Extremely Satisfied), then subtract from the maximum possible sum score (18) and divide by the range of possible scores \\((18-3=15)\\), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8739810400556802,"confidence_rate":0.9998165840888494},{"cnt":[[1191,788],[2564,788],[2564,831],[1191,831]],"region":{"top_left_x":1190,"top_left_y":787,"width":1374,"height":45},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca2342f6500e466a908da02b94d047df","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"The OAB-SAT-q Satisfaction Score will be computed at 12 months (and 3 and 6 months)","text_display":"The OAB-SAT-q Satisfaction Score will be computed at 12 months (and 3 and 6 months)","confidence":1,"confidence_rate":1},{"cnt":[[1189,831],[2479,831],[2479,874],[1189,874]],"region":{"top_left_x":1188,"top_left_y":831,"width":1292,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07f2842ac38f43f3802bd796a8b8c4fc","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"using the standard scoring algorithm. Specifically, instructions are to sum responses","text_display":" using the standard scoring algorithm. Specifically, instructions are to sum responses","confidence":1,"confidence_rate":1},{"cnt":[[1189,877],[2546,877],[2546,918],[1189,918]],"region":{"top_left_x":1188,"top_left_y":876,"width":1359,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"685dd4513e8247adb1c9b813c26a67ca","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"across questions 1, 2, and \\(3(1=\\) Extremely Dissatisfied, \\(\\ldots, 6=\\) Extremely Satisfied), then","text_display":" across questions 1, 2, and \\(3(1=\\) Extremely Dissatisfied, \\(\\ldots, 6=\\) Extremely Satisfied), then","confidence":0.8739810400556802,"confidence_rate":0.9986264890607442},{"cnt":[[1189,920],[2538,920],[2538,961],[1189,961]],"region":{"top_left_x":1188,"top_left_y":919,"width":1350,"height":43},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"314302224dd343d7afd778cd7c16ee59","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"subtract from the maximum possible sum score (18) and divide by the range of possible","text_display":" subtract from the maximum possible sum score (18) and divide by the range of possible","confidence":1,"confidence_rate":1},{"cnt":[[1189,963],[2507,963],[2507,1009],[1189,1009]],"region":{"top_left_x":1188,"top_left_y":963,"width":1320,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f2298fd1bd24c1a9b43e4466e3b9253","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"scores \\((18-3=15)\\), then multiply by 100 . If less than half of the responses are missing,","text_display":" scores \\((18-3=15)\\), then multiply by 100 . If less than half of the responses are missing,","confidence":0.9907424374250695,"confidence_rate":0.9999069975237725},{"cnt":[[1189,1007],[2529,1007],[2529,1050],[1189,1050]],"region":{"top_left_x":1188,"top_left_y":1006,"width":1341,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85d5ee46bf1d4587abaa8d4fa58dab86","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"then the score will be calculated by substituting the missing responses with the average","text_display":" then the score will be calculated by substituting the missing responses with the average","confidence":1,"confidence_rate":1},{"cnt":[[1189,1050],[2555,1050],[2555,1095],[1189,1095]],"region":{"top_left_x":1188,"top_left_y":1049,"width":1367,"height":47},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ba16fa864a7459a9aca929c76a80cac","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"of the non-missing responses, otherwise no score is calculated. If data for an assessment","text_display":" of the non-missing responses, otherwise no score is calculated. If data for an assessment","confidence":1,"confidence_rate":1},{"cnt":[[1189,1095],[2269,1095],[2269,1139],[1189,1139]],"region":{"top_left_x":1188,"top_left_y":1095,"width":1082,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1debeef5bc944cc918ade4d91dc7b0b","type":"text","conversion_output":false,"parent_id":"e3274732343d468d9c28bcd431fec6e3","text":"time point are missing, the outcome variable will be coded as missing.","text_display":" time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[324,1182],[729,1182],[729,1269],[324,1269]],"region":{"top_left_x":324,"top_left_y":1181,"width":406,"height":88},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0419161b3d654625ad4e40d51bfcbf33","type":"complex_cell","conversion_output":false,"parent_id":"7b3a6eaf20f84985aa3df84c06f5cb09","children_ids":["5b8ffde1a02d4760841283fe7afbca0f","5e469bf97f734ad2b5ac6bf7905b478e"],"text":"OAB-SAT-q Side Effects Score at 12 Months","text_display":"OAB-SAT-q Side Effects Score at 12 Months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1184],[727,1184],[727,1230],[327,1230]],"region":{"top_left_x":326,"top_left_y":1184,"width":402,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b8ffde1a02d4760841283fe7afbca0f","type":"text","conversion_output":false,"parent_id":"0419161b3d654625ad4e40d51bfcbf33","text":"OAB-SAT-q Side Effects","text_display":"OAB-SAT-q Side Effects","confidence":1,"confidence_rate":1},{"cnt":[[327,1230],[632,1230],[632,1266],[327,1266]],"region":{"top_left_x":326,"top_left_y":1229,"width":306,"height":38},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e469bf97f734ad2b5ac6bf7905b478e","type":"text","conversion_output":false,"parent_id":"0419161b3d654625ad4e40d51bfcbf33","text":"Score at 12 Months","text_display":" Score at 12 Months","confidence":1,"confidence_rate":1},{"cnt":[[816,1184],[996,1184],[996,1221],[816,1221]],"region":{"top_left_x":816,"top_left_y":1184,"width":180,"height":37},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b9ed5e399fa48499935cb97491005c0","type":"simple_cell","conversion_output":false,"parent_id":"7b3a6eaf20f84985aa3df84c06f5cb09","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":[[1184,1182],[2568,1182],[2568,1671],[1184,1671]],"region":{"top_left_x":1184,"top_left_y":1181,"width":1384,"height":491},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58b1eba5be984f9d8422b053cf492a4a","type":"complex_cell","conversion_output":false,"parent_id":"7b3a6eaf20f84985aa3df84c06f5cb09","children_ids":["d5b88666e53143e58f49d8f3d560b69e","aeb2bd43a0574789b9f8dacb66256c1b","ec17543db52e40bc853c0fa44c5f97d9","ec83acf15f8047e3a10ea526b4c27279","55068ca7fcff49d6a2dd5be0740a1f35","d953d9aab7bc4f82a6e3ef176736db3c","ce81f0b52dd1482a8e1921bde614630b","7ad7619ce2eb4484b38d41b378222f06","1f726d3a298f46ca984ecc129fe42972","1ca11b1e627d471382e99c1d88ae8672","b322bf2691e04386ab48417a07dad9a0"],"text":"The OAB-SAT-q Side Effects Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, if the response to question 5 is Never then the score is 100, regardless of the responses to questions 6 and 7. If the response to question 5 is not Never, then sum the responses across questions 5 (reverse coded: \\(1=\\) All of the time, \\(\\ldots, 5=\\) A little of the time \\(), 6(1=\\) Extremely bothersome, \\(\\ldots\\), \\(5=\\) Not at all bothersome), and \\(7(1= A\\) great deal, \\(\\ldots, 7=\\) Not at all), then subtract from the maximum possible sum score (15) and divide by the range of possible scores (15-3=12), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-SAT-q Side Effects Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, if the response to question 5 is Never then the score is 100, regardless of the responses to questions 6 and 7. If the response to question 5 is not Never, then sum the responses across questions 5 (reverse coded: \\(1=\\) All of the time, \\(\\ldots, 5=\\) A little of the time \\(), 6(1=\\) Extremely bothersome, \\(\\ldots\\), \\(5=\\) Not at all bothersome), and \\(7(1= A\\) great deal, \\(\\ldots, 7=\\) Not at all), then subtract from the maximum possible sum score (15) and divide by the range of possible scores (15-3=12), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.43433049534480506,"confidence_rate":0.9973195489169268},{"cnt":[[1191,1184],[2438,1184],[2438,1230],[1191,1230]],"region":{"top_left_x":1190,"top_left_y":1184,"width":1249,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5b88666e53143e58f49d8f3d560b69e","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"The OAB-SAT-q Side Effects Score will be computed at 12 months (and 3 and 6","text_display":"The OAB-SAT-q Side Effects Score will be computed at 12 months (and 3 and 6","confidence":1,"confidence_rate":1},{"cnt":[[1189,1227],[2538,1227],[2538,1273],[1189,1273]],"region":{"top_left_x":1188,"top_left_y":1227,"width":1350,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aeb2bd43a0574789b9f8dacb66256c1b","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"months) using the standard scoring algorithm. Specifically, if the response to question 5","text_display":" months) using the standard scoring algorithm. Specifically, if the response to question 5","confidence":1,"confidence_rate":1},{"cnt":[[1189,1273],[2503,1273],[2503,1316],[1189,1316]],"region":{"top_left_x":1188,"top_left_y":1272,"width":1315,"height":45},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec17543db52e40bc853c0fa44c5f97d9","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"is Never then the score is 100, regardless of the responses to questions 6 and 7. If the","text_display":" is Never then the score is 100, regardless of the responses to questions 6 and 7. If the","confidence":0.6526191778893917,"confidence_rate":0.9955644339303796},{"cnt":[[1189,1316],[2527,1316],[2527,1360],[1189,1360]],"region":{"top_left_x":1188,"top_left_y":1316,"width":1339,"height":44},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec83acf15f8047e3a10ea526b4c27279","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"response to question 5 is not Never, then sum the responses across questions 5 (reverse","text_display":" response to question 5 is not Never, then sum the responses across questions 5 (reverse","confidence":1,"confidence_rate":1},{"cnt":[[1188,1403],[1189,1358],[2499,1361],[2499,1406]],"region":{"top_left_x":1188,"top_left_y":1358,"width":1311,"height":48},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"55068ca7fcff49d6a2dd5be0740a1f35","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"coded: \\(1=\\) All of the time, \\(\\ldots, 5=\\) A little of the time \\(), 6(1=\\) Extremely bothersome, \\(\\ldots\\),","text_display":" coded: \\(1=\\) All of the time, \\(\\ldots, 5=\\) A little of the time \\(), 6(1=\\) Extremely bothersome, \\(\\ldots\\),","confidence":0.43433049534480506,"confidence_rate":0.9918573566540516},{"cnt":[[1189,1405],[2559,1405],[2559,1448],[1189,1448]],"region":{"top_left_x":1188,"top_left_y":1405,"width":1372,"height":44},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d953d9aab7bc4f82a6e3ef176736db3c","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"\\(5=\\) Not at all bothersome), and \\(7(1= A\\) great deal, \\(\\ldots, 7=\\) Not at all), then subtract from the","text_display":" \\(5=\\) Not at all bothersome), and \\(7(1= A\\) great deal, \\(\\ldots, 7=\\) Not at all), then subtract from the","confidence":0.43894172644596435,"confidence_rate":0.9919600572124769},{"cnt":[[1189,1448],[2546,1448],[2546,1492],[1189,1492]],"region":{"top_left_x":1188,"top_left_y":1448,"width":1359,"height":44},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce81f0b52dd1482a8e1921bde614630b","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"maximum possible sum score (15) and divide by the range of possible scores (15-3=12),","text_display":" maximum possible sum score (15) and divide by the range of possible scores (15-3=12),","confidence":0.46171669029354234,"confidence_rate":0.9914500515982183},{"cnt":[[1189,1492],[2566,1492],[2566,1535],[1189,1535]],"region":{"top_left_x":1188,"top_left_y":1491,"width":1378,"height":44},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ad7619ce2eb4484b38d41b378222f06","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"then multiply by 100 . If less than half of the responses are missing, then the score will be","text_display":" then multiply by 100 . If less than half of the responses are missing, then the score will be","confidence":0.9756577014923096,"confidence_rate":0.9997560350141173},{"cnt":[[1189,1535],[2490,1535],[2490,1580],[1189,1580]],"region":{"top_left_x":1188,"top_left_y":1534,"width":1302,"height":47},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f726d3a298f46ca984ecc129fe42972","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"calculated by substituting the missing responses with the average of the non-missing","text_display":" calculated by substituting the missing responses with the average of the non-missing","confidence":1,"confidence_rate":1},{"cnt":[[1189,1580],[2479,1580],[2479,1624],[1189,1624]],"region":{"top_left_x":1188,"top_left_y":1580,"width":1292,"height":44},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ca11b1e627d471382e99c1d88ae8672","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"responses, otherwise no score is calculated. If data for an assessment time point are","text_display":" responses, otherwise no score is calculated. If data for an assessment time point are","confidence":1,"confidence_rate":1},{"cnt":[[1189,1626],[2048,1626],[2048,1667],[1189,1667]],"region":{"top_left_x":1188,"top_left_y":1625,"width":861,"height":43},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b322bf2691e04386ab48417a07dad9a0","type":"text","conversion_output":false,"parent_id":"58b1eba5be984f9d8422b053cf492a4a","text":"missing, the outcome variable will be coded as missing.","text_display":" missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[305,1925],[683,1925],[683,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1925,"width":379,"height":37},"line":59,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"52990ef8a82a48ef87db620e3a0b3333","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 26","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-28","page":28,"lines":[{"cnt":[[303,133],[810,133],[810,219],[303,219]],"region":{"top_left_x":302,"top_left_y":133,"width":508,"height":87},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1512097740464f3fa49e967112fab799","type":"figure_label","conversion_output":false,"children_ids":["1d75409cd44b483180f810fbb43770f4","1a8991e2e41640e2b5c4f0780ed71bb5"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1d75409cd44b483180f810fbb43770f4","type":"text","conversion_output":false,"parent_id":"1512097740464f3fa49e967112fab799","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1a8991e2e41640e2b5c4f0780ed71bb5","type":"text","conversion_output":false,"parent_id":"1512097740464f3fa49e967112fab799","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,241],[2589,241],[2589,1684],[305,1684]],"region":{"top_left_x":305,"top_left_y":240,"width":2284,"height":1445},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cb8039c84c34b8bbb8ef66e39cd733b","type":"table","conversion_output":true,"children_ids":["b87381a675b14a37a6fe852c8243e8d5","167f0d5255bb4d178994f11d2bd2ebcd","88d590698a5247b89c243aa09310b076","b0f72ba42bd3409ca13ba6f455b4790e","ad96f9e632144fbbaf9a572eb1ce2be1","a620a470494b40099a3102ecba8ca7d3","b2a60dec1fd443379d0e73ec12e26cd0","78b3f29239b0480e837066e28f9fb81d","82e850282b7b425482768e392f11d444","fecbaf8bef9c4011bdbc2aacb4aa6420","439e92040b23491b81ee7ff29d414763","2f5ca736797440bfa4718798f9ddb36c","26d8eb08d74e43e795a0da4b7158a1fa","0f1d7f9d875a49ed8a2be31c2f140577","d5bdd8e159da416e8de0ce5823e8e2ea","12e311a074cc4f2c93f908785caddcf9","7c0c7ee294be4e9d83b3acff3b58793a","a5d3dd57690a455786e39e160ab09396","dc94ab9ba6a448a5afef6f0f664c864a"],"selected_labels":["1512097740464f3fa49e967112fab799"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline OAB-SAT-q Endorsement Score at 12 Months & Continuous & The OAB-SAT-q Endorsement Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 9 ( \\(1=\\) Definitely would not use the same treatment again, ..., 4=Definitely would use the same treatment again), 10 ( \\(1=\\) Definitely would not recommend, ..., \\(4=\\) Definitely would recommend), and 11 ( \\(1=\\) Extremely Dissatisfied, ..., 6=Extremely Satisfied), then subtract from the maximum possible sum score (14) and divide by the range of possible scores \\((14-3=11)\\), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Convenience Score at 12 Months & Continuous & The OAB-SAT-q Convenience Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to use the response to question \\(4(1=\\) Extremely Inconvenient, ..., \\(6=\\) Extremely Convenient \\()\\), then subtract from the maximum possible sum score (6) and divide by the range of possible scores \\((6-1=1)\\), then multiply by 100 . If the response to question 4 is missing then no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Preference Indicator at 12 Months & Dichotomous & \\begin{tabular}{l}\nThe OAB-SAT-q Preference Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the indicator is set to 1 if the response to question 8 is either \"Slight preference for the treatment I am receiving now\" or \"Definitely prefer the treatment I am receiving now\", otherwise it is set to 0 . If the response to question 8 is missing then indicator is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\nThe score is calculated as the percentage of participants with Indicator \\(=1\\) among all nonmissing Indicators.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline OAB-SAT-q Endorsement Score at 12 Months & Continuous & The OAB-SAT-q Endorsement Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 9 ( \\(1=\\) Definitely would not use the same treatment again, ..., 4=Definitely would use the same treatment again), 10 ( \\(1=\\) Definitely would not recommend, ..., \\(4=\\) Definitely would recommend), and 11 ( \\(1=\\) Extremely Dissatisfied, ..., 6=Extremely Satisfied), then subtract from the maximum possible sum score (14) and divide by the range of possible scores \\((14-3=11)\\), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Convenience Score at 12 Months & Continuous & The OAB-SAT-q Convenience Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to use the response to question \\(4(1=\\) Extremely Inconvenient, ..., \\(6=\\) Extremely Convenient \\()\\), then subtract from the maximum possible sum score (6) and divide by the range of possible scores \\((6-1=1)\\), then multiply by 100 . If the response to question 4 is missing then no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline OAB-SAT-q Preference Indicator at 12 Months & Dichotomous & \\begin{tabular}{l}\nThe OAB-SAT-q Preference Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the indicator is set to 1 if the response to question 8 is either \"Slight preference for the treatment I am receiving now\" or \"Definitely prefer the treatment I am receiving now\", otherwise it is set to 0 . If the response to question 8 is missing then indicator is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\nThe score is calculated as the percentage of participants with Indicator \\(=1\\) among all nonmissing Indicators.\n\\end{tabular} 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OAB-SAT-q Endorsement Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum responses across questions 9 ( \\(1=\\) Definitely would not use the same treatment again, ..., 4=Definitely would use the same treatment again), 10 ( \\(1=\\) Definitely would not recommend, ..., \\(4=\\) Definitely would recommend), and 11 ( \\(1=\\) Extremely Dissatisfied, ..., 6=Extremely Satisfied), then subtract from the maximum possible sum score (14) and divide by the range of possible scores \\((14-3=11)\\), then multiply by 100 . If less than half of the responses are missing, then the score will be calculated by substituting the missing responses with the average of the non-missing responses, otherwise no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-SAT-q Endorsement Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. 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If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.46694028395279624,"confidence_rate":0.9987667997493455},{"cnt":[[1189,344],[2455,344],[2455,389],[1189,389]],"region":{"top_left_x":1188,"top_left_y":343,"width":1268,"height":47},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e7069e2603e4a78b83d9130b40f61f2","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"The OAB-SAT-q Endorsement Score will be computed at 12 months (and 3 and 6","text_display":"The OAB-SAT-q Endorsement Score will be computed at 12 months (and 3 and 6","confidence":1,"confidence_rate":1},{"cnt":[[1189,387],[2460,387],[2460,435],[1189,435]],"region":{"top_left_x":1188,"top_left_y":387,"width":1272,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8cfa2036925426f951e881c20dabfc9","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"months) using the standard scoring algorithm. Specifically, instructions are to sum","text_display":" months) using the standard scoring algorithm. Specifically, instructions are to sum","confidence":1,"confidence_rate":1},{"cnt":[[1189,433],[2533,433],[2533,478],[1189,478]],"region":{"top_left_x":1188,"top_left_y":432,"width":1346,"height":47},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d2848a7079948e5b764ba312e9291c2","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"responses across questions 9 ( \\(1=\\) Definitely would not use the same treatment again, ...,","text_display":" responses across questions 9 ( \\(1=\\) Definitely would not use the same treatment again, ...,","confidence":0.730193336843513,"confidence_rate":0.9968604792853596},{"cnt":[[1189,476],[2403,476],[2403,522],[1189,522]],"region":{"top_left_x":1188,"top_left_y":476,"width":1216,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc048f77061746b0ae072e31ed3f4a41","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"4=Definitely would use the same treatment again), 10 ( \\(1=\\) Definitely would not","text_display":" 4=Definitely would use the same treatment again), 10 ( \\(1=\\) Definitely would not","confidence":0.7755863404571575,"confidence_rate":0.9971486126418369},{"cnt":[[1189,519],[2559,519],[2559,565],[1189,565]],"region":{"top_left_x":1188,"top_left_y":519,"width":1372,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1cb314143634b668e4ac8305559cd59","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"recommend, ..., \\(4=\\) Definitely would recommend), and 11 ( \\(1=\\) Extremely Dissatisfied, ...,","text_display":" recommend, ..., \\(4=\\) Definitely would recommend), and 11 ( \\(1=\\) Extremely Dissatisfied, ...,","confidence":0.46694028395279624,"confidence_rate":0.992561588227045},{"cnt":[[1189,563],[2512,563],[2512,608],[1189,608]],"region":{"top_left_x":1188,"top_left_y":562,"width":1324,"height":47},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f97a0a31f5d64088b9490ab3b40dd2ec","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"6=Extremely Satisfied), then subtract from the maximum possible sum score (14) and","text_display":" 6=Extremely Satisfied), then subtract from the maximum possible sum score (14) and","confidence":0.9990236759185791,"confidence_rate":0.9999887724653715},{"cnt":[[1189,608],[2548,608],[2548,654],[1189,654]],"region":{"top_left_x":1188,"top_left_y":608,"width":1361,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50fb25530681432687cae06730bb3587","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"divide by the range of possible scores \\((14-3=11)\\), then multiply by 100 . If less than half","text_display":" divide by the range of possible scores \\((14-3=11)\\), then multiply by 100 . If less than half","confidence":0.990234375,"confidence_rate":0.99990379265324},{"cnt":[[1189,651],[2559,651],[2559,697],[1189,697]],"region":{"top_left_x":1188,"top_left_y":651,"width":1372,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d520ff53a97476e989f798c2f1e6893","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"of the responses are missing, then the score will be calculated by substituting the missing","text_display":" of the responses are missing, then the score will be calculated by substituting the missing","confidence":1,"confidence_rate":1},{"cnt":[[1189,695],[2406,695],[2406,740],[1189,740]],"region":{"top_left_x":1188,"top_left_y":694,"width":1218,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b50d31e68ca4ee08b4de1e92b9d4c81","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"responses with the average of the non-missing responses, otherwise no score is","text_display":" responses with the average of the non-missing responses, otherwise no score is","confidence":1,"confidence_rate":1},{"cnt":[[1189,738],[2564,738],[2564,786],[1189,786]],"region":{"top_left_x":1188,"top_left_y":738,"width":1376,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4326154d14a4f36809ba94a0c59c2e0","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"calculated. If data for an assessment time point are missing, the outcome variable will be","text_display":" calculated. If data for an assessment time point are missing, the outcome variable will be","confidence":1,"confidence_rate":1},{"cnt":[[1189,786],[1468,786],[1468,831],[1189,831]],"region":{"top_left_x":1188,"top_left_y":785,"width":280,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d331abe4f6fa436fa4a9c1fd35d16c3d","type":"text","conversion_output":false,"parent_id":"26d8eb08d74e43e795a0da4b7158a1fa","text":"coded as missing.","text_display":" coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[318,868],[749,868],[749,963],[318,963]],"region":{"top_left_x":317,"top_left_y":867,"width":432,"height":97},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f1d7f9d875a49ed8a2be31c2f140577","type":"complex_cell","conversion_output":false,"parent_id":"7cb8039c84c34b8bbb8ef66e39cd733b","children_ids":["2646683fdb2644d0b05c874bf0b6c581","e2380a6ade2c46148f9bb14032228979"],"text":"OAB-SAT-q Convenience Score at 12 Months","text_display":"OAB-SAT-q Convenience Score at 12 Months","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,872],[745,872],[745,918],[324,918]],"region":{"top_left_x":324,"top_left_y":872,"width":421,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2646683fdb2644d0b05c874bf0b6c581","type":"text","conversion_output":false,"parent_id":"0f1d7f9d875a49ed8a2be31c2f140577","text":"OAB-SAT-q Convenience","text_display":"OAB-SAT-q Convenience","confidence":1,"confidence_rate":1},{"cnt":[[327,918],[636,918],[636,959],[327,959]],"region":{"top_left_x":326,"top_left_y":917,"width":311,"height":42},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2380a6ade2c46148f9bb14032228979","type":"text","conversion_output":false,"parent_id":"0f1d7f9d875a49ed8a2be31c2f140577","text":"Score at 12 Months","text_display":" Score at 12 Months","confidence":1,"confidence_rate":1},{"cnt":[[812,872],[1000,872],[1000,918],[812,918]],"region":{"top_left_x":811,"top_left_y":872,"width":190,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5bdd8e159da416e8de0ce5823e8e2ea","type":"simple_cell","conversion_output":false,"parent_id":"7cb8039c84c34b8bbb8ef66e39cd733b","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":[[1182,868],[2535,868],[2535,1188],[1182,1188]],"region":{"top_left_x":1182,"top_left_y":867,"width":1354,"height":322},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12e311a074cc4f2c93f908785caddcf9","type":"complex_cell","conversion_output":false,"parent_id":"7cb8039c84c34b8bbb8ef66e39cd733b","children_ids":["e0c4c4fc39c24d27b34a3d8b3e91aad0","9eb3c531a5054660a79f68fc299bdfb8","d246a9190d6342da97dcce176c9c0cf5","e983ff9d5fcf4abb82c483cd9aa288ee","b8108325e75d4f1bb08e29a32ea69c64","d30d57c31e334f91a5ad1aa55b93b116","96b7a0303ef749798ef86dc8fb747519"],"text":"The OAB-SAT-q Convenience Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to use the response to question \\(4(1=\\) Extremely Inconvenient, ..., \\(6=\\) Extremely Convenient \\()\\), then subtract from the maximum possible sum score (6) and divide by the range of possible scores \\((6-1=1)\\), then multiply by 100 . If the response to question 4 is missing then no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The OAB-SAT-q Convenience Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to use the response to question \\(4(1=\\) Extremely Inconvenient, ..., \\(6=\\) Extremely Convenient \\()\\), then subtract from the maximum possible sum score (6) and divide by the range of possible scores \\((6-1=1)\\), then multiply by 100 . If the response to question 4 is missing then no score is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.43059221831845207,"confidence_rate":0.9986367682959005},{"cnt":[[1189,872],[2455,872],[2455,918],[1189,918]],"region":{"top_left_x":1188,"top_left_y":872,"width":1268,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0c4c4fc39c24d27b34a3d8b3e91aad0","type":"text","conversion_output":false,"parent_id":"12e311a074cc4f2c93f908785caddcf9","text":"The OAB-SAT-q Convenience Score will be computed at 12 months (and 3 and 6","text_display":"The OAB-SAT-q Convenience Score will be computed at 12 months (and 3 and 6","confidence":0.9990236759185791,"confidence_rate":0.9999883714843234},{"cnt":[[1189,916],[2503,916],[2503,963],[1189,963]],"region":{"top_left_x":1188,"top_left_y":915,"width":1315,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9eb3c531a5054660a79f68fc299bdfb8","type":"text","conversion_output":false,"parent_id":"12e311a074cc4f2c93f908785caddcf9","text":"months) using the standard scoring algorithm. Specifically, instructions are to use the","text_display":" months) using the standard scoring algorithm. Specifically, instructions are to use the","confidence":1,"confidence_rate":1},{"cnt":[[1189,961],[2529,961],[2529,1007],[1189,1007]],"region":{"top_left_x":1188,"top_left_y":961,"width":1341,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d246a9190d6342da97dcce176c9c0cf5","type":"text","conversion_output":false,"parent_id":"12e311a074cc4f2c93f908785caddcf9","text":"response to question \\(4(1=\\) Extremely Inconvenient, ..., \\(6=\\) Extremely Convenient \\()\\), then","text_display":" response to question \\(4(1=\\) Extremely Inconvenient, ..., \\(6=\\) Extremely Convenient \\()\\), then","confidence":0.43059221831845207,"confidence_rate":0.9916921896555018},{"cnt":[[1189,1007],[2520,1007],[2520,1050],[1189,1050]],"region":{"top_left_x":1188,"top_left_y":1006,"width":1333,"height":44},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e983ff9d5fcf4abb82c483cd9aa288ee","type":"text","conversion_output":false,"parent_id":"12e311a074cc4f2c93f908785caddcf9","text":"subtract from the maximum possible sum score (6) and divide by the range of possible","text_display":" subtract from the maximum possible sum score (6) and divide by the range of possible","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[1189,1050],[2507,1050],[2507,1095],[1189,1095]],"region":{"top_left_x":1188,"top_left_y":1049,"width":1320,"height":47},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8108325e75d4f1bb08e29a32ea69c64","type":"text","conversion_output":false,"parent_id":"12e311a074cc4f2c93f908785caddcf9","text":"scores \\((6-1=1)\\), then multiply by 100 . If the response to question 4 is missing then no","text_display":" scores \\((6-1=1)\\), then multiply by 100 . If the response to question 4 is missing then no","confidence":0.8857421875,"confidence_rate":0.9988112036937052},{"cnt":[[1189,1093],[2442,1093],[2442,1139],[1189,1139]],"region":{"top_left_x":1188,"top_left_y":1093,"width":1255,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d30d57c31e334f91a5ad1aa55b93b116","type":"text","conversion_output":false,"parent_id":"12e311a074cc4f2c93f908785caddcf9","text":"score is calculated. If data for an assessment time point are missing, the outcome","text_display":" score is calculated. If data for an assessment time point are missing, the outcome","confidence":1,"confidence_rate":1},{"cnt":[[1189,1137],[1715,1137],[1715,1182],[1189,1182]],"region":{"top_left_x":1188,"top_left_y":1136,"width":527,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96b7a0303ef749798ef86dc8fb747519","type":"text","conversion_output":false,"parent_id":"12e311a074cc4f2c93f908785caddcf9","text":"variable will be coded as missing.","text_display":" variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[318,1223],[714,1223],[714,1316],[318,1316]],"region":{"top_left_x":317,"top_left_y":1223,"width":398,"height":94},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c0c7ee294be4e9d83b3acff3b58793a","type":"complex_cell","conversion_output":false,"parent_id":"7cb8039c84c34b8bbb8ef66e39cd733b","children_ids":["96696750562e4bd0a636dbf28961304e","311f9f2745f54858a0aa249373b90664"],"text":"OAB-SAT-q Preference Indicator at 12 Months","text_display":"OAB-SAT-q Preference Indicator at 12 Months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,1227],[708,1227],[708,1273],[324,1273]],"region":{"top_left_x":324,"top_left_y":1227,"width":384,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96696750562e4bd0a636dbf28961304e","type":"text","conversion_output":false,"parent_id":"7c0c7ee294be4e9d83b3acff3b58793a","text":"OAB-SAT-q Preference","text_display":"OAB-SAT-q Preference","confidence":1,"confidence_rate":1},{"cnt":[[327,1271],[688,1271],[688,1312],[327,1312]],"region":{"top_left_x":326,"top_left_y":1270,"width":363,"height":42},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"311f9f2745f54858a0aa249373b90664","type":"text","conversion_output":false,"parent_id":"7c0c7ee294be4e9d83b3acff3b58793a","text":"Indicator at 12 Months","text_display":" Indicator at 12 Months","confidence":1,"confidence_rate":1},{"cnt":[[812,1223],[1030,1223],[1030,1269],[812,1269]],"region":{"top_left_x":811,"top_left_y":1223,"width":220,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5d3dd57690a455786e39e160ab09396","type":"simple_cell","conversion_output":false,"parent_id":"7cb8039c84c34b8bbb8ef66e39cd733b","text":"Dichotomous","text_display":"Dichotomous","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1182,1223],[2566,1223],[2566,1645],[1182,1645]],"region":{"top_left_x":1182,"top_left_y":1223,"width":1384,"height":423},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc94ab9ba6a448a5afef6f0f664c864a","type":"complex_cell","conversion_output":false,"parent_id":"7cb8039c84c34b8bbb8ef66e39cd733b","children_ids":["4b89f2793f8d4f38a0cd39ae82c9b6fb","a4633e509f594f3d8c47901885257064","c83e8ade59924897996a071ca68595e3","d0ec4693e3554c96a18e7b191f1602e5","cb8fc1f64778451ca1b12bc91ca7ad56","9889ef1587eb4ef0bee771e3583f1733","0d11876eb38e461fa456e50a6ddef4b9","d51bef5be2d64a16b50e83c032bd9f8d"],"text":"\\begin{tabular}{l}\nThe OAB-SAT-q Preference Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the indicator is set to 1 if the response to question 8 is either \"Slight preference for the treatment I am receiving now\" or \"Definitely prefer the treatment I am receiving now\", otherwise it is set to 0 . If the response to question 8 is missing then indicator is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\nThe score is calculated as the percentage of participants with Indicator \\(=1\\) among all nonmissing Indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe OAB-SAT-q Preference Score will be computed at 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, the indicator is set to 1 if the response to question 8 is either \"Slight preference for the treatment I am receiving now\" or \"Definitely prefer the treatment I am receiving now\", otherwise it is set to 0 . If the response to question 8 is missing then indicator is calculated. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\nThe score is calculated as the percentage of participants with Indicator \\(=1\\) among all nonmissing Indicators.\n\\end{tabular}","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9980480668600649,"confidence_rate":0.999995617831377},{"cnt":[[1189,1227],[2551,1227],[2551,1273],[1189,1273]],"region":{"top_left_x":1188,"top_left_y":1227,"width":1363,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b89f2793f8d4f38a0cd39ae82c9b6fb","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"The OAB-SAT-q Preference Score will be computed at 12 months (and 3 and 6 months)","text_display":"The OAB-SAT-q Preference Score will be computed at 12 months (and 3 and 6 months)","confidence":1,"confidence_rate":1},{"cnt":[[1189,1271],[2559,1271],[2559,1316],[1189,1316]],"region":{"top_left_x":1188,"top_left_y":1270,"width":1372,"height":47},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4633e509f594f3d8c47901885257064","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"using the standard scoring algorithm. Specifically, the indicator is set to 1 if the response","text_display":" using the standard scoring algorithm. Specifically, the indicator is set to 1 if the response","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[1189,1314],[2447,1314],[2447,1360],[1189,1360]],"region":{"top_left_x":1188,"top_left_y":1314,"width":1259,"height":46},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c83e8ade59924897996a071ca68595e3","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"to question 8 is either \"Slight preference for the treatment I am receiving now\" or","text_display":" to question 8 is either \"Slight preference for the treatment I am receiving now\" or","confidence":1,"confidence_rate":1},{"cnt":[[1189,1357],[2468,1357],[2468,1403],[1189,1403]],"region":{"top_left_x":1188,"top_left_y":1357,"width":1281,"height":46},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0ec4693e3554c96a18e7b191f1602e5","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"\"Definitely prefer the treatment I am receiving now\", otherwise it is set to 0 . If the","text_display":" \"Definitely prefer the treatment I am receiving now\", otherwise it is set to 0 . If the","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[1189,1403],[2529,1403],[2529,1448],[1189,1448]],"region":{"top_left_x":1188,"top_left_y":1402,"width":1341,"height":47},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb8fc1f64778451ca1b12bc91ca7ad56","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"response to question 8 is missing then indicator is calculated. If data for an assessment","text_display":" response to question 8 is missing then indicator is calculated. If data for an assessment","confidence":1,"confidence_rate":1},{"cnt":[[1189,1446],[2271,1446],[2271,1494],[1189,1494]],"region":{"top_left_x":1188,"top_left_y":1446,"width":1084,"height":48},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9889ef1587eb4ef0bee771e3583f1733","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"time point are missing, the outcome variable will be coded as missing.","text_display":" time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1548],[2559,1548],[2559,1596],[1189,1596]],"region":{"top_left_x":1188,"top_left_y":1547,"width":1372,"height":49},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d11876eb38e461fa456e50a6ddef4b9","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"The score is calculated as the percentage of participants with Indicator \\(=1\\) among all non-","text_display":"\nThe score is calculated as the percentage of participants with Indicator \\(=1\\) among all non","confidence":0.9980480668600649,"confidence_rate":0.9999800630493146},{"cnt":[[1189,1591],[1490,1591],[1490,1639],[1189,1639]],"region":{"top_left_x":1188,"top_left_y":1591,"width":302,"height":48},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d51bef5be2d64a16b50e83c032bd9f8d","type":"text","conversion_output":false,"parent_id":"dc94ab9ba6a448a5afef6f0f664c864a","text":"missing Indicators.","text_display":"missing Indicators.","confidence":1,"confidence_rate":1},{"cnt":[[305,1925],[683,1925],[683,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1925,"width":379,"height":37},"line":56,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8b0d9d558fe844ce80cca49790acc53e","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 27","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-29","page":29,"lines":[{"cnt":[[305,133],[810,133],[810,217],[305,217]],"region":{"top_left_x":305,"top_left_y":133,"width":505,"height":84},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1a7f98a67fab4215bf63d2b352a2f9c0","type":"figure_label","conversion_output":false,"children_ids":["b6e4091e245247d49e817e7218dc209f","55c9c4acaf13456b8c06ae69a8bb75fc"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b6e4091e245247d49e817e7218dc209f","type":"text","conversion_output":false,"parent_id":"1a7f98a67fab4215bf63d2b352a2f9c0","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"55c9c4acaf13456b8c06ae69a8bb75fc","type":"text","conversion_output":false,"parent_id":"1a7f98a67fab4215bf63d2b352a2f9c0","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[307,243],[2587,243],[2587,1807],[307,1807]],"region":{"top_left_x":307,"top_left_y":242,"width":2280,"height":1565},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62b21607540c44a7b52ae9477f353d55","type":"table","conversion_output":true,"children_ids":["d410d43c81824f6a94539d8dca5e3f2c","345f1898baa74409a9598237fa2490c9","bc1fff8a665a403b997c4d5f1ccc77e8","ea46a073514d45c08ab6916c96225985","3eedd9de424046c48bf8a562eaeed5f8","bf4ab4dc5d6741859f2d140133d59d46","f2195db7f8754ce0ae97c2d114173115","2405b27c4a1c42f8ab6fe0c7f8a44928","381d73573e6f4dfea3b50a381b0766a4","5d0b47fdb39b4671b45362bda6a9ce82","d7d582727c4a40cf9023c935d8524d25","456c6c48219a4eabb4b30ae8b451ec23","9f88fe9c2c364463b87f72ef02c335ee","1b80b8e9162045c8a7f500de3fb61ac7","19b79122fdc14b79aa531a2a54d575bf","9264cf57d88c4c51beda0287c32cc9e1","3c8abd007e4c44c7a50330b28db72acd","5ca08bfcaeb549cf9e3c0679f0a6e49a","378cd977dac84342aab21575b0ec7e05","8a4108aabe114dd8ac3ade1662cebdb4","e6d99463985841e99a22946fc1e88ea1","ba94e96006d94b9cbfe8a42fee31b027","f6ef9266b03a4061a3f7a1ba90c17e9a"],"selected_labels":["1a7f98a67fab4215bf63d2b352a2f9c0"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Retreatment at 12 months & Categorical and Dichotomous & \\begin{tabular}{l}\nThe types of retreatment for SUI or UUI will be identified and categorized from the Additional Therapy and Concomitant Medications forms. Further details can be found in Attachment 16.1. \\\\\nAn indicator of retreatment will be calculated for each subject where subjects with retreatment identified above will be assigned \"Yes\", otherwise subjects are assigned \"No\". The rate of retreatment is calculated as the percentage of participants with indicator=\"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Time-to-Failure & Semi-continuous number of days/years until failure & \\begin{tabular}{l}\nFailure \\(=\\) The first time at which a subject seeks any additional treatment for SUI or UUI/OAB symptoms as determined by the Additional Therapy and Concomitant Medications forms. Further details can be found in Attachment 16.1. \\\\\nSuccess \\(=\\) Any subject for whom no additional treatment for SUI or UUI/OAB symptoms is identified, censored at 12 months if the subject completed the entire follow-up period. Subjects lost to follow-up will be censored at the time of their last visit (scheduled or unscheduled).\n\\end{tabular} \\\\\n\\hline Sling Revision for Worsened OAB Symptoms at 12 months & Dichotomous & \\begin{tabular}{l}\nAn indicator of sling revision will be calculated for each subject where those who have a sling revision for worsening OAB listed on the Additional Therapy form will be assigned a \"Yes\", otherwise subjects are assigned \"No\". \\\\\nThe rate of sling revision is calculated as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Change from Baseline IIQ Physical Activity Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Physical Activity Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions A, B, C, D, E, and U ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Retreatment at 12 months & Categorical and Dichotomous & \\begin{tabular}{l}\nThe types of retreatment for SUI or UUI will be identified and categorized from the Additional Therapy and Concomitant Medications forms. Further details can be found in Attachment 16.1. \\\\\nAn indicator of retreatment will be calculated for each subject where subjects with retreatment identified above will be assigned \"Yes\", otherwise subjects are assigned \"No\". The rate of retreatment is calculated as the percentage of participants with indicator=\"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Time-to-Failure & Semi-continuous number of days/years until failure & \\begin{tabular}{l}\nFailure \\(=\\) The first time at which a subject seeks any additional treatment for SUI or UUI/OAB symptoms as determined by the Additional Therapy and Concomitant Medications forms. Further details can be found in Attachment 16.1. \\\\\nSuccess \\(=\\) Any subject for whom no additional treatment for SUI or UUI/OAB symptoms is identified, censored at 12 months if the subject completed the entire follow-up period. Subjects lost to follow-up will be censored at the time of their last visit (scheduled or unscheduled).\n\\end{tabular} \\\\\n\\hline Sling Revision for Worsened OAB Symptoms at 12 months & Dichotomous & \\begin{tabular}{l}\nAn indicator of sling revision will be calculated for each subject where those who have a sling revision for worsening OAB listed on the Additional Therapy form will be assigned a \"Yes\", otherwise subjects are assigned \"No\". \\\\\nThe rate of sling revision is calculated as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular} \\\\\n\\hline Change from Baseline IIQ Physical Activity Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Physical Activity Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions A, B, C, D, E, and U ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.7007770538330078,"confidence_rate":0.999933928068081},{"cnt":[[315,242],[786,241],[788,1808],[317,1808]],"region":{"top_left_x":314,"top_left_y":241,"width":474,"height":1568},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d410d43c81824f6a94539d8dca5e3f2c","type":"table_column","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[803,242],[1162,242],[1162,1808],[803,1808]],"region":{"top_left_x":802,"top_left_y":242,"width":361,"height":1566},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"345f1898baa74409a9598237fa2490c9","type":"table_column","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[1178,242],[2572,242],[2572,1808],[1178,1808]],"region":{"top_left_x":1177,"top_left_y":242,"width":1396,"height":1566},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc1fff8a665a403b997c4d5f1ccc77e8","type":"table_column","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[307,251],[2587,251],[2587,305],[307,305]],"region":{"top_left_x":307,"top_left_y":250,"width":2281,"height":55},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea46a073514d45c08ab6916c96225985","type":"table_row","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[307,337],[2587,337],[2587,721],[307,721]],"region":{"top_left_x":307,"top_left_y":337,"width":2281,"height":384},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3eedd9de424046c48bf8a562eaeed5f8","type":"table_row","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[307,749],[2587,749],[2587,1132],[307,1132]],"region":{"top_left_x":307,"top_left_y":748,"width":2281,"height":385},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf4ab4dc5d6741859f2d140133d59d46","type":"table_row","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[307,1162],[2587,1162],[2587,1459],[307,1459]],"region":{"top_left_x":307,"top_left_y":1162,"width":2281,"height":298},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f2195db7f8754ce0ae97c2d114173115","type":"table_row","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[307,1485],[2587,1485],[2587,1779],[307,1779]],"region":{"top_left_x":307,"top_left_y":1484,"width":2281,"height":296},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2405b27c4a1c42f8ab6fe0c7f8a44928","type":"table_row","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"","text_display":""},{"cnt":[[326,255],[478,255],[478,292],[326,292]],"region":{"top_left_x":326,"top_left_y":254,"width":153,"height":38},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"381d73573e6f4dfea3b50a381b0766a4","type":"simple_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"Variable","text_display":"Variable","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[814,255],[903,255],[903,300],[814,300]],"region":{"top_left_x":813,"top_left_y":254,"width":90,"height":47},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d0b47fdb39b4671b45362bda6a9ce82","type":"simple_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"Type","text_display":"Type","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1186,255],[1357,255],[1357,292],[1186,292]],"region":{"top_left_x":1186,"top_left_y":254,"width":172,"height":38},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7d582727c4a40cf9023c935d8524d25","type":"simple_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"Definition","text_display":"Definition","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,346],[727,346],[727,383],[326,383]],"region":{"top_left_x":326,"top_left_y":345,"width":402,"height":38},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"456c6c48219a4eabb4b30ae8b451ec23","type":"simple_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"Retreatment at 12 months","text_display":"Retreatment at 12 months","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[809,342],[1067,342],[1067,439],[809,439]],"region":{"top_left_x":809,"top_left_y":341,"width":259,"height":99},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f88fe9c2c364463b87f72ef02c335ee","type":"complex_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","children_ids":["50fa3dd205d34666a375367bd22db606","24450f43890c40e7aaa3efb186ef93a4"],"text":"Categorical and Dichotomous","text_display":"Categorical and 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Further details can be found in Attachment 16.1. \\\\\nAn indicator of retreatment will be calculated for each subject where subjects with retreatment identified above will be assigned \"Yes\", otherwise subjects are assigned \"No\". The rate of retreatment is calculated as the percentage of participants with indicator=\"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe types of retreatment for SUI or UUI will be identified and categorized from the Additional Therapy and Concomitant Medications forms. Further details can be found in Attachment 16.1. \\\\\nAn indicator of retreatment will be calculated for each subject where subjects with retreatment identified above will be assigned \"Yes\", otherwise subjects are assigned \"No\". The rate of retreatment is calculated as the percentage of participants with indicator=\"Yes\" among all non-missing indicators.\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1186,346],[2475,346],[2475,389],[1186,389]],"region":{"top_left_x":1186,"top_left_y":345,"width":1289,"height":45},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6b362a8ab284b83b33cd57db4004ba0","type":"text","conversion_output":false,"parent_id":"1b80b8e9162045c8a7f500de3fb61ac7","text":"The types of retreatment for SUI or UUI will be identified and categorized from the","text_display":"The types of retreatment for SUI or UUI will be identified and categorized from the","confidence":1,"confidence_rate":1},{"cnt":[[1186,389],[2553,389],[2553,435],[1186,435]],"region":{"top_left_x":1186,"top_left_y":389,"width":1367,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb97899fa0d3450c920c1c480aa958b0","type":"text","conversion_output":false,"parent_id":"1b80b8e9162045c8a7f500de3fb61ac7","text":"Additional Therapy and Concomitant Medications forms. Further details can be found in","text_display":" Additional Therapy and Concomitant Medications forms. Further details can be found in","confidence":1,"confidence_rate":1},{"cnt":[[1186,433],[1461,433],[1461,474],[1186,474]],"region":{"top_left_x":1186,"top_left_y":432,"width":276,"height":42},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cccc17b8740043ee93a244b502d6dd42","type":"text","conversion_output":false,"parent_id":"1b80b8e9162045c8a7f500de3fb61ac7","text":"Attachment 16.1.","text_display":" Attachment 16.1.","confidence":1,"confidence_rate":1},{"cnt":[[1186,532],[2459,532],[2459,580],[1186,580]],"region":{"top_left_x":1186,"top_left_y":532,"width":1274,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4e5354c86144b6ba49b8786dc195418","type":"text","conversion_output":false,"parent_id":"1b80b8e9162045c8a7f500de3fb61ac7","text":"An indicator of retreatment will be calculated for each subject where subjects with","text_display":"\nAn indicator of retreatment will be calculated for each subject where subjects with","confidence":1,"confidence_rate":1},{"cnt":[[1186,578],[2483,578],[2483,625],[1186,625]],"region":{"top_left_x":1186,"top_left_y":577,"width":1298,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d7ac2eea5974b62812b38e737fd6c41","type":"text","conversion_output":false,"parent_id":"1b80b8e9162045c8a7f500de3fb61ac7","text":"retreatment identified above will be assigned \"Yes\", otherwise subjects are assigned","text_display":" retreatment identified above will be assigned \"Yes\", otherwise subjects are assigned","confidence":1,"confidence_rate":1},{"cnt":[[1186,619],[2436,619],[2436,669],[1186,669]],"region":{"top_left_x":1186,"top_left_y":618,"width":1250,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a715bbb469948c487d18bc44eccf2c3","type":"text","conversion_output":false,"parent_id":"1b80b8e9162045c8a7f500de3fb61ac7","text":"\"No\". The rate of retreatment is calculated as the percentage of participants with","text_display":" \"No\". The rate of retreatment is calculated as the percentage of participants with","confidence":1,"confidence_rate":1},{"cnt":[[1186,666],[1977,666],[1977,712],[1186,712]],"region":{"top_left_x":1186,"top_left_y":666,"width":791,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0c832162e764c239a38ed2e0ec3250a","type":"text","conversion_output":false,"parent_id":"1b80b8e9162045c8a7f500de3fb61ac7","text":"indicator=\"Yes\" among all non-missing indicators.","text_display":" indicator=\"Yes\" among all non-missing indicators.","confidence":1,"confidence_rate":1},{"cnt":[[326,757],[578,757],[578,799],[326,799]],"region":{"top_left_x":326,"top_left_y":757,"width":252,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19b79122fdc14b79aa531a2a54d575bf","type":"simple_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"Time-to-Failure","text_display":"Time-to-Failure","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[812,753],[1154,753],[1154,889],[812,889]],"region":{"top_left_x":811,"top_left_y":753,"width":343,"height":137},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9264cf57d88c4c51beda0287c32cc9e1","type":"complex_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","children_ids":["50f58d63c83c4a7d89c128bd09b0f94d","ae9affedc0474347be992421bb0c89f8","ee3c9f5748f74bd7b23ca539b650a5eb"],"text":"Semi-continuous number of days/years until failure","text_display":"Semi-continuous number of days/years until failure","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[814,757],[1080,757],[1080,794],[814,794]],"region":{"top_left_x":813,"top_left_y":757,"width":268,"height":38},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f58d63c83c4a7d89c128bd09b0f94d","type":"text","conversion_output":false,"parent_id":"9264cf57d88c4c51beda0287c32cc9e1","text":"Semi-continuous","text_display":"Semi-continuous","confidence":1,"confidence_rate":1},{"cnt":[[814,801],[1149,801],[1149,846],[814,846]],"region":{"top_left_x":813,"top_left_y":800,"width":337,"height":47},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae9affedc0474347be992421bb0c89f8","type":"text","conversion_output":false,"parent_id":"9264cf57d88c4c51beda0287c32cc9e1","text":"number of days/years","text_display":" number of days/years","confidence":1,"confidence_rate":1},{"cnt":[[814,844],[1002,844],[1002,885],[814,885]],"region":{"top_left_x":813,"top_left_y":844,"width":190,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee3c9f5748f74bd7b23ca539b650a5eb","type":"text","conversion_output":false,"parent_id":"9264cf57d88c4c51beda0287c32cc9e1","text":"until failure","text_display":" until failure","confidence":1,"confidence_rate":1},{"cnt":[[1182,751],[2570,751],[2570,1128],[1182,1128]],"region":{"top_left_x":1181,"top_left_y":750,"width":1389,"height":378},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c8abd007e4c44c7a50330b28db72acd","type":"complex_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","children_ids":["56092fe0e77d489a9593a518454ff390","812dac24e8bc4253b7072a133185e1c8","838c6fd586774ce78937db3aed74b185","e253b9267f7242bb99f7c131614ef216","3f7f425bea3b409fba5f2aa0d44b0dd4","ea3454b0d0e94725812739797617b7bc","80ba9be858a44d629dbff29fea149779"],"text":"\\begin{tabular}{l}\nFailure \\(=\\) The first time at which a subject seeks any additional treatment for SUI or UUI/OAB symptoms as determined by the Additional Therapy and Concomitant Medications forms. Further details can be found in Attachment 16.1. \\\\\nSuccess \\(=\\) Any subject for whom no additional treatment for SUI or UUI/OAB symptoms is identified, censored at 12 months if the subject completed the entire follow-up period. Subjects lost to follow-up will be censored at the time of their last visit (scheduled or unscheduled).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nFailure \\(=\\) The first time at which a subject seeks any additional treatment for SUI or UUI/OAB symptoms as determined by the Additional Therapy and Concomitant Medications forms. Further details can be found in Attachment 16.1. \\\\\nSuccess \\(=\\) Any subject for whom no additional treatment for SUI or UUI/OAB symptoms is identified, censored at 12 months if the subject completed the entire follow-up period. Subjects lost to follow-up will be censored at the time of their last visit (scheduled or unscheduled).\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.7007770538330078,"confidence_rate":0.9993173448370712},{"cnt":[[1186,755],[2479,755],[2479,801],[1186,801]],"region":{"top_left_x":1186,"top_left_y":755,"width":1293,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56092fe0e77d489a9593a518454ff390","type":"text","conversion_output":false,"parent_id":"3c8abd007e4c44c7a50330b28db72acd","text":"Failure \\(=\\) The first time at which a subject seeks any additional treatment for SUI or","text_display":"Failure \\(=\\) The first time at which a subject seeks any additional treatment for SUI or","confidence":0.7007770538330078,"confidence_rate":0.9961840146872262},{"cnt":[[1186,801],[2431,801],[2431,846],[1186,846]],"region":{"top_left_x":1186,"top_left_y":800,"width":1246,"height":47},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"812dac24e8bc4253b7072a133185e1c8","type":"text","conversion_output":false,"parent_id":"3c8abd007e4c44c7a50330b28db72acd","text":"UUI/OAB symptoms as determined by the Additional Therapy and Concomitant","text_display":" UUI/OAB symptoms as determined by the Additional Therapy and Concomitant","confidence":1,"confidence_rate":1},{"cnt":[[1186,844],[2245,844],[2245,885],[1186,885]],"region":{"top_left_x":1186,"top_left_y":844,"width":1060,"height":42},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"838c6fd586774ce78937db3aed74b185","type":"text","conversion_output":false,"parent_id":"3c8abd007e4c44c7a50330b28db72acd","text":"Medications forms. Further details can be found in Attachment 16.1.","text_display":" Medications forms. Further details can be found in Attachment 16.1.","confidence":1,"confidence_rate":1},{"cnt":[[1186,944],[2566,944],[2566,993],[1186,993]],"region":{"top_left_x":1186,"top_left_y":943,"width":1380,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e253b9267f7242bb99f7c131614ef216","type":"text","conversion_output":false,"parent_id":"3c8abd007e4c44c7a50330b28db72acd","text":"Success \\(=\\) Any subject for whom no additional treatment for SUI or UUI/OAB symptoms","text_display":"\nSuccess \\(=\\) Any subject for whom no additional treatment for SUI or UUI/OAB symptoms","confidence":0.91748046875,"confidence_rate":0.999043524528483},{"cnt":[[1186,991],[2544,991],[2544,1035],[1186,1035]],"region":{"top_left_x":1186,"top_left_y":991,"width":1358,"height":44},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f7f425bea3b409fba5f2aa0d44b0dd4","type":"text","conversion_output":false,"parent_id":"3c8abd007e4c44c7a50330b28db72acd","text":"is identified, censored at 12 months if the subject completed the entire follow-up period.","text_display":" is identified, censored at 12 months if the subject completed the entire follow-up period.","confidence":1,"confidence_rate":1},{"cnt":[[1186,1035],[2498,1035],[2498,1080],[1186,1080]],"region":{"top_left_x":1186,"top_left_y":1034,"width":1313,"height":47},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea3454b0d0e94725812739797617b7bc","type":"text","conversion_output":false,"parent_id":"3c8abd007e4c44c7a50330b28db72acd","text":"Subjects lost to follow-up will be censored at the time of their last visit (scheduled or","text_display":" Subjects lost to follow-up will be censored at the time of their last visit (scheduled or","confidence":1,"confidence_rate":1},{"cnt":[[1186,1078],[1409,1078],[1409,1123],[1186,1123]],"region":{"top_left_x":1186,"top_left_y":1077,"width":224,"height":47},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80ba9be858a44d629dbff29fea149779","type":"text","conversion_output":false,"parent_id":"3c8abd007e4c44c7a50330b28db72acd","text":"unscheduled).","text_display":" unscheduled).","confidence":1,"confidence_rate":1},{"cnt":[[320,1164],[786,1164],[786,1301],[320,1301]],"region":{"top_left_x":319,"top_left_y":1164,"width":467,"height":137},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ca08bfcaeb549cf9e3c0679f0a6e49a","type":"complex_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","children_ids":["dd02db172b9042379b1094d33eed741d","1e6e712c18da4765a36d49040d9476e4","b643c3be62324a718561ec3a302b6cbe"],"text":"Sling Revision for Worsened OAB Symptoms at 12 months","text_display":"Sling Revision for Worsened OAB Symptoms at 12 months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,1169],[781,1169],[781,1214],[326,1214]],"region":{"top_left_x":326,"top_left_y":1168,"width":456,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd02db172b9042379b1094d33eed741d","type":"text","conversion_output":false,"parent_id":"5ca08bfcaeb549cf9e3c0679f0a6e49a","text":"Sling Revision for Worsened","text_display":"Sling Revision for Worsened","confidence":1,"confidence_rate":1},{"cnt":[[324,1212],[673,1212],[673,1258],[324,1258]],"region":{"top_left_x":324,"top_left_y":1212,"width":349,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e6e712c18da4765a36d49040d9476e4","type":"text","conversion_output":false,"parent_id":"5ca08bfcaeb549cf9e3c0679f0a6e49a","text":"OAB Symptoms at 12","text_display":" OAB Symptoms at 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months","confidence":1,"confidence_rate":1},{"cnt":[[814,1169],[1028,1169],[1028,1208],[814,1208]],"region":{"top_left_x":813,"top_left_y":1168,"width":216,"height":40},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"378cd977dac84342aab21575b0ec7e05","type":"simple_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"Dichotomous","text_display":"Dichotomous","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1182,1164],[2570,1164],[2570,1453],[1182,1453]],"region":{"top_left_x":1181,"top_left_y":1164,"width":1389,"height":289},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a4108aabe114dd8ac3ade1662cebdb4","type":"complex_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","children_ids":["ba48d25b7ae74cb6b3838e4f2eb672bd","c7a2cb2ef6c34bcea00b782845ee2d67","47400d639bfb48a0a4c7de1aed74509d","39cb956f1020438f8738a6a2a9ccc414","98b76db354e745829c30525d397cf892"],"text":"\\begin{tabular}{l}\nAn indicator of sling revision will be calculated for each subject where those who have a sling revision for worsening OAB listed on the Additional Therapy form will be assigned a \"Yes\", otherwise subjects are assigned \"No\". \\\\\nThe rate of sling revision is calculated as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAn indicator of sling revision will be calculated for each subject where those who have a sling revision for worsening OAB listed on the Additional Therapy form will be assigned a \"Yes\", otherwise subjects are assigned \"No\". \\\\\nThe rate of sling revision is calculated as the percentage of participants with indicator equal to \"Yes\" among all non-missing indicators.\n\\end{tabular}","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.99658203125,"confidence_rate":0.9999848930270081},{"cnt":[[1186,1169],[2555,1169],[2555,1214],[1186,1214]],"region":{"top_left_x":1186,"top_left_y":1168,"width":1369,"height":47},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba48d25b7ae74cb6b3838e4f2eb672bd","type":"text","conversion_output":false,"parent_id":"8a4108aabe114dd8ac3ade1662cebdb4","text":"An indicator of sling revision will be calculated for each subject where those who have a","text_display":"An indicator of sling revision will be calculated for each subject where those who have a","confidence":1,"confidence_rate":1},{"cnt":[[1186,1212],[2563,1212],[2563,1258],[1186,1258]],"region":{"top_left_x":1186,"top_left_y":1212,"width":1378,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7a2cb2ef6c34bcea00b782845ee2d67","type":"text","conversion_output":false,"parent_id":"8a4108aabe114dd8ac3ade1662cebdb4","text":"sling revision for worsening OAB listed on the Additional Therapy form will be assigned","text_display":" sling revision for worsening OAB listed on the Additional Therapy form will be assigned","confidence":0.99658203125,"confidence_rate":0.9999627852212962},{"cnt":[[1186,1255],[1914,1255],[1914,1301],[1186,1301]],"region":{"top_left_x":1186,"top_left_y":1255,"width":728,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47400d639bfb48a0a4c7de1aed74509d","type":"text","conversion_output":false,"parent_id":"8a4108aabe114dd8ac3ade1662cebdb4","text":"a \"Yes\", otherwise subjects are assigned \"No\".","text_display":" a \"Yes\", otherwise subjects are assigned \"No\".","confidence":0.9980475902557373,"confidence_rate":0.9999616807698748},{"cnt":[[1186,1355],[2505,1355],[2505,1405],[1186,1405]],"region":{"top_left_x":1186,"top_left_y":1355,"width":1319,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39cb956f1020438f8738a6a2a9ccc414","type":"text","conversion_output":false,"parent_id":"8a4108aabe114dd8ac3ade1662cebdb4","text":"The rate of sling revision is calculated as the percentage of participants with indicator","text_display":"\nThe rate of sling revision is calculated as the percentage of participants with indicator","confidence":1,"confidence_rate":1},{"cnt":[[1186,1403],[1951,1403],[1951,1448],[1186,1448]],"region":{"top_left_x":1186,"top_left_y":1402,"width":765,"height":47},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98b76db354e745829c30525d397cf892","type":"text","conversion_output":false,"parent_id":"8a4108aabe114dd8ac3ade1662cebdb4","text":"equal to \"Yes\" among all non-missing indicators.","text_display":" equal to \"Yes\" among all non-missing indicators.","confidence":1,"confidence_rate":1},{"cnt":[[320,1489],[786,1489],[786,1624],[320,1624]],"region":{"top_left_x":319,"top_left_y":1489,"width":467,"height":135},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6d99463985841e99a22946fc1e88ea1","type":"complex_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","children_ids":["43dd7082577c4e0f82d0778849c39fce","e9151b800c6f4c0d868e3cfbb0f13707","ead0708a2129408abb094a55e2448000"],"text":"Change from Baseline IIQ Physical Activity Score at 12 Months","text_display":"Change from Baseline IIQ Physical Activity Score at 12 Months","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,1491],[742,1491],[742,1535],[324,1535]],"region":{"top_left_x":324,"top_left_y":1491,"width":419,"height":44},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43dd7082577c4e0f82d0778849c39fce","type":"text","conversion_output":false,"parent_id":"e6d99463985841e99a22946fc1e88ea1","text":"Change from Baseline IIQ","text_display":"Change from Baseline IIQ","confidence":1,"confidence_rate":1},{"cnt":[[324,1533],[781,1533],[781,1582],[324,1582]],"region":{"top_left_x":324,"top_left_y":1532,"width":458,"height":51},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9151b800c6f4c0d868e3cfbb0f13707","type":"text","conversion_output":false,"parent_id":"e6d99463985841e99a22946fc1e88ea1","text":"Physical Activity Score at 12","text_display":" Physical Activity Score at 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Months","confidence":1,"confidence_rate":1},{"cnt":[[814,1494],[998,1494],[998,1535],[814,1535]],"region":{"top_left_x":813,"top_left_y":1493,"width":185,"height":42},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba94e96006d94b9cbfe8a42fee31b027","type":"simple_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","text":"Continuous","text_display":"Continuous","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1182,1494],[2568,1494],[2568,1773],[1182,1773]],"region":{"top_left_x":1181,"top_left_y":1493,"width":1387,"height":281},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6ef9266b03a4061a3f7a1ba90c17e9a","type":"complex_cell","conversion_output":false,"parent_id":"62b21607540c44a7b52ae9477f353d55","children_ids":["46b3e35fc2bc4013a86f8f4a9b693b75","7332292691734e0d8417519e20325d71","c6db2e1209344ff3af61dfe9ac63da5d","809f4b95ffef4503b3c0ccbcf426eeef","012e292d37064068bbdbf0aac24582dd","22f33f73927140f29ebb02012645177f"],"text":"The 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If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline IIQ Travel Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Travel Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions F, G, H, I, J, and M ( \\(0=\\) Not at all, 1=Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline IIQ Social Relationships Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Social Relationships Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions K, L, N, O, P, Q, R, S, W, and X ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline IIQ Emotional Health Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Emotional Health Score will be computed at baseline, 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions T, V, Y, Z, AA, BB, CC, and DD, ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline & & (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline IIQ Travel Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Travel Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions F, G, H, I, J, and M ( \\(0=\\) Not at all, 1=Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline IIQ Social Relationships Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Social Relationships Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions K, L, N, O, P, Q, R, S, W, and X ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline IIQ Emotional Health Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Emotional Health Score will be computed at baseline, 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions T, V, Y, Z, AA, BB, CC, and DD, ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. 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Specifically, instructions are to average responses across questions F, G, H, I, J, and M ( \\(0=\\) Not at all, 1=Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The Incontinence Impact Questionnaire-Travel Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions F, G, H, I, J, and M ( \\(0=\\) Not at all, 1=Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.32561332677507027,"confidence_rate":0.9984036088952771},{"cnt":[[1186,541],[2522,541],[2522,586],[1186,586]],"region":{"top_left_x":1186,"top_left_y":540,"width":1337,"height":47},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e79b6e2ae4ca404aa5d809101eb174f7","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"The Incontinence Impact Questionnaire-Travel Score will be computed at baseline and","text_display":"The Incontinence Impact Questionnaire-Travel Score will be computed at baseline and","confidence":1,"confidence_rate":1},{"cnt":[[1191,584],[2466,584],[2466,630],[1191,630]],"region":{"top_left_x":1190,"top_left_y":584,"width":1276,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d30015f2c7647fcbc26449b780461c3","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically,","text_display":" 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically,","confidence":1,"confidence_rate":1},{"cnt":[[1186,627],[2537,627],[2537,673],[1186,673]],"region":{"top_left_x":1186,"top_left_y":627,"width":1352,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4365203511344bbd8b1a8aff84029687","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"instructions are to average responses across questions F, G, H, I, J, and M ( \\(0=\\) Not at all,","text_display":" instructions are to average responses across questions F, G, H, I, J, and M ( \\(0=\\) Not at all,","confidence":0.865234375,"confidence_rate":0.9985534986431099},{"cnt":[[1191,671],[2537,671],[2537,716],[1191,716]],"region":{"top_left_x":1190,"top_left_y":670,"width":1348,"height":47},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"910b3264ac5147cfb0dceb86ace4dd5f","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"1=Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are","text_display":" 1=Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are","confidence":0.32561332677507027,"confidence_rate":0.9887302003729759},{"cnt":[[1186,718],[2514,718],[2514,764],[1186,764]],"region":{"top_left_x":1186,"top_left_y":718,"width":1328,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b6259867ab14f93b58e79427b5bef02","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"missing, then the score will be calculated as the average of the non-missing responses.","text_display":" missing, then the score will be calculated as the average of the non-missing responses.","confidence":1,"confidence_rate":1},{"cnt":[[1186,762],[2544,762],[2544,805],[1186,805]],"region":{"top_left_x":1186,"top_left_y":761,"width":1358,"height":45},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62b7a46b62864f018a836a9687ccd4dc","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"The outcome will then be computed as the difference in score at 12 months (and 3 and 6","text_display":" The outcome will then be computed as the difference in score at 12 months (and 3 and 6","confidence":1,"confidence_rate":1},{"cnt":[[1186,805],[2529,805],[2529,851],[1186,851]],"region":{"top_left_x":1186,"top_left_y":805,"width":1343,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69ab5f4808be4839ac079da6e600dbd2","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"months) and the score at baseline. If data for an assessment time point are missing, the","text_display":" months) and the score at baseline. If data for an assessment time point are missing, the","confidence":1,"confidence_rate":1},{"cnt":[[1186,848],[1853,848],[1853,894],[1186,894]],"region":{"top_left_x":1186,"top_left_y":848,"width":668,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1b3a12e359f4cc2a1aa3a6289cc993c","type":"text","conversion_output":false,"parent_id":"1b9c2972d2b14604b02e7c35eb8e4ade","text":"outcome variable will be coded as missing.","text_display":" outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[324,931],[786,931],[786,1061],[324,1061]],"region":{"top_left_x":324,"top_left_y":930,"width":462,"height":131},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afcb8bd69ec44166a3c7f50c33a4cdaf","type":"complex_cell","conversion_output":false,"parent_id":"acdcb7843262461da22405e6af754f98","children_ids":["b128564fc01b4d619293fbc642ab24aa","921bec412fac48e3bb95fb742ed53067","9ddfd1ccaa8d4c828ae0875e9cedfd1a"],"text":"Change from Baseline IIQ Social Relationships Score at 12 Months","text_display":"Change from Baseline IIQ Social Relationships Score at 12 Months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[326,931],[738,931],[738,976],[326,976]],"region":{"top_left_x":326,"top_left_y":930,"width":412,"height":47},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b128564fc01b4d619293fbc642ab24aa","type":"text","conversion_output":false,"parent_id":"afcb8bd69ec44166a3c7f50c33a4cdaf","text":"Change from Baseline IIQ","text_display":"Change from Baseline IIQ","confidence":1,"confidence_rate":1},{"cnt":[[329,978],[781,978],[781,1019],[329,1019]],"region":{"top_left_x":328,"top_left_y":978,"width":454,"height":42},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"921bec412fac48e3bb95fb742ed53067","type":"text","conversion_output":false,"parent_id":"afcb8bd69ec44166a3c7f50c33a4cdaf","text":"Social Relationships Score at","text_display":" Social Relationships Score at","confidence":1,"confidence_rate":1},{"cnt":[[329,1022],[500,1022],[500,1058],[329,1058]],"region":{"top_left_x":328,"top_left_y":1021,"width":172,"height":38},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ddfd1ccaa8d4c828ae0875e9cedfd1a","type":"text","conversion_output":false,"parent_id":"afcb8bd69ec44166a3c7f50c33a4cdaf","text":"12 Months","text_display":" 12 Months","confidence":1,"confidence_rate":1},{"cnt":[[814,931],[998,931],[998,972],[814,972]],"region":{"top_left_x":813,"top_left_y":930,"width":185,"height":42},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7b6675774e04c3594fd1d7260af3f1e","type":"simple_cell","conversion_output":false,"parent_id":"acdcb7843262461da22405e6af754f98","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":[[1184,931],[2563,931],[2563,1288],[1184,1288]],"region":{"top_left_x":1184,"top_left_y":930,"width":1380,"height":358},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa8acf0ac02940fcad3d5c2f50005f05","type":"complex_cell","conversion_output":false,"parent_id":"acdcb7843262461da22405e6af754f98","children_ids":["18a0fc2e21104f1392a981ec49d56cd1","d73dba94613148bc99a2001544f0696a","353ca745205541dba64c045ca0a245ff","22106c37c9964563a674667052294057","9a0c236371c14a6d8e6d9c8bc81bfc79","f82c1c1c599043088b9a1afffb643164","bade484333d24656921e7779265ccf9c","ff1c5a3401c34c00b12e7af036af1c15"],"text":"The Incontinence Impact Questionnaire-Social Relationships Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions K, L, N, O, P, Q, R, S, W, and X ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The Incontinence Impact Questionnaire-Social Relationships Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions K, L, N, O, P, Q, R, S, W, and X ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.5667119927305142,"confidence_rate":0.9991808363788282},{"cnt":[[1186,933],[2537,933],[2537,976],[1186,976]],"region":{"top_left_x":1186,"top_left_y":932,"width":1352,"height":45},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18a0fc2e21104f1392a981ec49d56cd1","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"The Incontinence Impact Questionnaire-Social Relationships Score will be computed at","text_display":"The Incontinence Impact Questionnaire-Social Relationships Score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1186,978],[2466,978],[2466,1019],[1186,1019]],"region":{"top_left_x":1186,"top_left_y":978,"width":1280,"height":42},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d73dba94613148bc99a2001544f0696a","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm.","text_display":" baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm.","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[1188,1022],[2531,1022],[2531,1065],[1188,1065]],"region":{"top_left_x":1188,"top_left_y":1021,"width":1343,"height":44},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"353ca745205541dba64c045ca0a245ff","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"Specifically, instructions are to average responses across questions K, L, N, O, P, Q, R,","text_display":" Specifically, instructions are to average responses across questions K, L, N, O, P, Q, R,","confidence":0.89013671875,"confidence_rate":0.9987626787577681},{"cnt":[[1186,1065],[2531,1065],[2531,1110],[1186,1110]],"region":{"top_left_x":1186,"top_left_y":1064,"width":1345,"height":47},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22106c37c9964563a674667052294057","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"S, W, and X ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by","text_display":" S, W, and X ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by","confidence":0.5667119927305142,"confidence_rate":0.9947065454497571},{"cnt":[[1191,1108],[2518,1108],[2518,1154],[1191,1154]],"region":{"top_left_x":1190,"top_left_y":1108,"width":1328,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a0c236371c14a6d8e6d9c8bc81bfc79","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"100/3. If any responses are missing, then the score will be calculated as the average of","text_display":" 100/3. If any responses are missing, then the score will be calculated as the average of","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[1186,1152],[2561,1152],[2561,1197],[1186,1197]],"region":{"top_left_x":1186,"top_left_y":1151,"width":1376,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f82c1c1c599043088b9a1afffb643164","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"the non-missing responses. The outcome will then be computed as the difference in score","text_display":" the non-missing responses. The outcome will then be computed as the difference in score","confidence":1,"confidence_rate":1},{"cnt":[[1186,1197],[2518,1197],[2518,1240],[1186,1240]],"region":{"top_left_x":1186,"top_left_y":1196,"width":1332,"height":45},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bade484333d24656921e7779265ccf9c","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment","text_display":" at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment","confidence":1,"confidence_rate":1},{"cnt":[[1186,1240],[2269,1240],[2269,1284],[1186,1284]],"region":{"top_left_x":1186,"top_left_y":1240,"width":1083,"height":44},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff1c5a3401c34c00b12e7af036af1c15","type":"text","conversion_output":false,"parent_id":"aa8acf0ac02940fcad3d5c2f50005f05","text":"time point are missing, the outcome variable will be coded as missing.","text_display":" time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[320,1325],[742,1325],[742,1461],[320,1461]],"region":{"top_left_x":319,"top_left_y":1324,"width":424,"height":138},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a9a886ae5564c4ab9ebc8caec46ee4f","type":"complex_cell","conversion_output":false,"parent_id":"acdcb7843262461da22405e6af754f98","children_ids":["0ffd6a07437f4c5c93e5e83d00f701f3","58a8dab3271046aeb338de6c71677830","a6fe631a8f654d25893cdda4778e3c64"],"text":"Change from Baseline IIQ Emotional Health Score at 12 Months","text_display":"Change from Baseline IIQ Emotional Health Score at 12 Months","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,1329],[738,1329],[738,1375],[324,1375]],"region":{"top_left_x":324,"top_left_y":1329,"width":414,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ffd6a07437f4c5c93e5e83d00f701f3","type":"text","conversion_output":false,"parent_id":"0a9a886ae5564c4ab9ebc8caec46ee4f","text":"Change from Baseline IIQ","text_display":"Change from Baseline IIQ","confidence":1,"confidence_rate":1},{"cnt":[[326,1377],[742,1377],[742,1414],[326,1414]],"region":{"top_left_x":326,"top_left_y":1376,"width":417,"height":38},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58a8dab3271046aeb338de6c71677830","type":"text","conversion_output":false,"parent_id":"0a9a886ae5564c4ab9ebc8caec46ee4f","text":"Emotional Health Score at","text_display":" Emotional Health Score at","confidence":1,"confidence_rate":1},{"cnt":[[329,1416],[500,1416],[500,1457],[329,1457]],"region":{"top_left_x":328,"top_left_y":1415,"width":172,"height":42},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6fe631a8f654d25893cdda4778e3c64","type":"text","conversion_output":false,"parent_id":"0a9a886ae5564c4ab9ebc8caec46ee4f","text":"12 Months","text_display":" 12 Months","confidence":1,"confidence_rate":1},{"cnt":[[814,1329],[998,1329],[998,1370],[814,1370]],"region":{"top_left_x":813,"top_left_y":1329,"width":185,"height":42},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48eb0c5d17384987aa911907ac51e6fb","type":"simple_cell","conversion_output":false,"parent_id":"acdcb7843262461da22405e6af754f98","text":"Continuous","text_display":"Continuous","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,1325],[2563,1325],[2563,1686],[1184,1686]],"region":{"top_left_x":1184,"top_left_y":1324,"width":1380,"height":363},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f5a7058a82947d198b9bade24f328c9","type":"complex_cell","conversion_output":false,"parent_id":"acdcb7843262461da22405e6af754f98","children_ids":["1bea96b5185f436e90bd13c11a1bec59","54b0e4fad03243d1874eb6e85e435b16","224902e20363499ca28b5ee8ab8d57e7","e1d4590ef031485e802e7d412177c71c","8438ae0ab8394fb2ab69947498ebb214","03f98cc067da45b19d148789818f0de1","6593f721a3ad4b7e8af3000b172ad599","184cfed4f3fd4e618f7bca361ea4b5be"],"text":"The Incontinence Impact Questionnaire-Emotional Health Score will be computed at baseline, 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions T, V, Y, Z, AA, BB, CC, and DD, ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The Incontinence Impact Questionnaire-Emotional Health Score will be computed at baseline, 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to average responses across questions T, V, Y, Z, AA, BB, CC, and DD, ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by 100/3. If any responses are missing, then the score will be calculated as the average of the non-missing responses. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.543441809782379,"confidence_rate":0.9992813143208181},{"cnt":[[1186,1329],[2496,1329],[2496,1375],[1186,1375]],"region":{"top_left_x":1186,"top_left_y":1329,"width":1311,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bea96b5185f436e90bd13c11a1bec59","type":"text","conversion_output":false,"parent_id":"9f5a7058a82947d198b9bade24f328c9","text":"The Incontinence Impact Questionnaire-Emotional Health Score will be computed at","text_display":"The Incontinence Impact Questionnaire-Emotional Health Score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1186,1375],[2410,1375],[2410,1418],[1186,1418]],"region":{"top_left_x":1186,"top_left_y":1374,"width":1224,"height":44},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54b0e4fad03243d1874eb6e85e435b16","type":"text","conversion_output":false,"parent_id":"9f5a7058a82947d198b9bade24f328c9","text":"baseline, 12 months (and 3 and 6 months) using the standard scoring algorithm.","text_display":" baseline, 12 months (and 3 and 6 months) using the standard scoring algorithm.","confidence":1,"confidence_rate":1},{"cnt":[[1186,1416],[2537,1416],[2537,1461],[1186,1461]],"region":{"top_left_x":1186,"top_left_y":1415,"width":1352,"height":47},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"224902e20363499ca28b5ee8ab8d57e7","type":"text","conversion_output":false,"parent_id":"9f5a7058a82947d198b9bade24f328c9","text":"Specifically, instructions are to average responses across questions T, V, Y, Z, AA, BB,","text_display":" Specifically, instructions are to average responses across questions T, V, Y, Z, AA, BB,","confidence":0.9980475902557373,"confidence_rate":0.9999789860468112},{"cnt":[[1186,1459],[2544,1459],[2544,1509],[1186,1509]],"region":{"top_left_x":1186,"top_left_y":1459,"width":1358,"height":50},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1d4590ef031485e802e7d412177c71c","type":"text","conversion_output":false,"parent_id":"9f5a7058a82947d198b9bade24f328c9","text":"CC, and DD, ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by","text_display":" CC, and DD, ( \\(0=\\) Not at all, \\(1=\\) Slightly, \\(2=\\) Moderately, \\(3=\\) Greatly), and then multiply by","confidence":0.543441809782379,"confidence_rate":0.9943168400972431},{"cnt":[[1191,1507],[2518,1507],[2518,1552],[1191,1552]],"region":{"top_left_x":1190,"top_left_y":1506,"width":1328,"height":47},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8438ae0ab8394fb2ab69947498ebb214","type":"text","conversion_output":false,"parent_id":"9f5a7058a82947d198b9bade24f328c9","text":"100/3. 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The outcome will then be computed as the difference in score","confidence":1,"confidence_rate":1},{"cnt":[[1186,1593],[2520,1593],[2520,1639],[1186,1639]],"region":{"top_left_x":1186,"top_left_y":1593,"width":1335,"height":46},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6593f721a3ad4b7e8af3000b172ad599","type":"text","conversion_output":false,"parent_id":"9f5a7058a82947d198b9bade24f328c9","text":"at 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment","text_display":" at 12 months (and 3 and 6 months) and the score at baseline. 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Specifically, instructions are to sum the Physical Activity, Travel, Social Relationships, and Emotional Health subscale scores of the IIQ. If any subscale scores are missing, then no Total score will be calculated. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline EQ5D Total Score at 12 Months & Continuous & The EQ-5D Total Score will be computed at baseline and 12 months (and 3 and 6 months) using the algorithm obtained from https://archive.ahrq.gov/professionals/cliniciansproviders/resources/rice/EQ5Dscore.html. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline EQ5D Visual Analogue Scale (VAS) at 12 Months & Continuous & The EQ-5D VAS is the response to a single question from the EQ-5D. The outcome will then be computed as the difference in EQ-5D VAS at 12 months (and 3 and 6 months) and the EQ-5D VAS at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline PISQIR not sexually active partner related subscale score at 12 months & Continuous & The PISQ-IR not sexually active - partner related subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline IIQ Total Score at 12 Months & Continuous & The Incontinence Impact Questionnaire-Total Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum the Physical Activity, Travel, Social Relationships, and Emotional Health subscale scores of the IIQ. If any subscale scores are missing, then no Total score will be calculated. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline EQ5D Total Score at 12 Months & Continuous & The EQ-5D Total Score will be computed at baseline and 12 months (and 3 and 6 months) using the algorithm obtained from https://archive.ahrq.gov/professionals/cliniciansproviders/resources/rice/EQ5Dscore.html. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline EQ5D Visual Analogue Scale (VAS) at 12 Months & Continuous & The EQ-5D VAS is the response to a single question from the EQ-5D. The outcome will then be computed as the difference in EQ-5D VAS at 12 months (and 3 and 6 months) and the EQ-5D VAS at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline PISQIR not sexually active partner related subscale score at 12 months & Continuous & The PISQ-IR not sexually active - partner related subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. 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Specifically, instructions are to sum the Physical Activity, Travel, Social Relationships, and Emotional Health subscale scores of the IIQ. If any subscale scores are missing, then no Total score will be calculated. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The Incontinence Impact Questionnaire-Total Score will be computed at baseline and 12 months (and 3 and 6 months) using the standard scoring algorithm. Specifically, instructions are to sum the Physical Activity, Travel, Social Relationships, and Emotional Health subscale scores of the IIQ. If any subscale scores are missing, then no Total score will be calculated. The outcome will then be computed as the difference in Total score at 12 months (and 3 and 6 months) and the Total score at baseline. 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The outcome will then be computed as the difference in EQ-5D VAS at 12 months (and 3 and 6 months) and the EQ-5D VAS at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","text_display":"The EQ-5D VAS is the response to a single question from the EQ-5D. The outcome will then be computed as the difference in EQ-5D VAS at 12 months (and 3 and 6 months) and the EQ-5D VAS at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999986124995475},{"cnt":[[1191,1052],[2548,1052],[2548,1095],[1191,1095]],"region":{"top_left_x":1190,"top_left_y":1051,"width":1359,"height":45},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5977d2ea35544cba75053a1c2af7af4","type":"text","conversion_output":false,"parent_id":"df82854037cd4eb5b83f5c13c3ff7b33","text":"The EQ-5D VAS is the response to a single question from the EQ-5D. The outcome will","text_display":"The EQ-5D VAS is the response to a single question from the EQ-5D. 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If data for the assessment time point are missing, the","text_display":" and the EQ-5D VAS at baseline. If data for the assessment time point are missing, the","confidence":1,"confidence_rate":1},{"cnt":[[1191,1186],[1853,1186],[1853,1227],[1191,1227]],"region":{"top_left_x":1190,"top_left_y":1186,"width":664,"height":42},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cac597698487408f81a070167897ebf6","type":"text","conversion_output":false,"parent_id":"df82854037cd4eb5b83f5c13c3ff7b33","text":"outcome variable will be coded as missing.","text_display":" outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[322,1281],[786,1281],[786,1457],[322,1457]],"region":{"top_left_x":322,"top_left_y":1281,"width":464,"height":176},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cceb9e9460147b3b4e0f42e5bff40ef","type":"complex_cell","conversion_output":false,"parent_id":"97525ac878bf4ce298635c3d3bb585fc","children_ids":["c923883ca19f47c696c4a52ff9288688","e396b4211d774b7da15029e1d543fe4a","abed149196484f07915a457fe3a1394e","bf4715a42212477d85494603554a2ef1"],"text":"Change from Baseline PISQIR not sexually active partner related subscale score at 12 months","text_display":"Change from Baseline PISQIR not sexually active partner related subscale score at 12 months","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1286],[779,1286],[779,1327],[327,1327]],"region":{"top_left_x":326,"top_left_y":1285,"width":454,"height":42},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c923883ca19f47c696c4a52ff9288688","type":"text","conversion_output":false,"parent_id":"2cceb9e9460147b3b4e0f42e5bff40ef","text":"Change from Baseline PISQ-","text_display":"Change from Baseline PISQ","confidence":1,"confidence_rate":1},{"cnt":[[327,1329],[697,1329],[697,1370],[327,1370]],"region":{"top_left_x":326,"top_left_y":1329,"width":371,"height":42},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e396b4211d774b7da15029e1d543fe4a","type":"text","conversion_output":false,"parent_id":"2cceb9e9460147b3b4e0f42e5bff40ef","text":"IR not sexually active -","text_display":"IR not sexually active ","confidence":1,"confidence_rate":1},{"cnt":[[327,1372],[784,1372],[784,1416],[327,1416]],"region":{"top_left_x":326,"top_left_y":1372,"width":458,"height":44},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abed149196484f07915a457fe3a1394e","type":"text","conversion_output":false,"parent_id":"2cceb9e9460147b3b4e0f42e5bff40ef","text":"partner related subscale score","text_display":"partner related subscale score","confidence":1,"confidence_rate":1},{"cnt":[[327,1416],[532,1416],[532,1453],[327,1453]],"region":{"top_left_x":326,"top_left_y":1415,"width":207,"height":38},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf4715a42212477d85494603554a2ef1","type":"text","conversion_output":false,"parent_id":"2cceb9e9460147b3b4e0f42e5bff40ef","text":"at 12 months","text_display":" at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[816,1286],[996,1286],[996,1323],[816,1323]],"region":{"top_left_x":816,"top_left_y":1285,"width":180,"height":38},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22471dcf04c7490f96288ce4807ae254","type":"simple_cell","conversion_output":false,"parent_id":"97525ac878bf4ce298635c3d3bb585fc","text":"Continuous","text_display":"Continuous","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,1284],[2564,1284],[2564,1682],[1184,1682]],"region":{"top_left_x":1184,"top_left_y":1283,"width":1380,"height":400},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40935d28e6454586905c03a7c932b6de","type":"complex_cell","conversion_output":false,"parent_id":"97525ac878bf4ce298635c3d3bb585fc","children_ids":["40ac030cb5ae469d8718d58f8e667060","9b80c0f682814df1b8a45110782d1d8c","55f880dabe0f40fe9559629ff302f284","37a5485443584bbfaa8f9133b094704f","de8c4dd582e04c51b795b1722f013896","6328ec9320874d1d903cd3afe6bfe8b3","0b1ba7e8bbf54a3d9d7a831ca816b59d","edc843957fcb4a8f859beb937dfacc46","f8c8acb8a917488b9e572498e09c8bbd"],"text":"The PISQ-IR not sexually active - partner related subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point 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 baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9042563863331452,"confidence_rate":0.9998935058342923},{"cnt":[[1191,1286],[2494,1286],[2494,1327],[1191,1327]],"region":{"top_left_x":1190,"top_left_y":1285,"width":1305,"height":42},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40ac030cb5ae469d8718d58f8e667060","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","text":"The PISQ-IR not sexually active - partner related subscale score will be computed at","text_display":"The PISQ-IR not sexually active - partner related subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1191,1329],[2425,1329],[2425,1372],[1191,1372]],"region":{"top_left_x":1190,"top_left_y":1329,"width":1236,"height":44},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b80c0f682814df1b8a45110782d1d8c","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1372],[2559,1372],[2559,1416],[1189,1416]],"region":{"top_left_x":1188,"top_left_y":1372,"width":1372,"height":44},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55f880dabe0f40fe9559629ff302f284","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","text":"Specifically, instructions are to sum the scores for questions Q2a, Q2b (1=strongly agree,","text_display":" Specifically, instructions are to sum the scores for questions Q2a, Q2b (1=strongly agree,","confidence":1,"confidence_rate":1},{"cnt":[[1191,1416],[2559,1416],[2559,1461],[1191,1461]],"region":{"top_left_x":1190,"top_left_y":1415,"width":1370,"height":47},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37a5485443584bbfaa8f9133b094704f","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","text":"..., \\(4=\\) strongly disagree). If there is more than 1 missing response then a total score is not","text_display":" ..., \\(4=\\) strongly disagree). If there is more than 1 missing response then a total score is not","confidence":0.9042563863331452,"confidence_rate":0.9990419606834599},{"cnt":[[1189,1459],[2533,1459],[2533,1504],[1189,1504]],"region":{"top_left_x":1188,"top_left_y":1459,"width":1346,"height":46},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de8c4dd582e04c51b795b1722f013896","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","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":[[1189,1502],[2529,1502],[2529,1548],[1189,1548]],"region":{"top_left_x":1188,"top_left_y":1502,"width":1341,"height":46},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6328ec9320874d1d903cd3afe6bfe8b3","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","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":[[1191,1548],[2429,1548],[2429,1591],[1191,1591]],"region":{"top_left_x":1190,"top_left_y":1547,"width":1240,"height":45},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b1ba7e8bbf54a3d9d7a831ca816b59d","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","text":"score at 12 months (and 3 and 6 months) and the score at baseline. If data for an","text_display":" score at 12 months (and 3 and 6 months) and the score at baseline. If data for an","confidence":1,"confidence_rate":1},{"cnt":[[1191,1593],[2559,1593],[2559,1637],[1191,1637]],"region":{"top_left_x":1190,"top_left_y":1593,"width":1370,"height":44},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edc843957fcb4a8f859beb937dfacc46","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","text":"assessment time point are missing, the outcome variable will be coded as missing. Scores","text_display":" assessment time point are missing, the outcome variable will be coded as missing. Scores","confidence":1,"confidence_rate":1},{"cnt":[[1191,1637],[2254,1637],[2254,1682],[1191,1682]],"region":{"top_left_x":1190,"top_left_y":1636,"width":1064,"height":47},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8c8acb8a917488b9e572498e09c8bbd","type":"text","conversion_output":false,"parent_id":"40935d28e6454586905c03a7c932b6de","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":[[305,1927],[683,1927],[683,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":379,"height":35},"line":66,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b43ab8ad238e416c950261eac6d9b32a","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 30","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-32","page":32,"lines":[{"cnt":[[305,133],[810,133],[810,219],[305,219]],"region":{"top_left_x":305,"top_left_y":133,"width":505,"height":87},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8e11793a5ad34793b41e64ea57fb4156","type":"figure_label","conversion_output":false,"children_ids":["7908a968df2a41ce88e4e122cac032b4","fa7491933b2a44999e1aab9b639eb676"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7908a968df2a41ce88e4e122cac032b4","type":"text","conversion_output":false,"parent_id":"8e11793a5ad34793b41e64ea57fb4156","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fa7491933b2a44999e1aab9b639eb676","type":"text","conversion_output":false,"parent_id":"8e11793a5ad34793b41e64ea57fb4156","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,243],[2589,243],[2589,1815],[305,1815]],"region":{"top_left_x":305,"top_left_y":242,"width":2284,"height":1574},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a7c4644d9554db58b10d26176b6a9ac","type":"table","conversion_output":true,"children_ids":["e83460360a0140f3bc9bed9dcca5a168","0aba213d3a8f4e9bbcf7164ca950f997","6666c24ede65440d8ff701fb4efc373c","d45715e7758249e09797c0058a32f589","e3adf2c87e064bc4aaf718fdde09e482","0e532a546bce44cf9c312e351438aa76","e68c9b022c66489daa6211820459838f","4e96ada4996449c5921d04eb9ee49fce","ac3b066370f64676932086fd6284b2df","338636eaed7a4db1af5646534e098b35","c638f71996f44ff2a14ceb0aac3a85a4","e7c4497817914e1fbfb569420c1ec904","7b329fefb7324defad07e746ad28f63c","eb6d8b2b2bfa473a9b1e388440c41428","fe4258c411ff482891a9ab96e022156b","eb188ec093134cac972e1f8f6c89f2f9","3385292a1d88425d82b48a0df35d86cb","2c11a7d118604de19618b891f2a555d4","775a8fdd5fd74951821f4ee70060fa8c"],"selected_labels":["8e11793a5ad34793b41e64ea57fb4156"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline PISQIR not sexually active condition specific subscale score at 12 months & Continuous & The PISQ-IR not sexually active - condition specific subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline Change from Baseline PISQIR not sexually active global quality subscale score at 12 months & Continuous & The PISQ-IR not sexually active - global quality subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 4=\\) strongly disagree; Q6: \\(1=\\) not at all, \\(\\ldots, 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline Change from Baseline PISQIR not sexually active condition impact subscale score 12 months & Continuous & The PISQ-IR not sexually active - condition subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline PISQIR not sexually active condition specific subscale score at 12 months & Continuous & The PISQ-IR not sexually active - condition specific subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline Change from Baseline PISQIR not sexually active global quality subscale score at 12 months & Continuous & The PISQ-IR not sexually active - global quality subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 4=\\) strongly disagree; Q6: \\(1=\\) not at all, \\(\\ldots, 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. \\\\\n\\hline Change from Baseline PISQIR not sexually active condition impact subscale score 12 months & Continuous & The PISQ-IR not sexually active - condition subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active. 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PISQ-IR not sexually active - condition specific subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point 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 baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data for an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are not sexually active.","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8829664490354449,"confidence_rate":0.9998590978566353},{"cnt":[[1191,357],[2546,357],[2546,400],[1191,400]],"region":{"top_left_x":1190,"top_left_y":356,"width":1357,"height":45},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6191a4195af4db3934ba77ac3a99756","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","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":[[1189,400],[2425,400],[2425,443],[1189,443]],"region":{"top_left_x":1188,"top_left_y":400,"width":1238,"height":44},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db78c0390df64db48da9ee9b24107555","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":1,"confidence_rate":1},{"cnt":[[1191,446],[2542,446],[2542,487],[1191,487]],"region":{"top_left_x":1190,"top_left_y":445,"width":1352,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d24b5c97f5b45a7af22767c8b4b9b55","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"Specifically, instructions are to sum the scores for questions Q2c, Q2d, Q2e (1=strongly","text_display":" Specifically, instructions are to sum the scores for questions Q2c, Q2d, Q2e (1=strongly","confidence":1,"confidence_rate":1},{"cnt":[[1189,489],[2477,489],[2477,530],[1189,530]],"region":{"top_left_x":1188,"top_left_y":488,"width":1289,"height":43},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b35eba8e7954fba97e9db133e2408b4","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"agree, ..., \\(4=\\) strongly disagree). If there is more than 1 missing response then a total","text_display":" agree, ..., \\(4=\\) strongly disagree). If there is more than 1 missing response then a total","confidence":0.8829664490354449,"confidence_rate":0.9987435367222813},{"cnt":[[1191,532],[2542,532],[2542,575],[1191,575]],"region":{"top_left_x":1190,"top_left_y":532,"width":1352,"height":44},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b83222bbfd14c5f91424fa38548f997","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"score is not calculated. To handle missing values, the final score is obtained by dividing","text_display":" score is not calculated. To handle missing values, the final score is obtained by dividing","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[1189,575],[2501,575],[2501,619],[1189,619]],"region":{"top_left_x":1188,"top_left_y":575,"width":1313,"height":44},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bd0a6b73c694ceb9901097b1b5ef929","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"the sum by the number of items answered. The outcome will then be computed as the","text_display":" the sum by the number of items answered. The outcome will then be computed as the","confidence":1,"confidence_rate":1},{"cnt":[[1191,619],[2533,619],[2533,662],[1191,662]],"region":{"top_left_x":1190,"top_left_y":618,"width":1344,"height":45},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"def1bb734552447882ec0297f3089c08","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data","text_display":" difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data","confidence":1,"confidence_rate":1},{"cnt":[[1191,662],[2546,662],[2546,708],[1191,708]],"region":{"top_left_x":1190,"top_left_y":662,"width":1357,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a78ca7ac5bc4e2ea152cd6659b26258","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"for an assessment time point are missing, the outcome variable will be coded as missing.","text_display":" for an assessment time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[1191,710],[2364,710],[2364,751],[1191,751]],"region":{"top_left_x":1190,"top_left_y":709,"width":1175,"height":42},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"751f3c1c104d4706a9e6166bb538f929","type":"text","conversion_output":false,"parent_id":"7b329fefb7324defad07e746ad28f63c","text":"Scores should only be calculated for participants that are not sexually active.","text_display":" Scores should only be calculated for participants that are not sexually active.","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[324,799],[781,799],[781,972],[324,972]],"region":{"top_left_x":324,"top_left_y":798,"width":458,"height":174},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb6d8b2b2bfa473a9b1e388440c41428","type":"complex_cell","conversion_output":false,"parent_id":"1a7c4644d9554db58b10d26176b6a9ac","children_ids":["c316d3b2b95d46e5bf2c62d40ec3efdc","933a741a121e466d81009e1e02ae44bc","b6802e49574c4ca08573ab722307dbb2","a99bb9120a0d4677b63ee7a7ecf4ea32"],"text":"Change from Baseline PISQIR not sexually active global quality subscale score at 12 months","text_display":"Change from Baseline PISQIR not sexually active global quality subscale score at 12 months","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,801],[779,801],[779,842],[327,842]],"region":{"top_left_x":326,"top_left_y":800,"width":454,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c316d3b2b95d46e5bf2c62d40ec3efdc","type":"text","conversion_output":false,"parent_id":"eb6d8b2b2bfa473a9b1e388440c41428","text":"Change from Baseline PISQ-","text_display":"Change from Baseline PISQ","confidence":1,"confidence_rate":1},{"cnt":[[327,844],[697,844],[697,889],[327,889]],"region":{"top_left_x":326,"top_left_y":844,"width":371,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"933a741a121e466d81009e1e02ae44bc","type":"text","conversion_output":false,"parent_id":"eb6d8b2b2bfa473a9b1e388440c41428","text":"IR not sexually active -","text_display":"IR not sexually active ","confidence":1,"confidence_rate":1},{"cnt":[[327,889],[775,889],[775,933],[327,933]],"region":{"top_left_x":326,"top_left_y":889,"width":449,"height":44},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6802e49574c4ca08573ab722307dbb2","type":"text","conversion_output":false,"parent_id":"eb6d8b2b2bfa473a9b1e388440c41428","text":"global quality subscale score","text_display":"global quality subscale score","confidence":1,"confidence_rate":1},{"cnt":[[327,935],[532,935],[532,972],[327,972]],"region":{"top_left_x":326,"top_left_y":934,"width":207,"height":38},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a99bb9120a0d4677b63ee7a7ecf4ea32","type":"text","conversion_output":false,"parent_id":"eb6d8b2b2bfa473a9b1e388440c41428","text":"at 12 months","text_display":" at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[816,801],[996,801],[996,838],[816,838]],"region":{"top_left_x":816,"top_left_y":800,"width":180,"height":38},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe4258c411ff482891a9ab96e022156b","type":"simple_cell","conversion_output":false,"parent_id":"1a7c4644d9554db58b10d26176b6a9ac","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":[[1184,799],[2570,799],[2570,1288],[1184,1288]],"region":{"top_left_x":1184,"top_left_y":798,"width":1387,"height":490},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb188ec093134cac972e1f8f6c89f2f9","type":"complex_cell","conversion_output":false,"parent_id":"1a7c4644d9554db58b10d26176b6a9ac","children_ids":["12e78f98e8734f2a91ae2c99a99e28be","2a438a04ce714b92962ece2e31b4c708","16fe79d20e2c4eb59d331c004e273675","ef17128a6f78479189521e913d42937c","49731291303e4fae9850e477e0575281","2348c27c2792464da9ecc374b71c0f6d","c19915d3515944b79fcae7344169bcdd","f759d42abdf7401f804008d287dff624","e2c49eb0a25846758a5c50d5b85d25d7","b98dfd15aeac427784228022a6e744c1","7a9502a197c44089aaa0f46054639eee"],"text":"The PISQ-IR not sexually active - global quality subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 4=\\) strongly disagree; Q6: \\(1=\\) not at all, \\(\\ldots, 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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 - global quality subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 4=\\) strongly disagree; Q6: \\(1=\\) not at all, \\(\\ldots, 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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":0.5191158553808292,"confidence_rate":0.9994426341747323},{"cnt":[[1191,801],[2486,801],[2486,844],[1191,844]],"region":{"top_left_x":1190,"top_left_y":800,"width":1296,"height":45},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12e78f98e8734f2a91ae2c99a99e28be","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"The PISQ-IR not sexually active - global quality subscale score will be computed at","text_display":"The PISQ-IR not sexually active - global quality subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1191,844],[2425,844],[2425,889],[1191,889]],"region":{"top_left_x":1190,"top_left_y":844,"width":1236,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a438a04ce714b92962ece2e31b4c708","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":1,"confidence_rate":1},{"cnt":[[1191,889],[2486,889],[2486,933],[1191,933]],"region":{"top_left_x":1190,"top_left_y":889,"width":1296,"height":44},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16fe79d20e2c4eb59d331c004e273675","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"Specifically, instructions are to sum the scores for questions Q4a, Q4b, Q5a, and Q6","text_display":" Specifically, instructions are to sum the scores for questions Q4a, Q4b, Q5a, and Q6","confidence":1,"confidence_rate":1},{"cnt":[[1191,935],[2455,935],[2455,976],[1191,976]],"region":{"top_left_x":1190,"top_left_y":934,"width":1266,"height":43},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef17128a6f78479189521e913d42937c","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"using reverse scores for all but Q5a (Q4a and Q4b are Likert scales of 1 to 5; Q5a:","text_display":" using reverse scores for all but Q5a (Q4a and Q4b are Likert scales of 1 to 5; Q5a:","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[1193,978],[2566,978],[2566,1019],[1193,1019]],"region":{"top_left_x":1192,"top_left_y":978,"width":1374,"height":42},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49731291303e4fae9850e477e0575281","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"\\(1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree; Q6: \\(1=\\) not at all, \\(\\ldots, 4= a\\) lot). If there are more","text_display":" \\(1=\\) strongly agree, \\(\\ldots, 4=\\) strongly disagree; Q6: \\(1=\\) not at all, \\(\\ldots, 4= a\\) lot). If there are more","confidence":0.5191158553808292,"confidence_rate":0.9938913677395629},{"cnt":[[1189,1022],[2520,1022],[2520,1065],[1189,1065]],"region":{"top_left_x":1188,"top_left_y":1021,"width":1333,"height":44},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2348c27c2792464da9ecc374b71c0f6d","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"than 2 missing responses then a total score is not calculated. To handle missing values,","text_display":" than 2 missing responses then a total score is not calculated. To handle missing values,","confidence":1,"confidence_rate":1},{"cnt":[[1191,1065],[2499,1065],[2499,1110],[1191,1110]],"region":{"top_left_x":1190,"top_left_y":1064,"width":1309,"height":47},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c19915d3515944b79fcae7344169bcdd","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"the final score is obtained by dividing the sum by the number of items answered. The","text_display":" the final score is obtained by dividing the sum by the number of items answered. The","confidence":1,"confidence_rate":1},{"cnt":[[1191,1108],[2477,1108],[2477,1154],[1191,1154]],"region":{"top_left_x":1190,"top_left_y":1108,"width":1287,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f759d42abdf7401f804008d287dff624","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"outcome will then be computed as the difference in score at 12 months (and 3 and 6","text_display":" outcome will then be computed as the difference in score at 12 months (and 3 and 6","confidence":1,"confidence_rate":1},{"cnt":[[1189,1152],[2512,1152],[2512,1197],[1189,1197]],"region":{"top_left_x":1188,"top_left_y":1151,"width":1324,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2c49eb0a25846758a5c50d5b85d25d7","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"months) and the score at baseline. If data at an assessment time point are missing, the","text_display":" months) and the score at baseline. If data at an assessment time point are missing, the","confidence":1,"confidence_rate":1},{"cnt":[[1191,1197],[2421,1197],[2421,1240],[1191,1240]],"region":{"top_left_x":1190,"top_left_y":1196,"width":1231,"height":45},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b98dfd15aeac427784228022a6e744c1","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"outcome variable will be coded as missing. Scores should only be calculated for","text_display":" outcome variable will be coded as missing. Scores should only be calculated for","confidence":1,"confidence_rate":1},{"cnt":[[1189,1240],[1801,1240],[1801,1284],[1189,1284]],"region":{"top_left_x":1188,"top_left_y":1240,"width":614,"height":44},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a9502a197c44089aaa0f46054639eee","type":"text","conversion_output":false,"parent_id":"eb188ec093134cac972e1f8f6c89f2f9","text":"participants that are not sexually active.","text_display":" participants that are not sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[324,1329],[784,1329],[784,1504],[324,1504]],"region":{"top_left_x":324,"top_left_y":1329,"width":460,"height":176},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3385292a1d88425d82b48a0df35d86cb","type":"complex_cell","conversion_output":false,"parent_id":"1a7c4644d9554db58b10d26176b6a9ac","children_ids":["176cb1c7a3bd4dfe965d5e9f52bb50ce","7b43772992584332abaf6c5123e7d730","5877d9d91f5f44098b8424a0f18fa83a","720f6b0940bb454f93115c99cc266601"],"text":"Change from Baseline PISQIR not sexually active condition impact subscale score 12 months","text_display":"Change from Baseline PISQIR not sexually active condition impact subscale score 12 months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1333],[779,1333],[779,1379],[327,1379]],"region":{"top_left_x":326,"top_left_y":1333,"width":454,"height":46},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"176cb1c7a3bd4dfe965d5e9f52bb50ce","type":"text","conversion_output":false,"parent_id":"3385292a1d88425d82b48a0df35d86cb","text":"Change from Baseline PISQ-","text_display":"Change from Baseline PISQ","confidence":1,"confidence_rate":1},{"cnt":[[327,1381],[699,1381],[699,1422],[327,1422]],"region":{"top_left_x":326,"top_left_y":1381,"width":374,"height":42},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b43772992584332abaf6c5123e7d730","type":"text","conversion_output":false,"parent_id":"3385292a1d88425d82b48a0df35d86cb","text":"IR not sexually active -","text_display":"IR not sexually active ","confidence":1,"confidence_rate":1},{"cnt":[[327,1422],[732,1422],[732,1466],[327,1466]],"region":{"top_left_x":326,"top_left_y":1422,"width":406,"height":44},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5877d9d91f5f44098b8424a0f18fa83a","type":"text","conversion_output":false,"parent_id":"3385292a1d88425d82b48a0df35d86cb","text":"condition impact subscale","text_display":"condition impact subscale","confidence":1,"confidence_rate":1},{"cnt":[[327,1468],[584,1468],[584,1504],[327,1504]],"region":{"top_left_x":326,"top_left_y":1467,"width":259,"height":38},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"720f6b0940bb454f93115c99cc266601","type":"text","conversion_output":false,"parent_id":"3385292a1d88425d82b48a0df35d86cb","text":"score 12 months","text_display":" score 12 months","confidence":1,"confidence_rate":1},{"cnt":[[816,1333],[996,1333],[996,1370],[816,1370]],"region":{"top_left_x":816,"top_left_y":1333,"width":180,"height":38},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c11a7d118604de19618b891f2a555d4","type":"simple_cell","conversion_output":false,"parent_id":"1a7c4644d9554db58b10d26176b6a9ac","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":[[1184,1329],[2566,1329],[2566,1777],[1184,1777]],"region":{"top_left_x":1184,"top_left_y":1329,"width":1382,"height":449},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"775a8fdd5fd74951821f4ee70060fa8c","type":"complex_cell","conversion_output":false,"parent_id":"1a7c4644d9554db58b10d26176b6a9ac","children_ids":["19273608f69143288ca3f875e9f2cfc9","47b9b676b6ef4e39b7bb665e2a26a85c","d75a803ab32549e4959475ab1e5cf2f1","adafaae1ed304eeb9b9a9b2198b9f0e0","6ed6db80562541659aa0cb3ad01ab525","fc19540ee26248d28e5d1dee408b8e76","b33ea21a480b420c9a56cb674598f18f","28454814a39b45fab9cdb859c4fce2c8","9f782be98d604bc5a20688dc23b3a2b3","337365020d9e49eabcf3da7a6e71c107"],"text":"The PISQ-IR not sexually active - condition subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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 baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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":0.6848324157837149,"confidence_rate":0.9996000246221632},{"cnt":[[1189,1336],[2553,1336],[2553,1379],[1189,1379]],"region":{"top_left_x":1188,"top_left_y":1335,"width":1365,"height":44},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19273608f69143288ca3f875e9f2cfc9","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"The PISQ-IR not sexually active - condition subscale score will be computed at baseline","text_display":"The PISQ-IR not sexually active - condition subscale score will be computed at baseline","confidence":1,"confidence_rate":1},{"cnt":[[1189,1379],[2501,1379],[2501,1422],[1189,1422]],"region":{"top_left_x":1188,"top_left_y":1378,"width":1313,"height":45},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47b9b676b6ef4e39b7bb665e2a26a85c","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically,","text_display":" and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically,","confidence":1,"confidence_rate":1},{"cnt":[[1191,1424],[2561,1424],[2561,1466],[1191,1466]],"region":{"top_left_x":1190,"top_left_y":1424,"width":1372,"height":42},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d75a803ab32549e4959475ab1e5cf2f1","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"instructions are to sum the scores for questions Q3, Q5b, Q5c using reverse scores for Q3","text_display":" instructions are to sum the scores for questions Q3, Q5b, Q5c using reverse scores for Q3","confidence":1,"confidence_rate":1},{"cnt":[[1191,1468],[2525,1468],[2525,1511],[1191,1511]],"region":{"top_left_x":1190,"top_left_y":1467,"width":1335,"height":44},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adafaae1ed304eeb9b9a9b2198b9f0e0","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"(Q3: 1=not at all, ..., 4=a lot; Q5b, Q5c: 1=strongly agree, ..., 4=strongly disagree). If","text_display":" (Q3: 1=not at all, ..., 4=a lot; Q5b, Q5c: 1=strongly agree, ..., 4=strongly disagree). If","confidence":0.6848324157837149,"confidence_rate":0.9960228654200335},{"cnt":[[1189,1511],[2473,1511],[2473,1554],[1189,1554]],"region":{"top_left_x":1188,"top_left_y":1510,"width":1285,"height":45},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ed6db80562541659aa0cb3ad01ab525","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"there is more than 1 missing response then a total score is not calculated. To handle","text_display":" there is more than 1 missing response then a total score is not calculated. To handle","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[1189,1554],[2512,1554],[2512,1600],[1189,1600]],"region":{"top_left_x":1188,"top_left_y":1554,"width":1324,"height":46},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc19540ee26248d28e5d1dee408b8e76","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"missing values, the final score is obtained by dividing the sum by the number of items","text_display":" missing values, the final score is obtained by dividing the sum by the number of items","confidence":1,"confidence_rate":1},{"cnt":[[1189,1598],[2512,1598],[2512,1643],[1189,1643]],"region":{"top_left_x":1188,"top_left_y":1597,"width":1324,"height":47},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b33ea21a480b420c9a56cb674598f18f","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"answered. The outcome will then be computed as the difference in score at 12 months","text_display":" answered. The outcome will then be computed as the difference in score at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[1189,1641],[2516,1641],[2516,1686],[1189,1686]],"region":{"top_left_x":1188,"top_left_y":1640,"width":1328,"height":47},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28454814a39b45fab9cdb859c4fce2c8","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"(and 3 and 6 months) and the score at baseline. If data at an assessment time point are","text_display":" (and 3 and 6 months) and the score at baseline. If data at an assessment time point are","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[1189,1686],[2559,1686],[2559,1730],[1189,1730]],"region":{"top_left_x":1188,"top_left_y":1686,"width":1372,"height":44},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f782be98d604bc5a20688dc23b3a2b3","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","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":[[1189,1732],[1855,1732],[1855,1773],[1189,1773]],"region":{"top_left_x":1188,"top_left_y":1731,"width":668,"height":43},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"337365020d9e49eabcf3da7a6e71c107","type":"text","conversion_output":false,"parent_id":"775a8fdd5fd74951821f4ee70060fa8c","text":"for participants that are not sexually active.","text_display":" for participants that are not sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[681,1927],[681,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":377,"height":35},"line":66,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c36b41ddd6314d02a15dc0ff7fddfef5","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 31","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-33","page":33,"lines":[{"cnt":[[305,133],[810,133],[810,219],[305,219]],"region":{"top_left_x":305,"top_left_y":133,"width":505,"height":87},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1e08fa13e5c144e5be850dd31aee06b5","type":"figure_label","conversion_output":false,"children_ids":["08dc5185cf924fb387b3aed1b5ce1afa","8de3156c5b4e4a278e743acf5c6bf053"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"08dc5185cf924fb387b3aed1b5ce1afa","type":"text","conversion_output":false,"parent_id":"1e08fa13e5c144e5be850dd31aee06b5","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8de3156c5b4e4a278e743acf5c6bf053","type":"text","conversion_output":false,"parent_id":"1e08fa13e5c144e5be850dd31aee06b5","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,243],[2589,243],[2589,1815],[305,1815]],"region":{"top_left_x":305,"top_left_y":242,"width":2284,"height":1574},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7797f506932402d845e395f89be7814","type":"table","conversion_output":true,"children_ids":["02b3f051fe124cc19c4d8769df85add8","493aa16ead0349589c72ed5e393d7ddd","2e40aaa0cda2480abe45f1a8e9ac9e60","ecaaaf270d824ee58c01aa84b94f3e52","7035d807c0c94e7f86cfc2baad9e1e3c","07acf78d9b3241cdab907afe923993fc","5fc2d3da4d6b4f48be0fda3e65085d35","bc271f4061f149a5ad7028a18f9d0a79","c9fae54ed4ec406a8c358444d4eb2283","edca1c20c91c40f1973e73bfb0a39022","ab5657a66b404bb68bc4926089c2b4b0","9d7912e8171c44bbbebe77a75f3244b8","57bb87a9a66f46cd95869ead7615e15e","55672da78ae449ae84859f10ae720669","198c6ad93d604ba2817c711d9c4e22e2","9d2d815b235b4690a6cb08a38566c4b4","9571fb906e5041f081fc16a637e94322","da4c5dd0d26841b59147faedfae73575","654091ae1e9c4a7e95aaf8270a7f47b6"],"selected_labels":["1e08fa13e5c144e5be850dd31aee06b5"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline PISQIR sexually active - arousal, orgasm subscale score change from baseline at 12 months & Continuous & The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 5=\\) much more intense; check box response to \\(Q 1=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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active condition specific subscale score at 12 months & Continuous & The PISQ-IR sexually active - condition specific subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active - partner related subscale score at 12 months & Continuous & The PISQ-IR sexually active - partner related subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline PISQIR sexually active - arousal, orgasm subscale score change from baseline at 12 months & Continuous & The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 5=\\) much more intense; check box response to \\(Q 1=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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active condition specific subscale score at 12 months & Continuous & The PISQ-IR sexually active - condition specific subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active - partner related subscale score at 12 months & Continuous & The PISQ-IR sexually active - partner related subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. 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arousal, orgasm subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 5=\\) much more intense; check box response to \\(Q 1=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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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 baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, \\(\\ldots, 5=\\) much more intense; check box response to \\(Q 1=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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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":0.44033644143529616,"confidence_rate":0.9990918301676442},{"cnt":[[1189,355],[2460,355],[2460,400],[1189,400]],"region":{"top_left_x":1188,"top_left_y":354,"width":1272,"height":47},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e478b3e1bb90403da0e4cbfd0bd0d149","type":"text","conversion_output":false,"parent_id":"57bb87a9a66f46cd95869ead7615e15e","text":"The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at","text_display":"The PISQ-IR sexually active - arousal, orgasm subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1189,400],[2425,400],[2425,443],[1189,443]],"region":{"top_left_x":1188,"top_left_y":400,"width":1238,"height":44},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbef7b44ce04480b96caf57346387f58","type":"text","conversion_output":false,"parent_id":"57bb87a9a66f46cd95869ead7615e15e","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[1191,443],[2483,443],[2483,487],[1191,487]],"region":{"top_left_x":1190,"top_left_y":443,"width":1294,"height":44},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"190abff0a9704d968c3d6602e543b275","type":"text","conversion_output":false,"parent_id":"57bb87a9a66f46cd95869ead7615e15e","text":"Specifically, instructions are to sum the scores for questions Q7, Q8a, Q10, and Q11","text_display":" Specifically, instructions are to sum the scores for questions Q7, Q8a, Q10, and Q11","confidence":1,"confidence_rate":1},{"cnt":[[1189,489],[2473,489],[2473,532],[1189,532]],"region":{"top_left_x":1188,"top_left_y":488,"width":1285,"height":45},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be0f5c92962b49bfbf0b1a3020651486","type":"text","conversion_output":false,"parent_id":"57bb87a9a66f46cd95869ead7615e15e","text":"using reverse scores for Q11 (Q7, Q8a, Q11: 1=never, ..., \\(5=[\\) almost \\(]\\) always; Q10:","text_display":" using reverse scores for Q11 (Q7, Q8a, Q11: 1=never, ..., \\(5=[\\) almost \\(]\\) always; Q10:","confidence":0.44033644143529616,"confidence_rate":0.9913122541681725},{"cnt":[[1193,532],[2512,532],[2512,575],[1193,575]],"region":{"top_left_x":1192,"top_left_y":532,"width":1320,"height":44},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d4f8cc45d7d492f951f684a21576950","type":"text","conversion_output":false,"parent_id":"57bb87a9a66f46cd95869ead7615e15e","text":"\\(1=\\) much less intense, \\(\\ldots, 5=\\) much more intense; check box response to \\(Q 1=1\\) ). If there","text_display":" \\(1=\\) much less intense, \\(\\ldots, 5=\\) much more intense; check box response to \\(Q 1=1\\) ). If there","confidence":0.8859595086079791,"confidence_rate":0.998752489811623},{"cnt":[[1189,575],[2551,575],[2551,619],[1189,619]],"region":{"top_left_x":1188,"top_left_y":575,"width":1363,"height":44},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50ee7ca185aa4bdf8bcfc385b4434377","type":"text","conversion_output":false,"parent_id":"57bb87a9a66f46cd95869ead7615e15e","text":"are more than 2 missing responses then a total score is not calculated. To handle missing","text_display":" are more than 2 missing responses then a total score is not calculated. 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If data at an assessment time point are missing, the","text_display":" months) and the score at baseline. If data at an assessment time point are missing, the","confidence":1,"confidence_rate":1},{"cnt":[[1189,753],[2421,753],[2421,799],[1189,799]],"region":{"top_left_x":1188,"top_left_y":753,"width":1233,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d06d8e7f91ba47ccb9cb861ea1d29a8f","type":"text","conversion_output":false,"parent_id":"57bb87a9a66f46cd95869ead7615e15e","text":"outcome variable will be coded as missing. Scores should only be calculated for","text_display":" outcome variable will be coded as missing. 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Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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 baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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":0.7673797639581608,"confidence_rate":0.9997197872786954},{"cnt":[[1189,889],[2490,889],[2490,933],[1189,933]],"region":{"top_left_x":1188,"top_left_y":889,"width":1302,"height":44},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8138e1ab6b4d4f6ba32689ae4e2893fc","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"The PISQ-IR sexually active - condition specific subscale score will be computed at","text_display":"The PISQ-IR sexually active - condition specific subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1189,931],[2425,931],[2425,976],[1189,976]],"region":{"top_left_x":1188,"top_left_y":930,"width":1238,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76fb3c0664c34df5903fe15b9f79c1eb","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":1,"confidence_rate":1},{"cnt":[[1189,978],[2551,978],[2551,1024],[1189,1024]],"region":{"top_left_x":1188,"top_left_y":978,"width":1363,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4111ccd7c35495ab1215967b007f741","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"Specifically, instructions are to sum the scores for questions Q8b, Q8c, Q9 using reverse","text_display":" Specifically, instructions are to sum the scores for questions Q8b, Q8c, Q9 using reverse","confidence":1,"confidence_rate":1},{"cnt":[[1189,1022],[2503,1022],[2503,1067],[1189,1067]],"region":{"top_left_x":1188,"top_left_y":1021,"width":1315,"height":47},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e3dcbcb8a9e4c0685a820359ac8f768","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"scores for all (Q8b, Q8c, Q9: 1=never, ..., \\(5=\\) [almost] always). If there is more than 1","text_display":" scores for all (Q8b, Q8c, Q9: 1=never, ..., \\(5=\\) [almost] always). If there is more than 1","confidence":0.7673797639581608,"confidence_rate":0.9972167911574433},{"cnt":[[1189,1065],[2542,1065],[2542,1110],[1189,1110]],"region":{"top_left_x":1188,"top_left_y":1064,"width":1354,"height":47},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18865395e6954a42908514be44cfaf1f","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"missing response then a total score is not calculated. To handle missing values, the final","text_display":" missing response then a total score is not calculated. To handle missing values, the final","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[1189,1108],[2507,1108],[2507,1154],[1189,1154]],"region":{"top_left_x":1188,"top_left_y":1108,"width":1320,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6587c0d5af414470b2728ee6bcce6249","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","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":[[1189,1152],[2535,1152],[2535,1197],[1189,1197]],"region":{"top_left_x":1188,"top_left_y":1151,"width":1348,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1730311ee9454f228f5ac43ccb552226","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"will then be computed as the difference in score at 12 months (and 3 and 6 months) and","text_display":" will then be computed as the difference in score at 12 months (and 3 and 6 months) and","confidence":1,"confidence_rate":1},{"cnt":[[1189,1197],[2455,1197],[2455,1240],[1189,1240]],"region":{"top_left_x":1188,"top_left_y":1196,"width":1268,"height":45},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cda897ec47704d6c8508f5b6a6a3eca8","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"the score at baseline. If data at an assessment time point are missing, the outcome","text_display":" the score at baseline. If data at an assessment time point are missing, the outcome","confidence":1,"confidence_rate":1},{"cnt":[[1189,1240],[2533,1240],[2533,1286],[1189,1286]],"region":{"top_left_x":1188,"top_left_y":1240,"width":1346,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"595ae2c805e44b0884dcfa0805d44527","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","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":1,"confidence_rate":1},{"cnt":[[1189,1286],[1490,1286],[1490,1329],[1189,1329]],"region":{"top_left_x":1188,"top_left_y":1285,"width":302,"height":45},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c825b4edcdb94092832128d590fe3cb2","type":"text","conversion_output":false,"parent_id":"9d2d815b235b4690a6cb08a38566c4b4","text":"are sexually active.","text_display":" are sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[322,1372],[784,1372],[784,1552],[322,1552]],"region":{"top_left_x":322,"top_left_y":1372,"width":462,"height":181},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9571fb906e5041f081fc16a637e94322","type":"complex_cell","conversion_output":false,"parent_id":"b7797f506932402d845e395f89be7814","children_ids":["b28ad7ffd0764d928d622593a22eaf65","ae48d05c36a240a78f98452ff34b0923","5eb945eb5a4043a1ac030d8e6853a782","afe76df0faba426485c1c31c40dcf3f9"],"text":"Change from Baseline PISQIR sexually active - partner related subscale score at 12 months","text_display":"Change from Baseline PISQIR sexually active - partner related subscale score at 12 months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1377],[779,1377],[779,1422],[327,1422]],"region":{"top_left_x":326,"top_left_y":1376,"width":454,"height":47},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b28ad7ffd0764d928d622593a22eaf65","type":"text","conversion_output":false,"parent_id":"9571fb906e5041f081fc16a637e94322","text":"Change from Baseline PISQ-","text_display":"Change from Baseline PISQ","confidence":1,"confidence_rate":1},{"cnt":[[327,1422],[758,1422],[758,1466],[327,1466]],"region":{"top_left_x":326,"top_left_y":1422,"width":432,"height":44},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae48d05c36a240a78f98452ff34b0923","type":"text","conversion_output":false,"parent_id":"9571fb906e5041f081fc16a637e94322","text":"IR sexually active - partner","text_display":"IR sexually active - partner","confidence":1,"confidence_rate":1},{"cnt":[[327,1468],[753,1468],[753,1504],[327,1504]],"region":{"top_left_x":326,"top_left_y":1467,"width":428,"height":38},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eb945eb5a4043a1ac030d8e6853a782","type":"text","conversion_output":false,"parent_id":"9571fb906e5041f081fc16a637e94322","text":"related subscale score at 12","text_display":" related subscale score at 12","confidence":1,"confidence_rate":1},{"cnt":[[327,1511],[446,1511],[446,1548],[327,1548]],"region":{"top_left_x":326,"top_left_y":1510,"width":120,"height":38},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afe76df0faba426485c1c31c40dcf3f9","type":"text","conversion_output":false,"parent_id":"9571fb906e5041f081fc16a637e94322","text":"months","text_display":" months","confidence":1,"confidence_rate":1},{"cnt":[[815,1414],[816,1375],[996,1378],[996,1417]],"region":{"top_left_x":815,"top_left_y":1375,"width":182,"height":42},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da4c5dd0d26841b59147faedfae73575","type":"simple_cell","conversion_output":false,"parent_id":"b7797f506932402d845e395f89be7814","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":[[1184,1372],[2559,1372],[2559,1777],[1184,1777]],"region":{"top_left_x":1184,"top_left_y":1372,"width":1376,"height":406},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"654091ae1e9c4a7e95aaf8270a7f47b6","type":"complex_cell","conversion_output":false,"parent_id":"b7797f506932402d845e395f89be7814","children_ids":["7267d2460d9142c38de06b41f9809648","bbd56bc2d6c04510bb102b2d943f85e7","2c2d1e65519746899a103ad0c1adfa15","1e5a47bc05e841b9baaa5af9663a9f14","abac5a24b53a4c92a2b0bdcec52dc038","a6f1bff6ac164a19bb0297a22c089374","26fa1d78811848318042f74177197534","bfa120ba7f954b96bee643e32fdf17c9","7f08a5b47e1d4a398d4783a2b495a2b8"],"text":"The PISQ-IR sexually active - partner related subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be","text_display":"The PISQ-IR sexually active - partner related subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.7509073404015163,"confidence_rate":0.999636798548464},{"cnt":[[1189,1377],[2438,1377],[2438,1422],[1189,1422]],"region":{"top_left_x":1188,"top_left_y":1376,"width":1251,"height":47},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7267d2460d9142c38de06b41f9809648","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"The PISQ-IR sexually active - partner related subscale score will be computed at","text_display":"The PISQ-IR sexually active - partner related subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1189,1422],[2425,1422],[2425,1466],[1189,1466]],"region":{"top_left_x":1188,"top_left_y":1422,"width":1238,"height":44},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbd56bc2d6c04510bb102b2d943f85e7","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1466],[2490,1466],[2490,1511],[1189,1511]],"region":{"top_left_x":1188,"top_left_y":1465,"width":1302,"height":46},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c2d1e65519746899a103ad0c1adfa15","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"Specifically, instructions are to sum the scores for questions Q13, Q14a, Q14b using","text_display":" Specifically, instructions are to sum the scores for questions Q13, Q14a, Q14b using","confidence":1,"confidence_rate":1},{"cnt":[[1189,1511],[2481,1511],[2481,1554],[1189,1554]],"region":{"top_left_x":1188,"top_left_y":1510,"width":1294,"height":45},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e5a47bc05e841b9baaa5af9663a9f14","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"reverse scores for Q14a and Q14b (Q13: 1=all of the time, ..., 4=hardly ever/rarely;","text_display":" reverse scores for Q14a and Q14b (Q13: 1=all of the time, ..., 4=hardly ever/rarely;","confidence":0.9892578125,"confidence_rate":0.9998786556622493},{"cnt":[[1189,1554],[2466,1554],[2466,1600],[1189,1600]],"region":{"top_left_x":1188,"top_left_y":1554,"width":1279,"height":46},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abac5a24b53a4c92a2b0bdcec52dc038","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"Q14a, Q14b: 1=very positive, ..., 4=very negative). If there is more than 1 missing","text_display":" Q14a, Q14b: 1=very positive, ..., 4=very negative). If there is more than 1 missing","confidence":0.7509073404015163,"confidence_rate":0.9968568948041049},{"cnt":[[1189,1598],[2538,1598],[2538,1643],[1189,1643]],"region":{"top_left_x":1188,"top_left_y":1597,"width":1350,"height":47},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6f1bff6ac164a19bb0297a22c089374","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"response then a total score is not calculated. To handle missing values, the final score is","text_display":" response then a total score is not calculated. To handle missing values, the final score is","confidence":1,"confidence_rate":1},{"cnt":[[1189,1641],[2525,1641],[2525,1686],[1189,1686]],"region":{"top_left_x":1188,"top_left_y":1640,"width":1337,"height":47},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26fa1d78811848318042f74177197534","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"obtained by dividing the sum by the number of items answered. The outcome will then","text_display":" obtained by dividing the sum by the number of items answered. The outcome will then","confidence":1,"confidence_rate":1},{"cnt":[[1189,1684],[2538,1684],[2538,1730],[1189,1730]],"region":{"top_left_x":1188,"top_left_y":1684,"width":1350,"height":46},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfa120ba7f954b96bee643e32fdf17c9","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"be computed as the difference in score at 12 months (and 3 and 6 months) and the score","text_display":" be computed as the difference in score at 12 months (and 3 and 6 months) and the score","confidence":1,"confidence_rate":1},{"cnt":[[1189,1728],[2553,1728],[2553,1773],[1189,1773]],"region":{"top_left_x":1188,"top_left_y":1727,"width":1365,"height":47},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f08a5b47e1d4a398d4783a2b495a2b8","type":"text","conversion_output":false,"parent_id":"654091ae1e9c4a7e95aaf8270a7f47b6","text":"at baseline. If data at an assessment time point are missing, the outcome variable will be","text_display":" at baseline. If data at an assessment time point are missing, the outcome variable will be","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[683,1927],[683,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":379,"height":35},"line":67,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f551e56a6b404a66b76bd48d71b5accd","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 32","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-34","page":34,"lines":[{"cnt":[[305,133],[810,133],[810,219],[305,219]],"region":{"top_left_x":305,"top_left_y":133,"width":505,"height":87},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1153fd831834448ab78ce0267bfceba3","type":"figure_label","conversion_output":false,"children_ids":["a9869e30d1a94c29ad11f18e84683bf2","02587296bc8d4694a38e7c4d75257366"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a9869e30d1a94c29ad11f18e84683bf2","type":"text","conversion_output":false,"parent_id":"1153fd831834448ab78ce0267bfceba3","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"02587296bc8d4694a38e7c4d75257366","type":"text","conversion_output":false,"parent_id":"1153fd831834448ab78ce0267bfceba3","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,243],[2589,243],[2589,1781],[305,1781]],"region":{"top_left_x":305,"top_left_y":242,"width":2284,"height":1540},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a94a652d97a04df98629140a9038aaad","type":"table","conversion_output":true,"children_ids":["8b7234b93fab45f385e865b0215a5cdb","b8a5373bde1a4a57a61b42847edc0e79","947933aaccf44378895da4dca8177dcb","80e384815ac64ff9b5fa4331f2326b00","21d03033d980487f946ff88890580248","0eb88a3cebaf4101b85ef5d2f8c7c00c","73c543c5f8194ce6bdaeffe3488ab904","4b1c056234794afda2ac2287fe0de756","afcbc99972e3442faec0a7e30a1abd4d","46b4333a419c421c95d5d839769ec7aa","a959cfacec814f7f96f22fa33bc3fdea","e994d554743e4baebd86c2203f513a17","22fdc21ad8da4d1ca210e12d6705116d","6c47f06ca8df4888a4910c66a47b4668","4598e8b8e52d41b6810f9cdd4d1bdd02","71fbb8fbc9a0425bac89a14ffc105c3e","6d3cd16feec04dd4ab27cffe4b348073","8ed44cf150c04d9a9bf04b5b0bd5c255","a73df7678697479b857b8d01b0859e48","e329a0f977e34e35851535104fce6b8a","5786b4b1d98f4ea3b64174c1de39cb6b"],"selected_labels":["1153fd831834448ab78ce0267bfceba3"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline & & coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner. \\\\\n\\hline Change from Baseline PISQIR sexually active - desire subscale score at 12 months & Continuous & The PISQ-IR sexually active - desire subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: 1=never, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active condition impact subscale score at 12 months & Continuous & The PISQ-IR sexually active - condition impact subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active - global quality rating subscale score at 12 months & Continuous & The PISQ-IR sexually active - global quality rating subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied, ..., 5=dissatisfied; Q20a: 1=strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline & & coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner. \\\\\n\\hline Change from Baseline PISQIR sexually active - desire subscale score at 12 months & Continuous & The PISQ-IR sexually active - desire subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: 1=never, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active condition impact subscale score at 12 months & Continuous & The PISQ-IR sexually active - condition impact subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline PISQIR sexually active - global quality rating subscale score at 12 months & Continuous & The PISQ-IR sexually active - global quality rating subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied, ..., 5=dissatisfied; Q20a: 1=strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.6387023871417352,"confidence_rate":0.9998735003344058},{"cnt":[[311,242],[786,241],[788,1782],[314,1782]],"region":{"top_left_x":311,"top_left_y":241,"width":477,"height":1542},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b7234b93fab45f385e865b0215a5cdb","type":"table_column","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[803,242],[1009,242],[1009,1782],[803,1782]],"region":{"top_left_x":803,"top_left_y":242,"width":206,"height":1540},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8a5373bde1a4a57a61b42847edc0e79","type":"table_column","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[1178,242],[2568,242],[2568,1782],[1178,1782]],"region":{"top_left_x":1177,"top_left_y":242,"width":1391,"height":1540},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"947933aaccf44378895da4dca8177dcb","type":"table_column","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[305,251],[2590,251],[2590,305],[305,305]],"region":{"top_left_x":305,"top_left_y":250,"width":2285,"height":55},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"80e384815ac64ff9b5fa4331f2326b00","type":"table_row","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[305,337],[2590,337],[2590,443],[305,443]],"region":{"top_left_x":305,"top_left_y":337,"width":2285,"height":107},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21d03033d980487f946ff88890580248","type":"table_row","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[305,532],[2587,532],[2587,991],[305,991]],"region":{"top_left_x":305,"top_left_y":532,"width":2283,"height":460},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0eb88a3cebaf4101b85ef5d2f8c7c00c","type":"table_row","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[305,1017],[2590,1017],[2590,1481],[305,1481]],"region":{"top_left_x":305,"top_left_y":1017,"width":2285,"height":464},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73c543c5f8194ce6bdaeffe3488ab904","type":"table_row","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[305,1509],[2587,1509],[2587,1751],[305,1751]],"region":{"top_left_x":305,"top_left_y":1508,"width":2283,"height":244},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b1c056234794afda2ac2287fe0de756","type":"table_row","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"","text_display":""},{"cnt":[[327,255],[476,255],[476,292],[327,292]],"region":{"top_left_x":326,"top_left_y":254,"width":151,"height":38},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afcbc99972e3442faec0a7e30a1abd4d","type":"simple_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"Variable","text_display":"Variable","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[816,255],[905,255],[905,300],[816,300]],"region":{"top_left_x":816,"top_left_y":254,"width":89,"height":47},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46b4333a419c421c95d5d839769ec7aa","type":"simple_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"Type","text_display":"Type","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1189,255],[1360,255],[1360,292],[1189,292]],"region":{"top_left_x":1188,"top_left_y":254,"width":172,"height":38},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a959cfacec814f7f96f22fa33bc3fdea","type":"simple_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"Definition","text_display":"Definition","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,342],[2483,342],[2483,437],[1184,437]],"region":{"top_left_x":1184,"top_left_y":341,"width":1300,"height":96},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e994d554743e4baebd86c2203f513a17","type":"complex_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","children_ids":["745b276b0e124b7085f02d400782e20b","2abceda062b34774bb0de31e9c254973"],"text":"coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner.","text_display":"coded as missing. Scores should only be calculated for participants that are sexually active and have a sexual partner.","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1189,346],[2477,346],[2477,389],[1189,389]],"region":{"top_left_x":1188,"top_left_y":345,"width":1289,"height":45},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"745b276b0e124b7085f02d400782e20b","type":"text","conversion_output":false,"parent_id":"e994d554743e4baebd86c2203f513a17","text":"coded as missing. Scores should only be calculated for participants that are sexually","text_display":"coded as missing. Scores should only be calculated for participants that are sexually","confidence":1,"confidence_rate":1},{"cnt":[[1189,389],[1693,389],[1693,435],[1189,435]],"region":{"top_left_x":1188,"top_left_y":389,"width":506,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2abceda062b34774bb0de31e9c254973","type":"text","conversion_output":false,"parent_id":"e994d554743e4baebd86c2203f513a17","text":"active and have a sexual partner.","text_display":" active and have a sexual partner.","confidence":1,"confidence_rate":1},{"cnt":[[324,539],[784,539],[784,671],[324,671]],"region":{"top_left_x":324,"top_left_y":538,"width":460,"height":133},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22fdc21ad8da4d1ca210e12d6705116d","type":"complex_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","children_ids":["dd5aca0166014675874ee15da00bb2bd","504c818bff024f01934ee39513cdaf0e","1867e734539a4bc39770c47e01f3e848"],"text":"Change from Baseline PISQIR sexually active - desire subscale score at 12 months","text_display":"Change from Baseline PISQIR sexually active - desire subscale score at 12 months","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,541],[779,541],[779,584],[327,584]],"region":{"top_left_x":326,"top_left_y":540,"width":454,"height":45},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd5aca0166014675874ee15da00bb2bd","type":"text","conversion_output":false,"parent_id":"22fdc21ad8da4d1ca210e12d6705116d","text":"Change from Baseline PISQ-","text_display":"Change from Baseline PISQ","confidence":1,"confidence_rate":1},{"cnt":[[327,584],[740,584],[740,630],[327,630]],"region":{"top_left_x":326,"top_left_y":584,"width":415,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"504c818bff024f01934ee39513cdaf0e","type":"text","conversion_output":false,"parent_id":"22fdc21ad8da4d1ca210e12d6705116d","text":"IR sexually active - desire","text_display":"IR sexually active - desire","confidence":1,"confidence_rate":1},{"cnt":[[327,632],[762,632],[762,669],[327,669]],"region":{"top_left_x":326,"top_left_y":631,"width":436,"height":38},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1867e734539a4bc39770c47e01f3e848","type":"text","conversion_output":false,"parent_id":"22fdc21ad8da4d1ca210e12d6705116d","text":"subscale score at 12 months","text_display":" subscale score at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[816,541],[996,541],[996,580],[816,580]],"region":{"top_left_x":816,"top_left_y":540,"width":180,"height":40},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c47f06ca8df4888a4910c66a47b4668","type":"simple_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","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":[[1184,539],[2559,539],[2559,983],[1184,983]],"region":{"top_left_x":1184,"top_left_y":538,"width":1376,"height":445},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4598e8b8e52d41b6810f9cdd4d1bdd02","type":"complex_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","children_ids":["7c302c83632644a7a30634250c11cbb6","db2f41d9f06a4246b431ea6f193bc5fe","eb88e40a70874ad49680eb33ab4423d2","16cfcff061c04f39995b1ab4a2c5bc74","5d5496fff0a8432ca419171513811bae","32c3a51ab8df4b8c903b9ddd427395db","2c2a89de3a3c4240a0bad45697201339","fc8f027b20b54e8990f0426372f3fab9","0f5f29a2812c4f2ab66ebd6d0c9f3e30","e39ea34a5a1b411aa23d1dcdbb0c9b52"],"text":"The PISQ-IR sexually active - desire subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: 1=never, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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 baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q15, Q16, Q17 using reverse scores for Q16 and Q17 (Q15: 1=never, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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":0.6722488527777615,"confidence_rate":0.9992726547334839},{"cnt":[[1189,541],[2555,541],[2555,586],[1189,586]],"region":{"top_left_x":1188,"top_left_y":540,"width":1367,"height":47},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c302c83632644a7a30634250c11cbb6","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"The PISQ-IR sexually active - desire subscale score will be computed at baseline and 12","text_display":"The PISQ-IR sexually active - desire subscale score will be computed at baseline and 12","confidence":1,"confidence_rate":1},{"cnt":[[1189,584],[2390,584],[2390,630],[1189,630]],"region":{"top_left_x":1188,"top_left_y":584,"width":1203,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db2f41d9f06a4246b431ea6f193bc5fe","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"months (and 3 and 6 months) using standard scoring algorithms. Specifically,","text_display":" months (and 3 and 6 months) using standard scoring algorithms. Specifically,","confidence":1,"confidence_rate":1},{"cnt":[[1189,627],[2529,627],[2529,673],[1189,673]],"region":{"top_left_x":1188,"top_left_y":627,"width":1341,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb88e40a70874ad49680eb33ab4423d2","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"instructions are to sum the scores for questions Q15, Q16, Q17 using reverse scores for","text_display":" instructions are to sum the scores for questions Q15, Q16, Q17 using reverse scores for","confidence":1,"confidence_rate":1},{"cnt":[[1189,671],[2490,671],[2490,716],[1189,716]],"region":{"top_left_x":1188,"top_left_y":670,"width":1302,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16cfcff061c04f39995b1ab4a2c5bc74","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"Q16 and Q17 (Q15: 1=never, ..., 5=always; Q16: 1=daily, ...,5=never; Q17: 1=very","text_display":" Q16 and Q17 (Q15: 1=never, ..., 5=always; Q16: 1=daily, ...,5=never; Q17: 1=very","confidence":0.6722488527777615,"confidence_rate":0.9953388184719988},{"cnt":[[1189,718],[2546,718],[2546,764],[1189,764]],"region":{"top_left_x":1188,"top_left_y":718,"width":1359,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d5496fff0a8432ca419171513811bae","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"high, ..., \\(5=\\) very low or none at all). If there is more than 1 missing response then a total","text_display":" high, ..., \\(5=\\) very low or none at all). If there is more than 1 missing response then a total","confidence":0.7631631443627418,"confidence_rate":0.9974044948272597},{"cnt":[[1189,762],[2542,762],[2542,807],[1189,807]],"region":{"top_left_x":1188,"top_left_y":761,"width":1354,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32c3a51ab8df4b8c903b9ddd427395db","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"score is not calculated. To handle missing values, the final score is obtained by dividing","text_display":" score is not calculated. To handle missing values, the final score is obtained by dividing","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[1189,805],[2503,805],[2503,851],[1189,851]],"region":{"top_left_x":1188,"top_left_y":805,"width":1315,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c2a89de3a3c4240a0bad45697201339","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"the sum by the number of items answered. The outcome will then be computed as the","text_display":" the sum by the number of items answered. The outcome will then be computed as the","confidence":1,"confidence_rate":1},{"cnt":[[1189,848],[2533,848],[2533,894],[1189,894]],"region":{"top_left_x":1188,"top_left_y":848,"width":1346,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc8f027b20b54e8990f0426372f3fab9","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data","text_display":" difference in score at 12 months (and 3 and 6 months) and the score at baseline. If data","confidence":1,"confidence_rate":1},{"cnt":[[1189,892],[2533,892],[2533,937],[1189,937]],"region":{"top_left_x":1188,"top_left_y":891,"width":1346,"height":47},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f5f29a2812c4f2ab66ebd6d0c9f3e30","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"at an assessment time point are missing, the outcome variable will be coded as missing.","text_display":" at an assessment time point are missing, the outcome variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[1189,935],[2308,935],[2308,980],[1189,980]],"region":{"top_left_x":1188,"top_left_y":934,"width":1121,"height":47},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e39ea34a5a1b411aa23d1dcdbb0c9b52","type":"text","conversion_output":false,"parent_id":"4598e8b8e52d41b6810f9cdd4d1bdd02","text":"Scores should only be calculated for participants that are sexually active.","text_display":" Scores should only be calculated for participants that are sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[322,1026],[784,1026],[784,1206],[322,1206]],"region":{"top_left_x":322,"top_left_y":1025,"width":462,"height":181},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71fbb8fbc9a0425bac89a14ffc105c3e","type":"complex_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","children_ids":["153110162e214f7788e76fd26f2d95e7","a6968879911d46c08341f489a300a1ba","aa5bd779833340dd915b3394428b1391","0f74847517a64d6abac295ca95b80347"],"text":"Change from Baseline PISQIR sexually active condition impact subscale score at 12 months","text_display":"Change from Baseline PISQIR sexually active condition impact subscale score at 12 months","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1030],[779,1030],[779,1076],[327,1076]],"region":{"top_left_x":326,"top_left_y":1030,"width":454,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"153110162e214f7788e76fd26f2d95e7","type":"text","conversion_output":false,"parent_id":"71fbb8fbc9a0425bac89a14ffc105c3e","text":"Change from Baseline PISQ-","text_display":"Change from Baseline PISQ","confidence":1,"confidence_rate":1},{"cnt":[[327,1074],[641,1074],[641,1119],[327,1119]],"region":{"top_left_x":326,"top_left_y":1073,"width":315,"height":47},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6968879911d46c08341f489a300a1ba","type":"text","conversion_output":false,"parent_id":"71fbb8fbc9a0425bac89a14ffc105c3e","text":"IR sexually active -","text_display":"IR sexually active ","confidence":1,"confidence_rate":1},{"cnt":[[327,1117],[732,1117],[732,1162],[327,1162]],"region":{"top_left_x":326,"top_left_y":1116,"width":406,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa5bd779833340dd915b3394428b1391","type":"text","conversion_output":false,"parent_id":"71fbb8fbc9a0425bac89a14ffc105c3e","text":"condition impact subscale","text_display":"condition impact subscale","confidence":1,"confidence_rate":1},{"cnt":[[327,1162],[623,1162],[623,1201],[327,1201]],"region":{"top_left_x":326,"top_left_y":1162,"width":298,"height":40},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f74847517a64d6abac295ca95b80347","type":"text","conversion_output":false,"parent_id":"71fbb8fbc9a0425bac89a14ffc105c3e","text":"score at 12 months","text_display":" score at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[814,1030],[1000,1030],[1000,1067],[814,1067]],"region":{"top_left_x":813,"top_left_y":1030,"width":188,"height":38},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d3cd16feec04dd4ab27cffe4b348073","type":"simple_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","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":[[1184,1026],[2553,1026],[2553,1474],[1184,1474]],"region":{"top_left_x":1184,"top_left_y":1025,"width":1369,"height":450},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ed44cf150c04d9a9bf04b5b0bd5c255","type":"complex_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","children_ids":["6eb74204c63042449935262c915ce5c0","fff996e43c28485aae59e0fea3cac243","3a69471452384a5f9d2824a5a229fd64","c8782ee2642e4bd09f8974050ac9c1e3","f8118508f93f4799b25d130f55ef31b3","0b9890f46fce45cd876c7e515e9f3d6b","ee8b0c59adf24dd18cf4a44301b8218c","520ffb38d0b24b20b4d69a9a513d791c","28ccb01a3bff4cfd93eac2c34202077a","faf0f513a76f40b4b1df0c1488fa1c96"],"text":"The PISQ-IR sexually active - condition impact subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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 baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to 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, ..., 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point 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":0.99951171875,"confidence_rate":0.9999989925608835},{"cnt":[[1189,1030],[2477,1030],[2477,1076],[1189,1076]],"region":{"top_left_x":1188,"top_left_y":1030,"width":1289,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6eb74204c63042449935262c915ce5c0","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"The PISQ-IR sexually active - condition impact subscale score will be computed at","text_display":"The PISQ-IR sexually active - condition impact subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1189,1074],[2425,1074],[2425,1119],[1189,1119]],"region":{"top_left_x":1188,"top_left_y":1073,"width":1238,"height":47},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fff996e43c28485aae59e0fea3cac243","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1117],[2542,1117],[2542,1162],[1189,1162]],"region":{"top_left_x":1188,"top_left_y":1116,"width":1354,"height":47},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a69471452384a5f9d2824a5a229fd64","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"Specifically, instructions are to sum the scores for questions Q18, Q20b-d using reverse","text_display":" Specifically, instructions are to sum the scores for questions Q18, Q20b-d using reverse","confidence":1,"confidence_rate":1},{"cnt":[[1189,1162],[2546,1162],[2546,1206],[1189,1206]],"region":{"top_left_x":1188,"top_left_y":1162,"width":1359,"height":44},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8782ee2642e4bd09f8974050ac9c1e3","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"scores for Q18 (Q18: 1=not at all, ..., 4=a lot; Q20b-d: 1=strongly agree, ..., 4=strongly","text_display":" scores for Q18 (Q18: 1=not at all, ..., 4=a lot; Q20b-d: 1=strongly agree, ..., 4=strongly","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[1189,1206],[2538,1206],[2538,1251],[1189,1251]],"region":{"top_left_x":1188,"top_left_y":1205,"width":1350,"height":47},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8118508f93f4799b25d130f55ef31b3","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"disagree). If there are more than 2 missing responses then a total score is not calculated.","text_display":" disagree). If there are more than 2 missing responses then a total score is not calculated.","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[1189,1251],[2542,1251],[2542,1294],[1189,1294]],"region":{"top_left_x":1188,"top_left_y":1251,"width":1354,"height":44},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b9890f46fce45cd876c7e515e9f3d6b","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"To handle missing values, the final score is obtained by dividing the sum by the number","text_display":" To handle missing values, the final score is obtained by dividing the sum by the number","confidence":1,"confidence_rate":1},{"cnt":[[1189,1294],[2525,1294],[2525,1340],[1189,1340]],"region":{"top_left_x":1188,"top_left_y":1294,"width":1337,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee8b0c59adf24dd18cf4a44301b8218c","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"of items answered. The outcome will then be computed as the difference in score at 12","text_display":" of items answered. The outcome will then be computed as the difference in score at 12","confidence":1,"confidence_rate":1},{"cnt":[[1189,1338],[2494,1338],[2494,1381],[1189,1381]],"region":{"top_left_x":1188,"top_left_y":1337,"width":1307,"height":45},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"520ffb38d0b24b20b4d69a9a513d791c","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"months (and 3 and 6 months) and the score at baseline. If data at an assessment time","text_display":" months (and 3 and 6 months) and the score at baseline. If data at an assessment time","confidence":1,"confidence_rate":1},{"cnt":[[1189,1381],[2542,1381],[2542,1427],[1189,1427]],"region":{"top_left_x":1188,"top_left_y":1381,"width":1354,"height":46},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28ccb01a3bff4cfd93eac2c34202077a","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"point are missing, the outcome variable will be coded as missing. Scores should only be","text_display":" point are missing, the outcome variable will be coded as missing. Scores should only be","confidence":1,"confidence_rate":1},{"cnt":[[1189,1427],[1962,1427],[1962,1470],[1189,1470]],"region":{"top_left_x":1188,"top_left_y":1426,"width":774,"height":44},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faf0f513a76f40b4b1df0c1488fa1c96","type":"text","conversion_output":false,"parent_id":"8ed44cf150c04d9a9bf04b5b0bd5c255","text":"calculated for participants that are sexually active.","text_display":" calculated for participants that are sexually active.","confidence":1,"confidence_rate":1},{"cnt":[[322,1515],[784,1515],[784,1693],[322,1693]],"region":{"top_left_x":322,"top_left_y":1515,"width":462,"height":178},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a73df7678697479b857b8d01b0859e48","type":"complex_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","children_ids":["70241f30e8bf451291c342bd42c2e360","c4165877a82741dd9fdf0e6994115386","e7fc06cb0258488fa36f57274ad2d8cc","6255b651d84a480eb309da5b08aa5dff"],"text":"Change from Baseline PISQIR sexually active - global quality rating subscale score at 12 months","text_display":"Change from Baseline PISQIR sexually active - global quality rating subscale score at 12 months","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,1520],[779,1520],[779,1565],[327,1565]],"region":{"top_left_x":326,"top_left_y":1519,"width":454,"height":47},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70241f30e8bf451291c342bd42c2e360","type":"text","conversion_output":false,"parent_id":"a73df7678697479b857b8d01b0859e48","text":"Change from Baseline PISQ-","text_display":"Change from Baseline PISQ","confidence":1,"confidence_rate":1},{"cnt":[[327,1563],[745,1563],[745,1608],[327,1608]],"region":{"top_left_x":326,"top_left_y":1562,"width":419,"height":47},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4165877a82741dd9fdf0e6994115386","type":"text","conversion_output":false,"parent_id":"a73df7678697479b857b8d01b0859e48","text":"IR sexually active - global","text_display":"IR sexually active - global","confidence":1,"confidence_rate":1},{"cnt":[[327,1606],[768,1606],[768,1652],[327,1652]],"region":{"top_left_x":326,"top_left_y":1606,"width":443,"height":46},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7fc06cb0258488fa36f57274ad2d8cc","type":"text","conversion_output":false,"parent_id":"a73df7678697479b857b8d01b0859e48","text":"quality rating subscale score","text_display":" quality rating subscale score","confidence":1,"confidence_rate":1},{"cnt":[[327,1652],[532,1652],[532,1691],[327,1691]],"region":{"top_left_x":326,"top_left_y":1651,"width":207,"height":40},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6255b651d84a480eb309da5b08aa5dff","type":"text","conversion_output":false,"parent_id":"a73df7678697479b857b8d01b0859e48","text":"at 12 months","text_display":" at 12 months","confidence":1,"confidence_rate":1},{"cnt":[[814,1520],[1000,1520],[1000,1561],[814,1561]],"region":{"top_left_x":813,"top_left_y":1519,"width":188,"height":42},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e329a0f977e34e35851535104fce6b8a","type":"simple_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","text":"Continuous","text_display":"Continuous","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1184,1515],[2559,1515],[2559,1745],[1184,1745]],"region":{"top_left_x":1184,"top_left_y":1515,"width":1376,"height":230},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5786b4b1d98f4ea3b64174c1de39cb6b","type":"complex_cell","conversion_output":false,"parent_id":"a94a652d97a04df98629140a9038aaad","children_ids":["660605d17bd24242a29f81fd87a8923a","136938082182430997ff369083b3b27f","70f3624e5d8145809421b5ad043513f3","0ace39d0f45047738932d010479acbe1","8ce313ce468342b4ae88dd33d9da8c5e"],"text":"The PISQ-IR sexually active - global quality rating subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied, ..., 5=dissatisfied; Q20a: 1=strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total","text_display":"The PISQ-IR sexually active - global quality rating subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to sum the scores for questions Q19a-Q19c, Q20a using reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied, ..., 5=dissatisfied; Q20a: 1=strongly agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.6387023871417352,"confidence_rate":0.9990844370582201},{"cnt":[[1189,1520],[2529,1520],[2529,1565],[1189,1565]],"region":{"top_left_x":1188,"top_left_y":1519,"width":1341,"height":47},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"660605d17bd24242a29f81fd87a8923a","type":"text","conversion_output":false,"parent_id":"5786b4b1d98f4ea3b64174c1de39cb6b","text":"The PISQ-IR sexually active - global quality rating subscale score will be computed at","text_display":"The PISQ-IR sexually active - global quality rating subscale score will be computed at","confidence":1,"confidence_rate":1},{"cnt":[[1189,1563],[2425,1563],[2425,1608],[1189,1608]],"region":{"top_left_x":1188,"top_left_y":1562,"width":1238,"height":47},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"136938082182430997ff369083b3b27f","type":"text","conversion_output":false,"parent_id":"5786b4b1d98f4ea3b64174c1de39cb6b","text":"baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","text_display":" baseline and 12 months (and 3 and 6 months) using standard scoring algorithms.","confidence":1,"confidence_rate":1},{"cnt":[[1189,1606],[2499,1606],[2499,1652],[1189,1652]],"region":{"top_left_x":1188,"top_left_y":1606,"width":1311,"height":46},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70f3624e5d8145809421b5ad043513f3","type":"text","conversion_output":false,"parent_id":"5786b4b1d98f4ea3b64174c1de39cb6b","text":"Specifically, instructions are to sum the scores for questions Q19a-Q19c, Q20a using","text_display":" Specifically, instructions are to sum the scores for questions Q19a-Q19c, Q20a using","confidence":1,"confidence_rate":1},{"cnt":[[1189,1650],[2559,1650],[2559,1695],[1189,1695]],"region":{"top_left_x":1188,"top_left_y":1649,"width":1372,"height":47},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ace39d0f45047738932d010479acbe1","type":"text","conversion_output":false,"parent_id":"5786b4b1d98f4ea3b64174c1de39cb6b","text":"reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied, ..., 5=dissatisfied; Q20a: 1=strongly","text_display":" reverse scores for Q19a-Q19c (Q19a-c: 1=satisfied, ..., 5=dissatisfied; Q20a: 1=strongly","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[1189,1693],[2516,1693],[2516,1738],[1189,1738]],"region":{"top_left_x":1188,"top_left_y":1692,"width":1328,"height":47},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ce313ce468342b4ae88dd33d9da8c5e","type":"text","conversion_output":false,"parent_id":"5786b4b1d98f4ea3b64174c1de39cb6b","text":"agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total","text_display":" agree, \\(\\ldots, 4=\\) strongly disagree). If there are more than 2 missing responses then a total","confidence":0.6387023871417352,"confidence_rate":0.9954357878098926},{"cnt":[[305,1927],[681,1927],[681,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":377,"height":35},"line":64,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"712eef7c0f2d4f509d5de6b9736a8a24","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 33","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-35","page":35,"lines":[{"cnt":[[303,133],[810,133],[810,219],[303,219]],"region":{"top_left_x":302,"top_left_y":133,"width":508,"height":87},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"45d22c6370164f1e877769c18d322b06","type":"figure_label","conversion_output":false,"children_ids":["060065ef90ce4474892bbea5b5a2fcd5","cb36445da1bf4ababf8902a4741fb99c"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"060065ef90ce4474892bbea5b5a2fcd5","type":"text","conversion_output":false,"parent_id":"45d22c6370164f1e877769c18d322b06","text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"cb36445da1bf4ababf8902a4741fb99c","type":"text","conversion_output":false,"parent_id":"45d22c6370164f1e877769c18d322b06","text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,243],[2589,243],[2589,1693],[305,1693]],"region":{"top_left_x":305,"top_left_y":242,"width":2284,"height":1451},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0faa03351b44432b87b21f666f170830","type":"table","conversion_output":true,"children_ids":["2b8529c318234376a3093b4337bfc33d","0cd091944194454687a8698b2bed61c7","34b292a23576454d85bdf10a1bda07c5","00c2effa629b4b8db443fe673b6009f5","7e94699e7a3e4ff9a0ba36bde547b757","102c12997f6a46ecbb164df397736eb3","bae494d4a08f47c0a360da99bb4836ab","b121feff3bb8450ea07eea3ec0da4205","ddbfd95e5b4f43f2ae95930b16c0a1e2","cb026321accb4bc9b1e78b0a925cd16d","dd9d239a17ab40c1bf74a4d3d2528579","25de4f7a703c4843a935a5465be76cb1","84b990ca637440908f9ea1b5bd9a4638","41c2460eb11f486394ac5726a918eac4","182bba2f5ca64b43a04109ef84ec5214","564fc8f45d9848a392e8bba0d30d7517","10d565c9be3b40e69f8a1d7065b3d3d8","974965d37d6e47338f0c1f2255bc6ecd","b3b95a94083648bda1478c6e0eee46ce","85c1b0b1e62f4011a6c4c658b719acf8","99db08106ad24b9a8d4ebb3e36dffd98","64ab97212c964541b4a3f1e31bf09ee8","56af4e6dc5d348c1bd185dd92a02482f","5083998a0b3d4a8dade14274b8715a8f","7206a430700149c8af1427e86d6b20ba"],"selected_labels":["45d22c6370164f1e877769c18d322b06"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline & & 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline Adaptation Index Hygiene subscale as 12 months & Continuous & The AI Hygiene subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to average the responses for questions Q1-Q4, Q9, and Q14 ( \\(0=\\) never, 25=rarely, 50=sometimes, \\(75=\\) often, \\(100=\\) always). If there are at least 5 non-missing responses, then the score is the average of the non-missing responses, otherwise, the score is not calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. \\\\\n\\hline Change from Baseline Fecal Incontinence Adaptation Index Avoidance subscale as 12 months & Continuous & The AI Hygiene subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to average the responses for questions Q5-Q8, Q10-Q13, and Q15-17 ( \\(0=\\) never, 25=rarely, 50=sometimes, 75=often, 100=always). If there are at least 9 non-missing responses, then the score is the average of the non-missing responses, otherwise, the score is not calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. \\\\\n\\hline Patient Global Impression of Improvement at 12 months & Dichotomous & For defining improvement, Yes=\"much better\" or \"very much better\" on the PGI-I scale. The outcome will be computed at 12 months (and 3 and 6 months) \\\\\n\\hline Patient Global Impression of Severity at 12 months & Categorical & For defining severity, Normal/mild=\"Normal\" or \"Mild\" on the PGI-S scale. The outcome will be computed at 12 months (baseline, 3 months, and 6 months) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline & & 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 12 months (and 3 and 6 months) and the score at baseline. If data at an assessment time point are missing, the outcome variable will be coded as missing. Scores should only be calculated for participants that are sexually active. \\\\\n\\hline Change from Baseline Adaptation Index Hygiene subscale as 12 months & Continuous & The AI Hygiene subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to average the responses for questions Q1-Q4, Q9, and Q14 ( \\(0=\\) never, 25=rarely, 50=sometimes, \\(75=\\) often, \\(100=\\) always). If there are at least 5 non-missing responses, then the score is the average of the non-missing responses, otherwise, the score is not calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. \\\\\n\\hline Change from Baseline Fecal Incontinence Adaptation Index Avoidance subscale as 12 months & Continuous & The AI Hygiene subscale score will be computed at baseline and 12 months (and 3 and 6 months) using standard scoring algorithms. Specifically, instructions are to average the responses for questions Q5-Q8, Q10-Q13, and Q15-17 ( \\(0=\\) never, 25=rarely, 50=sometimes, 75=often, 100=always). If there are at least 9 non-missing responses, then the score is the average of the non-missing responses, otherwise, the score is not calculated. The outcome will then be computed as the difference in score at 12 months (and 3 and 6 months) and the score at baseline. \\\\\n\\hline Patient Global Impression of Improvement at 12 months & Dichotomous & For defining improvement, Yes=\"much better\" or \"very much better\" on the PGI-I scale. The outcome will be computed at 12 months (and 3 and 6 months) \\\\\n\\hline Patient Global Impression of Severity at 12 months & Categorical & For defining severity, Normal/mild=\"Normal\" or \"Mild\" on the PGI-S scale. The outcome will be computed at 12 months (baseline, 3 months, and 6 months) 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If there are at least 9 non-missing responses, then","text_display":" 50=sometimes, 75=often, 100=always). 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It is calculated by summing the Brink pressure, duration, and displacement metrics if the assessment could be performed (i.e. not unable to perform due to pain). The outcome will then be computed as the difference in Brink Score at 12 months (and 6 months) and the Brink Score at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline Maximum Pelvic Floor Muscle Contraction Pressure (Maximum Amplitude) at 12 months & Continuous & The maximum amplitude from the Peritron device will be averaged across the valid squeeze measures (out of 3 possible). The outcome will then be computed as the difference in average maximum amplitude at 12 months (and 8 weeks) and the average maximum amplitude at baseline. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Network\nProtocol ESTEEM Statistical Analysis Plan}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Type & Definition \\\\\n\\hline Change from Baseline Brink Score at 12 months & Continuous & The Brink Score will be calculated from the pelvic floor muscle assessment form. It is calculated by summing the Brink pressure, duration, and displacement metrics if the assessment could be performed (i.e. not unable to perform due to pain). The outcome will then be computed as the difference in Brink Score at 12 months (and 6 months) and the Brink Score at baseline. If data for the assessment time point are missing, the outcome variable will be coded as missing. \\\\\n\\hline Change from Baseline Maximum Pelvic Floor Muscle Contraction Pressure (Maximum Amplitude) at 12 months & Continuous & The maximum amplitude from the Peritron device will be averaged across the valid squeeze measures (out of 3 possible). The outcome will then be computed as the difference in average maximum amplitude at 12 months (and 8 weeks) and the average maximum amplitude at baseline. 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The outcome will","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[1188,487],[2530,487],[2530,532],[1188,532]],"region":{"top_left_x":1187,"top_left_y":486,"width":1344,"height":47},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdf57dcdb2704a189e6eeb0ad039e3e0","type":"text","conversion_output":false,"parent_id":"f3d5bebca90e4fb29780469e3d572050","text":"then be computed as the difference in Brink Score at 12 months (and 6 months) and the","text_display":" then be computed as the difference in Brink Score at 12 months (and 6 months) and the","confidence":1,"confidence_rate":1},{"cnt":[[1188,530],[2526,530],[2526,576],[1188,576]],"region":{"top_left_x":1187,"top_left_y":530,"width":1339,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10009467617f4821aa28b168668d2db0","type":"text","conversion_output":false,"parent_id":"f3d5bebca90e4fb29780469e3d572050","text":"Brink Score at baseline. If data for the assessment time point are missing, the outcome","text_display":" Brink Score at baseline. If data for the assessment time point are missing, the outcome","confidence":1,"confidence_rate":1},{"cnt":[[1188,573],[1712,573],[1712,619],[1188,619]],"region":{"top_left_x":1187,"top_left_y":573,"width":525,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddbe892c6ca944f3babb07abffdc03f3","type":"text","conversion_output":false,"parent_id":"f3d5bebca90e4fb29780469e3d572050","text":"variable will be coded as missing.","text_display":" variable will be coded as missing.","confidence":1,"confidence_rate":1},{"cnt":[[324,656],[778,656],[778,877],[324,877]],"region":{"top_left_x":323,"top_left_y":655,"width":456,"height":222},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74a5d742c3c04848b36e3de7028689ee","type":"complex_cell","conversion_output":false,"parent_id":"f3d29a68ad494136ae0330b2acc264a9","children_ids":["ff30838009cd418385834ceed01e1e66","bf1abac1ec8249babfce66386ff85588","d2863c7d785845fda0277c8854be0bdd","dfdda8a85e274ef2aa3dc9781245099f","d0b7c6c2e4ff48a0b670138e88dc473c"],"text":"Change from Baseline Maximum Pelvic Floor Muscle Contraction Pressure (Maximum Amplitude) at 12 months","text_display":"Change from Baseline Maximum Pelvic Floor Muscle Contraction Pressure (Maximum Amplitude) at 12 months","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[328,658],[677,658],[677,701],[328,701]],"region":{"top_left_x":327,"top_left_y":657,"width":350,"height":45},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff30838009cd418385834ceed01e1e66","type":"text","conversion_output":false,"parent_id":"74a5d742c3c04848b36e3de7028689ee","text":"Change from Baseline","text_display":"Change from Baseline","confidence":1,"confidence_rate":1},{"cnt":[[328,703],[692,703],[692,740],[328,740]],"region":{"top_left_x":327,"top_left_y":703,"width":365,"height":38},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf1abac1ec8249babfce66386ff85588","type":"text","conversion_output":false,"parent_id":"74a5d742c3c04848b36e3de7028689ee","text":"Maximum Pelvic Floor","text_display":" Maximum Pelvic Floor","confidence":1,"confidence_rate":1},{"cnt":[[328,747],[776,747],[776,786],[328,786]],"region":{"top_left_x":327,"top_left_y":746,"width":450,"height":40},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2863c7d785845fda0277c8854be0bdd","type":"text","conversion_output":false,"parent_id":"74a5d742c3c04848b36e3de7028689ee","text":"Muscle Contraction Pressure","text_display":" Muscle Contraction Pressure","confidence":1,"confidence_rate":1},{"cnt":[[328,790],[776,790],[776,836],[328,836]],"region":{"top_left_x":327,"top_left_y":790,"width":450,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfdda8a85e274ef2aa3dc9781245099f","type":"text","conversion_output":false,"parent_id":"74a5d742c3c04848b36e3de7028689ee","text":"(Maximum Amplitude) at 12","text_display":" (Maximum Amplitude) at 12","confidence":1,"confidence_rate":1},{"cnt":[[328,833],[447,833],[447,870],[328,870]],"region":{"top_left_x":327,"top_left_y":833,"width":121,"height":38},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0b7c6c2e4ff48a0b670138e88dc473c","type":"text","conversion_output":false,"parent_id":"74a5d742c3c04848b36e3de7028689ee","text":"months","text_display":" months","confidence":1,"confidence_rate":1},{"cnt":[[813,660],[997,660],[997,697],[813,697]],"region":{"top_left_x":813,"top_left_y":660,"width":185,"height":37},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16a63d18d741463ab52f393295076f38","type":"simple_cell","conversion_output":false,"parent_id":"f3d29a68ad494136ae0330b2acc264a9","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":[[1186,656],[2528,656],[2528,838],[1186,838]],"region":{"top_left_x":1185,"top_left_y":655,"width":1344,"height":183},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c86fbc1a85f4aef98c76f97d6d584ef","type":"complex_cell","conversion_output":false,"parent_id":"f3d29a68ad494136ae0330b2acc264a9","children_ids":["ec170c086b08459f868426bdec5890c8","821385709c524525bd493fdc4bcd52c5","1e95414c7f5a4435a15a88a78c38ed63","d46f4f7cffba487ca9c99ae3d0e0fa44"],"text":"The maximum amplitude from the Peritron device will be averaged across the valid squeeze measures (out of 3 possible). The outcome will then be computed as the difference in average maximum amplitude at 12 months (and 8 weeks) and the average maximum amplitude at baseline.","text_display":"The maximum amplitude from the Peritron device will be averaged across the valid squeeze measures (out of 3 possible). The outcome will then be computed as the difference in average maximum amplitude at 12 months (and 8 weeks) and the average maximum amplitude at baseline.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1190,658],[2474,658],[2474,701],[1190,701]],"region":{"top_left_x":1189,"top_left_y":657,"width":1285,"height":45},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec170c086b08459f868426bdec5890c8","type":"text","conversion_output":false,"parent_id":"1c86fbc1a85f4aef98c76f97d6d584ef","text":"The maximum amplitude from the Peritron device will be averaged across the valid","text_display":"The maximum amplitude from the Peritron device will be averaged across the valid","confidence":1,"confidence_rate":1},{"cnt":[[1190,703],[2424,703],[2424,747],[1190,747]],"region":{"top_left_x":1189,"top_left_y":703,"width":1236,"height":44},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"821385709c524525bd493fdc4bcd52c5","type":"text","conversion_output":false,"parent_id":"1c86fbc1a85f4aef98c76f97d6d584ef","text":"squeeze measures (out of 3 possible). The outcome will then be computed as the","text_display":" squeeze measures (out of 3 possible). The outcome will then be computed as the","confidence":1,"confidence_rate":1},{"cnt":[[1190,747],[2526,747],[2526,790],[1190,790]],"region":{"top_left_x":1189,"top_left_y":746,"width":1337,"height":45},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e95414c7f5a4435a15a88a78c38ed63","type":"text","conversion_output":false,"parent_id":"1c86fbc1a85f4aef98c76f97d6d584ef","text":"difference in average maximum amplitude at 12 months (and 8 weeks) and the average","text_display":" difference in average maximum amplitude at 12 months (and 8 weeks) and the average","confidence":1,"confidence_rate":1},{"cnt":[[1190,790],[1692,790],[1692,833],[1190,833]],"region":{"top_left_x":1189,"top_left_y":790,"width":504,"height":44},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d46f4f7cffba487ca9c99ae3d0e0fa44","type":"text","conversion_output":false,"parent_id":"1c86fbc1a85f4aef98c76f97d6d584ef","text":"maximum amplitude at baseline.","text_display":" maximum amplitude at baseline.","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[683,1927],[683,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1927,"width":379,"height":35},"line":37,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4e67e5b8a3b742faa7f96200f8d92af0","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 35","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-37","page":37,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0753c53356d5419cb842ee00ee5623f4","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"38347ff90d654c92bedd96568370ec85","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[367,314],[913,314],[913,367],[367,367]],"region":{"top_left_x":367,"top_left_y":313,"width":547,"height":55},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6faa8b6ccfd4da5af97cae5bb5ade83","type":"section_header","conversion_output":false,"children_ids":["d3d9cf23ea874ba388956f016f44e119"],"text":"","text_display":""},{"cnt":[[374,318],[909,318],[909,363],[374,363]],"region":{"top_left_x":373,"top_left_y":317,"width":536,"height":47},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3d9cf23ea874ba388956f016f44e119","type":"text","conversion_output":true,"parent_id":"f6faa8b6ccfd4da5af97cae5bb5ade83","text":"9.3 Primary Analysis Methods","text_display":"\n\n\\subsection*{9.3 Primary Analysis Methods}","confidence":1,"confidence_rate":1},{"cnt":[[372,374],[1815,374],[1815,419],[372,419]],"region":{"top_left_x":371,"top_left_y":373,"width":1445,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9854d8edcc564454bcc3fdb7a6530313","type":"text","conversion_output":true,"text":"The mean change from baseline in UDI scores will be compared between groups at 1 year. As","text_display":"\n\nThe mean change from baseline in UDI scores will be compared between groups at 1 year. As","confidence":1,"confidence_rate":1},{"cnt":[[372,417],[1833,417],[1833,462],[372,462]],"region":{"top_left_x":371,"top_left_y":416,"width":1462,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aafab4de6a5f468cb15f94ebbe6f347b","type":"text","conversion_output":true,"text":"explained previously, participants will be permitted to seek additional treatment for SUI and/or","text_display":" explained previously, participants will be permitted to seek additional treatment for SUI and/or","confidence":1,"confidence_rate":1},{"cnt":[[370,460],[1708,460],[1708,505],[370,505]],"region":{"top_left_x":369,"top_left_y":459,"width":1340,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11231d4a7c444ddaaa24bc17f52179bd","type":"text","conversion_output":true,"text":"OAB after 3 months following MUS. Because such treatment is expected to impact the","text_display":" OAB after 3 months following MUS. Because such treatment is expected to impact the","confidence":0.998046875,"confidence_rate":0.9999787498471376},{"cnt":[[370,505],[1854,505],[1854,552],[370,552]],"region":{"top_left_x":369,"top_left_y":504,"width":1486,"height":49},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7dd87a2a985941fe81ac7d99eae95783","type":"text","conversion_output":true,"text":"participant's UDI score at 1 year, we will use an analysis method that accounts for the impact of","text_display":" participant's UDI score at 1 year, we will use an analysis method that accounts for the impact of","confidence":0.9970703125,"confidence_rate":0.9999720576529205},{"cnt":[[370,550],[1796,550],[1796,595],[370,595]],"region":{"top_left_x":369,"top_left_y":550,"width":1428,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5757ff19c674aef9f66d13e96996890","type":"text","conversion_output":true,"text":"additional treatment. Specifically, a general linear mixed model will be constructed to model","text_display":" additional treatment. Specifically, a general linear mixed model will be constructed to model","confidence":1,"confidence_rate":1},{"cnt":[[370,593],[1833,593],[1833,638],[370,638]],"region":{"top_left_x":369,"top_left_y":592,"width":1464,"height":47},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba12c2106c7a46e6bc9ddce327585202","type":"text","conversion_output":true,"text":"change from baseline in UDI scores using scores recorded at time points up to 1 year following","text_display":" change from baseline in UDI scores using scores recorded at time points up to 1 year following","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[370,638],[1846,638],[1846,681],[370,681]],"region":{"top_left_x":369,"top_left_y":638,"width":1477,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f578664d18ae451fa3caa20ba1dd3952","type":"text","conversion_output":true,"text":"MUS. For participants who request additional treatment, only UDI measurements up to the time","text_display":" MUS. For participants who request additional treatment, only UDI measurements up to the time","confidence":1,"confidence_rate":1},{"cnt":[[370,679],[1876,679],[1876,724],[370,724]],"region":{"top_left_x":369,"top_left_y":678,"width":1507,"height":47},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"711b0a6a2abd491ba6dc567198856016","type":"text","conversion_output":true,"text":"of additional treatment will be included in the model, and measurements taken between additional","text_display":" of additional treatment will be included in the model, and measurements taken between additional","confidence":1,"confidence_rate":1},{"cnt":[[370,726],[1790,726],[1790,769],[370,769]],"region":{"top_left_x":369,"top_left_y":726,"width":1421,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c6040c3e4d414e968f3a3bbeb0c94c24","type":"text","conversion_output":true,"text":"treatment and 1 year will be considered missing for the purpose of the primary analysis. The","text_display":" treatment and 1 year will be considered missing for the purpose of the primary analysis. The","confidence":1,"confidence_rate":1},{"cnt":[[370,769],[1833,769],[1833,814],[370,814]],"region":{"top_left_x":369,"top_left_y":769,"width":1464,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7efdad7bf6e042cd804b2ab0215a453a","type":"text","conversion_output":true,"text":"model will include fixed effects for treatment group, time, request for additional treatment, and","text_display":" model will include fixed effects for treatment group, time, request for additional treatment, and","confidence":1,"confidence_rate":1},{"cnt":[[370,812],[1871,812],[1871,857],[370,857]],"region":{"top_left_x":369,"top_left_y":812,"width":1503,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd7146ddb6714bfa8991bf3dd216db1e","type":"text","conversion_output":true,"text":"interactions between those variables. It will also be adjusted for the design effects of stratification","text_display":" interactions between those variables. It will also be adjusted for the design effects of stratification","confidence":0.9990234375,"confidence_rate":0.9999909533775151},{"cnt":[[370,855],[1852,855],[1852,900],[370,900]],"region":{"top_left_x":369,"top_left_y":855,"width":1483,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13f3c8aa6b7f4299875f6752e9150bd0","type":"text","conversion_output":true,"text":"by center and by baseline urge IE group. Thus, the models will allow for different trajectories of","text_display":" by center and by baseline urge IE group. Thus, the models will allow for different trajectories of","confidence":1,"confidence_rate":1},{"cnt":[[370,902],[1878,902],[1878,947],[370,947]],"region":{"top_left_x":369,"top_left_y":902,"width":1509,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e65cea7ca474427b8d83c7799bb64243","type":"text","conversion_output":true,"text":"change for women who are or are not randomized to BPTx and for those who do or do not request","text_display":" change for women who are or are not randomized to BPTx and for those who do or do not request","confidence":1,"confidence_rate":1},{"cnt":[[370,945],[1811,945],[1811,986],[370,986]],"region":{"top_left_x":369,"top_left_y":945,"width":1443,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4b65e511d9e4fa2a82af72014ed8203","type":"text","conversion_output":true,"text":"additional treatment. A statistical test based on the model will be conducted to assess whether","text_display":" additional treatment. A statistical test based on the model will be conducted to assess whether","confidence":1,"confidence_rate":1},{"cnt":[[370,988],[1833,988],[1833,1033],[370,1033]],"region":{"top_left_x":369,"top_left_y":988,"width":1464,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"506b92a58cde4b2890b9ae4e00a59e81","type":"text","conversion_output":true,"text":"mean changes from baseline in UDI scores at 1 year are significantly different between the two","text_display":" mean changes from baseline in UDI scores at 1 year are significantly different between the two","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[370,1031],[1794,1031],[1794,1076],[370,1076]],"region":{"top_left_x":369,"top_left_y":1031,"width":1425,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25b84e7ff40f41b7af6c61787c7e452e","type":"text","conversion_output":true,"text":"treatment groups, accounting for the percent of women in each group who request additional","text_display":" treatment groups, accounting for the percent of women in each group who request additional","confidence":1,"confidence_rate":1},{"cnt":[[370,1076],[1807,1076],[1807,1119],[370,1119]],"region":{"top_left_x":369,"top_left_y":1076,"width":1438,"height":44},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e83d45b7e4049b9994254c2d096f183","type":"text","conversion_output":true,"text":"treatment. Sensitivity analysis will be conducted to test the robustness of test results to model","text_display":" treatment. Sensitivity analysis will be conducted to test the robustness of test results to model","confidence":1,"confidence_rate":1},{"cnt":[[370,1121],[595,1121],[595,1167],[370,1167]],"region":{"top_left_x":369,"top_left_y":1121,"width":227,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"844edb05c32a46dab386525876934802","type":"text","conversion_output":true,"text":"specifications.","text_display":" specifications.","confidence":1,"confidence_rate":1},{"cnt":[[370,1229],[1848,1229],[1848,1274],[370,1274]],"region":{"top_left_x":369,"top_left_y":1228,"width":1479,"height":47},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d5aaeee0f2447218957c1290fa30318","type":"text","conversion_output":true,"text":"We will report whether change in total UDI score between baseline and one year is significantly","text_display":"\n\nWe will report whether change in total UDI score between baseline and one year is significantly","confidence":1,"confidence_rate":1},{"cnt":[[370,1274],[1772,1274],[1772,1317],[370,1317]],"region":{"top_left_x":369,"top_left_y":1274,"width":1404,"height":43},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02a8d5222df5408e85b91ea21071a6e8","type":"text","conversion_output":true,"text":"different in the two groups. If the difference is statistically significant, the potential clinical","text_display":" different in the two groups. If the difference is statistically significant, the potential clinical","confidence":1,"confidence_rate":1},{"cnt":[[370,1315],[1841,1315],[1841,1360],[370,1360]],"region":{"top_left_x":369,"top_left_y":1314,"width":1473,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9276accb03c47c59a55d587dfc8534b","type":"text","conversion_output":true,"text":"significance of the difference will be discussed. We recognize that our sample size would allow","text_display":" significance of the difference will be discussed. We recognize that our sample size would allow","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[370,1360],[1833,1360],[1833,1407],[370,1407]],"region":{"top_left_x":369,"top_left_y":1359,"width":1464,"height":49},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04da8122b99c4b9e985f922c9dded95c","type":"text","conversion_output":true,"text":"us to find a difference between groups that is statistically significant yet smaller than published","text_display":" us to find a difference between groups that is statistically significant yet smaller than published","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[370,1405],[1876,1405],[1876,1450],[370,1450]],"region":{"top_left_x":369,"top_left_y":1405,"width":1507,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab0b561c033a4a73a796fd5cca02bd30","type":"text","conversion_output":true,"text":"MIDs for total UDI score for women with MUI. However, published MIDs were calculated based","text_display":" MIDs for total UDI score for women with MUI. However, published MIDs were calculated based","confidence":1,"confidence_rate":1},{"cnt":[[370,1448],[1871,1448],[1871,1493],[370,1493]],"region":{"top_left_x":369,"top_left_y":1448,"width":1503,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10358253f69444f0bd5e66eb6d795cfe","type":"text","conversion_output":true,"text":"on populations that may be somewhat different from the one targeted for enrollment in ESTEEM,","text_display":" on populations that may be somewhat different from the one targeted for enrollment in ESTEEM,","confidence":1,"confidence_rate":1},{"cnt":[[370,1491],[1815,1491],[1815,1536],[370,1536]],"region":{"top_left_x":369,"top_left_y":1491,"width":1447,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69302c341144489eb0e0aaa84330747b","type":"text","conversion_output":true,"text":"and a secondary aim of ESTEEM is to explore whether the true MID in this population differs","text_display":" and a secondary aim of ESTEEM is to explore whether the true MID in this population differs","confidence":1,"confidence_rate":1},{"cnt":[[370,1536],[896,1536],[896,1583],[370,1583]],"region":{"top_left_x":369,"top_left_y":1536,"width":527,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a581a163ee8e4e4db210980bc7956cb9","type":"text","conversion_output":true,"text":"from previously published values.","text_display":" from previously published values.","confidence":1,"confidence_rate":1},{"cnt":[[370,1598],[947,1598],[947,1652],[370,1652]],"region":{"top_left_x":369,"top_left_y":1598,"width":579,"height":55},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b29eac95dd744f10ba6ba4d713bad49a","type":"section_header","conversion_output":false,"children_ids":["c1ededf129e9468da2e5350a94e8ed03"],"text":"","text_display":""},{"cnt":[[372,1603],[943,1603],[943,1648],[372,1648]],"region":{"top_left_x":371,"top_left_y":1602,"width":573,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1ededf129e9468da2e5350a94e8ed03","type":"text","conversion_output":true,"parent_id":"b29eac95dd744f10ba6ba4d713bad49a","text":"9.4 Secondary Analysis Methods","text_display":"\n\n\\subsection*{9.4 Secondary Analysis Methods}","confidence":1,"confidence_rate":1},{"cnt":[[372,1659],[1729,1659],[1729,1704],[372,1704]],"region":{"top_left_x":371,"top_left_y":1658,"width":1359,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0fd3fcb6e3a84fd79fcaf0a555528291","type":"text","conversion_output":true,"text":"The mean change from baseline in UDI-irritative and UDI-stress scores at 1 year will be","text_display":"\n\nThe mean change from baseline in UDI-irritative and UDI-stress scores at 1 year will be","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[370,1702],[1867,1702],[1867,1747],[370,1747]],"region":{"top_left_x":369,"top_left_y":1701,"width":1498,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99f407f16c874f32961b30b44e566bc7","type":"text","conversion_output":true,"text":"compared between groups using the same analysis methods described for the primary analysis. If","text_display":" compared between groups using the same analysis methods described for the primary analysis. If","confidence":1,"confidence_rate":1},{"cnt":[[370,1747],[1833,1747],[1833,1790],[370,1790]],"region":{"top_left_x":369,"top_left_y":1746,"width":1464,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f85cdbde906468db7a626a86a4b91fe","type":"text","conversion_output":true,"text":"the difference is statistically significant, the potential clinical significance of the difference will","text_display":" the difference is statistically significant, the potential clinical significance of the difference will","confidence":1,"confidence_rate":1},{"cnt":[[370,1790],[1850,1790],[1850,1835],[370,1835]],"region":{"top_left_x":369,"top_left_y":1789,"width":1481,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d08ba77ba2a4e6dbebd1a392e1d307a","type":"text","conversion_output":true,"text":"be discussed. Additional analyses will be conducted to determine whether the MIDs in this MUI","text_display":" be discussed. Additional analyses will be conducted to determine whether the MIDs in this MUI","confidence":1,"confidence_rate":1},{"cnt":[[370,1835],[1154,1835],[1154,1880],[370,1880]],"region":{"top_left_x":369,"top_left_y":1834,"width":785,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3c5d7f49e6d474ea66bfb7251404f21","type":"text","conversion_output":true,"text":"population differ from previously published MIDs.","text_display":" population differ from previously published MIDs.","confidence":1,"confidence_rate":1},{"cnt":[[370,1899],[872,1899],[872,1951],[370,1951]],"region":{"top_left_x":369,"top_left_y":1899,"width":504,"height":52},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9233ac3daa2b47f3b564335559ffe6a2","type":"section_header","conversion_output":false,"children_ids":["5c3c990e1fd748e4b6eb5349f528e838"],"text":"","text_display":""},{"cnt":[[372,1899],[870,1899],[870,1944],[372,1944]],"region":{"top_left_x":371,"top_left_y":1899,"width":500,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c3c990e1fd748e4b6eb5349f528e838","type":"text","conversion_output":true,"parent_id":"9233ac3daa2b47f3b564335559ffe6a2","text":"9.5 Other Analysis Methods","text_display":"\n\n\\subsection*{9.5 Other Analysis Methods}","confidence":1,"confidence_rate":1},{"cnt":[[430,1966],[1012,1966],[1012,2013],[430,2013]],"region":{"top_left_x":429,"top_left_y":1965,"width":583,"height":49},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8cb39687f4846e9948511c634fdb3d7","type":"section_header","conversion_output":false,"children_ids":["933d79266f6e4fc1af04f267b17aced1"],"text":"","text_display":""},{"cnt":[[434,1968],[1008,1968],[1008,2009],[434,2009]],"region":{"top_left_x":433,"top_left_y":1967,"width":575,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"933d79266f6e4fc1af04f267b17aced1","type":"text","conversion_output":true,"parent_id":"a8cb39687f4846e9948511c634fdb3d7","text":"9.5.1 Other UUI/OAB Outcomes","text_display":"\n\n\\subsection*{9.5.1 Other UUI/OAB Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[430,2054],[660,2054],[660,2105],[430,2105]],"region":{"top_left_x":429,"top_left_y":2053,"width":231,"height":53},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"886a18a779b74855b28281e57fd5140b","type":"section_header","conversion_output":false,"children_ids":["559e095155a348459e86c65cdb875855"],"text":"","text_display":""},{"cnt":[[434,2058],[655,2058],[655,2101],[434,2101]],"region":{"top_left_x":433,"top_left_y":2058,"width":223,"height":44},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"559e095155a348459e86c65cdb875855","type":"text","conversion_output":true,"parent_id":"886a18a779b74855b28281e57fd5140b","text":"Bladder diary","text_display":"\n\n\\section*{Bladder diary}","confidence":1,"confidence_rate":1},{"cnt":[[434,2110],[1850,2110],[1850,2155],[434,2155]],"region":{"top_left_x":433,"top_left_y":2109,"width":1417,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b91ba7801d93426997d451d0a15bd486","type":"text","conversion_output":true,"text":"We will compare change in number of urge IEs and urgency-episodes and nocturia episodes","text_display":"\n\nWe will compare change in number of urge IEs and urgency-episodes and nocturia episodes","confidence":1,"confidence_rate":1},{"cnt":[[434,2155],[1824,2155],[1824,2202],[434,2202]],"region":{"top_left_x":433,"top_left_y":2154,"width":1392,"height":49},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"177821f8e457490283d9ae0c59221e44","type":"text","conversion_output":true,"text":"between groups from baseline to 6 and 12 months. Of note, not all four symptoms of OAB","text_display":" between groups from baseline to 6 and 12 months. Of note, not all four symptoms of OAB","confidence":1,"confidence_rate":1},{"cnt":[[434,2200],[1841,2200],[1841,2245],[434,2245]],"region":{"top_left_x":433,"top_left_y":2200,"width":1409,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cf082f9a61c4da5978981464a2fafe3","type":"text","conversion_output":true,"text":"(frequency, urgency, nocturia, and UUI) are required to be present at baseline for eligibility","text_display":" (frequency, urgency, nocturia, and UUI) are required to be present at baseline for eligibility","confidence":1,"confidence_rate":1},{"cnt":[[434,2243],[1854,2243],[1854,2288],[434,2288]],"region":{"top_left_x":433,"top_left_y":2242,"width":1422,"height":47},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83a5fbe4b5da4da39f590f9bf38bf4b2","type":"text","conversion_output":true,"text":"into this trial (only UUI required). Changes from baseline in bladder diary outcomes will be","text_display":" into this trial (only UUI required). Changes from baseline in bladder diary outcomes will be","confidence":1,"confidence_rate":1},{"cnt":[[434,2333],[434,2286],[1869,2288],[1869,2335]],"region":{"top_left_x":433,"top_left_y":2285,"width":1437,"height":51},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b6c514a297b437594d30940d4c82dab","type":"text","conversion_output":true,"text":"calculated and analyzed using the methods described for the analysis of the primary outcome.","text_display":" calculated and analyzed using the methods described for the analysis of the primary outcome.","confidence":1,"confidence_rate":1},{"cnt":[[434,2396],[1807,2396],[1807,2443],[434,2443]],"region":{"top_left_x":433,"top_left_y":2395,"width":1374,"height":48},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba0c492382af47e9bfe04bafb4b55acf","type":"text","conversion_output":true,"text":"For urinary frequency, women reporting on average \\(>8\\) voids/ 24 hours at baseline will be","text_display":"\n\nFor urinary frequency, women reporting on average \\(>8\\) voids/ 24 hours at baseline will be","confidence":0.53125,"confidence_rate":0.993631250252655},{"cnt":[[434,2438],[1781,2438],[1781,2486],[434,2486]],"region":{"top_left_x":433,"top_left_y":2438,"width":1349,"height":48},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30435da43a1b40ec8cec40c5b951dd70","type":"text","conversion_output":true,"text":"considered symptomatic, and normalization of voiding frequency will be defined as \\(<8\\)","text_display":" considered symptomatic, and normalization of voiding frequency will be defined as \\(<8\\)","confidence":0.9970703125,"confidence_rate":0.9999666597894927},{"cnt":[[309,2552],[681,2552],[681,2587],[309,2587]],"region":{"top_left_x":309,"top_left_y":2552,"width":373,"height":35},"line":51,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6aefcfc96bcd4c07945a45de50d9a8c1","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 36","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-38","page":38,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bec4e4841a474307ab5a7fde87cfa63a","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[801,180],[801,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":493,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f578d6e0a0bb4b1ea2e248fc751c2089","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[434,316],[1820,316],[1820,359],[434,359]],"region":{"top_left_x":433,"top_left_y":315,"width":1387,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b324562081543a8af7047b4ec5f6316","type":"text","conversion_output":true,"text":"voids/ 24 hours at 1 year. A \\(50 \\%\\) improvement will be defined as a reduction by half in the","text_display":"\nvoids/ 24 hours at 1 year. A \\(50 \\%\\) improvement will be defined as a reduction by half in the","confidence":0.97265625,"confidence_rate":0.9997334533374248},{"cnt":[[434,357],[1863,357],[1863,402],[434,402]],"region":{"top_left_x":433,"top_left_y":356,"width":1430,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4346f36d1114f7a9add514e27e71cac","type":"text","conversion_output":true,"text":"number of voids that patients had at baseline. The number of women who had normalization","text_display":" number of voids that patients had at baseline. The number of women who had normalization","confidence":1,"confidence_rate":1},{"cnt":[[434,404],[1876,404],[1876,449],[434,449]],"region":{"top_left_x":433,"top_left_y":403,"width":1443,"height":47},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a13bd6b8f1dc4ce4ac3cd18f10976377","type":"text","conversion_output":true,"text":"of voiding frequency and \\(50 \\%\\) improvement will be compared between groups separately and","text_display":" of voiding frequency and \\(50 \\%\\) improvement will be compared between groups separately and","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[434,447],[1794,447],[1794,492],[434,492]],"region":{"top_left_x":433,"top_left_y":446,"width":1361,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ee43c6f296e4f5c979baaf5da7a664a","type":"text","conversion_output":true,"text":"collectively. We will also assess the proportion of women who had worsening of urinary","text_display":" collectively. We will also assess the proportion of women who had worsening of urinary","confidence":1,"confidence_rate":1},{"cnt":[[434,490],[1807,490],[1807,535],[434,535]],"region":{"top_left_x":433,"top_left_y":489,"width":1374,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cc705ef6916475fbf946f3cfe168be2","type":"text","conversion_output":true,"text":"frequency (includes women who developed de novo frequency and those who worsened).","text_display":" frequency (includes women who developed de novo frequency and those who worsened).","confidence":1,"confidence_rate":1},{"cnt":[[434,535],[1833,535],[1833,578],[434,578]],"region":{"top_left_x":433,"top_left_y":534,"width":1400,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2862a9ebf3324a90bd9696e31f8f9e91","type":"text","conversion_output":true,"text":"These dichotomous outcomes will be analyzed using logistic regression, controlling for the","text_display":" These dichotomous outcomes will be analyzed using logistic regression, controlling for the","confidence":1,"confidence_rate":1},{"cnt":[[434,580],[1850,580],[1850,625],[434,625]],"region":{"top_left_x":433,"top_left_y":580,"width":1417,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d3742ce5ed04729836bf9284a6da0b8","type":"text","conversion_output":true,"text":"design effects of stratification by center and by baseline urge IE group. To assess the impact","text_display":" design effects of stratification by center and by baseline urge IE group. To assess the impact","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[434,623],[1876,623],[1876,668],[434,668]],"region":{"top_left_x":433,"top_left_y":623,"width":1443,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a795f484b604425bb5633ea3756025d","type":"text","conversion_output":true,"text":"of additional treatment prior to 1 year, sensitivity analyses will be conducted in which women","text_display":" of additional treatment prior to 1 year, sensitivity analyses will be conducted in which women","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[434,666],[1626,666],[1626,711],[434,711]],"region":{"top_left_x":433,"top_left_y":666,"width":1194,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5512e37f3c0482682f884c7bf03535b","type":"text","conversion_output":true,"text":"who request additional treatment will be assigned the less-favorable outcome.","text_display":" who request additional treatment will be assigned the less-favorable outcome.","confidence":0.99755859375,"confidence_rate":0.9999701907937938},{"cnt":[[432,773],[810,773],[810,823],[432,823]],"region":{"top_left_x":431,"top_left_y":773,"width":379,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82b24c325fa847baaa0fb12a444e4632","type":"section_header","conversion_output":false,"children_ids":["3c225caff65747ee9a8d33352fc03fc8"],"text":"","text_display":""},{"cnt":[[434,778],[806,778],[806,819],[434,819]],"region":{"top_left_x":433,"top_left_y":777,"width":373,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c225caff65747ee9a8d33352fc03fc8","type":"text","conversion_output":true,"parent_id":"82b24c325fa847baaa0fb12a444e4632","text":"\\(O A B-S A T-q\\) and \\(O A B-q\\)","text_display":"\n\n\\section*{\\(O A B-S A T-q\\) and \\(O A B-q\\)}","confidence":0.9990234375,"confidence_rate":0.9999555900930661},{"cnt":[[434,829],[1863,829],[1863,870],[434,870]],"region":{"top_left_x":433,"top_left_y":829,"width":1430,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e30c97f8860145c59fb6bffae5a5c790","type":"text","conversion_output":true,"text":"For these scales and associated subscales, differences from baseline will be calculated for the","text_display":"\n\nFor these scales and associated subscales, differences from baseline will be calculated for the","confidence":1,"confidence_rate":1},{"cnt":[[434,872],[1828,872],[1828,917],[434,917]],"region":{"top_left_x":433,"top_left_y":872,"width":1396,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0abaf964f6744d4aa8178d460bf47a34","type":"text","conversion_output":true,"text":"OAB-q, and methods described for analysis of the primary outcome will be used to test for","text_display":" OAB-q, and methods described for analysis of the primary outcome will be used to test for","confidence":0.8995596889872104,"confidence_rate":0.9988745713253968},{"cnt":[[434,920],[1871,920],[1871,965],[434,965]],"region":{"top_left_x":433,"top_left_y":919,"width":1439,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b05439f8110420e86a74d0f5b779ace","type":"text","conversion_output":true,"text":"differences between treatment groups at 12 months. For the OAB-SAT-q, differences in post-","text_display":" differences between treatment groups at 12 months. For the OAB-SAT-q, differences in post","confidence":0.996584415435791,"confidence_rate":0.999965088048318},{"cnt":[[434,962],[1222,962],[1222,1008],[434,1008]],"region":{"top_left_x":433,"top_left_y":962,"width":790,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1a189101a224bdb95a9be43124b0337","type":"text","conversion_output":true,"text":"treatment scores will be compared between groups.","text_display":"treatment scores will be compared between groups.","confidence":0.99853515625,"confidence_rate":0.9999728537447163},{"cnt":[[434,1070],[1863,1070],[1863,1115],[434,1115]],"region":{"top_left_x":433,"top_left_y":1069,"width":1430,"height":47},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97d8b35ffe754bab9bf7d29830c0710b","type":"text","conversion_output":true,"text":"The scoring manual for the OAB-SAT-q states that higher scores should correspond to better","text_display":"\n\nThe scoring manual for the OAB-SAT-q states that higher scores should correspond to better","confidence":0.9892857074737549,"confidence_rate":0.9998866158614395},{"cnt":[[434,1113],[1852,1113],[1852,1158],[434,1158]],"region":{"top_left_x":433,"top_left_y":1112,"width":1419,"height":47},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"929711bc1ba24d4bb2f40ac33320e250","type":"text","conversion_output":true,"text":"outcomes and also details that final composite scores for each dimension should be obtained","text_display":" outcomes and also details that final composite scores for each dimension should be obtained","confidence":1,"confidence_rate":1},{"cnt":[[434,1158],[1835,1158],[1835,1205],[434,1205]],"region":{"top_left_x":433,"top_left_y":1158,"width":1402,"height":48},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eaf584aad35d451c83abdf2b7271db5c","type":"text","conversion_output":true,"text":"by subtracting raw scores from the highest possible score and dividing by range. However,","text_display":" by subtracting raw scores from the highest possible score and dividing by range. However,","confidence":1,"confidence_rate":1},{"cnt":[[434,1203],[1861,1203],[1861,1248],[434,1248]],"region":{"top_left_x":433,"top_left_y":1203,"width":1428,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d777888d010544f4a63abec9893af653","type":"text","conversion_output":true,"text":"based on the direction of score for individual responses, this derivation would result in lower","text_display":" based on the direction of score for individual responses, this derivation would result in lower","confidence":1,"confidence_rate":1},{"cnt":[[434,1246],[1863,1246],[1863,1291],[434,1291]],"region":{"top_left_x":433,"top_left_y":1246,"width":1430,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7abb982955774eacb9c3da446f543db7","type":"text","conversion_output":true,"text":"scores corresponding with better outcomes. We have adjusting the scoring algorithm instead","text_display":" scores corresponding with better outcomes. We have adjusting the scoring algorithm instead","confidence":1,"confidence_rate":1},{"cnt":[[434,1289],[1863,1289],[1863,1334],[434,1334]],"region":{"top_left_x":433,"top_left_y":1289,"width":1430,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2d48ff6d94045cb88be9629626bd461","type":"text","conversion_output":true,"text":"to be: 100*(raw score - lowest possible score)/score range. This calculation results in higher","text_display":" to be: 100*(raw score - lowest possible score)/score range. This calculation results in higher","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[434,1334],[1515,1334],[1515,1377],[434,1377]],"region":{"top_left_x":433,"top_left_y":1334,"width":1082,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7317a410a2e44d72acbfe2d53a59466f","type":"text","conversion_output":true,"text":"scores corresponding to better outcomes and an overall scale of 0-100.","text_display":" scores corresponding to better outcomes and an overall scale of 0-100.","confidence":0.99755859375,"confidence_rate":0.9999674086465526},{"cnt":[[434,1444],[1790,1444],[1790,1489],[434,1489]],"region":{"top_left_x":433,"top_left_y":1443,"width":1357,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c95a8e45e3745709d05881db5271455","type":"text","conversion_output":true,"text":"Additionally, it was observed that the scoring of the OAB-SAT-q Endorsement subscale","text_display":"\n\nAdditionally, it was observed that the scoring of the OAB-SAT-q Endorsement subscale","confidence":1,"confidence_rate":1},{"cnt":[[434,1487],[1772,1487],[1772,1532],[434,1532]],"region":{"top_left_x":433,"top_left_y":1486,"width":1340,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"618238189c224f9a9b32300e121c85f7","type":"text","conversion_output":true,"text":"could have unintended behavior when dealing with missing data. The range of possible","text_display":" could have unintended behavior when dealing with missing data. The range of possible","confidence":1,"confidence_rate":1},{"cnt":[[434,1530],[1785,1530],[1785,1575],[434,1575]],"region":{"top_left_x":433,"top_left_y":1529,"width":1353,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7ff8b09fab34c0bba515b3ce389db67","type":"text","conversion_output":true,"text":"responses for component questions 9 and 10 ( 1 through 4 ) is different from the range of","text_display":" responses for component questions 9 and 10 ( 1 through 4 ) is different from the range of","confidence":0.9990236759185791,"confidence_rate":0.9999907849387211},{"cnt":[[434,1575],[1876,1575],[1876,1618],[434,1618]],"region":{"top_left_x":433,"top_left_y":1574,"width":1443,"height":44},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac67e61b856b4fe499fbbdd2eb2cbc9e","type":"text","conversion_output":true,"text":"possible responses for component question 11 ( 1 through 6 ), so if any question is missing, the","text_display":" possible responses for component question 11 ( 1 through 6 ), so if any question is missing, the","confidence":0.6835136413574219,"confidence_rate":0.9965468063536309},{"cnt":[[434,1620],[1811,1620],[1811,1663],[434,1663]],"region":{"top_left_x":433,"top_left_y":1619,"width":1379,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc1b60dcc1634ac997c2bc41fd05d00f","type":"text","conversion_output":true,"text":"range of possible values for the imputed value of the missing response does not match the","text_display":" range of possible values for the imputed value of the missing response does not match the","confidence":1,"confidence_rate":1},{"cnt":[[434,1663],[1803,1663],[1803,1708],[434,1708]],"region":{"top_left_x":433,"top_left_y":1662,"width":1370,"height":47},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cf56ee71b5a4e0aabc70978a2a66a8c","type":"text","conversion_output":true,"text":"range of the original question. For example, if Q9=4, Q10=Missing, and Q11=6, then the","text_display":" range of the original question. For example, if Q9=4, Q10=Missing, and Q11=6, then the","confidence":0.7596278190612793,"confidence_rate":0.9969833868692464},{"cnt":[[434,1706],[1837,1706],[1837,1751],[434,1751]],"region":{"top_left_x":433,"top_left_y":1705,"width":1404,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00fc05eb66404e718c3bd7f87a503596","type":"text","conversion_output":true,"text":"imputed value for Q10 is 5, which is outside of the 1-4 range possible for Q10. This further","text_display":" imputed value for Q10 is 5, which is outside of the 1-4 range possible for Q10. This further","confidence":0.5851292610168457,"confidence_rate":0.9944902604026302},{"cnt":[[434,1749],[1867,1749],[1867,1794],[434,1794]],"region":{"top_left_x":433,"top_left_y":1748,"width":1434,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc1dc1e56482461aa2e26c3779f04b16","type":"text","conversion_output":true,"text":"causes problems when transforming the score as the transformed score can exceed 100 . From","text_display":" causes problems when transforming the score as the transformed score can exceed 100 . From","confidence":0.9970703125,"confidence_rate":0.999970061800863},{"cnt":[[434,1794],[1687,1794],[1687,1841],[434,1841]],"region":{"top_left_x":433,"top_left_y":1793,"width":1254,"height":49},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09a71f07d80f4c35ad2b45891c0d65b5","type":"text","conversion_output":true,"text":"the example provided, the transformed score is \\(100^{*}(\\operatorname{sum}(4,5,6)-3) / 11=109.09\\).","text_display":" the example provided, the transformed score is \\(100^{*}(\\operatorname{sum}(4,5,6)-3) / 11=109.09\\).","confidence":0.9902620129287243,"confidence_rate":0.9998969978172397},{"cnt":[[434,1904],[1729,1904],[1729,1949],[434,1949]],"region":{"top_left_x":433,"top_left_y":1903,"width":1297,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da2ddcfaa0944677ae88fd714047d681","type":"text","conversion_output":true,"text":"We have adjusted the missing value handling instead to be: average the non-missing","text_display":"\n\nWe have adjusted the missing value handling instead to be: average the non-missing","confidence":1,"confidence_rate":1},{"cnt":[[434,1946],[1740,1946],[1740,1992],[434,1992]],"region":{"top_left_x":433,"top_left_y":1946,"width":1308,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"024f7d404d6449e8b19315cf236e494a","type":"text","conversion_output":true,"text":"responses as proportions of their maximum possible values (divide each non-missing","text_display":" responses as proportions of their maximum possible values (divide each non-missing","confidence":1,"confidence_rate":1},{"cnt":[[434,1989],[1863,1989],[1863,2035],[434,2035]],"region":{"top_left_x":433,"top_left_y":1989,"width":1430,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"446bc79b51be4f7f97623be47dad3d01","type":"text","conversion_output":true,"text":"response by its maximum possible value) and then scaling that average against the maximum","text_display":" response by its maximum possible value) and then scaling that average against the maximum","confidence":1,"confidence_rate":1},{"cnt":[[434,2035],[1807,2035],[1807,2082],[434,2082]],"region":{"top_left_x":433,"top_left_y":2034,"width":1374,"height":48},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0340c6a7cc9f4a4dbf21eba7bd1b3068","type":"text","conversion_output":true,"text":"possible value of the missing response. For example, if \\(Q 9=4, Q 10=\\) Missing, and \\(Q 11=6\\),","text_display":" possible value of the missing response. For example, if \\(Q 9=4, Q 10=\\) Missing, and \\(Q 11=6\\),","confidence":0.98681640625,"confidence_rate":0.9998748071886348},{"cnt":[[434,2080],[1697,2080],[1697,2123],[434,2123]],"region":{"top_left_x":433,"top_left_y":2079,"width":1265,"height":44},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0606245440124501b9a297737c743ed8","type":"text","conversion_output":true,"text":"then the imputed value for question 10 is as follows \\([(4 / 4+6 / 6) / 2] * 4=4\\) and the","text_display":" then the imputed value for question 10 is as follows \\([(4 / 4+6 / 6) / 2] * 4=4\\) and the","confidence":0.9965846532722935,"confidence_rate":0.999961560375473},{"cnt":[[434,2123],[1781,2123],[1781,2168],[434,2168]],"region":{"top_left_x":433,"top_left_y":2122,"width":1349,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"800cc121dc8c407e9ef9f3be35b49c9b","type":"text","conversion_output":true,"text":"transformed Endorsement score is \\(100^{*}(\\operatorname{sum}(4,4,6)-3) / 11=100\\), so the score does not","text_display":" transformed Endorsement score is \\(100^{*}(\\operatorname{sum}(4,4,6)-3) / 11=100\\), so the score does not","confidence":0.9588997936776877,"confidence_rate":0.9995804010563883},{"cnt":[[434,2166],[621,2166],[621,2206],[434,2206]],"region":{"top_left_x":433,"top_left_y":2165,"width":188,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a50e09ccedbb4355921bb1c25989cb81","type":"text","conversion_output":true,"text":"exceed 100 .","text_display":" exceed 100 .","confidence":0.69580078125,"confidence_rate":0.9820288476113627},{"cnt":[[430,2230],[831,2230],[831,2275],[430,2275]],"region":{"top_left_x":429,"top_left_y":2230,"width":403,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d49c4ab7329a4259a3b895ab45a1353c","type":"section_header","conversion_output":false,"children_ids":["a1dc87bf2cc04facb87eea00a80f65a4"],"text":"","text_display":""},{"cnt":[[434,2234],[827,2234],[827,2271],[434,2271]],"region":{"top_left_x":433,"top_left_y":2234,"width":395,"height":37},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1dc87bf2cc04facb87eea00a80f65a4","type":"text","conversion_output":true,"parent_id":"d49c4ab7329a4259a3b895ab45a1353c","text":"9.5.2 Time-to-Failure","text_display":"\n\n\\subsection*{9.5.2 Time-to-Failure}","confidence":1,"confidence_rate":1},{"cnt":[[434,2320],[1708,2320],[1708,2365],[434,2365]],"region":{"top_left_x":433,"top_left_y":2320,"width":1276,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35dd2931e13945c6ae8895f88130af52","type":"text","conversion_output":true,"text":"Although our primary outcome is at 12 months, the team was interested in whether","text_display":"\n\nAlthough our primary outcome is at 12 months, the team was interested in whether","confidence":1,"confidence_rate":1},{"cnt":[[434,2363],[1863,2363],[1863,2408],[434,2408]],"region":{"top_left_x":433,"top_left_y":2363,"width":1430,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c183a4561b1a4e66b608d9fff5034a8e","type":"text","conversion_output":true,"text":"perioperative BPTx may be associated with a delayed time to failure compared to Control. In","text_display":" perioperative BPTx may be associated with a delayed time to failure compared to Control. In","confidence":1,"confidence_rate":1},{"cnt":[[434,2408],[1863,2408],[1863,2451],[434,2451]],"region":{"top_left_x":433,"top_left_y":2408,"width":1430,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61dc35edef5848ea969ecf7411f19610","type":"text","conversion_output":true,"text":"other words, is BPTx associated with a significant effect, but the effect is not sustained at the","text_display":" other words, is BPTx associated with a significant effect, but the effect is not sustained at the","confidence":1,"confidence_rate":1},{"cnt":[[436,2454],[1867,2454],[1867,2499],[436,2499]],"region":{"top_left_x":436,"top_left_y":2453,"width":1431,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4902577b668473e833283614ddb6a42","type":"text","conversion_output":true,"text":"12-month time point? For example, if BPTx could delay the need for anti-muscarinics for up","text_display":" 12-month time point? For example, if BPTx could delay the need for anti-muscarinics for up","confidence":0.98388671875,"confidence_rate":0.9998290197579605},{"cnt":[[309,2552],[681,2552],[681,2587],[309,2587]],"region":{"top_left_x":309,"top_left_y":2552,"width":373,"height":35},"line":47,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"55a444274c03446e9e7d9536dfe912a3","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 37","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-39","page":39,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c70a3c11c4ee4e0fb85e92edac4f076f","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[801,180],[801,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":493,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b466461623b04962972c2bc9260766fd","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[434,314],[1863,314],[1863,359],[434,359]],"region":{"top_left_x":433,"top_left_y":313,"width":1430,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c1e365f3a084d52b3bab4f3c9cebdf4","type":"text","conversion_output":true,"text":"to 9 months, this would be relevant information for counseling women and perhaps clinically","text_display":"\nto 9 months, this would be relevant information for counseling women and perhaps clinically","confidence":1,"confidence_rate":1},{"cnt":[[434,357],[1768,357],[1768,402],[434,402]],"region":{"top_left_x":433,"top_left_y":356,"width":1336,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"000d3b7cdaab45fcbf8b513a6ab3ce1a","type":"text","conversion_output":true,"text":"recommending perioperative BPTx. As described previously, failure will be defined as","text_display":" recommending perioperative BPTx. As described previously, failure will be defined as","confidence":1,"confidence_rate":1},{"cnt":[[434,404],[1605,404],[1605,449],[434,449]],"region":{"top_left_x":433,"top_left_y":403,"width":1172,"height":47},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5294c5f9ca7483aa3690720a3f406b4","type":"text","conversion_output":true,"text":"initiation of any additional treatment for either SUI or UUI/OAB symptoms.","text_display":" initiation of any additional treatment for either SUI or UUI/OAB symptoms.","confidence":1,"confidence_rate":1},{"cnt":[[434,511],[1824,511],[1824,556],[434,556]],"region":{"top_left_x":433,"top_left_y":511,"width":1392,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96000e4c223e4fa098c4e53d204b8d0a","type":"text","conversion_output":true,"text":"A class of survival model which can account for interval censoring (outcomes measured at","text_display":"\n\nA class of survival model which can account for interval censoring (outcomes measured at","confidence":1,"confidence_rate":1},{"cnt":[[434,556],[1828,554],[1828,602],[434,604]],"region":{"top_left_x":433,"top_left_y":554,"width":1396,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e7e4b85a04a40049170e0b9d8353526","type":"text","conversion_output":true,"text":"pre-planned time points as opposed to continuously over time) will be used to determine if","text_display":" pre-planned time points as opposed to continuously over time) will be used to determine if","confidence":1,"confidence_rate":1},{"cnt":[[434,602],[1850,602],[1850,647],[434,647]],"region":{"top_left_x":433,"top_left_y":601,"width":1417,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8c840f093d194a158bf9d33a7fe7f42a","type":"text","conversion_output":true,"text":"combined MUS+BPTx is associated with a decrease time to failure compared to MUS alone","text_display":" combined MUS+BPTx is associated with a decrease time to failure compared to MUS alone","confidence":1,"confidence_rate":1},{"cnt":[[434,645],[1800,645],[1800,690],[434,690]],"region":{"top_left_x":433,"top_left_y":644,"width":1368,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8fc2462a25a044ad9199c0c6cecd5032","type":"text","conversion_output":true,"text":"between 3-12 months. Depending on the distribution of the observed data, an accelerated","text_display":" between 3-12 months. Depending on the distribution of the observed data, an accelerated","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[434,688],[1779,688],[1779,733],[434,733]],"region":{"top_left_x":433,"top_left_y":687,"width":1346,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ae0b417d0c847f1a0c8091ecf7eb618","type":"text","conversion_output":true,"text":"failure time frailty model or a Bayesian survival model may be used. The model will be","text_display":" failure time frailty model or a Bayesian survival model may be used. The model will be","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[434,730],[1768,730],[1768,778],[434,778]],"region":{"top_left_x":433,"top_left_y":730,"width":1336,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2628d85384244a68a6a1b83e0b9bcd41","type":"text","conversion_output":true,"text":"adjusted for the design effects of stratification by center and by baseline urge IE group.","text_display":" adjusted for the design effects of stratification by center and by baseline urge IE group.","confidence":1,"confidence_rate":1},{"cnt":[[430,793],[1296,793],[1296,844],[430,844]],"region":{"top_left_x":429,"top_left_y":792,"width":867,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d9e035bc29a4922b2489f25b9442590","type":"section_header","conversion_output":false,"children_ids":["1da96f4c34a24d0683be41ecad9ac5da"],"text":"","text_display":""},{"cnt":[[434,799],[1291,799],[1291,840],[434,840]],"region":{"top_left_x":433,"top_left_y":799,"width":859,"height":42},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1da96f4c34a24d0683be41ecad9ac5da","type":"text","conversion_output":true,"parent_id":"7d9e035bc29a4922b2489f25b9442590","text":"9.5.3 Predictors of Treatment Success and Failure","text_display":"\n\n\\subsection*{9.5.3 Predictors of Treatment Success and Failure}","confidence":1,"confidence_rate":1},{"cnt":[[434,885],[1871,885],[1871,930],[434,930]],"region":{"top_left_x":433,"top_left_y":885,"width":1439,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"439ba777012c433b914bdac671ead241","type":"text","conversion_output":true,"text":"Regression models will be created to identify predictors of change from baseline to 1 year for","text_display":"\n\nRegression models will be created to identify predictors of change from baseline to 1 year for","confidence":1,"confidence_rate":1},{"cnt":[[434,928],[1841,928],[1841,973],[434,973]],"region":{"top_left_x":433,"top_left_y":928,"width":1409,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25416808a19548b384c6add1f364a8f5","type":"text","conversion_output":true,"text":"UDI total score and stress and irritative subscale scores. Participants who request additional","text_display":" UDI total score and stress and irritative subscale scores. Participants who request additional","confidence":1,"confidence_rate":1},{"cnt":[[434,975],[1820,975],[1820,1018],[434,1018]],"region":{"top_left_x":433,"top_left_y":975,"width":1387,"height":44},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b045bae27974af8b7eacdb7602000a8","type":"text","conversion_output":true,"text":"treatment prior to 1 year will not be included in the predictive models. Potential predictors","text_display":" treatment prior to 1 year will not be included in the predictive models. Potential predictors","confidence":1,"confidence_rate":1},{"cnt":[[434,1018],[1876,1018],[1876,1061],[434,1061]],"region":{"top_left_x":433,"top_left_y":1018,"width":1443,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ceef45b60fd54aaf8e2e1b9b2904409a","type":"text","conversion_output":true,"text":"will include age, diary parameters such as number of UUI episodes/3 days, functional bladder","text_display":" will include age, diary parameters such as number of UUI episodes/3 days, functional bladder","confidence":0.99072265625,"confidence_rate":0.9999039154789536},{"cnt":[[434,1061],[1764,1061],[1764,1106],[434,1106]],"region":{"top_left_x":433,"top_left_y":1061,"width":1331,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd184c09bb794824a71f348b73deb190","type":"text","conversion_output":true,"text":"capacity, bother severity at baseline. The relationship between potential predictors and","text_display":" capacity, bother severity at baseline. The relationship between potential predictors and","confidence":1,"confidence_rate":1},{"cnt":[[434,1104],[1794,1104],[1794,1149],[434,1149]],"region":{"top_left_x":433,"top_left_y":1104,"width":1361,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4912cdb1b194cc387ef0a3a0398bef7","type":"text","conversion_output":true,"text":"outcomes will be explored in models that include one predictor plus stratification factors","text_display":" outcomes will be explored in models that include one predictor plus stratification factors","confidence":1,"confidence_rate":1},{"cnt":[[434,1147],[1824,1147],[1824,1195],[434,1195]],"region":{"top_left_x":433,"top_left_y":1147,"width":1392,"height":48},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b02fcb468f9444a982036da1cf4d11f9","type":"text","conversion_output":true,"text":"(center and baseline urge IE group). Predictive models will be constructed using backward","text_display":" (center and baseline urge IE group). Predictive models will be constructed using backward","confidence":1,"confidence_rate":1},{"cnt":[[434,1195],[1869,1195],[1869,1240],[434,1240]],"region":{"top_left_x":433,"top_left_y":1194,"width":1437,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c354ff951369472f9eae491b93818331","type":"text","conversion_output":true,"text":"selection of predictors. The impact of collinearity between predictors will be assessed and the","text_display":" selection of predictors. The impact of collinearity between predictors will be assessed and the","confidence":1,"confidence_rate":1},{"cnt":[[434,1238],[971,1238],[971,1283],[434,1283]],"region":{"top_left_x":433,"top_left_y":1237,"width":539,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53e89ad7685947d2bfa9535fb49cf143","type":"text","conversion_output":true,"text":"final model modified as necessary.","text_display":" final model modified as necessary.","confidence":1,"confidence_rate":1},{"cnt":[[430,1298],[1124,1298],[1124,1354],[430,1354]],"region":{"top_left_x":429,"top_left_y":1297,"width":695,"height":57},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43827228328844f689b804817b2d2168","type":"section_header","conversion_output":false,"children_ids":["39c148dd69c145bdad7b3915d32a08a4"],"text":"","text_display":""},{"cnt":[[434,1302],[1119,1302],[1119,1351],[434,1351]],"region":{"top_left_x":433,"top_left_y":1301,"width":687,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39c148dd69c145bdad7b3915d32a08a4","type":"text","conversion_output":true,"parent_id":"43827228328844f689b804817b2d2168","text":"9.5.4 Quality of Life/Global Impression","text_display":"\n\n\\subsection*{9.5.4 Quality of Life/Global Impression}","confidence":1,"confidence_rate":1},{"cnt":[[434,1392],[1818,1392],[1818,1433],[434,1433]],"region":{"top_left_x":433,"top_left_y":1392,"width":1385,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fcc0fe71b4a74052943b14ada00bdbd5","type":"text","conversion_output":true,"text":"For these scales and associated subscales, differences from baseline will be calculated and","text_display":"\n\nFor these scales and associated subscales, differences from baseline will be calculated and","confidence":1,"confidence_rate":1},{"cnt":[[434,1435],[1811,1435],[1811,1480],[434,1480]],"region":{"top_left_x":433,"top_left_y":1435,"width":1379,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"acbea6f6f0ca4770b53aa49392333c60","type":"text","conversion_output":true,"text":"methods described for analysis of the primary outcome will be used to test for differences","text_display":" methods described for analysis of the primary outcome will be used to test for differences","confidence":1,"confidence_rate":1},{"cnt":[[434,1478],[1390,1478],[1390,1523],[434,1523]],"region":{"top_left_x":433,"top_left_y":1478,"width":958,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff829e1726c54920b6a54b198502108a","type":"text","conversion_output":true,"text":"between treatment groups from baseline and 6 and 12 months.","text_display":" between treatment groups from baseline and 6 and 12 months.","confidence":1,"confidence_rate":1},{"cnt":[[430,1543],[1313,1543],[1313,1596],[430,1596]],"region":{"top_left_x":429,"top_left_y":1542,"width":884,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9754b215a30f4e9faad3bbebee70e7b6","type":"section_header","conversion_output":false,"children_ids":["01632c6a9c454d81b4471dfe69541d6d"],"text":"","text_display":""},{"cnt":[[434,1545],[1308,1545],[1308,1592],[434,1592]],"region":{"top_left_x":433,"top_left_y":1544,"width":876,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01632c6a9c454d81b4471dfe69541d6d","type":"text","conversion_output":true,"parent_id":"9754b215a30f4e9faad3bbebee70e7b6","text":"9.5.5 Safety and Initiation of Additional Treatment","text_display":"\n\n\\subsection*{9.5.5 Safety and Initiation of Additional Treatment}","confidence":0.9970715045928955,"confidence_rate":0.9999476300884966},{"cnt":[[434,1633],[1760,1633],[1760,1678],[434,1678]],"region":{"top_left_x":433,"top_left_y":1632,"width":1327,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2676569acd64ec18d904b02b48faa0f","type":"text","conversion_output":true,"text":"We will describe rates of sling revision due to worsening OAB symptoms and rates of","text_display":"\n\nWe will describe rates of sling revision due to worsening OAB symptoms and rates of","confidence":0.83740234375,"confidence_rate":0.997985547346047},{"cnt":[[434,1676],[758,1676],[758,1717],[434,1717]],"region":{"top_left_x":433,"top_left_y":1675,"width":326,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bd68e18b85d4056b1cca8afdb03b6c7","type":"text","conversion_output":true,"text":"additional treatment.","text_display":" additional treatment.","confidence":1,"confidence_rate":1},{"cnt":[[430,1738],[1560,1738],[1560,1794],[430,1794]],"region":{"top_left_x":429,"top_left_y":1738,"width":1131,"height":56},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51a1dd3fd3d24bba937a0e7c44652060","type":"section_header","conversion_output":false,"children_ids":["90f2c4a81a004f94bc94c4b290ff4021"],"text":"","text_display":""},{"cnt":[[434,1742],[1558,1742],[1558,1790],[434,1790]],"region":{"top_left_x":433,"top_left_y":1742,"width":1125,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90f2c4a81a004f94bc94c4b290ff4021","type":"text","conversion_output":true,"parent_id":"51a1dd3fd3d24bba937a0e7c44652060","text":"9.5.6 Determine MIDs and Clinically-Meaningful MUI Definitions","text_display":"\n\n\\subsection*{9.5.6 Determine MIDs and Clinically-Meaningful MUI Definitions}","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[434,1830],[1869,1830],[1869,1876],[434,1876]],"region":{"top_left_x":433,"top_left_y":1830,"width":1437,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6760822e064f4336b75293cfa214ff53","type":"text","conversion_output":true,"text":"We will explore potential MIDs for UDI total score and stress and irritative subscores for this","text_display":"\n\nWe will explore potential MIDs for UDI total score and stress and irritative subscores for this","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[434,1873],[1833,1873],[1833,1919],[434,1919]],"region":{"top_left_x":433,"top_left_y":1873,"width":1400,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b4846b54ace41239cbc86185051631c","type":"text","conversion_output":true,"text":"MUI population. MIDs will be calculated using anchor- and distribution-based approaches.","text_display":" MUI population. MIDs will be calculated using anchor- and distribution-based approaches.","confidence":1,"confidence_rate":1},{"cnt":[[434,1919],[1764,1919],[1764,1962],[434,1962]],"region":{"top_left_x":433,"top_left_y":1918,"width":1331,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97e95c4dc4c9477e8d99b12ac01ab8df","type":"text","conversion_output":true,"text":"Potential anchors include global impression of change, incontinence episodes from the","text_display":" Potential anchors include global impression of change, incontinence episodes from the","confidence":1,"confidence_rate":1},{"cnt":[[434,1962],[1867,1962],[1867,2007],[434,2007]],"region":{"top_left_x":433,"top_left_y":1961,"width":1434,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f070f3b16ff4ca69a6e7eccea17b284","type":"text","conversion_output":true,"text":"bladder diary, and request for additional treatment. The change from baseline UDI total score","text_display":" bladder diary, and request for additional treatment. The change from baseline UDI total score","confidence":1,"confidence_rate":1},{"cnt":[[434,2007],[1790,2007],[1790,2052],[434,2052]],"region":{"top_left_x":433,"top_left_y":2006,"width":1357,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2dc77f603e384cc98691bbe8686577b8","type":"text","conversion_output":true,"text":"and stress and irritative subscores for each ESTEEM participant will be compared to the","text_display":" and stress and irritative subscores for each ESTEEM participant will be compared to the","confidence":1,"confidence_rate":1},{"cnt":[[434,2050],[1794,2050],[1794,2095],[434,2095]],"region":{"top_left_x":433,"top_left_y":2049,"width":1361,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84bfe377da4e4c94be2559b462efb4dc","type":"text","conversion_output":true,"text":"MIDs estimated from the ESTEEM data, and the percentage of participants who meet or","text_display":" MIDs estimated from the ESTEEM data, and the percentage of participants who meet or","confidence":1,"confidence_rate":1},{"cnt":[[434,2093],[1386,2093],[1386,2140],[434,2140]],"region":{"top_left_x":433,"top_left_y":2092,"width":953,"height":48},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3dda028da300441fbd6584528d79e6e2","type":"text","conversion_output":true,"text":"exceed the MID will be compared between treatment groups..","text_display":" exceed the MID will be compared between treatment groups..","confidence":1,"confidence_rate":1},{"cnt":[[434,2202],[1846,2202],[1846,2247],[434,2247]],"region":{"top_left_x":433,"top_left_y":2202,"width":1413,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8155bece2254021be6168d1b3dfc60f","type":"text","conversion_output":true,"text":"We will attempt to create threshold definitions, based on baseline measures of the UDI, IIQ,","text_display":"\n\nWe will attempt to create threshold definitions, based on baseline measures of the UDI, IIQ,","confidence":1,"confidence_rate":1},{"cnt":[[434,2245],[1867,2245],[1867,2292],[434,2292]],"region":{"top_left_x":433,"top_left_y":2245,"width":1434,"height":48},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3a471e81b0d494ba3c2233f99ce9269","type":"text","conversion_output":true,"text":"OAB-q, UDE, and baseline bladder diary parameters in isolation and in combination, that are","text_display":" OAB-q, UDE, and baseline bladder diary parameters in isolation and in combination, that are","confidence":1,"confidence_rate":1},{"cnt":[[434,2290],[1867,2290],[1867,2335],[434,2335]],"region":{"top_left_x":433,"top_left_y":2290,"width":1434,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e102275e3647454384cd6a6bd027a766","type":"text","conversion_output":true,"text":"predictive of clinical success at 1 year. Definitions of success will be based on a change from","text_display":" predictive of clinical success at 1 year. Definitions of success will be based on a change from","confidence":0.9931671619415283,"confidence_rate":0.9999334363049678},{"cnt":[[434,2333],[1820,2333],[1820,2378],[434,2378]],"region":{"top_left_x":433,"top_left_y":2333,"width":1387,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb367ceac281499aa9dec00b9ae97f3b","type":"text","conversion_output":true,"text":"baseline in total UDI score, UDI-irritative score or UDI-stress score at least as large as the","text_display":" baseline in total UDI score, UDI-irritative score or UDI-stress score at least as large as the","confidence":1,"confidence_rate":1},{"cnt":[[434,2376],[900,2376],[900,2426],[434,2426]],"region":{"top_left_x":433,"top_left_y":2376,"width":468,"height":50},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dcdece945e9d4bc4a5d1c700b85f8980","type":"text","conversion_output":true,"text":"MID for this MUI population.","text_display":" MID for this MUI population.","confidence":1,"confidence_rate":1},{"cnt":[[309,2552],[681,2552],[681,2587],[309,2587]],"region":{"top_left_x":309,"top_left_y":2552,"width":373,"height":35},"line":46,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f1e560f092af433f98fc009fcd97f184","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 38","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-40","page":40,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c3146e6b18e5452ab3dc73fbeba2db09","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a0987b64a35d4f52944c6443d01ab1de","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[430,314],[1205,314],[1205,367],[430,367]],"region":{"top_left_x":429,"top_left_y":313,"width":777,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"468f39e33a0c4baab90ee72001aa43f3","type":"section_header","conversion_output":false,"children_ids":["7e51aef46f604e8abe4fd986cbfd9e99"],"text":"","text_display":""},{"cnt":[[434,318],[1205,318],[1205,363],[434,363]],"region":{"top_left_x":433,"top_left_y":317,"width":773,"height":47},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e51aef46f604e8abe4fd986cbfd9e99","type":"text","conversion_output":true,"parent_id":"468f39e33a0c4baab90ee72001aa43f3","text":"9.5.7 Compare Pelvic Floor Muscle Strength","text_display":"\n\n\\subsection*{9.5.7 Compare Pelvic Floor Muscle Strength}","confidence":0.9990234375,"confidence_rate":0.9999792121384572},{"cnt":[[434,406],[1867,406],[1867,449],[434,449]],"region":{"top_left_x":433,"top_left_y":406,"width":1434,"height":44},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51e5db54246346129c7f2ecadebd02fe","type":"text","conversion_output":true,"text":"As mentioned above, all women will undergo PFM strength measurements using the Peritron","text_display":"\n\nAs mentioned above, all women will undergo PFM strength measurements using the Peritron","confidence":1,"confidence_rate":1},{"cnt":[[434,449],[1749,449],[1749,492],[434,492]],"region":{"top_left_x":433,"top_left_y":449,"width":1316,"height":43},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb5d8122445b4fa792670b1435cdbf61","type":"text","conversion_output":true,"text":"device by masked coordinators at baseline, postoperative at 2 weeks, 8 weeks (end of","text_display":" device by masked coordinators at baseline, postoperative at 2 weeks, 8 weeks (end of","confidence":1,"confidence_rate":1},{"cnt":[[434,492],[1871,492],[1871,537],[434,537]],"region":{"top_left_x":433,"top_left_y":491,"width":1439,"height":47},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3bc728082264889801369cc0e37024c","type":"text","conversion_output":true,"text":"intervention), and 12 months (primary endpoint). The difference in the maximum pelvic floor","text_display":" intervention), and 12 months (primary endpoint). The difference in the maximum pelvic floor","confidence":1,"confidence_rate":1},{"cnt":[[434,537],[1852,537],[1852,580],[434,580]],"region":{"top_left_x":433,"top_left_y":537,"width":1419,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c75d45d2b9e47aeb919b43bc3ba5e79","type":"text","conversion_output":true,"text":"muscle contraction pressure (maximum amplitude) will be compared between the BPTx and","text_display":" muscle contraction pressure (maximum amplitude) will be compared between the BPTx and","confidence":1,"confidence_rate":1},{"cnt":[[434,580],[1858,580],[1858,625],[434,625]],"region":{"top_left_x":433,"top_left_y":580,"width":1426,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b2395787c864b7db05a1a1b29694196","type":"text","conversion_output":true,"text":"the control groups. A table of comparative studies using the Peritron device to measure PFM","text_display":" the control groups. A table of comparative studies using the Peritron device to measure PFM","confidence":1,"confidence_rate":1},{"cnt":[[434,623],[1592,623],[1592,668],[434,668]],"region":{"top_left_x":433,"top_left_y":623,"width":1159,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d1b27b7566346099a3d0639f4fbba15","type":"text","conversion_output":true,"text":"strength changes with PFM therapy is provided in Table 12 of the protocol.","text_display":" strength changes with PFM therapy is provided in Table 12 of the protocol.","confidence":1,"confidence_rate":1},{"cnt":[[434,735],[1755,735],[1755,778],[434,778]],"region":{"top_left_x":433,"top_left_y":734,"width":1323,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1dbc016352874c0d8457c43a9fa89ad9","type":"text","conversion_output":true,"text":"Based on the existing comparative studies using the Peritron, continent women have a","text_display":"\n\nBased on the existing comparative studies using the Peritron, continent women have a","confidence":1,"confidence_rate":1},{"cnt":[[434,778],[1798,778],[1798,821],[434,821]],"region":{"top_left_x":433,"top_left_y":777,"width":1366,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc6668aa7fdc4a89a9463a0707497ab5","type":"text","conversion_output":true,"text":"maximum amplitude PFM contraction between \\(36-45 cm H 2 O\\). Incontinent women have","text_display":" maximum amplitude PFM contraction between \\(36-45 cm H 2 O\\). Incontinent women have","confidence":0.3958446222865888,"confidence_rate":0.9901895721582693},{"cnt":[[434,821],[1811,821],[1811,866],[434,866]],"region":{"top_left_x":433,"top_left_y":820,"width":1379,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ef0bfb5ac4a4a5191b40e4462b47abd","type":"text","conversion_output":true,"text":"significantly lower maximum contractions, ranging from 15.5 to 26.5 cm H 2 O , with most","text_display":" significantly lower maximum contractions, ranging from 15.5 to 26.5 cm H 2 O , with most","confidence":0.4834183882921934,"confidence_rate":0.9928991275352931},{"cnt":[[434,864],[1858,864],[1858,909],[434,909]],"region":{"top_left_x":433,"top_left_y":863,"width":1426,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e3f80e62ce9499d9262478ed8f02af5","type":"text","conversion_output":true,"text":"studies showing a maximum contraction of 25 cm H 2 O . In these studies, incontinent women","text_display":" studies showing a maximum contraction of 25 cm H 2 O . In these studies, incontinent women","confidence":0.9941432476043701,"confidence_rate":0.9999418435680746},{"cnt":[[434,907],[1820,907],[1820,954],[434,954]],"region":{"top_left_x":433,"top_left_y":906,"width":1387,"height":48},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7fdcb8716f8645aea1c55c22b122f423","type":"text","conversion_output":true,"text":"can improve their maximum contraction pressure up to \\(34-41 cm H 2 O\\) with PFM training,","text_display":" can improve their maximum contraction pressure up to \\(34-41 cm H 2 O\\) with PFM training,","confidence":0.9295676506590098,"confidence_rate":0.9992473381066551},{"cnt":[[434,954],[1867,954],[1867,999],[434,999]],"region":{"top_left_x":433,"top_left_y":953,"width":1434,"height":47},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f5aab30db684898ab117b9e5ae4202d","type":"text","conversion_output":true,"text":"which is comparable to continent women. In addition, these studies report women experience","text_display":" which is comparable to continent women. In addition, these studies report women experience","confidence":1,"confidence_rate":1},{"cnt":[[434,997],[1854,997],[1854,1042],[434,1042]],"region":{"top_left_x":433,"top_left_y":996,"width":1422,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bce1bfced5f6460dbcf8c71f6d51ca82","type":"text","conversion_output":true,"text":"significant improvement in UI symptoms, although there is limited information on the direct","text_display":" significant improvement in UI symptoms, although there is limited information on the direct","confidence":1,"confidence_rate":1},{"cnt":[[434,1040],[1644,1040],[1644,1085],[434,1085]],"region":{"top_left_x":433,"top_left_y":1039,"width":1211,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a92105c2005b442aa683e96e8922def3","type":"text","conversion_output":true,"text":"specific relationship between PFM strength changes and UI symptom changes.","text_display":" specific relationship between PFM strength changes and UI symptom changes.","confidence":0.9990234375,"confidence_rate":0.9999876324859995},{"cnt":[[434,1149],[1820,1149],[1820,1192],[434,1192]],"region":{"top_left_x":433,"top_left_y":1149,"width":1387,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fedd711791940769d2cd8eeaf8353e1","type":"text","conversion_output":true,"text":"Assuming that women in ESTEEM will have a mean baseline PFM maximum contraction","text_display":"\n\nAssuming that women in ESTEEM will have a mean baseline PFM maximum contraction","confidence":1,"confidence_rate":1},{"cnt":[[434,1195],[1757,1195],[1757,1240],[434,1240]],"region":{"top_left_x":433,"top_left_y":1194,"width":1325,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adea1caa9b1a4f0d8763e9dc4bf39ea4","type":"text","conversion_output":true,"text":"amplitude of 25 cm H 2 O , and that women randomized to control will not demonstrate","text_display":" amplitude of 25 cm H 2 O , and that women randomized to control will not demonstrate","confidence":0.8939931984059513,"confidence_rate":0.9988211468477889},{"cnt":[[434,1238],[1830,1238],[1830,1283],[434,1283]],"region":{"top_left_x":433,"top_left_y":1237,"width":1398,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30d949566c8b4941972d9ae2e7cebed9","type":"text","conversion_output":true,"text":"significant improvement postoperatively (no change from mean maximum amplitude of 25","text_display":" significant improvement postoperatively (no change from mean maximum amplitude of 25","confidence":1,"confidence_rate":1},{"cnt":[[434,1280],[1869,1280],[1869,1326],[434,1326]],"region":{"top_left_x":433,"top_left_y":1280,"width":1437,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a65108544db54f3fa30b810691465f5f","type":"text","conversion_output":true,"text":"cm H 2 O (SD 13), and that women randomized to BPTx will demonstrate improvement to 35","text_display":" cm H 2 O (SD 13), and that women randomized to BPTx will demonstrate improvement to 35","confidence":0.6995108085732227,"confidence_rate":0.996245234897756},{"cnt":[[434,1326],[1858,1326],[1858,1369],[434,1369]],"region":{"top_left_x":433,"top_left_y":1325,"width":1426,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc83dd2dca8f42fead3fe3b133672ba6","type":"text","conversion_output":true,"text":"(SD 13) to 40 (SD 16) cm H2O at 6-12 months, the power to detect a difference between the","text_display":" (SD 13) to 40 (SD 16) cm H2O at 6-12 months, the power to detect a difference between the","confidence":0.5932950001219943,"confidence_rate":0.994632359263787},{"cnt":[[434,1371],[1798,1371],[1798,1414],[434,1414]],"region":{"top_left_x":433,"top_left_y":1370,"width":1366,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"214ce366267840debeebf48035b6f47b","type":"text","conversion_output":true,"text":"groups with the current ESTEEM sample size of 400 women would be greater than 0.99 .","text_display":" groups with the current ESTEEM sample size of 400 women would be greater than 0.99 .","confidence":0.99560546875,"confidence_rate":0.9999536409105637},{"cnt":[[434,1414],[1837,1414],[1837,1457],[434,1457]],"region":{"top_left_x":433,"top_left_y":1413,"width":1404,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a6b159e6338414483c74cd843759c12","type":"text","conversion_output":true,"text":"Also, the difference from 25 (SD 13) that we could detect with \\(80 \\%\\) power is 3.66 cm H 2 O","text_display":" Also, the difference from 25 (SD 13) that we could detect with \\(80 \\%\\) power is 3.66 cm H 2 O","confidence":0.7388131292536855,"confidence_rate":0.9970366517651239},{"cnt":[[434,1457],[1850,1457],[1850,1502],[434,1502]],"region":{"top_left_x":433,"top_left_y":1456,"width":1417,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1340ab8e070419d968d5cba8c15df3d","type":"text","conversion_output":true,"text":"between groups and with \\(90 \\%\\) power we could detect a difference as small as 4.23 cm H 2 O .","text_display":" between groups and with \\(90 \\%\\) power we could detect a difference as small as 4.23 cm H 2 O .","confidence":0.8353553491097125,"confidence_rate":0.9982717060224641},{"cnt":[[434,1564],[1863,1564],[1863,1609],[434,1609]],"region":{"top_left_x":433,"top_left_y":1564,"width":1430,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74b573d14b8249e093894e2ea8ea12af","type":"text","conversion_output":true,"text":"For analyses, we will compare the mean change from baseline in PFM maximum contraction","text_display":"\n\nFor analyses, we will compare the mean change from baseline in PFM maximum contraction","confidence":1,"confidence_rate":1},{"cnt":[[434,1609],[1833,1609],[1833,1654],[434,1654]],"region":{"top_left_x":433,"top_left_y":1609,"width":1400,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3407160b50a5473bbe343efec21ac851","type":"text","conversion_output":true,"text":"strength between the BPTx and control groups at 8 weeks and at 12 months. General linear","text_display":" strength between the BPTx and control groups at 8 weeks and at 12 months. General linear","confidence":1,"confidence_rate":1},{"cnt":[[434,1654],[1841,1654],[1841,1697],[434,1697]],"region":{"top_left_x":433,"top_left_y":1654,"width":1409,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f595f688bc140cd862e2eb527d212a1","type":"text","conversion_output":true,"text":"mixed modeling will be used, controlling for stratification factors and time ( 8 weeks and 12","text_display":" mixed modeling will be used, controlling for stratification factors and time ( 8 weeks and 12","confidence":1,"confidence_rate":1},{"cnt":[[434,1697],[1824,1697],[1824,1742],[434,1742]],"region":{"top_left_x":433,"top_left_y":1697,"width":1392,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"63a8de33c3db4a94b841dc2cbbd8d456","type":"text","conversion_output":true,"text":"months). We will test whether there is significant interaction between treatment group and","text_display":" months). We will test whether there is significant interaction between treatment group and","confidence":1,"confidence_rate":1},{"cnt":[[434,1740],[1850,1740],[1850,1785],[434,1785]],"region":{"top_left_x":433,"top_left_y":1740,"width":1417,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9365e5227bb42389ebc792149da4105","type":"text","conversion_output":true,"text":"time. Because additional treatment is not expected to impact this outcome, it will be ignored","text_display":" time. Because additional treatment is not expected to impact this outcome, it will be ignored","confidence":1,"confidence_rate":1},{"cnt":[[434,1783],[1841,1783],[1841,1828],[434,1828]],"region":{"top_left_x":433,"top_left_y":1783,"width":1409,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"639a170cd1d4422bac537740a9046e63","type":"text","conversion_output":true,"text":"for the purpose of this analysis. We will estimate the correlation between PFM strength and","text_display":" for the purpose of this analysis. We will estimate the correlation between PFM strength and","confidence":1,"confidence_rate":1},{"cnt":[[434,1830],[1815,1830],[1815,1876],[434,1876]],"region":{"top_left_x":433,"top_left_y":1830,"width":1383,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f795e0ca309a4d36a63c29db8a63d513","type":"text","conversion_output":true,"text":"UI symptoms at baseline and at 12 months. Using regression models, we will also explore","text_display":" UI symptoms at baseline and at 12 months. Using regression models, we will also explore","confidence":1,"confidence_rate":1},{"cnt":[[434,1873],[1841,1873],[1841,1919],[434,1919]],"region":{"top_left_x":433,"top_left_y":1873,"width":1409,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14ec923983574327a0f73db8c2d72758","type":"text","conversion_output":true,"text":"potential predictors of unsuccessful pelvic floor muscle strengthening and urge suppression","text_display":" potential predictors of unsuccessful pelvic floor muscle strengthening and urge suppression","confidence":1,"confidence_rate":1},{"cnt":[[434,1916],[1835,1916],[1835,1962],[434,1962]],"region":{"top_left_x":433,"top_left_y":1916,"width":1402,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fa57e9b510ba4ed5962fd6856e429c3e","type":"text","conversion_output":true,"text":"and their effects on urinary outcomes. We will assess the effect of self-efficacy, adherence,","text_display":" and their effects on urinary outcomes. We will assess the effect of self-efficacy, adherence,","confidence":1,"confidence_rate":1},{"cnt":[[434,1959],[1626,1959],[1626,2004],[434,2004]],"region":{"top_left_x":433,"top_left_y":1959,"width":1194,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e30b83c221f4d74a9541924372c5d31","type":"text","conversion_output":true,"text":"and barriers to performing pelvic muscle contractions and behavioral therapy.","text_display":" and barriers to performing pelvic muscle contractions and behavioral therapy.","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[305,2045],[746,2045],[746,2090],[305,2090]],"region":{"top_left_x":305,"top_left_y":2045,"width":441,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bfbcb20171ca4ee1bd93b6027fde87f3","type":"section_header","conversion_output":false,"children_ids":["c1da400b7636423495a1035329f83631"],"text":"","text_display":""},{"cnt":[[309,2050],[741,2050],[741,2086],[309,2086]],"region":{"top_left_x":309,"top_left_y":2049,"width":433,"height":38},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1da400b7636423495a1035329f83631","type":"text","conversion_output":true,"parent_id":"bfbcb20171ca4ee1bd93b6027fde87f3","text":"10 SAFETY ANALYSES","text_display":"\n\n\\section*{10 SAFETY ANALYSES}","confidence":1,"confidence_rate":1},{"cnt":[[370,2131],[1115,2131],[1115,2187],[370,2187]],"region":{"top_left_x":369,"top_left_y":2131,"width":747,"height":57},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0fd0c2dbec84fffab6803cb66fc3c4d","type":"section_header","conversion_output":false,"children_ids":["da6b158713de481eabcfd661b9a8f989"],"text":"","text_display":""},{"cnt":[[374,2136],[1111,2136],[1111,2185],[374,2185]],"region":{"top_left_x":373,"top_left_y":2135,"width":738,"height":50},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da6b158713de481eabcfd661b9a8f989","type":"text","conversion_output":true,"parent_id":"d0fd0c2dbec84fffab6803cb66fc3c4d","text":"10.1 Overview of Safety Analysis Methods","text_display":"\n\n\\subsection*{10.1 Overview of Safety Analysis Methods}","confidence":1,"confidence_rate":1},{"cnt":[[370,2194],[1863,2194],[1863,2237],[370,2237]],"region":{"top_left_x":369,"top_left_y":2193,"width":1494,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30cf47836396416eb3c9f7bc9eb4cb98","type":"text","conversion_output":true,"text":"All safety analyses will be performed using all participants who were randomized. Descriptive p-","text_display":"\n\nAll safety analyses will be performed using all participants who were randomized. Descriptive p","confidence":1,"confidence_rate":1},{"cnt":[[372,2239],[1813,2239],[1813,2282],[372,2282]],"region":{"top_left_x":371,"top_left_y":2238,"width":1443,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d1e39ee3cb64b93ae369d010594b576","type":"text","conversion_output":true,"text":"values comparing the study arms will be provided on most safety table summaries and will be","text_display":"values comparing the study arms will be provided on most safety table summaries and will be","confidence":1,"confidence_rate":1},{"cnt":[[372,2282],[1867,2282],[1867,2327],[372,2327]],"region":{"top_left_x":371,"top_left_y":2281,"width":1496,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91345a4bfed84570aa2a605e08a1940e","type":"text","conversion_output":true,"text":"obtained using chi-square tests or Fisher's exact tests (in the case of small numbers of events) for","text_display":" obtained using chi-square tests or Fisher's exact tests (in the case of small numbers of events) for","confidence":1,"confidence_rate":1},{"cnt":[[372,2325],[1734,2325],[1734,2370],[372,2370]],"region":{"top_left_x":371,"top_left_y":2324,"width":1363,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2c80e419c954de88f2d7ceeabc98110","type":"text","conversion_output":true,"text":"binary outcomes. If the number of events allow, a 2 -sided Cochran Mantel-Haenszel test","text_display":" binary outcomes. If the number of events allow, a 2 -sided Cochran Mantel-Haenszel test","confidence":0.689453125,"confidence_rate":0.9960933711426478},{"cnt":[[372,2368],[1785,2368],[1785,2415],[372,2415]],"region":{"top_left_x":371,"top_left_y":2367,"width":1415,"height":48},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b032d0fd2bbd454399649f2cd079b057","type":"text","conversion_output":true,"text":"controlling for strata defined by site and baseline urge IE group will be used to obtain the p-","text_display":" controlling for strata defined by site and baseline urge IE group will be used to obtain the p","confidence":1,"confidence_rate":1},{"cnt":[[372,2415],[483,2415],[483,2451],[372,2451]],"region":{"top_left_x":371,"top_left_y":2414,"width":113,"height":38},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddf9d1019b0e4dfdbf218785d0abaa96","type":"text","conversion_output":true,"text":"values.","text_display":"values.","confidence":1,"confidence_rate":1},{"cnt":[[309,2552],[681,2552],[681,2587],[309,2587]],"region":{"top_left_x":309,"top_left_y":2552,"width":373,"height":35},"line":47,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2241228efe3c413faa7dc3b0e535fbb2","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 39","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-41","page":41,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9f3bc070eda1424e8c22ce3f97cccd2b","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4eb4c87099844717b2060b826b5f0c26","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,314],[763,314],[763,363],[370,363]],"region":{"top_left_x":369,"top_left_y":313,"width":394,"height":51},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d41c5ea464144145bb9606c6309ca175","type":"section_header","conversion_output":false,"children_ids":["efa4802b39324e81903da8467f89b848"],"text":"","text_display":""},{"cnt":[[374,318],[758,318],[758,359],[374,359]],"region":{"top_left_x":373,"top_left_y":317,"width":386,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"efa4802b39324e81903da8467f89b848","type":"text","conversion_output":true,"parent_id":"d41c5ea464144145bb9606c6309ca175","text":"10.2 Adverse Events","text_display":"\n\n\\subsection*{10.2 Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[370,374],[1865,374],[1865,419],[370,419]],"region":{"top_left_x":369,"top_left_y":373,"width":1496,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e40f95b4a1e240b6ae36430040417e74","type":"text","conversion_output":true,"text":"Per the protocol, participants were asked to report any adverse events from initiation of treatment","text_display":"\n\nPer the protocol, participants were asked to report any adverse events from initiation of treatment","confidence":1,"confidence_rate":1},{"cnt":[[370,417],[1794,417],[1794,462],[370,462]],"region":{"top_left_x":369,"top_left_y":416,"width":1425,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f0c2fc7444e405fad5d378fd66247bc","type":"text","conversion_output":true,"text":"through 12 months follow-up. All adverse events were collected on an adverse event log and","text_display":" through 12 months follow-up. All adverse events were collected on an adverse event log and","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[370,460],[862,460],[862,505],[370,505]],"region":{"top_left_x":369,"top_left_y":459,"width":493,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0f19aa9b4ef4d1e95b5fc8bef391664","type":"text","conversion_output":true,"text":"coded using MedDRA (V17.0).","text_display":" coded using MedDRA (V17.0).","confidence":1,"confidence_rate":1},{"cnt":[[370,571],[1833,571],[1833,614],[370,614]],"region":{"top_left_x":369,"top_left_y":571,"width":1464,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"471781b95bc847d480f1824c73a7b6ff","type":"text","conversion_output":true,"text":"Postoperative complications noted as adverse symptoms and events in the ESTEEM manual of","text_display":"\n\nPostoperative complications noted as adverse symptoms and events in the ESTEEM manual of","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[370,614],[1760,614],[1760,660],[370,660]],"region":{"top_left_x":369,"top_left_y":614,"width":1391,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c3d1a4e041b401eafec1fbc16c793e0","type":"text","conversion_output":true,"text":"procedures (MOP) (see table below) will be proactively reviewed and reported. ESTEEM","text_display":" procedures (MOP) (see table below) will be proactively reviewed and reported. ESTEEM","confidence":1,"confidence_rate":1},{"cnt":[[370,657],[1841,657],[1841,703],[370,703]],"region":{"top_left_x":369,"top_left_y":657,"width":1473,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70b4345db23f42bfa4bc8764cb0d4e67","type":"text","conversion_output":true,"text":"complications are divided into \"adverse symptoms\" and \"adverse events\". To help standardized","text_display":" complications are divided into \"adverse symptoms\" and \"adverse events\". To help standardized","confidence":1,"confidence_rate":1},{"cnt":[[370,700],[1833,700],[1833,746],[370,746]],"region":{"top_left_x":369,"top_left_y":700,"width":1464,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd72b4669ef34dca85a92b7ffed99027","type":"text","conversion_output":true,"text":"the data collection process for complications, adverse symptoms and events will be captured as","text_display":" the data collection process for complications, adverse symptoms and events will be captured as","confidence":1,"confidence_rate":1},{"cnt":[[370,743],[501,743],[501,784],[370,784]],"region":{"top_left_x":369,"top_left_y":743,"width":132,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b773a32762c74c4a9e3db7c50f186362","type":"text","conversion_output":true,"text":"follows:","text_display":" follows:","confidence":1,"confidence_rate":1},{"cnt":[[370,855],[1654,855],[1654,900],[370,900]],"region":{"top_left_x":369,"top_left_y":855,"width":1286,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c29add4a899f457a9a9f5b1f4642f978","type":"text","conversion_output":true,"text":"Adverse symptoms will be captured using either an active approach using validated","text_display":"\n\nAdverse symptoms will be captured using either an active approach using validated","confidence":1,"confidence_rate":1},{"cnt":[[370,898],[1033,898],[1033,943],[370,943]],"region":{"top_left_x":369,"top_left_y":898,"width":665,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19f546848d284bd6b02cedafaacb4e9c","type":"text","conversion_output":true,"text":"questionnaires or an open-ended approach.","text_display":" questionnaires or an open-ended approach.","confidence":1,"confidence_rate":1},{"cnt":[[434,954],[1835,954],[1835,999],[434,999]],"region":{"top_left_x":433,"top_left_y":953,"width":1402,"height":47},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59773d708d1b41078aadb454b567f301","type":"text","conversion_output":true,"text":"a. Active capture for adverse symptoms: Specific patient-reported adverse symptoms will","text_display":"\na. Active capture for adverse symptoms: Specific patient-reported adverse symptoms will","confidence":1,"confidence_rate":1},{"cnt":[[494,993],[1796,993],[1796,1042],[494,1042]],"region":{"top_left_x":494,"top_left_y":992,"width":1303,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75f3a7a150df41dab045a825cc31a20e","type":"text","conversion_output":true,"text":"be identified by responses on validated questionnaires (denoted by * in table below).","text_display":" be identified by responses on validated questionnaires (denoted by * in table below).","confidence":0.9985356330871582,"confidence_rate":0.9999837174642737},{"cnt":[[494,1040],[1656,1040],[1656,1085],[494,1085]],"region":{"top_left_x":494,"top_left_y":1039,"width":1163,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"239859dcbbf544c0bd49aba475e72d30","type":"text","conversion_output":true,"text":"These 3 adverse symptoms include a patient report of new or worsening: 1)","text_display":" These 3 adverse symptoms include a patient report of new or worsening: 1)","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[494,1083],[1734,1083],[1734,1130],[494,1130]],"region":{"top_left_x":494,"top_left_y":1082,"width":1240,"height":49},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c688677dfac4439fabe3c547dac753de","type":"text","conversion_output":true,"text":"pelvic/vaginal pain, 2 ) sensation of incomplete bladder emptying (based on UDI","text_display":" pelvic/vaginal pain, 2 ) sensation of incomplete bladder emptying (based on UDI","confidence":0.9736454486846924,"confidence_rate":0.9996930579515987},{"cnt":[[494,1128],[1841,1128],[1841,1175],[494,1175]],"region":{"top_left_x":494,"top_left_y":1127,"width":1348,"height":49},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1dfc70677ad14b7aad6f448f21f3cb8d","type":"text","conversion_output":true,"text":"responses) and 3) dyspareunia (based on PISQ-IR response). These are captured at 3, 6,","text_display":" responses) and 3) dyspareunia (based on PISQ-IR response). These are captured at 3, 6,","confidence":0.9975600242614746,"confidence_rate":0.9999731546753936},{"cnt":[[494,1173],[1846,1173],[1846,1218],[494,1218]],"region":{"top_left_x":494,"top_left_y":1173,"width":1352,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9b2da48afe84593a1ea3e254e51b8a8","type":"text","conversion_output":true,"text":"and 12 months. To aid with retrospective collection of these AEs, the DCC will provide","text_display":" and 12 months. To aid with retrospective collection of these AEs, the DCC will provide","confidence":1,"confidence_rate":1},{"cnt":[[494,1216],[1846,1216],[1846,1261],[494,1261]],"region":{"top_left_x":494,"top_left_y":1216,"width":1352,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7319faa9bce84d879c957bfdbe1d324e","type":"text","conversion_output":true,"text":"each site with a report listing longitudinal responses to the applicable UDI and PISQ-IR","text_display":" each site with a report listing longitudinal responses to the applicable UDI and PISQ-IR","confidence":1,"confidence_rate":1},{"cnt":[[494,1259],[1790,1259],[1790,1308],[494,1308]],"region":{"top_left_x":494,"top_left_y":1258,"width":1296,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5512cebbc1343669b2793e0ee4e6d04","type":"text","conversion_output":true,"text":"questions for participants who reported one of these symptoms at 3-12 months. The","text_display":" questions for participants who reported one of these symptoms at 3-12 months. The","confidence":0.61865234375,"confidence_rate":0.9944317025523213},{"cnt":[[494,1302],[1854,1302],[1854,1351],[494,1351]],"region":{"top_left_x":494,"top_left_y":1301,"width":1361,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a28a68a1b5294e48ae979a2c2dbcdef2","type":"text","conversion_output":true,"text":"clinical site will report these adverse symptoms on the adverse events CRF per the usual","text_display":" clinical site will report these adverse symptoms on the adverse events CRF per the usual","confidence":1,"confidence_rate":1},{"cnt":[[494,1349],[971,1349],[971,1394],[494,1394]],"region":{"top_left_x":494,"top_left_y":1349,"width":478,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5a7f13478fe401a8755f4e00d3fef6d","type":"text","conversion_output":true,"text":"process described in the MOP.","text_display":" process described in the MOP.","confidence":1,"confidence_rate":1},{"cnt":[[494,1435],[1818,1435],[1818,1480],[494,1480]],"region":{"top_left_x":494,"top_left_y":1435,"width":1324,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13cf4f3f19ad470a9f4070ba64c23537","type":"text","conversion_output":true,"text":"The clinical site will be responsible for reviewing the UDI and PISQ-IR responses for","text_display":"\n\nThe clinical site will be responsible for reviewing the UDI and PISQ-IR responses for","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[494,1478],[1869,1478],[1869,1525],[494,1525]],"region":{"top_left_x":494,"top_left_y":1478,"width":1376,"height":48},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45b39409947d4d67a9676faedf0c4cac","type":"text","conversion_output":true,"text":"these 3 items and identifying any new or worsening symptoms. Once a new or worsening","text_display":" these 3 items and identifying any new or worsening symptoms. Once a new or worsening","confidence":1,"confidence_rate":1},{"cnt":[[494,1523],[1828,1523],[1828,1571],[494,1571]],"region":{"top_left_x":494,"top_left_y":1523,"width":1335,"height":48},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c943030a7d994c0cb56e5e3016bd3326","type":"text","conversion_output":true,"text":"symptom is identified, the clinical site will track these adverse symptoms per the usual","text_display":" symptom is identified, the clinical site will track these adverse symptoms per the usual","confidence":1,"confidence_rate":1},{"cnt":[[494,1568],[1790,1568],[1790,1613],[494,1613]],"region":{"top_left_x":494,"top_left_y":1568,"width":1296,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3642832a7cc748dcb3fc41777e2d5af1","type":"text","conversion_output":true,"text":"process in the MOP. Sites should review the UDI and PISQ-IR CRFs at the time the","text_display":" process in the MOP. Sites should review the UDI and PISQ-IR CRFs at the time the","confidence":1,"confidence_rate":1},{"cnt":[[494,1611],[1807,1611],[1807,1656],[494,1656]],"region":{"top_left_x":494,"top_left_y":1611,"width":1313,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cef891b0f2a1428785adec408ea0b21f","type":"text","conversion_output":true,"text":"participant completes them so that any additional information needed to complete the","text_display":" participant completes them so that any additional information needed to complete the","confidence":1,"confidence_rate":1},{"cnt":[[494,1654],[1311,1654],[1311,1695],[494,1695]],"region":{"top_left_x":494,"top_left_y":1654,"width":817,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fa8b5610f9814879a607e59abc105310","type":"text","conversion_output":true,"text":"adverse event CRF can also be collected at that time.","text_display":" adverse event CRF can also be collected at that time.","confidence":0.9921875,"confidence_rate":0.9998647819451815},{"cnt":[[432,1742],[1841,1742],[1841,1790],[432,1790]],"region":{"top_left_x":431,"top_left_y":1742,"width":1411,"height":48},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2820987ba2e24438965b711552ac18f4","type":"text","conversion_output":true,"text":"b. Open-ended capture for adverse symptoms: 2 adverse symptoms will be captured using","text_display":"\nb. Open-ended capture for adverse symptoms: 2 adverse symptoms will be captured using","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[494,1788],[1704,1788],[1704,1833],[494,1833]],"region":{"top_left_x":494,"top_left_y":1787,"width":1210,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e008e4c0977e4dd4b0f814d8fd04597f","type":"text","conversion_output":true,"text":"the open-ended approach because they are not captured in any of the validated","text_display":" the open-ended approach because they are not captured in any of the validated","confidence":1,"confidence_rate":1},{"cnt":[[494,1830],[1783,1830],[1783,1876],[494,1876]],"region":{"top_left_x":494,"top_left_y":1830,"width":1290,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a771d35ff944a47a08fa3d3e4a4d0e5","type":"text","conversion_output":true,"text":"questionnaires administered in ESTEEM. These include: 1) New/worsening partner","text_display":" questionnaires administered in ESTEEM. These include: 1) New/worsening partner","confidence":1,"confidence_rate":1},{"cnt":[[494,1873],[1755,1873],[1755,1921],[494,1921]],"region":{"top_left_x":494,"top_left_y":1873,"width":1262,"height":48},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3752d20505e64da3be3413b0dfebd409","type":"text","conversion_output":true,"text":"dyspareunia and 2) New/worsening constipation. Using the open-ended approach,","text_display":" dyspareunia and 2) New/worsening constipation. Using the open-ended approach,","confidence":0.99658203125,"confidence_rate":0.9999582469283965},{"cnt":[[494,1921],[1313,1921],[1313,1966],[494,1966]],"region":{"top_left_x":494,"top_left_y":1920,"width":819,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8bb93b87936b40cb80effe076390d45e","type":"text","conversion_output":true,"text":"symptoms are captured if reported by the participant.","text_display":" symptoms are captured if reported by the participant.","confidence":1,"confidence_rate":1},{"cnt":[[370,2015],[1858,2015],[1858,2065],[370,2065]],"region":{"top_left_x":369,"top_left_y":2015,"width":1490,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3feb8107f54843458a2c7d90eb629695","type":"text","conversion_output":true,"text":"Adverse events will be captured using the standard capture for AEs as described in the MOP and","text_display":"\n\nAdverse events will be captured using the standard capture for AEs as described in the MOP and","confidence":1,"confidence_rate":1},{"cnt":[[370,2058],[1833,2058],[1833,2108],[370,2108]],"region":{"top_left_x":369,"top_left_y":2058,"width":1464,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6c07fe3e5f9426685c14a02020e3c99","type":"text","conversion_output":true,"text":"manually reviewed to determine which events meet the criteria for post-operative complication","text_display":" manually reviewed to determine which events meet the criteria for post-operative complication","confidence":1,"confidence_rate":1},{"cnt":[[370,2105],[1828,2105],[1828,2151],[370,2151]],"region":{"top_left_x":369,"top_left_y":2105,"width":1460,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83def406352f4e8dbec6d5af301de10e","type":"text","conversion_output":true,"text":"listed in the table below. This is an open-ended capture approach using chart review, physician","text_display":" listed in the table below. This is an open-ended capture approach using chart review, physician","confidence":1,"confidence_rate":1},{"cnt":[[370,2148],[1364,2148],[1364,2196],[370,2196]],"region":{"top_left_x":369,"top_left_y":2148,"width":996,"height":48},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da5cd8901e8b4ea59a610a9d6ff8a543","type":"text","conversion_output":true,"text":"report, or patient report corroborated by medical documentation.","text_display":" report, or patient report corroborated by medical documentation.","confidence":1,"confidence_rate":1},{"cnt":[[279,2239],[1910,2239],[1910,2398],[279,2398]],"region":{"top_left_x":279,"top_left_y":2238,"width":1631,"height":160},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"108680c5456b44589255af9c64ab25e0","type":"table","conversion_output":true,"text":"\\begin{tabular}{|l|l|}\n\\hline Postoperative complications & \\\\\n\\hline Adverse symptom & Definition \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Postoperative complications & \\\\\n\\hline Adverse symptom & Definition \\\\\n\\hline\n\\end{tabular}","confidence":1,"confidence_rate":1},{"cnt":[[305,2552],[685,2552],[685,2589],[305,2589]],"region":{"top_left_x":305,"top_left_y":2552,"width":381,"height":37},"line":41,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8168c8a00af54bee8dfced270112cce1","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 40","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-42","page":42,"lines":[{"cnt":[[305,138],[421,138],[421,165],[305,165]],"region":{"top_left_x":305,"top_left_y":137,"width":117,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"db5744e743094c4f95ac3d25e64db17f","type":"section_header","conversion_output":false,"children_ids":["438b906d55404041bc6e6df79031d495"],"text":"","text_display":""},{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"438b906d55404041bc6e6df79031d495","type":"text","conversion_output":true,"parent_id":"db5744e743094c4f95ac3d25e64db17f","text":"Network","text_display":"\n\n\\section*{Network}","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[801,180],[801,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":493,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1e8dcaaed37e4b87a7758246be09f880","type":"text","conversion_output":true,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"\n\nProtocol ESTEEM Statistical Analysis Plan","confidence":1,"confidence_rate":1},{"cnt":[[279,309],[1910,309],[1910,2434],[279,2434]],"region":{"top_left_x":279,"top_left_y":309,"width":1631,"height":2126},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f229564d5ac543b49812692b8cd974f2","type":"table","conversion_output":true,"children_ids":["92404b83bd5e48a9927ce316d0765cc4","08b436075d6d444588f0aefd8f5ffda9","3854f495f8524fd5834a876476e35de2","a30393a6b97241fc9e183e5fcb9ff32f","a5ba699064654714bcb27dcbd57d4417","ed42e81cfc194b7e87226a9571069a30","03e22e5a606943118def2fde03adbd57","cbcc0cc27b4049dcb71a80e853a6248d","1a83ae8c8bed41529e392035c48d1a22","1566b6d7a347435885d464a1852e0345","290c899e67ce459ab54adfc77452bd11","3c709227e60744c18b290a722e3524d0","a406555237fb44df8f6519754f1e984b","9959c5718ea04899a3547193ca935b7b","fa22f566544e455c8ba27ea9a8f27b59","68a2dfe0a6c04e5aa20b77847fe2631c","585dd52bd7fa45829ce48f9b88eb67c5","705403ad68424b22ab638879e86d43b5","ae584a3538f641208860c22c0639ed53","da8bda1bd15b4ae7a65c5401825c6ddc","718faa77b5604b63acd944198745d73e","9268f5b0b4bc40f7b9ac62deb6a0da59","5ef7e82c8bed4854990eec6682b7ce16","d97b7af2dcee4ef8a189f3edbb2d10ca","0be66c3c21a14b5e9ecc0204d6d49e31","0afdbfc2adb6400a819355a514e2b0d6","6379909def6247b8bbf20fd9490f6830","1fafa79c79664f39b25ebcfc45f8ac7e","c07c150c7c114f41a6d02f651ba8d5c5","bd4e9ff3384645d495b1fd743194481f","df3ff20b1c194c43913d02270c7bdf69","ea2a1c45a90c46dfa8c47c783ea14da0","c4cb206f47b943fba7946646cce4f7c4","aec17faa594f4ee0b3752f6c798534ca","d47e8302c10f463e995a3e02e75a87eb","ebf1de6d56d94b04a2e652d596a41572","a44541bf6ab74698854ab3b3eec19b48","37ffe6d143934b7d80f49a0147e67bcf","881bd2b53e6d44239b6f3e5604e93dbf","179be1297cb74daeadd46f38139eacab","7ae1d8e54b404465ab94a08ccbd0f4d6","4b7c9718623b4666b123e2a1228ffceb","abf8de71e5f2485b95183adf7fe85c8f"],"text":"\\begin{tabular}{|l|l|}\n\\hline New/worsening abdominal/genital pain at or beyond 3 month visit & UDI item N captured at \\(3,6,12\\) months and per patient report, chart review, physician report \\\\\n\\hline New/worsening dyspareunia at or beyond 3 month visit & PISQ item C5 captured at 3, 6, 12 months and per patient report, chart review, physician report \\\\\n\\hline New/worsening report of difficulty emptying bladder at or beyond 3 months & UDI item J captured at 3, 6, 12 months and per patient report, chart review, physician report \\\\\n\\hline New/worsening partner dyspareunia at or beyond 3 month visit & Per patient report, chart review, physician report \\\\\n\\hline New/worsening urge incontinence at or beyond 3 month visit & UDI item C captured at 3, 6, 12 months and per patient report, chart review, physician report \\\\\n\\hline Adverse Event & \\\\\n\\hline Postop need for catheter and/or ISC at or beyond 2 weeks & Captured by chart review, physician report, exam, or patient report corroborated by medical documentation \\\\\n\\hline Vaginal mesh exposure & Captured by chart review, physician report, exam, or patient report corroborated by medical documentation \\\\\n\\hline Vaginal mesh erosion into organ & Captured by chart review, physician report, exam or patient report corroborated by medical documentation \\\\\n\\hline Other wound healing problems > 6 weeks & Captured by chart review, physician report, exam or patient report corroborated by medical documentation \\\\\n\\hline New/worsening vaginal infection & Captured by chart review, physician report, exam, or patient report corroborated by medical documentation \\\\\n\\hline Urinary tract infection beyond 2 weeks & \\begin{tabular}{l}\nUTI based on clinical judgment or confirmation of culture proven, also includes empiric antibiotic treatment for symptoms thought to be due to UTI, or patient report corroborated by medical documentation. 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Worsening symptoms will be assessed by","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[370,1433],[1861,1433],[1861,1478],[370,1478]],"region":{"top_left_x":369,"top_left_y":1433,"width":1492,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"420901e9d2ba412b8a5508631c62b122","type":"text","conversion_output":true,"text":"identifying worsening responses (compare to baseline) to the specific patient-questionnaire items","text_display":" identifying worsening responses (compare to baseline) to the specific patient-questionnaire items","confidence":1,"confidence_rate":1},{"cnt":[[370,1478],[1850,1478],[1850,1523],[370,1523]],"region":{"top_left_x":369,"top_left_y":1478,"width":1481,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be73f226acf14a0d9cb937884541d14c","type":"text","conversion_output":true,"text":"identified at post-baseline collection times. Post-operative complications will be summarized by","text_display":" identified at post-baseline collection times. Post-operative complications will be summarized by","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[370,1521],[1841,1521],[1841,1566],[370,1566]],"region":{"top_left_x":369,"top_left_y":1521,"width":1473,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d3d36aef8ec4cc486b1faadbc6ab828","type":"text","conversion_output":true,"text":"complication type. Summaries will be the number of individuals experiencing complications by","text_display":" complication type. Summaries will be the number of individuals experiencing complications by","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[370,1568],[629,1568],[629,1609],[370,1609]],"region":{"top_left_x":369,"top_left_y":1568,"width":261,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be66a8ce75834abd9296997a9c9f6eb0","type":"text","conversion_output":true,"text":"treatment group.","text_display":" treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[370,1624],[1085,1624],[1085,1678],[370,1678]],"region":{"top_left_x":369,"top_left_y":1624,"width":716,"height":54},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c645a9b35e04d9eae0ea7f7c4d1d82a","type":"section_header","conversion_output":false,"children_ids":["5ea5a991371347379edf5f08863faefd"],"text":"","text_display":""},{"cnt":[[374,1629],[1081,1629],[1081,1674],[374,1674]],"region":{"top_left_x":373,"top_left_y":1628,"width":708,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ea5a991371347379edf5f08863faefd","type":"text","conversion_output":true,"parent_id":"2c645a9b35e04d9eae0ea7f7c4d1d82a","text":"10.3 Deaths and Serious Adverse Events","text_display":"\n\n\\subsection*{10.3 Deaths and Serious Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[370,1687],[1796,1687],[1796,1732],[370,1732]],"region":{"top_left_x":369,"top_left_y":1686,"width":1428,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"807e3c4526de4362a765522659a9d1fd","type":"text","conversion_output":true,"text":"A serious adverse event (SAE) is any event that is life threatening, results in death, causes or","text_display":"\n\nA serious adverse event (SAE) is any event that is life threatening, results in death, causes or","confidence":1,"confidence_rate":1},{"cnt":[[370,1732],[1876,1732],[1876,1777],[370,1777]],"region":{"top_left_x":369,"top_left_y":1731,"width":1507,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a99fe4aafb44e438b608512aa110c43","type":"text","conversion_output":true,"text":"prolongs hospitalization, leads to a disability or birth defect, or requires an intervention to prevent","text_display":" prolongs hospitalization, leads to a disability or birth defect, or requires an intervention to prevent","confidence":1,"confidence_rate":1},{"cnt":[[370,1775],[1858,1775],[1858,1820],[370,1820]],"region":{"top_left_x":369,"top_left_y":1774,"width":1490,"height":46},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"446643aba65f4a339053d33bc0962ec3","type":"text","conversion_output":true,"text":"a disability. SAEs will be listed and SAEs and treatment-related SAEs will be summarized in the","text_display":" a disability. SAEs will be listed and SAEs and treatment-related SAEs will be summarized in the","confidence":1,"confidence_rate":1},{"cnt":[[370,1818],[1863,1818],[1863,1863],[370,1863]],"region":{"top_left_x":369,"top_left_y":1817,"width":1494,"height":46},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56ec251ff65048d8867caaed84de75df","type":"text","conversion_output":true,"text":"manner mentioned in Section 10.2 if there are enough events to summarize. Deaths will be listed.","text_display":" manner mentioned in Section 10.2 if there are enough events to summarize. Deaths will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[305,1899],[1018,1899],[1018,1953],[305,1953]],"region":{"top_left_x":305,"top_left_y":1899,"width":714,"height":54},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecb030f1d0de4b8db1fdb1995578ed3c","type":"section_header","conversion_output":false,"children_ids":["99c6a4d3edc3489fa736ed43551987e2"],"text":"","text_display":""},{"cnt":[[309,1904],[1012,1904],[1012,1949],[309,1949]],"region":{"top_left_x":309,"top_left_y":1903,"width":703,"height":46},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99c6a4d3edc3489fa736ed43551987e2","type":"text","conversion_output":true,"parent_id":"ecb030f1d0de4b8db1fdb1995578ed3c","text":"11 ANALYSIS OF OTHER OUTCOMES","text_display":"\n\n\\section*{11 ANALYSIS OF OTHER OUTCOMES}","confidence":1,"confidence_rate":1},{"cnt":[[305,1994],[1510,1994],[1510,2039],[305,2039]],"region":{"top_left_x":305,"top_left_y":1993,"width":1206,"height":46},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f95d7d17ace94dd9956a7775e37960e6","type":"text","conversion_output":true,"text":"No analyses of outcomes other than efficacy and safety outcomes are planned.","text_display":"\n\nNo analyses of outcomes other than efficacy and safety outcomes are planned.","confidence":1,"confidence_rate":1},{"cnt":[[305,2075],[907,2075],[907,2127],[305,2127]],"region":{"top_left_x":305,"top_left_y":2075,"width":602,"height":52},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1602648d5f474939b964456734097b2a","type":"section_header","conversion_output":false,"children_ids":["4bd35227fb2848e896a403afddcae5cd"],"text":"","text_display":""},{"cnt":[[309,2080],[904,2080],[904,2121],[309,2121]],"region":{"top_left_x":309,"top_left_y":2079,"width":596,"height":42},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bd35227fb2848e896a403afddcae5cd","type":"text","conversion_output":true,"parent_id":"1602648d5f474939b964456734097b2a","text":"12 REPORTING CONVENTIONS","text_display":"\n\n\\section*{12 REPORTING CONVENTIONS}","confidence":1,"confidence_rate":1},{"cnt":[[309,2170],[1416,2170],[1416,2215],[309,2215]],"region":{"top_left_x":309,"top_left_y":2169,"width":1107,"height":47},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c01f53932ec54b6ca7158eaf6914fac5","type":"text","conversion_output":true,"text":"Unless required otherwise by a journal, the following rules are standard:","text_display":"\n\nUnless required otherwise by a journal, the following rules are standard:","confidence":1,"confidence_rate":1},{"cnt":[[370,2237],[1717,2237],[1717,2279],[370,2279]],"region":{"top_left_x":369,"top_left_y":2236,"width":1348,"height":44},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ecd056c209442e5aa0824432a94a065","type":"text","conversion_output":true,"text":"- Moment statistics including mean and standard deviation will be reported at 1 more","text_display":"\n- Moment statistics including mean and standard deviation will be reported at 1 more","confidence":1,"confidence_rate":1},{"cnt":[[434,2279],[1141,2279],[1141,2327],[434,2327]],"region":{"top_left_x":433,"top_left_y":2279,"width":708,"height":48},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd7cc1eaa7054afa9a03ee66392e7de7","type":"text","conversion_output":true,"text":"significant digit than the precision of the data.","text_display":" significant digit than the precision of the data.","confidence":1,"confidence_rate":1},{"cnt":[[372,2346],[1876,2346],[1876,2391],[372,2391]],"region":{"top_left_x":371,"top_left_y":2346,"width":1505,"height":46},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"442b51df89944f9fa63738b4cae181da","type":"text","conversion_output":true,"text":"- Order statistics including median, min and max will be reported to the same level of precision","text_display":"\n- Order statistics including median, min and max will be reported to the same level of precision","confidence":1,"confidence_rate":1},{"cnt":[[432,2391],[1846,2391],[1846,2434],[432,2434]],"region":{"top_left_x":431,"top_left_y":2391,"width":1415,"height":44},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c0e48e1f8eb435197c3891743bd4df4","type":"text","conversion_output":true,"text":"as the original observations. If any values are calculated out to have more significant digits,","text_display":" as the original observations. If any values are calculated out to have more significant digits,","confidence":1,"confidence_rate":1},{"cnt":[[434,2434],[1850,2434],[1850,2481],[434,2481]],"region":{"top_left_x":433,"top_left_y":2434,"width":1417,"height":48},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f97900a2c515436eb23f8997d88ee38d","type":"text","conversion_output":true,"text":"then the value should be rounded so that it is the same level of precision as the original data.","text_display":" then the value should be rounded so that it is the same level of precision as the original data.","confidence":1,"confidence_rate":1},{"cnt":[[305,2552],[681,2552],[681,2589],[305,2589]],"region":{"top_left_x":305,"top_left_y":2552,"width":377,"height":37},"line":68,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"86d16ca9dbdf411493f1963645f0782d","type":"page_info","conversion_output":false,"text":"Version 2.2 09/12/2018; Page 42","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"20516320-e8c9-4a70-9741-7338b6671353-44","page":44,"lines":[{"cnt":[[309,138],[419,138],[419,165],[309,165]],"region":{"top_left_x":309,"top_left_y":137,"width":110,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"503eecb2190245cdbacde95b5e2a7060","type":"page_info","conversion_output":false,"text":"Network","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,180],[804,180],[804,213],[309,213]],"region":{"top_left_x":309,"top_left_y":180,"width":495,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8208a9470ffc425089470e16fbf51fed","type":"page_info","conversion_output":false,"text":"Protocol ESTEEM Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[372,318],[1848,318],[1848,363],[372,363]],"region":{"top_left_x":371,"top_left_y":317,"width":1477,"height":47},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5753854d16e348feb8c7ea781c53cb2f","type":"text","conversion_output":true,"text":"- Following SAS rules, the median will be reported as the average of the two middle numbers","text_display":"\n- Following SAS rules, the median will be reported as the average of the two middle numbers","confidence":1,"confidence_rate":1},{"cnt":[[434,363],[1003,363],[1003,402],[434,402]],"region":{"top_left_x":433,"top_left_y":363,"width":571,"height":39},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"268c7d7c102f4c3ebc0df6779eaf632d","type":"text","conversion_output":true,"text":"if the dataset contains even numbers.","text_display":" if the dataset contains even numbers.","confidence":1,"confidence_rate":1},{"cnt":[[374,430],[1717,430],[1717,475],[374,475]],"region":{"top_left_x":373,"top_left_y":429,"width":1344,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b27eae100059486bae0def155a402f30","type":"text","conversion_output":true,"text":"- Test statistics including \\(t\\) and \\(z\\) test statistics will be reported to two decimal places.","text_display":"\n- Test statistics including \\(t\\) and \\(z\\) test statistics will be reported to two decimal places.","confidence":0.5921946985181421,"confidence_rate":0.9948767003187939},{"cnt":[[372,494],[1807,494],[1807,541],[372,541]],"region":{"top_left_x":371,"top_left_y":494,"width":1436,"height":48},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"466d1e6c787449cd82e7abf7f56bbbe9","type":"text","conversion_output":true,"text":"- P-value will be reported to 3 decimal places if \\(>0.001\\). If it is less than 0.001 then report","text_display":"\n- P-value will be reported to 3 decimal places if \\(>0.001\\). If it is less than 0.001 then report","confidence":0.9951193332672119,"confidence_rate":0.9999551146212957},{"cnt":[[434,541],[1205,541],[1205,587],[434,587]],"region":{"top_left_x":433,"top_left_y":541,"width":773,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00ec90f7251e4cce937e903517864cac","type":"text","conversion_output":true,"text":"' \\(<0.001\\) '. Report p -values as 0.05 rather than .05 .","text_display":" ' \\(<0.001\\) '. Report p -values as 0.05 rather than .05 .","confidence":0.8033909258901346,"confidence_rate":0.9970460761497886},{"cnt":[[370,608],[1871,608],[1871,655],[370,655]],"region":{"top_left_x":369,"top_left_y":608,"width":1503,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e601ea6e9ba451197b3c2bf3d756a24","type":"text","conversion_output":true,"text":"- No preliminary rounding should be performed, rounding should only occur after analysis. To","text_display":"\n- No preliminary rounding should be performed, rounding should only occur after analysis. To","confidence":1,"confidence_rate":1},{"cnt":[[432,653],[1807,653],[1807,698],[432,698]],"region":{"top_left_x":431,"top_left_y":653,"width":1376,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4cfb73dd4fe4b909a685d19e62444f8","type":"text","conversion_output":true,"text":"round, consider digit to right of last significant digit: if \\(<5\\) round down, if \\(>=5\\) round up.","text_display":" round, consider digit to right of last significant digit: if \\(<5\\) round down, if \\(>=5\\) round up.","confidence":0.9785773754119873,"confidence_rate":0.999789775306752},{"cnt":[[305,735],[1493,735],[1493,784],[305,784]],"region":{"top_left_x":305,"top_left_y":734,"width":1189,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db55bb7d0e5f4d78986ff085a8a986ae","type":"section_header","conversion_output":false,"children_ids":["f0fee24fa35d41c7a5995d89c666b482"],"text":"","text_display":""},{"cnt":[[309,739],[1489,739],[1489,780],[309,780]],"region":{"top_left_x":309,"top_left_y":739,"width":1180,"height":41},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0fee24fa35d41c7a5995d89c666b482","type":"text","conversion_output":true,"parent_id":"db55bb7d0e5f4d78986ff085a8a986ae","text":"13 CHANGES TO THE ANALYSIS PLANNED IN THE PROTOCOL","text_display":"\n\n\\section*{13 CHANGES TO THE ANALYSIS PLANNED IN THE PROTOCOL}","confidence":1,"confidence_rate":1},{"cnt":[[370,827],[1781,827],[1781,872],[370,872]],"region":{"top_left_x":369,"top_left_y":827,"width":1413,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e28c45e489984d87a8fe5158676a386c","type":"text","conversion_output":true,"text":"At the request of the DSMB, a sensitivity analysis will be conducted to assess the impact of","text_display":"\n\nAt the request of the DSMB, a sensitivity analysis will be conducted to assess the impact of","confidence":1,"confidence_rate":1},{"cnt":[[370,872],[1807,872],[1807,917],[370,917]],"region":{"top_left_x":369,"top_left_y":872,"width":1438,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16ecf99d65044c92a7a5ac1d3a147803","type":"text","conversion_output":true,"text":"including vs. excluding data from a clinical site at which potential data quality concerns were","text_display":" including vs. excluding data from a clinical site at which potential data quality concerns were","confidence":1,"confidence_rate":1},{"cnt":[[370,915],[887,915],[887,960],[370,960]],"region":{"top_left_x":369,"top_left_y":915,"width":519,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a071e4a9ba2426287ec7b12113a4c18","type":"text","conversion_output":true,"text":"raised during conduct of the trial.","text_display":" raised during conduct of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[370,1003],[1717,1003],[1717,1051],[370,1051]],"region":{"top_left_x":369,"top_left_y":1003,"width":1348,"height":48},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e9d704b55f7491394bbbc7a57e82e85","type":"text","conversion_output":true,"text":"At the request of the writing team, additional endpoints describing the dryness status of","text_display":"\n\nAt the request of the writing team, additional endpoints describing the dryness status of","confidence":1,"confidence_rate":1},{"cnt":[[370,1044],[1828,1044],[1828,1094],[370,1094]],"region":{"top_left_x":369,"top_left_y":1044,"width":1460,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"309416a5e7f04f00ba73aebe4fecfc1a","type":"text","conversion_output":true,"text":"participants based on the UDI and bladder diary responses will be added. For further details on","text_display":" participants based on the UDI and bladder diary responses will be added. For further details on","confidence":1,"confidence_rate":1},{"cnt":[[370,1091],[1317,1091],[1317,1137],[370,1137]],"region":{"top_left_x":369,"top_left_y":1091,"width":948,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f82b8aa92b5a4048ba38b21540e12fc8","type":"text","conversion_output":true,"text":"how these diary indicators will be calculated, see Section 9.2.","text_display":" how these diary indicators will be calculated, see Section 9.2.","confidence":1,"confidence_rate":1},{"cnt":[[370,1177],[1858,1177],[1858,1222],[370,1222]],"region":{"top_left_x":369,"top_left_y":1177,"width":1490,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e64d3c2d3a2844b38b15a1dfbc421fea","type":"text","conversion_output":true,"text":"Due to the relatively small number of participants who met failure (additional treatment) criteria,","text_display":"\n\nDue to the relatively small number of participants who 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These will be determined through an analysis of the Additional Therapy Form (CRF \\#31)","text_display":" symptoms. These will be determined through an analysis of the Additional Therapy Form (CRF \\#31)","confidence":1,"confidence_rate":1},{"cnt":[[305,1311],[1051,1311],[1051,1356],[305,1356]],"region":{"top_left_x":305,"top_left_y":1310,"width":746,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb5618b9172341f18f8d4531f3e2edbe","type":"text","conversion_output":true,"text":"and Concomitant Medications Form (CRF \\#28).","text_display":" and Concomitant Medications Form (CRF \\#28).","confidence":1,"confidence_rate":1},{"cnt":[[432,1405],[1850,1405],[1850,1454],[432,1454]],"region":{"top_left_x":431,"top_left_y":1405,"width":1419,"height":50},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65ddc363c7f9460eb56f1791767dfd9f","type":"text","conversion_output":true,"text":"a. 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