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When the PADCD date is reached, all","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[370,816],[801,816],[801,862],[370,862]],"region":{"top_left_x":369,"top_left_y":816,"width":433,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53b7ca6878874757ab15bca44144cca5","type":"text","conversion_output":true,"text":"subjects will discontinue IP.","text_display":" subjects will discontinue IP.","confidence":1,"confidence_rate":1},{"cnt":[[370,868],[1833,868],[1833,913],[370,913]],"region":{"top_left_x":369,"top_left_y":867,"width":1464,"height":47},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f000b8dadd649c1848866f7aef5cb4f","type":"text","conversion_output":true,"text":"For all subjects, whose last regular study visit within 6 months ( +45 days time window) prior to","text_display":"\nFor all subjects, whose last regular study visit within 6 months ( +45 days time window) prior to","confidence":0.9645203822292387,"confidence_rate":0.9996655715408058},{"cnt":[[370,911],[1742,911],[1742,954],[370,954]],"region":{"top_left_x":369,"top_left_y":910,"width":1374,"height":44},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f8799943e6b4100946f3ca1dc82d11e","type":"text","conversion_output":true,"text":"the PADCD was a yearly visit (eg, month 12,24 , etc) and radiological assessments were","text_display":" the PADCD was a yearly visit (eg, month 12,24 , etc) and radiological assessments were","confidence":0.83740234375,"confidence_rate":0.9981140080990571},{"cnt":[[370,952],[1880,952],[1880,995],[370,995]],"region":{"top_left_x":369,"top_left_y":951,"width":1511,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5909e6e03cee42df87e8591362939014","type":"text","conversion_output":true,"text":"performed, this visit will be considered an end of treatment (EOT) visit (corresponding case report","text_display":" performed, this visit will be considered an end of treatment (EOT) visit (corresponding case report","confidence":1,"confidence_rate":1},{"cnt":[[370,993],[1818,993],[1818,1038],[370,1038]],"region":{"top_left_x":369,"top_left_y":992,"width":1449,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0aacf1abb4284e06942b977adb3a9926","type":"text","conversion_output":true,"text":"form [CRF] will have to be completed). For those subjects, the next visit will be regarded as a","text_display":" form [CRF] will have to be completed). For those subjects, the next visit will be regarded as a","confidence":0.9970703125,"confidence_rate":0.999970660556062},{"cnt":[[370,1036],[1846,1036],[1846,1079],[370,1079]],"region":{"top_left_x":369,"top_left_y":1035,"width":1477,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77f9a82e811647a486d2d448498fdc84","type":"text","conversion_output":true,"text":"long-term follow-up (LTFU) visit, at which an antibody sample will be taken. Those subjects, for","text_display":" long-term follow-up (LTFU) visit, at which an antibody sample will be taken. Those subjects, for","confidence":1,"confidence_rate":1},{"cnt":[[370,1079],[1841,1079],[1841,1119],[370,1119]],"region":{"top_left_x":369,"top_left_y":1078,"width":1473,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49a0419ab1bc42a08543aa95b583a917","type":"text","conversion_output":true,"text":"whom the radiological assessments were not performed, will need to attend the next scheduled","text_display":" whom the radiological assessments were not performed, will need to attend the next scheduled","confidence":1,"confidence_rate":1},{"cnt":[[370,1117],[1772,1117],[1772,1162],[370,1162]],"region":{"top_left_x":369,"top_left_y":1117,"width":1404,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7f7a6af88cb4a09b5c42f22abca8bf4","type":"text","conversion_output":true,"text":"6 months visit, when radiological assessments (vertebral x-rays, dual X-ray absorptiometry","text_display":" 6 months visit, when radiological assessments (vertebral x-rays, dual X-ray absorptiometry","confidence":1,"confidence_rate":1},{"cnt":[[370,1160],[1841,1160],[1841,1205],[370,1205]],"region":{"top_left_x":369,"top_left_y":1160,"width":1473,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e572803ef704b4bac41c613d13b1fe5","type":"text","conversion_output":true,"text":"\\([ DXA ])\\) will take place and an antibody sample will be taken. For these subjects this visit will be","text_display":" \\([ DXA ])\\) will take place and an antibody sample will be taken. For these subjects this visit will be","confidence":0.6551519974432387,"confidence_rate":0.9959805946338455},{"cnt":[[370,1203],[754,1203],[754,1240],[370,1240]],"region":{"top_left_x":369,"top_left_y":1203,"width":386,"height":37},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40629c73561b4e3ca147d2b88cffe397","type":"text","conversion_output":true,"text":"considered as EOT visit.","text_display":" considered as EOT visit.","confidence":1,"confidence_rate":1},{"cnt":[[370,1250],[1852,1250],[1852,1296],[370,1296]],"region":{"top_left_x":369,"top_left_y":1250,"width":1483,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df524bc861cd44cab0a508644d8f13aa","type":"text","conversion_output":true,"text":"It is highly recommended that all subjects should receive at least 500 mg elemental calcium and","text_display":"\nIt is highly recommended that all subjects should receive at least 500 mg elemental calcium and","confidence":0.99658203125,"confidence_rate":0.9999673926902055},{"cnt":[[370,1296],[1747,1296],[1747,1338],[370,1338]],"region":{"top_left_x":369,"top_left_y":1295,"width":1378,"height":44},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3aa79516496e44abbce6602b6433edd8","type":"text","conversion_output":true,"text":"at least 400 IU vitamin D daily throughout treatment with IP. If a subject has greater than","text_display":" at least 400 IU vitamin D daily throughout treatment with IP. If a subject has greater than","confidence":0.8717012128327042,"confidence_rate":0.9986140062300627},{"cnt":[[372,1336],[1760,1336],[1760,1381],[372,1381]],"region":{"top_left_x":371,"top_left_y":1336,"width":1389,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33d760ee505d46da8c99f0b0d5ff848f","type":"text","conversion_output":true,"text":"\\(10 \\%\\) loss of BMD at the total hip or lumbar spine over any 1-year period, then an informed","text_display":" \\(10 \\%\\) loss of BMD at the total hip or lumbar spine over any 1-year period, then an informed","confidence":0.8853096961975098,"confidence_rate":0.9986909891591959},{"cnt":[[370,1379],[1721,1379],[1721,1422],[370,1422]],"region":{"top_left_x":369,"top_left_y":1379,"width":1352,"height":44},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57679124fcb64c01820998e61b0bd188","type":"text","conversion_output":true,"text":"discussion between the investigator and the subject regarding alternative therapies and","text_display":" discussion between the investigator and the subject regarding alternative therapies and","confidence":1,"confidence_rate":1},{"cnt":[[370,1420],[892,1420],[892,1463],[370,1463]],"region":{"top_left_x":369,"top_left_y":1420,"width":523,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"572b24e8b6774681a5d1a0247fa5c61e","type":"text","conversion_output":true,"text":"appropriate treatment is required.","text_display":" appropriate treatment is required.","confidence":0.9921875,"confidence_rate":0.9997989131062949},{"cnt":[[370,1472],[1807,1472],[1807,1515],[370,1515]],"region":{"top_left_x":369,"top_left_y":1471,"width":1438,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18aa8e7d1e1847c583f9db3ba573bc82","type":"text","conversion_output":true,"text":"The number of primary endpoint events observed will drive the timing of the primary and final","text_display":"\nThe number of primary endpoint events observed will drive the timing of the primary and final","confidence":1,"confidence_rate":1},{"cnt":[[370,1515],[1818,1515],[1818,1558],[370,1558]],"region":{"top_left_x":369,"top_left_y":1514,"width":1449,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"994dab4ed57d4d8ebdd6fa3fc1b114ef","type":"text","conversion_output":true,"text":"analyses. The actual timing of the primary analysis will depend on the subject enrollment rate","text_display":" analyses. The actual timing of the primary analysis will depend on the subject enrollment rate","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[370,1555],[1182,1555],[1182,1596],[370,1596]],"region":{"top_left_x":369,"top_left_y":1555,"width":813,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"402d0c4f667e4628b8a8636305ff0414","type":"text","conversion_output":true,"text":"and the rate at which clinical fractures are observed.","text_display":" and the rate at which clinical fractures are observed.","confidence":1,"confidence_rate":1},{"cnt":[[370,1607],[1833,1607],[1833,1652],[370,1652]],"region":{"top_left_x":369,"top_left_y":1607,"width":1464,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73250e9ca8ac4218aea1940bdba20aed","type":"text","conversion_output":true,"text":"All subjects, whose last regular study visit within 6 months ( +45 days time window) prior to the","text_display":"\nAll subjects, whose last regular study visit within 6 months ( +45 days time window) prior to the","confidence":0.9985356330871582,"confidence_rate":0.9999864312018168},{"cnt":[[370,1646],[1738,1646],[1738,1691],[370,1691]],"region":{"top_left_x":369,"top_left_y":1645,"width":1370,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7484e0477812475bb673a0e81db2dc9f","type":"text","conversion_output":true,"text":"PADCD was a 6 months visit (eg, month 6,18 , etc), will have to attend the next regularly","text_display":" PADCD was a 6 months visit (eg, month 6,18 , etc), will have to attend the next regularly","confidence":0.9873161315917969,"confidence_rate":0.99987235819291},{"cnt":[[370,1689],[1757,1689],[1757,1734],[370,1734]],"region":{"top_left_x":369,"top_left_y":1688,"width":1389,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fc398daf211443f95f2baf8fb47c6e6","type":"text","conversion_output":true,"text":"scheduled yearly study visit (eg, month 12 ) within 6 months after PADCD at the latest and","text_display":" scheduled yearly study visit (eg, month 12 ) within 6 months after PADCD at the latest and","confidence":0.6648775733774528,"confidence_rate":0.995967041876694},{"cnt":[[370,1732],[1450,1732],[1450,1777],[370,1777]],"region":{"top_left_x":369,"top_left_y":1731,"width":1082,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e60105b7918a4905ba4191df321ce7c4","type":"text","conversion_output":true,"text":"perform all corresponding assessments, including antibody sampling.","text_display":" perform all corresponding assessments, including antibody sampling.","confidence":1,"confidence_rate":1},{"cnt":[[370,1783],[1751,1783],[1751,1828],[370,1828]],"region":{"top_left_x":369,"top_left_y":1783,"width":1382,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65f65fa0d8984d07bb3107816d754720","type":"text","conversion_output":true,"text":"Data on fractures occurring between the last visit prior to PADCD and PADCD have to be","text_display":"\nData on fractures occurring between the last visit prior to PADCD and PADCD have to be","confidence":0.9975595474243164,"confidence_rate":0.9999731494227478},{"cnt":[[370,1826],[1656,1826],[1656,1871],[370,1871]],"region":{"top_left_x":369,"top_left_y":1826,"width":1288,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56ca6adda8e640efa0523d4aca4cce5c","type":"text","conversion_output":true,"text":"collected via telephone or physical visits within 6 months after PADCD at the latest.","text_display":" collected via telephone or physical visits within 6 months after PADCD at the latest.","confidence":0.9975595474243164,"confidence_rate":0.9999737268469312},{"cnt":[[370,1878],[1837,1878],[1837,1923],[370,1923]],"region":{"top_left_x":369,"top_left_y":1877,"width":1468,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2fa1ea72251c401088f3cbbc1a88dca2","type":"text","conversion_output":true,"text":"Subjects who withdraw from IP prior to the observed PADCD will continue to attend Q6M study","text_display":"\nSubjects who withdraw from IP prior to the observed PADCD will continue to attend Q6M study","confidence":1,"confidence_rate":1},{"cnt":[[370,1921],[1497,1921],[1497,1966],[370,1966]],"region":{"top_left_x":369,"top_left_y":1920,"width":1129,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"371c4e9c7bfc48b9b1529b91fa14d86f","type":"text","conversion_output":true,"text":"visits for assessment of the primary and secondary end-point and safety.","text_display":" visits for assessment of the primary and secondary end-point and safety.","confidence":1,"confidence_rate":1},{"cnt":[[370,1972],[1811,1972],[1811,2015],[370,2015]],"region":{"top_left_x":369,"top_left_y":1972,"width":1443,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b07f86120a04d25afe7bedd513d30d5","type":"text","conversion_output":true,"text":"Subjects completing or discontinuing AIT will have the opportunity to remain on IP for at least","text_display":"\nSubjects completing or discontinuing AIT will have the opportunity to remain on IP for at least","confidence":1,"confidence_rate":1},{"cnt":[[370,2015],[1846,2015],[1846,2056],[370,2056]],"region":{"top_left_x":369,"top_left_y":2015,"width":1477,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f63a668fcd974422bb15a9c16ffd5cad","type":"text","conversion_output":true,"text":"2 doses of IP after their last scheduled study visit during which they were still on AIT. Following","text_display":" 2 doses of IP after their last scheduled study visit during which they were still on AIT. Following","confidence":1,"confidence_rate":1},{"cnt":[[370,2054],[1867,2054],[1867,2099],[370,2099]],"region":{"top_left_x":369,"top_left_y":2053,"width":1498,"height":47},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24ccdc030e5742c88aa441b15dc9a356","type":"text","conversion_output":true,"text":"the study PADCD, subjects will be followed for DFS, BMFS, and OS every 12 months (Q12M) by","text_display":" the study PADCD, subjects will be followed for DFS, BMFS, and OS every 12 months (Q12M) by","confidence":1,"confidence_rate":1},{"cnt":[[370,2097],[1867,2097],[1867,2142],[370,2142]],"region":{"top_left_x":369,"top_left_y":2096,"width":1498,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"810871894be94639ba1a53f5acea4e84","type":"text","conversion_output":true,"text":"clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until","text_display":" clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until","confidence":1,"confidence_rate":1},{"cnt":[[370,2140],[1794,2140],[1794,2185],[370,2185]],"region":{"top_left_x":369,"top_left_y":2139,"width":1425,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e754b15f841d4c92be314daddd6e3d08","type":"text","conversion_output":true,"text":"a maximum of either 18 or 66 months after the PADCD, depending on an interim analysis at","text_display":" a maximum of either 18 or 66 months after the PADCD, depending on an interim analysis at","confidence":1,"confidence_rate":1},{"cnt":[[370,2179],[1734,2179],[1734,2224],[370,2224]],"region":{"top_left_x":369,"top_left_y":2178,"width":1365,"height":46},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"975e7f022ce74572a207d3f521ac7771","type":"text","conversion_output":true,"text":"PADCD (see Sections 7.16 and 10.5). Based on the Data Monitoring Committee (DMC)","text_display":" PADCD (see Sections 7.16 and 10.5). Based on the Data Monitoring Committee (DMC)","confidence":1,"confidence_rate":1},{"cnt":[[370,2221],[1792,2221],[1792,2267],[370,2267]],"region":{"top_left_x":369,"top_left_y":2221,"width":1423,"height":46},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"625aa119dbdc4730a93460d53d89d226","type":"text","conversion_output":true,"text":"recommendation that interim futility analysis of DFS did not indicate futility, it was decided to","text_display":" recommendation that interim futility analysis of DFS did not indicate futility, it was decided to","confidence":1,"confidence_rate":1},{"cnt":[[370,2264],[1858,2264],[1858,2310],[370,2310]],"region":{"top_left_x":369,"top_left_y":2264,"width":1490,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50851c5a67d74ef18482e0f079efffdc","type":"text","conversion_output":true,"text":"follow subjects until a maximum of approximately 66 months after PADCD. 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Please refer to Sections 4.3 and 4.4 for eligibility criteria for receiving","text_display":" denosumab in the OLP. 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Treatment Phase","text_display":"\n\n\\section*{Blinded Treatment Phase}","confidence":1,"confidence_rate":1},{"cnt":[[370,1693],[1781,1693],[1781,1738],[370,1738]],"region":{"top_left_x":369,"top_left_y":1692,"width":1413,"height":47},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d342c7f8d7104033ab6eb67acb15da6e","type":"text","conversion_output":true,"text":"Written informed consent must be obtained from all subjects prior to screening for eligibility.","text_display":"\n\nWritten informed consent must be obtained from all subjects prior to screening for eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[370,1745],[1785,1745],[1785,1790],[370,1790]],"region":{"top_left_x":369,"top_left_y":1744,"width":1417,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13afb703a83f4be180ce334269d22404","type":"text","conversion_output":true,"text":"Screening assessments will include a medical and medication history, physical examination","text_display":" Screening assessments will include a medical and medication history, physical examination","confidence":1,"confidence_rate":1},{"cnt":[[372,1788],[1858,1788],[1858,1833],[372,1833]],"region":{"top_left_x":371,"top_left_y":1787,"width":1488,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"662e4fb89929471098264611cd61b8dd","type":"text","conversion_output":true,"text":"(ECOG performance status), weight, height and vital signs (temperature, pulse, blood pressure),","text_display":" (ECOG performance status), weight, height and vital signs (temperature, pulse, blood 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(if applicable) and denosumab antibody analysis.","confidence":1,"confidence_rate":1},{"cnt":[[370,1921],[1858,1921],[1858,1966],[370,1966]],"region":{"top_left_x":369,"top_left_y":1920,"width":1490,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d34689546894ef49da5097f0ad8250c","type":"text","conversion_output":true,"text":"Eligible subjects will be randomized into 1 of the 2 treatment groups within 35 days of screening.","text_display":"\nEligible subjects will be randomized into 1 of the 2 treatment groups within 35 days of screening.","confidence":0.99853515625,"confidence_rate":0.9999869115349181},{"cnt":[[372,1964],[1867,1964],[1867,2009],[372,2009]],"region":{"top_left_x":371,"top_left_y":1963,"width":1496,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c96f7ddc55d74d358bebfbb6556d551d","type":"text","conversion_output":true,"text":"First administration of IP (day 1 ) must take place within 8 days of randomization. During this visit","text_display":" First administration of IP (day 1 ) must take place within 8 days of randomization. During this visit","confidence":0.7209749221801758,"confidence_rate":0.997083271546211},{"cnt":[[370,2007],[1841,2007],[1841,2050],[370,2050]],"region":{"top_left_x":369,"top_left_y":2006,"width":1473,"height":44},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c34c6d519e364445a89e68cf27aca6ac","type":"text","conversion_output":true,"text":"the baseline related assessments will be completed. After the initial dose of IP is administered,","text_display":" the baseline related assessments will be completed. After the initial dose of IP is administered,","confidence":1,"confidence_rate":1},{"cnt":[[370,2047],[1850,2047],[1850,2090],[370,2090]],"region":{"top_left_x":369,"top_left_y":2047,"width":1481,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a32c09b47634d69bdc3a550a02a6c0f","type":"text","conversion_output":true,"text":"subjects will return for study visits and receive IP every 6 months. The treatment phase will end","text_display":" subjects will return for study visits and receive IP every 6 months. The treatment phase will end","confidence":0.9980478286743164,"confidence_rate":0.999981389894164},{"cnt":[[370,2088],[1846,2088],[1846,2133],[370,2133]],"region":{"top_left_x":369,"top_left_y":2088,"width":1477,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6594cbf1fe884c5dad6691e42c453889","type":"text","conversion_output":true,"text":"when the PADCD is reached (see Glossary). At the end of the treatment phase all subjects will","text_display":" when the PADCD is reached (see Glossary). 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For those subjects, the next visit will be regarded as LTFU visit, at which an antibody","text_display":" completed). For those subjects, the next visit will be regarded as LTFU visit, at which an antibody","confidence":1,"confidence_rate":1},{"cnt":[[370,2350],[1721,2350],[1721,2393],[370,2393]],"region":{"top_left_x":369,"top_left_y":2350,"width":1352,"height":44},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4cebf5e33e36451abff606764343a3d1","type":"text","conversion_output":true,"text":"sample will be taken. Those subjects, for whom the radiological assessments were not","text_display":" sample will be taken. Those subjects, for whom the radiological assessments were not","confidence":1,"confidence_rate":1},{"cnt":[[370,2393],[1863,2393],[1863,2436],[370,2436]],"region":{"top_left_x":369,"top_left_y":2393,"width":1494,"height":44},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bef8db5314be43139e566d75a2b77ff5","type":"text","conversion_output":true,"text":"performed, will need to attend the next scheduled 6 months visit, when radiological assessments","text_display":" performed, will need to attend the next scheduled 6 months visit, when radiological assessments","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[370,2434],[1854,2434],[1854,2477],[370,2477]],"region":{"top_left_x":369,"top_left_y":2434,"width":1486,"height":44},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e612474ea5ac4acbbaee3f4ef92761f4","type":"text","conversion_output":true,"text":"(vertebral x-rays, DXA) will take place and an antibody sample will be taken. 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For details of eligibility see Sections 4.3","text_display":" to 36 months (maximum of 7 doses) of denosumab. For details of eligibility see Sections 4.3","confidence":0.9758095376656991,"confidence_rate":0.9997575753554774},{"cnt":[[370,1285],[505,1285],[505,1326],[370,1326]],"region":{"top_left_x":369,"top_left_y":1284,"width":136,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ba3b6558fda48e8ad94ce883c49330b","type":"text","conversion_output":true,"text":"and 4.4.","text_display":" and 4.4.","confidence":0.998046875,"confidence_rate":0.9998496240125406},{"cnt":[[370,1334],[1760,1334],[1760,1381],[370,1381]],"region":{"top_left_x":369,"top_left_y":1334,"width":1391,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9bd90c1f8d294034a5747a82b3e77b46","type":"text","conversion_output":true,"text":"Informed consent must be obtained before unblinding to confirm eligibility. Please refer to","text_display":"\nInformed consent must be obtained before unblinding to confirm eligibility. Please refer to","confidence":1,"confidence_rate":1},{"cnt":[[370,1377],[1562,1377],[1562,1422],[370,1422]],"region":{"top_left_x":369,"top_left_y":1377,"width":1193,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"828a04308806415c925baa378f76b4c4","type":"text","conversion_output":true,"text":"Appendix A (Schedule of Assessments) for a detailed list of OLP procedures.","text_display":" Appendix A (Schedule of Assessments) for a detailed list of OLP 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Primary analysis Data CutOff Date (PADCD) - the date when approximately 247 subjects have experienced their first clinical","confidence":0.7834721913234262,"confidence_rate":0.9981669474298223},{"cnt":[[662,1624],[1749,1624],[1749,1656],[662,1656]],"region":{"top_left_x":661,"top_left_y":1624,"width":1088,"height":33},"line":18,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b5bba17ae90e4d448e09ebb2f5023538","type":"text","conversion_output":true,"text":"fracture and allsubjects have either withdrawn or had the opportunity to receive at least 2 doses of IP.","text_display":" fracture and allsubjects have either withdrawn or had the opportunity to receive at least 2 doses of IP.","confidence":0.7323684187099389,"confidence_rate":0.9972228670721102},{"cnt":[[623,1659],[2009,1659],[2009,1691],[623,1691]],"region":{"top_left_x":623,"top_left_y":1658,"width":1386,"height":33},"line":19,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f6b59afccf20480f92b700d6ad92d9b9","type":"text","conversion_output":true,"text":"3. Subjects will be followed for disease-free survival (DFS), bone metastasis-free survival (BMFS), and overall survival (OS) once","text_display":"\n3. Subjects will be followed for disease-free survival (DFS), bone metastasis-free survival (BMFS), and overall survival (OS) once","confidence":0.901566655149395,"confidence_rate":0.9992327293100298},{"cnt":[[666,1689],[1996,1689],[1996,1721],[666,1721]],"region":{"top_left_x":666,"top_left_y":1688,"width":1330,"height":33},"line":20,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"74b84647c7774bb7855fbc0b44d3a365","type":"text","conversion_output":true,"text":"every 12 months (Q12M) by clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until","text_display":" every 12 months (Q12M) by clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until","confidence":0.9800764714784691,"confidence_rate":0.9998541796310774},{"cnt":[[666,1714],[1145,1714],[1145,1747],[666,1747]],"region":{"top_left_x":666,"top_left_y":1714,"width":480,"height":33},"line":21,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2af95404da1d4468bcb9a45e7058f694","type":"text","conversion_output":true,"text":"approximately 66 months after the PADCD.","text_display":" approximately 66 months after the PADCD.","confidence":0.9970703125,"confidence_rate":0.999938877129854},{"cnt":[[623,1749],[2030,1749],[2030,1781],[623,1781]],"region":{"top_left_x":623,"top_left_y":1748,"width":1408,"height":34},"line":22,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6c4f53bb59d6416eb97eb5b93f1fe832","type":"text","conversion_output":true,"text":"4. After regulatory and IRB/IEC approval of Amendment 4 , the opportunity to start open label denosumab will open for a 12","text_display":"\n4. After regulatory and IRB/IEC approval of Amendment 4 , the opportunity to start open label denosumab will open for a 12","confidence":0.9868226051330566,"confidence_rate":0.9998971759295704},{"cnt":[[664,1779],[2060,1779],[2060,1811],[664,1811]],"region":{"top_left_x":663,"top_left_y":1778,"width":1398,"height":34},"line":23,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ad85b1f1c3be4174b82de38b27e6f3c9","type":"text","conversion_output":true,"text":"month period. Subjects who consent and fulfil the eligibility criteria will receive denosumab in the OLP for up to 36 months","text_display":" month period. 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Subjects receiving treatment in the open label phase will be followed for approximately 66 months after PADCD or until the end","confidence":0.994140625,"confidence_rate":0.999957105967501},{"cnt":[[726,1399],[1076,1399],[1076,1429],[726,1429]],"region":{"top_left_x":726,"top_left_y":1398,"width":351,"height":31},"line":13,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"cd5cb4f8d43f47649d1aecbb19b53d53","type":"text","conversion_output":true,"text":"of treatment, whichever is longer.","text_display":" of treatment, whichever is longer.","confidence":1,"confidence_rate":1},{"cnt":[[690,1429],[1936,1429],[1936,1459],[690,1459]],"region":{"top_left_x":689,"top_left_y":1428,"width":1247,"height":31},"line":14,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"de2c79090c0243f8a8b2faa37c417fcc","type":"text","conversion_output":true,"text":"5. Subjects not receiving treatment in the open label phase will be followed for approximately 66 months after PADCD.","text_display":"\n5. Subjects not receiving treatment in the open label phase will be followed for approximately 66 months after 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There were no new","text_display":" increases BMD at the lumbar spine, total hip, and femoral neck. 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Denosumab treatment also significantly reduced the","text_display":" adjusted p -values \\(<0.001\\) ). 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49 fractures in 809 patients in the placebo group","text_display":" denosumab group compared with 49 fractures in 809 patients in the placebo group","confidence":1,"confidence_rate":1},{"cnt":[[370,2512],[1764,2512],[1764,2565],[370,2565]],"region":{"top_left_x":369,"top_left_y":2511,"width":1395,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6930ec7210f74edaa0daf30291f71cdf","type":"text","conversion_output":true,"text":"(odds ratio \\(0.53[95 \\% CI 0.33-0.85]\\), p -value \\(=0.009\\) ) and the incidence of new or","text_display":" (odds ratio \\(0.53[95 \\% CI 0.33-0.85]\\), p -value \\(=0.009\\) ) and the incidence of new 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104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[1854,249],[1854,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":1486,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c81b7573c4114a74ba1329b25857c9a4","type":"text","conversion_output":true,"text":"worsening vertebral fractures at 36 months ( 31 of 835 patients in the denosumab group","text_display":"\nworsening vertebral fractures at 36 months ( 31 of 835 patients in the denosumab group","confidence":0.9775879383087158,"confidence_rate":0.9997733554007202},{"cnt":[[370,314],[1489,314],[1489,367],[370,367]],"region":{"top_left_x":369,"top_left_y":313,"width":1120,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fd62f10c335455fa87d5c88fe6f384f","type":"text","conversion_output":true,"text":"compared with 55 of 809 patients in the placebo group; odds ratio","text_display":" compared with 55 of 809 patients in the placebo group; odds ratio","confidence":1,"confidence_rate":1},{"cnt":[[370,378],[1674,378],[1674,432],[370,432]],"region":{"top_left_x":369,"top_left_y":378,"width":1305,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cfe3ed41963485bac0e36cb48231215","type":"text","conversion_output":true,"text":"\\(0.54[95 \\% Cl 0.34-0.84], p =0.007)\\). There were no differences between the","text_display":" \\(0.54[95 \\% Cl 0.34-0.84], p =0.007)\\). There were no differences between the","confidence":0.4618832951700824,"confidence_rate":0.9902698870301992},{"cnt":[[370,447],[1798,447],[1798,501],[370,501]],"region":{"top_left_x":369,"top_left_y":446,"width":1430,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c5d4b62a271443bbce1796c6b586fb6","type":"text","conversion_output":true,"text":"denosumab and placebo groups with respect to subject incidence of adverse events","text_display":" denosumab and placebo groups with respect to subject incidence of adverse events","confidence":1,"confidence_rate":1},{"cnt":[[370,511],[1794,511],[1794,569],[370,569]],"region":{"top_left_x":369,"top_left_y":511,"width":1425,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecf06db7005a4e29b75e1b246427d5f3","type":"text","conversion_output":true,"text":"( 1366 [80\\%] vs 1334 [79\\%]), or serious adverse events (SAEs) ( 521 vs 511; 30\\% in","text_display":" ( 1366 [80\\%] vs 1334 [79\\%]), or serious adverse events (SAEs) ( 521 vs 511; 30\\% in","confidence":0.37637475734936504,"confidence_rate":0.9898727756963007},{"cnt":[[370,576],[1850,576],[1850,632],[370,632]],"region":{"top_left_x":369,"top_left_y":575,"width":1481,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2c03bff15f54d7983f839fa2f224eb9","type":"text","conversion_output":true,"text":"each group). Despite proactive adjudication of every potential osteonecrosis of the jaw","text_display":" each group). Despite proactive adjudication of every potential osteonecrosis of the jaw","confidence":1,"confidence_rate":1},{"cnt":[[370,645],[1876,645],[1876,698],[370,698]],"region":{"top_left_x":369,"top_left_y":644,"width":1507,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ae0ad4daf3a4e7d8a7af874ddfe4ebf","type":"text","conversion_output":true,"text":"(ONJ) by an international expert panel, no ONJ case was observed. No atypical femoral","text_display":" (ONJ) by an international expert panel, no ONJ case was observed. 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When the PADCD is reached, all subjects will discontinue IP.","confidence":1,"confidence_rate":1},{"cnt":[[369,887],[1837,885],[1837,941],[370,943]],"region":{"top_left_x":369,"top_left_y":885,"width":1468,"height":59},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ede19851b62441a8959eea63a0a86fc","type":"text","conversion_output":true,"text":"For all subjects whose last regular study visit within 6 months (+45 days time window)","text_display":"\n\nFor all subjects whose last regular study visit within 6 months (+45 days time window)","confidence":0.46231619842028415,"confidence_rate":0.9918260768044233},{"cnt":[[370,954],[1680,954],[1680,1008],[370,1008]],"region":{"top_left_x":369,"top_left_y":953,"width":1312,"height":55},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e06c70d9c664308b80ab41123685898","type":"text","conversion_output":true,"text":"prior to the PADCD was a yearly visit (eg, month 12,24 , etc) and radiological","text_display":" prior to the PADCD was a yearly visit (eg, month 12,24 , etc) and radiological","confidence":0.9980475902557373,"confidence_rate":0.9999772756281954},{"cnt":[[370,1018],[1837,1018],[1837,1072],[370,1072]],"region":{"top_left_x":369,"top_left_y":1018,"width":1468,"height":55},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b777b09b1bb94c3eb62b7b8175e06aec","type":"text","conversion_output":true,"text":"assessments were performed, this visit will be considered an EOT visit (corresponding","text_display":" assessments were performed, this visit will be considered an EOT visit (corresponding","confidence":1,"confidence_rate":1},{"cnt":[[370,1085],[1863,1085],[1863,1137],[370,1137]],"region":{"top_left_x":369,"top_left_y":1084,"width":1494,"height":53},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ec525ed472d4ac3af90fb1cd6af7004","type":"text","conversion_output":true,"text":"case report form [CRF] will have to be completed). For those subjects, the next visit will","text_display":" case report form [CRF] will have to be completed). For those subjects, the next visit will","confidence":1,"confidence_rate":1},{"cnt":[[370,1152],[1800,1152],[1800,1205],[370,1205]],"region":{"top_left_x":369,"top_left_y":1151,"width":1432,"height":55},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c07d28ea5e2464aaa19e38550e47be5","type":"text","conversion_output":true,"text":"be regarded as long-term follow-up (LTFU) visit, at which an antibody sample will be","text_display":" be regarded as long-term follow-up (LTFU) visit, at which an antibody sample will be","confidence":1,"confidence_rate":1},{"cnt":[[370,1216],[1858,1216],[1858,1270],[370,1270]],"region":{"top_left_x":369,"top_left_y":1216,"width":1490,"height":54},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3f1e6fb2964487394b8f853f6edeb8d","type":"text","conversion_output":true,"text":"taken. Those subjects, for whom the radiological assessments were not performed, will","text_display":" taken. Those subjects, for whom the radiological assessments were not performed, will","confidence":1,"confidence_rate":1},{"cnt":[[370,1285],[1749,1285],[1749,1334],[370,1334]],"region":{"top_left_x":369,"top_left_y":1284,"width":1380,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a265e864bad64c8bb5cab31d0fc6b6aa","type":"text","conversion_output":true,"text":"need to attend the next scheduled 6 months visit, when radiological assessments","text_display":" need to attend the next scheduled 6 months visit, when radiological assessments","confidence":0.9990234375,"confidence_rate":0.9999887697222805},{"cnt":[[370,1349],[1772,1349],[1772,1403],[370,1403]],"region":{"top_left_x":369,"top_left_y":1349,"width":1404,"height":54},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b033d0db8217408f893ed1f04b720b2f","type":"text","conversion_output":true,"text":"(vertebral x-rays, dual X-ray absorptiometry [DXA]) will take place and an antibody","text_display":" (vertebral x-rays, dual X-ray absorptiometry [DXA]) will take place and an antibody","confidence":0.98046875,"confidence_rate":0.9997758830117405},{"cnt":[[370,1414],[1755,1414],[1755,1467],[370,1467]],"region":{"top_left_x":369,"top_left_y":1413,"width":1387,"height":55},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e346d0dac5f24913ba6a912223c1d431","type":"text","conversion_output":true,"text":"sample will be taken. For these subjects this visit will be considered as EOT visit.","text_display":" sample will be taken. For these subjects this visit will be considered as EOT visit.","confidence":1,"confidence_rate":1},{"cnt":[[370,1500],[1871,1500],[1871,1553],[370,1553]],"region":{"top_left_x":369,"top_left_y":1499,"width":1503,"height":55},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ec6429d6a0847fd988fb8e27e571332","type":"text","conversion_output":true,"text":"All subjects, whose last regular study visit within 6 months ( +45 days time window) prior","text_display":"\n\nAll subjects, whose last regular study visit within 6 months ( +45 days time window) prior","confidence":0.9136121426002453,"confidence_rate":0.9991058539550288},{"cnt":[[370,1568],[1824,1568],[1824,1620],[370,1620]],"region":{"top_left_x":369,"top_left_y":1568,"width":1456,"height":52},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b0bc15ddb0947458d3bedcbaaf9dd24","type":"text","conversion_output":true,"text":"to the PADCD was a 6 months visit (eg, month 6,18 , etc), will have to attend the next","text_display":" to the PADCD was a 6 months visit (eg, month 6,18 , etc), will have to attend the next","confidence":0.991714471951127,"confidence_rate":0.9999142300307954},{"cnt":[[370,1633],[1876,1633],[1876,1687],[370,1687]],"region":{"top_left_x":369,"top_left_y":1632,"width":1507,"height":55},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"311b93b3e3b3419385e45e7980725a10","type":"text","conversion_output":true,"text":"regularly scheduled yearly study visit (eg, month 12 ) within 6 months after PADCD at the","text_display":" regularly scheduled yearly study visit (eg, month 12 ) within 6 months after PADCD at the","confidence":0.887094259262085,"confidence_rate":0.9988026770155296},{"cnt":[[370,1702],[1723,1702],[1723,1755],[370,1755]],"region":{"top_left_x":369,"top_left_y":1701,"width":1355,"height":55},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f9c8b88c83742c59a68e5eb80363c59","type":"text","conversion_output":true,"text":"latest and perform all corresponding assessments, including antibody sampling.","text_display":" latest and perform all corresponding assessments, including antibody sampling.","confidence":1,"confidence_rate":1},{"cnt":[[370,1788],[1837,1788],[1837,1841],[370,1841]],"region":{"top_left_x":369,"top_left_y":1787,"width":1468,"height":55},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2acc755969104817bda967d8570723e5","type":"text","conversion_output":true,"text":"Data on fractures occurring between the last visit prior to PADCD and PADCD have to","text_display":"\n\nData on fractures occurring between the last visit prior to PADCD and PADCD have to","confidence":0.9912109375,"confidence_rate":0.9998996878256531},{"cnt":[[370,1852],[1858,1852],[1858,1904],[370,1904]],"region":{"top_left_x":369,"top_left_y":1851,"width":1490,"height":53},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0df7a6b08a94cecaaa4fad2c4f4d42b","type":"text","conversion_output":true,"text":"be collected via telephone or physical visits within six months after PADCD at the latest.","text_display":" be collected via telephone or physical visits within six months after PADCD at the latest.","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[370,1938],[1880,1938],[1880,1989],[370,1989]],"region":{"top_left_x":369,"top_left_y":1937,"width":1511,"height":53},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed14397039164690a7de24f22e983685","type":"text","conversion_output":true,"text":"Subjects who withdraw from IP prior to the observed PADCD will continue to attend Q6M","text_display":"\n\nSubjects who withdraw from IP prior to the observed PADCD will continue to attend Q6M","confidence":1,"confidence_rate":1},{"cnt":[[370,2007],[1708,2007],[1708,2058],[370,2058]],"region":{"top_left_x":369,"top_left_y":2006,"width":1340,"height":53},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ccef7e400d24addb3368512fe98a990","type":"text","conversion_output":true,"text":"study visits for assessment of the primary and secondary end-point and safety.","text_display":" study visits for assessment of the primary and secondary end-point and safety.","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[370,2093],[1863,2093],[1863,2144],[370,2144]],"region":{"top_left_x":369,"top_left_y":2092,"width":1494,"height":53},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0600fb208414f579535af55cd7d11f8","type":"text","conversion_output":true,"text":"Subjects completing or discontinuing AIT will have the opportunity to remain on IP for at","text_display":"\n\nSubjects completing or discontinuing AIT will have the opportunity to remain on IP for at","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[370,2157],[1820,2157],[1820,2209],[370,2209]],"region":{"top_left_x":369,"top_left_y":2157,"width":1451,"height":52},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0cc5c4b91c44e8c88a064fa42283830","type":"text","conversion_output":true,"text":"least 2 doses of IP after their last scheduled study visit during which they were still on","text_display":" least 2 doses of IP after their last scheduled study visit during which they were still on","confidence":1,"confidence_rate":1},{"cnt":[[370,2221],[1792,2221],[1792,2275],[370,2275]],"region":{"top_left_x":369,"top_left_y":2221,"width":1423,"height":55},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a85c31153854ca6bb7fac4ce44f6529","type":"text","conversion_output":true,"text":"AIT. Following the study PADCD, subjects will be followed for DFS, BMFS, and OS","text_display":" AIT. Following the study PADCD, subjects will be followed for DFS, BMFS, and OS","confidence":1,"confidence_rate":1},{"cnt":[[370,2288],[1800,2288],[1800,2340],[370,2340]],"region":{"top_left_x":369,"top_left_y":2288,"width":1432,"height":52},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb3ec8ef0c1a49968d0fc58264c57695","type":"text","conversion_output":true,"text":"every 12 months (Q12M) by clinic visits or telephone contacts starting from their last","text_display":" every 12 months (Q12M) by clinic visits or telephone contacts starting from their last","confidence":0.998046875,"confidence_rate":0.9999792019733479},{"cnt":[[370,2355],[1863,2355],[1863,2408],[370,2408]],"region":{"top_left_x":369,"top_left_y":2354,"width":1494,"height":55},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25538962bb8b4f60acb5e94b1cfe107a","type":"text","conversion_output":true,"text":"study visit (considered as EOT visit) until a maximum of either 18 or 66 months after the","text_display":" study visit (considered as EOT visit) until a maximum of either 18 or 66 months after the","confidence":0.99755859375,"confidence_rate":0.9999755563853322},{"cnt":[[370,2419],[1790,2419],[1790,2477],[370,2477]],"region":{"top_left_x":369,"top_left_y":2419,"width":1421,"height":59},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"432fef72eb8844a082d55f4bc03209ce","type":"text","conversion_output":true,"text":"PADCD, depending on an interim analysis at PADCD (see Sections 7.16 and 10.5).","text_display":" PADCD, depending on an interim analysis at PADCD (see Sections 7.16 and 10.5).","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[370,2488],[1852,2488],[1852,2539],[370,2539]],"region":{"top_left_x":369,"top_left_y":2487,"width":1483,"height":53},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c778244c17fb417abfa0239969678611","type":"text","conversion_output":true,"text":"Based on the DMC recommendation that interim futility analysis of DFS did not indicate","text_display":" Based on the DMC recommendation that interim futility analysis of DFS did not indicate","confidence":1,"confidence_rate":1},{"cnt":[[370,2647],[638,2647],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2646,"width":270,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1233f539dc0e468194cc686a7d978a9b","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1884,2612],[1884,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":257,"height":72},"line":39,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"6c8b0028d92e4d1680683c987f45bc4c","type":"page_info","conversion_output":false,"text":"AMGEN \\({ }^{\\circ}\\)","text_display":"","confidence":0.7361892575863749,"confidence_rate":0.9831290441041189}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-029","page":29,"lines":[{"cnt":[[370,64],[922,64],[922,105],[370,105]],"region":{"top_left_x":369,"top_left_y":64,"width":553,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40b03db15d0045ea98dddcb158a50e31","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,103],[1033,103],[1033,144],[370,144]],"region":{"top_left_x":369,"top_left_y":103,"width":665,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"498e27a1a88743018539c669319d18c0","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d6529409eca4280b2338ab6f9b0c6d0","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9659682237543166,"confidence_rate":0.9986159850343261},{"cnt":[[1629,142],[1882,142],[1882,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":255,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01faa32ad5ca4498ab170b3edd05035a","type":"page_info","conversion_output":false,"text":"Page 29 of 104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[1811,249],[1811,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":1443,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df043e8428c04c89b652f847fb27ca9e","type":"text","conversion_output":true,"text":"futility, it was decided to follow subjects until a maximum of approximately 66 months","text_display":"\nfutility, it was decided to follow subjects until a maximum of approximately 66 months","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[370,314],[1858,314],[1858,367],[370,367]],"region":{"top_left_x":369,"top_left_y":313,"width":1490,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cfbf5ec773445aca61e51c9ce69b5ef","type":"text","conversion_output":true,"text":"after PADCD. Following regulatory and Institutional Review Board / Independent Ethics","text_display":" after PADCD. Following regulatory and Institutional Review Board / Independent Ethics","confidence":1,"confidence_rate":1},{"cnt":[[370,380],[1852,380],[1852,432],[370,432]],"region":{"top_left_x":369,"top_left_y":380,"width":1483,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"549d0e9784b24423ad1b3f9c8c9d69a0","type":"text","conversion_output":true,"text":"Committee (IRB/IEC) approval of Protocol Amendment 4, further data will be assessed.","text_display":" Committee (IRB/IEC) approval of Protocol Amendment 4, further data will be assessed.","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[365,464],[707,464],[707,524],[365,524]],"region":{"top_left_x":365,"top_left_y":464,"width":342,"height":61},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be68052365064ac8a3ddd7b5d6fb3b58","type":"section_header","conversion_output":false,"children_ids":["74c71fae3edb4f1e835881afb8f4e76c"],"text":"","text_display":""},{"cnt":[[370,468],[703,468],[703,518],[370,518]],"region":{"top_left_x":369,"top_left_y":468,"width":334,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74c71fae3edb4f1e835881afb8f4e76c","type":"text","conversion_output":true,"parent_id":"be68052365064ac8a3ddd7b5d6fb3b58","text":"Open-label Phase","text_display":"\n\n\\section*{Open-label Phase}","confidence":1,"confidence_rate":1},{"cnt":[[370,554],[1871,554],[1871,608],[370,608]],"region":{"top_left_x":369,"top_left_y":554,"width":1503,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e002b0707ce148e2b80a87d9be749c2a","type":"text","conversion_output":true,"text":"Due to the statistically significant differences in the primary endpoint and fracture-related","text_display":"\n\nDue to the statistically significant differences in the primary endpoint and fracture-related","confidence":1,"confidence_rate":1},{"cnt":[[370,619],[1841,619],[1841,672],[370,672]],"region":{"top_left_x":369,"top_left_y":618,"width":1473,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e457d3e4bd3453cbbcf201a64ded0cc","type":"text","conversion_output":true,"text":"secondary endpoints between the denosumab arm and the placebo arm demonstrated","text_display":" secondary endpoints between the denosumab arm and the placebo arm demonstrated","confidence":1,"confidence_rate":1},{"cnt":[[370,683],[1708,683],[1708,741],[370,741]],"region":{"top_left_x":369,"top_left_y":683,"width":1340,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c88cf3b6ca3a4422b339890257d8f9c6","type":"text","conversion_output":true,"text":"at the primary analysis (Gnant et al.; 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period, an informed discussion will take place between the investigator and the subject","confidence":1,"confidence_rate":1},{"cnt":[[370,621],[1792,621],[1792,672],[370,672]],"region":{"top_left_x":369,"top_left_y":620,"width":1423,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e5cd87b38024854ba9527f12968ec99","type":"text","conversion_output":true,"text":"regarding alternative therapies and appropriate treatment. If the selected treatment","text_display":" regarding alternative therapies and appropriate treatment. 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This number will be used to identify","confidence":1,"confidence_rate":1},{"cnt":[[370,1210],[1828,1210],[1828,1261],[370,1261]],"region":{"top_left_x":369,"top_left_y":1209,"width":1460,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a53cb400467745fbbb816ac8e9bc630e","type":"text","conversion_output":true,"text":"the subject throughout the clinical study and must be used on all study documentation","text_display":" the subject throughout the clinical study and must be used on all study documentation","confidence":1,"confidence_rate":1},{"cnt":[[370,1276],[1717,1276],[1717,1330],[370,1330]],"region":{"top_left_x":369,"top_left_y":1276,"width":1348,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b0073913b964cd19b85d1768bc83071","type":"text","conversion_output":true,"text":"related to that subject. The subject identification number must remain constant","text_display":" related to that subject. The subject identification number must remain constant","confidence":1,"confidence_rate":1},{"cnt":[[370,1345],[1820,1345],[1820,1396],[370,1396]],"region":{"top_left_x":369,"top_left_y":1344,"width":1451,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb434143ee0e4a63aa222e1ee78f3376","type":"text","conversion_output":true,"text":"throughout the entire clinical study; it must not be changed at the time of rescreening,","text_display":" throughout the entire clinical study; it must not be changed at the time of rescreening,","confidence":1,"confidence_rate":1},{"cnt":[[370,1409],[1772,1409],[1772,1459],[370,1459]],"region":{"top_left_x":369,"top_left_y":1409,"width":1404,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0344464bda9f457eb37431c1413460b7","type":"text","conversion_output":true,"text":"enrollment, or randomization. This number will not necessarily be the same as the","text_display":" enrollment, or randomization. This number will not necessarily be the same as the","confidence":1,"confidence_rate":1},{"cnt":[[370,1474],[1154,1474],[1154,1528],[370,1528]],"region":{"top_left_x":369,"top_left_y":1473,"width":785,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53ac003382a24434b77f6465ca7b8e23","type":"text","conversion_output":true,"text":"randomization number assigned for the study.","text_display":" randomization number assigned for the study.","confidence":1,"confidence_rate":1},{"cnt":[[370,1560],[1880,1560],[1880,1613],[370,1613]],"region":{"top_left_x":369,"top_left_y":1559,"width":1511,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b99053ed50284d18b826e9c35fa02235","type":"text","conversion_output":true,"text":"The subject identification number will consist of 9 digits. The first 3 digits will represent a","text_display":"\n\nThe subject identification number will consist of 9 digits. The first 3 digits will represent a","confidence":0.9327766275964677,"confidence_rate":0.999343710547679},{"cnt":[[370,1626],[1734,1626],[1734,1678],[370,1678]],"region":{"top_left_x":369,"top_left_y":1626,"width":1365,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc54ab5455af403a9dee8e70df55b8f8","type":"text","conversion_output":true,"text":"protocol identifier (ie, 018 ) and will be identical for all sites. The next 3 digits will","text_display":" protocol identifier (ie, 018 ) and will be identical for all sites. The next 3 digits will","confidence":0.9000937241362408,"confidence_rate":0.9989584004343773},{"cnt":[[370,1693],[1824,1693],[1824,1747],[370,1747]],"region":{"top_left_x":369,"top_left_y":1692,"width":1456,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e910663f02d74065abf00778e4e40d8b","type":"text","conversion_output":true,"text":"represent the site number (eg, 001, 002, 003) and will be identical for all subjects at a","text_display":" represent the site number (eg, 001, 002, 003) and will be identical for all subjects at a","confidence":0.941462516784668,"confidence_rate":0.9993584958102764},{"cnt":[[370,1757],[1755,1757],[1755,1811],[370,1811]],"region":{"top_left_x":369,"top_left_y":1757,"width":1387,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c123a51187794b32b8c88d8a30dda0be","type":"text","conversion_output":true,"text":"particular site. The last 3 digits will represent the subject identification and will be","text_display":" particular site. The last 3 digits will represent the subject identification and will be","confidence":1,"confidence_rate":1},{"cnt":[[370,1824],[1794,1824],[1794,1878],[370,1878]],"region":{"top_left_x":369,"top_left_y":1824,"width":1425,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e46418524519404ebc33d0128b8ef7ac","type":"text","conversion_output":true,"text":"assigned in sequential order, per site, as subjects are screened (eg, 001, 002, 003).","text_display":" assigned in sequential order, per site, as subjects are screened (eg, 001, 002, 003).","confidence":1,"confidence_rate":1},{"cnt":[[370,1891],[1732,1891],[1732,1944],[370,1944]],"region":{"top_left_x":369,"top_left_y":1890,"width":1363,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7a010a215fe452d808242d7b7f914a8","type":"text","conversion_output":true,"text":"Therefore, the first subject to enter screening at site 001 will receive the number","text_display":" Therefore, the first subject to enter screening at site 001 will receive the number","confidence":1,"confidence_rate":1},{"cnt":[[365,1955],[576,1955],[576,2013],[365,2013]],"region":{"top_left_x":365,"top_left_y":1955,"width":211,"height":59},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cafe81052d74aaabd1fe2e7e6f9bd09","type":"form_field","conversion_output":true,"text":"","text_display":"\n□","subtype":"box"},{"cnt":[[569,1955],[1497,1955],[1497,2009],[569,2009]],"region":{"top_left_x":569,"top_left_y":1955,"width":929,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e232d9a601f4041a956c7ca1e23a46b","type":"text","conversion_output":true,"text":"; the second subject at this site will receive the number","text_display":" ; the second subject at this site will receive the number","confidence":1,"confidence_rate":1},{"cnt":[[1495,1955],[1695,1955],[1695,2009],[1495,2009]],"region":{"top_left_x":1495,"top_left_y":1955,"width":201,"height":54},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2601306accc6482f9abad7224a21ba04","type":"form_field","conversion_output":true,"text":"","text_display":" □","subtype":"box"},{"cnt":[[1693,1955],[1876,1955],[1876,2007],[1693,2007]],"region":{"top_left_x":1692,"top_left_y":1955,"width":184,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10ebf9156efc4cfbaa2e97ad59b5f415","type":"text","conversion_output":true,"text":", etc. This","text_display":" , etc. This","confidence":0.99951171875,"confidence_rate":0.9999694754347522},{"cnt":[[370,2020],[1760,2020],[1760,2073],[370,2073]],"region":{"top_left_x":369,"top_left_y":2019,"width":1391,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdade6550c204b8ea66294fa55092b51","type":"text","conversion_output":true,"text":"number will not be the same as the randomization number assigned for the study.","text_display":" number will not be the same as the randomization number assigned for the study.","confidence":1,"confidence_rate":1},{"cnt":[[370,2108],[1871,2108],[1871,2161],[370,2161]],"region":{"top_left_x":369,"top_left_y":2107,"width":1503,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da1cb8d3c8fa4150802043ba694eeb23","type":"text","conversion_output":true,"text":"Refer to Section 7 and Appendix A for screening procedures and medical history details.","text_display":"\n\nRefer to Section 7 and Appendix A for screening procedures and medical history details.","confidence":0.99658203125,"confidence_rate":0.9999639604036571},{"cnt":[[370,2174],[1785,2174],[1785,2228],[370,2228]],"region":{"top_left_x":369,"top_left_y":2174,"width":1417,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a444aa8490cc49b09f8fe34e8964bf9e","type":"text","conversion_output":true,"text":"Subjects may be re-screened 1 time. If a subject fails to meet all entry criteria after","text_display":" Subjects may be re-screened 1 time. If a subject fails to meet all entry criteria after","confidence":1,"confidence_rate":1},{"cnt":[[370,2239],[1338,2239],[1338,2292],[370,2292]],"region":{"top_left_x":369,"top_left_y":2238,"width":970,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85a9c0d1d64b4e2798428091430be1d4","type":"text","conversion_output":true,"text":"2 attempts, the subject will not be enrolled into the study.","text_display":" 2 attempts, the subject will not be enrolled into the study.","confidence":1,"confidence_rate":1},{"cnt":[[365,2320],[1549,2320],[1549,2387],[365,2387]],"region":{"top_left_x":365,"top_left_y":2320,"width":1185,"height":67},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7458e06018174ceeb3505075226d552c","type":"section_header","conversion_output":false,"children_ids":["80e03f4847a8467998ec73d1acb18b58"],"text":"","text_display":""},{"cnt":[[370,2329],[1540,2329],[1540,2383],[370,2383]],"region":{"top_left_x":369,"top_left_y":2328,"width":1172,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80e03f4847a8467998ec73d1acb18b58","type":"text","conversion_output":true,"parent_id":"7458e06018174ceeb3505075226d552c","text":"5.2 Treatment Assignment (Blinded Treatment Phase)","text_display":"\n\n\\subsection*{5.2 Treatment Assignment (Blinded Treatment Phase)}","confidence":0.57568359375,"confidence_rate":0.9900102850071945},{"cnt":[[369,2443],[370,2389],[1796,2392],[1796,2445]],"region":{"top_left_x":369,"top_left_y":2389,"width":1428,"height":57},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5b9711a325241639fc0b867c65e6062","type":"text","conversion_output":true,"text":"A subject who gives written informed consent and who satisfies all the inclusion and","text_display":"\n\nA subject who gives written informed consent and who satisfies all the inclusion and","confidence":1,"confidence_rate":1},{"cnt":[[370,2458],[1760,2458],[1760,2512],[370,2512]],"region":{"top_left_x":369,"top_left_y":2457,"width":1391,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b442627291e041a59b84f9a2a9525959","type":"text","conversion_output":true,"text":"exclusion criteria may be randomized into the study. Questions regarding subject","text_display":" exclusion criteria may be randomized into the study. Questions regarding subject","confidence":1,"confidence_rate":1},{"cnt":[[370,2647],[640,2647],[640,2690],[370,2690]],"region":{"top_left_x":369,"top_left_y":2646,"width":272,"height":44},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae5807697ad04afc9a6cf169a6324f21","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1886,2612],[1886,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":259,"height":72},"line":45,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"149833b4c01a432cb7687bdd8cbe0e35","type":"page_info","conversion_output":false,"text":"AMGEN \\({ }^{\\circ}\\)","text_display":"","confidence":0.5017375946044922,"confidence_rate":0.9624093054864471}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-037","page":37,"lines":[{"cnt":[[370,64],[922,64],[922,105],[370,105]],"region":{"top_left_x":369,"top_left_y":64,"width":553,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fb76ac976cf4b209d51721ad0cf20bf","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,103],[1033,103],[1033,144],[370,144]],"region":{"top_left_x":369,"top_left_y":103,"width":665,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50e0edd4a9914378a90c5c02c78bacd5","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"230dce54601041dba0fc355c7c1899c3","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9674137807451189,"confidence_rate":0.9986757186930738},{"cnt":[[1629,142],[1882,142],[1882,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":255,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7384a30c94e4aa58503d5ab05e3c209","type":"page_info","conversion_output":false,"text":"Page 37 of 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assessments and meeting all eligibility criteria.","confidence":1,"confidence_rate":1},{"cnt":[[370,533],[1489,533],[1489,587],[370,587]],"region":{"top_left_x":369,"top_left_y":532,"width":1120,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"003c0b5315e74fda9d257e092e030608","type":"text","conversion_output":true,"text":"Administration of IP must occur within 8 days after randomization.","text_display":" Administration of IP must occur within 8 days after randomization.","confidence":1,"confidence_rate":1},{"cnt":[[370,619],[1865,619],[1865,672],[370,672]],"region":{"top_left_x":369,"top_left_y":618,"width":1496,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e311f3c1ff846e880e515083169f63c","type":"text","conversion_output":true,"text":"Once a subject is ready for her initial or on-study scheduled dose, the site personnel will","text_display":"\n\nOnce a subject is ready for her initial or on-study scheduled dose, the site personnel will","confidence":1,"confidence_rate":1},{"cnt":[[370,687],[1764,687],[1764,737],[370,737]],"region":{"top_left_x":369,"top_left_y":687,"width":1395,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c97ee19b91a4cae9e855023250acc90","type":"text","conversion_output":true,"text":"call the IVRS vendor to obtain a box number assignment. 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Subjects will remain on study treatment until the required number of events is","text_display":" 6 months. Subjects will remain on study treatment until the required number of events is","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[370,1079],[1648,1079],[1648,1128],[370,1128]],"region":{"top_left_x":369,"top_left_y":1078,"width":1279,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f75700919f2e488f8c4e36a7149bfe00","type":"text","conversion_output":true,"text":"reached and until they have had the opportunity to receive a minimum of at","text_display":" reached and until they have had the opportunity to receive a minimum of at","confidence":1,"confidence_rate":1},{"cnt":[[370,1143],[1669,1143],[1669,1192],[370,1192]],"region":{"top_left_x":369,"top_left_y":1142,"width":1301,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88c971650e434ca9acb7917a6d6b829e","type":"text","conversion_output":true,"text":"least 2 doses of IP, whichever occurs later. Denosumab and placebo will be","text_display":" least 2 doses of IP, whichever occurs later. Denosumab and placebo will be","confidence":1,"confidence_rate":1},{"cnt":[[370,1210],[904,1210],[904,1259],[370,1259]],"region":{"top_left_x":369,"top_left_y":1209,"width":536,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0da1b2c00e747ab9f05b9de933bca05","type":"text","conversion_output":true,"text":"administered as a SC injection.","text_display":" administered as a SC injection.","confidence":1,"confidence_rate":1},{"cnt":[[370,1296],[1824,1296],[1824,1347],[370,1347]],"region":{"top_left_x":369,"top_left_y":1295,"width":1456,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80d6eef7bacf4968bb0278e99a9d6872","type":"text","conversion_output":true,"text":"All doses should be administered by a licensed health care professional after all other","text_display":"\n\nAll doses should be administered by a licensed health care professional after all other","confidence":1,"confidence_rate":1},{"cnt":[[370,1362],[1824,1362],[1824,1412],[370,1412]],"region":{"top_left_x":369,"top_left_y":1362,"width":1456,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39c0d7962954426d950bc4cce137660d","type":"text","conversion_output":true,"text":"study visit procedures have been completed. The first dose of investigational product","text_display":" study visit procedures have been completed. The first dose of investigational product","confidence":1,"confidence_rate":1},{"cnt":[[370,1427],[1321,1427],[1321,1476],[370,1476]],"region":{"top_left_x":369,"top_left_y":1426,"width":953,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5854e55739442eeae57c44eebeff349","type":"text","conversion_output":true,"text":"must be administered within 8 days after randomization.","text_display":" must be administered within 8 days after randomization.","confidence":1,"confidence_rate":1},{"cnt":[[370,1515],[1717,1515],[1717,1566],[370,1566]],"region":{"top_left_x":369,"top_left_y":1514,"width":1348,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de56e0a3af9d48c78eed1e1ecbc87869","type":"text","conversion_output":true,"text":"There have been no reports of overdose with this product. It is possible that an","text_display":"\n\nThere have been no reports of overdose with this product. It is possible that an","confidence":1,"confidence_rate":1},{"cnt":[[370,1581],[1854,1581],[1854,1631],[370,1631]],"region":{"top_left_x":369,"top_left_y":1581,"width":1486,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8031aaf941864c98b8320c0073b960d1","type":"text","conversion_output":true,"text":"overdose may result in hypocalcemia. Hypocalcemia, if severe, should be managed by","text_display":" overdose may result in hypocalcemia. 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If more than 45 days have elapsed since the","text_display":" 45 days after their scheduled dose). If more than 45 days have elapsed since the","confidence":0.97705078125,"confidence_rate":0.999733177539358},{"cnt":[[370,2148],[1835,2148],[1835,2194],[370,2194]],"region":{"top_left_x":369,"top_left_y":2148,"width":1466,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81504bc951d040d181140e7a7b1ed667","type":"text","conversion_output":true,"text":"scheduled IP dose, the IP dose will be considered a missed dose. The next dose is to","text_display":" scheduled IP dose, the IP dose will be considered a missed dose. The next dose is to","confidence":1,"confidence_rate":1},{"cnt":[[370,2213],[1480,2213],[1480,2267],[370,2267]],"region":{"top_left_x":369,"top_left_y":2212,"width":1112,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ecb17a3420a4aa4b1fed238b11feb51","type":"text","conversion_output":true,"text":"be given on the next scheduled visit date (based on study day 1).","text_display":" be given on the next scheduled visit date (based on study day 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Re-exposure to investigational product may occur only when","text_display":" to investigational product. 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Examination}","confidence":0.998046875,"confidence_rate":0.9999325872780016},{"cnt":[[370,1121],[1830,1121],[1830,1171],[370,1171]],"region":{"top_left_x":369,"top_left_y":1121,"width":1462,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dcc7d93177f44c0a63b979afec95463","type":"text","conversion_output":true,"text":"Each physical examination visit will include assessment of ECOG performance status,","text_display":"\n\nEach physical examination visit will include assessment of ECOG performance status,","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[370,1186],[1811,1186],[1811,1235],[370,1235]],"region":{"top_left_x":369,"top_left_y":1185,"width":1443,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61eff4d0ba04407c902d4cc7eeb840c0","type":"text","conversion_output":true,"text":"height (during screening only), weight, and vital signs (temperature, pulse, and blood","text_display":" height (during screening only), weight, and vital signs (temperature, pulse, and blood","confidence":1,"confidence_rate":1},{"cnt":[[370,1250],[1835,1250],[1835,1302],[370,1302]],"region":{"top_left_x":369,"top_left_y":1250,"width":1466,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb85629ae50d4980aa97657ad4d62b87","type":"text","conversion_output":true,"text":"pressure). Refer to Appendix E for ECOG performance status criteria. Results from a","text_display":" pressure). Refer to Appendix E for ECOG performance status criteria. Results from a","confidence":1,"confidence_rate":1},{"cnt":[[370,1319],[1803,1319],[1803,1369],[370,1369]],"region":{"top_left_x":369,"top_left_y":1319,"width":1434,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b85b8b8c077a4f368aa155e842dd3c94","type":"text","conversion_output":true,"text":"physical examination performed as standard of care within the 30-day period prior to","text_display":" physical examination performed as standard of care within the 30-day period prior to","confidence":0.9951221942901611,"confidence_rate":0.9999450605987517},{"cnt":[[370,1384],[1414,1384],[1414,1435],[370,1435]],"region":{"top_left_x":369,"top_left_y":1383,"width":1045,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ef6512eae1c41a8952a68b35977a019","type":"text","conversion_output":true,"text":"signing the ICF may be used as screening data for this study.","text_display":" signing the ICF may be used as screening data for this study.","confidence":1,"confidence_rate":1},{"cnt":[[365,1465],[1171,1465],[1171,1519],[365,1519]],"region":{"top_left_x":365,"top_left_y":1465,"width":806,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6371216aadfb46d9b9e731ab3e46e4af","type":"section_header","conversion_output":false,"children_ids":["bcbb79a28baf487bba54db55f0a339c7"],"text":"","text_display":""},{"cnt":[[370,1470],[1167,1470],[1167,1515],[370,1515]],"region":{"top_left_x":369,"top_left_y":1469,"width":798,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcbb79a28baf487bba54db55f0a339c7","type":"text","conversion_output":true,"parent_id":"6371216aadfb46d9b9e731ab3e46e4af","text":"7.7 Clinical Fracture Assessment","text_display":"\n\n\\subsection*{7.7 Clinical Fracture Assessment}","confidence":1,"confidence_rate":1},{"cnt":[[370,1536],[1852,1536],[1852,1588],[370,1588]],"region":{"top_left_x":369,"top_left_y":1536,"width":1483,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a4f878a1fac4be28c506f4157a7d3f6","type":"text","conversion_output":true,"text":"At each study visit the investigator will assess if the subject has any relevant symptoms","text_display":"\n\nAt each study visit the investigator will assess if the subject has any relevant symptoms","confidence":1,"confidence_rate":1},{"cnt":[[370,1603],[1777,1603],[1777,1652],[370,1652]],"region":{"top_left_x":369,"top_left_y":1602,"width":1408,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94b8ac1564404c4bbe5225a0a3afb859","type":"text","conversion_output":true,"text":"of clinical fractures. If new symptoms are reported, the investigator will use clinical","text_display":" of clinical fractures. If new symptoms are reported, the investigator will use clinical","confidence":1,"confidence_rate":1},{"cnt":[[367,1667],[1813,1667],[1813,1717],[367,1717]],"region":{"top_left_x":367,"top_left_y":1667,"width":1447,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ec9ba4e4d8340e0be4806c1c2728294","type":"text","conversion_output":true,"text":"judgment to determine if these symptoms warrant further investigation and whether a","text_display":" judgment to determine if these symptoms warrant further investigation and whether a","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[370,1732],[1807,1732],[1807,1781],[370,1781]],"region":{"top_left_x":369,"top_left_y":1731,"width":1438,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddf42b8c6a7d493298fab1db0dd74aa4","type":"text","conversion_output":true,"text":"diagnostic x-ray should be performed. All clinical fractures, except those of the skull,","text_display":" diagnostic x-ray should be performed. All clinical fractures, except those of the skull,","confidence":1,"confidence_rate":1},{"cnt":[[370,1800],[1777,1800],[1777,1850],[370,1850]],"region":{"top_left_x":369,"top_left_y":1800,"width":1408,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57d699af54114d10809e3794b8bb3500","type":"text","conversion_output":true,"text":"face, fingers, and toes, which are typically not associated with osteoporosis, will be","text_display":" face, fingers, and toes, which are typically not associated with osteoporosis, will be","confidence":1,"confidence_rate":1},{"cnt":[[370,1865],[1111,1865],[1111,1914],[370,1914]],"region":{"top_left_x":369,"top_left_y":1864,"width":742,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d51d0be2935a41b882b9dc91b89f39dd","type":"text","conversion_output":true,"text":"included in the analysis of clinical fractures.","text_display":" included in the analysis of clinical fractures.","confidence":1,"confidence_rate":1},{"cnt":[[370,1951],[1867,1951],[1867,2002],[370,2002]],"region":{"top_left_x":369,"top_left_y":1950,"width":1498,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd6a711ce5d04b898ce810b39bcfdbfe","type":"text","conversion_output":true,"text":"A qualified member of the study site will contact the subject via telephone approximately","text_display":"\n\nA qualified member of the study site will contact the subject via telephone approximately","confidence":1,"confidence_rate":1},{"cnt":[[370,2020],[1841,2020],[1841,2069],[370,2069]],"region":{"top_left_x":369,"top_left_y":2019,"width":1473,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89e1d28269fd46e8b5109bcbf194dda7","type":"text","conversion_output":true,"text":"every 12 weeks after the study visit to check if there have been any clinical fractures in","text_display":" every 12 weeks after the study visit to check if there have been any clinical fractures in","confidence":1,"confidence_rate":1},{"cnt":[[370,2084],[1854,2084],[1854,2133],[370,2133]],"region":{"top_left_x":369,"top_left_y":2083,"width":1486,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89f89a30ffce45a18eda917215c699e5","type":"text","conversion_output":true,"text":"order to aid event tracking. These telephone contacts will begin at a timepoint closer to","text_display":" order to aid event tracking. These telephone contacts will begin at a timepoint closer to","confidence":1,"confidence_rate":1},{"cnt":[[370,2148],[1876,2148],[1876,2202],[370,2202]],"region":{"top_left_x":369,"top_left_y":2148,"width":1507,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b2e0f7524014a39b8acc09a28832527","type":"text","conversion_output":true,"text":"the required number of events that define the end of the study. In case a clinical fracture","text_display":" the required number of events that define the end of the study. In case a clinical fracture","confidence":1,"confidence_rate":1},{"cnt":[[370,2217],[1364,2217],[1364,2267],[370,2267]],"region":{"top_left_x":369,"top_left_y":2217,"width":996,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74d4f466237f40f881e0395f199ca6e6","type":"text","conversion_output":true,"text":"is reported, the patient should attend an unscheduled visit.","text_display":" is reported, the patient should attend an unscheduled visit.","confidence":1,"confidence_rate":1},{"cnt":[[370,2303],[1878,2303],[1878,2353],[370,2353]],"region":{"top_left_x":369,"top_left_y":2303,"width":1509,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d107e007db3e4aa3b054123215b19855","type":"text","conversion_output":true,"text":"The CRF will capture subject reports of pain and/or other symptoms indicative of fracture","text_display":"\n\nThe CRF will capture subject reports of pain and/or other symptoms indicative of fracture","confidence":1,"confidence_rate":1},{"cnt":[[370,2368],[1858,2368],[1858,2417],[370,2417]],"region":{"top_left_x":369,"top_left_y":2367,"width":1490,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"827971c9504f43e5b345bc85f967fd7e","type":"text","conversion_output":true,"text":"or deterioration of mobility. The investigator will be asked to confirm if in his/her opinion","text_display":" or deterioration of mobility. The investigator will be asked to confirm if in his/her opinion","confidence":1,"confidence_rate":1},{"cnt":[[370,2436],[1130,2436],[1130,2486],[370,2486]],"region":{"top_left_x":369,"top_left_y":2436,"width":762,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aed224267daf4445b8d722abaa19f315","type":"text","conversion_output":true,"text":"the symptom locality is linked to the fracture.","text_display":" the symptom locality is linked to the fracture.","confidence":1,"confidence_rate":1},{"cnt":[[370,2649],[638,2649],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2649,"width":270,"height":39},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c23de2df6544396a3ff0520960232d3","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1884,2612],[1884,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":257,"height":72},"line":42,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"a8624bc4feb54c5a807b033f0048b747","type":"page_info","conversion_output":false,"text":"AMGEN \\({ }^{\\circ}\\)","text_display":"","confidence":0.7305443559307605,"confidence_rate":0.9827087217945301}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-043","page":43,"lines":[{"cnt":[[370,64],[922,64],[922,105],[370,105]],"region":{"top_left_x":369,"top_left_y":64,"width":553,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de1f08ec7afd4b229ebded80b3d83375","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,103],[1033,103],[1033,144],[370,144]],"region":{"top_left_x":369,"top_left_y":103,"width":665,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c42bb13dff44c00b83e2bb820ce440a","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"471fe7d0494e4a5191b376a6d09bdec3","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9659682237543166,"confidence_rate":0.9986159850343261},{"cnt":[[1629,142],[1884,142],[1884,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":257,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e409cd6d47604cee9559b5ac8a3d3921","type":"page_info","conversion_output":false,"text":"Page 43 of 104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,247],[1869,247],[1869,299],[370,299]],"region":{"top_left_x":369,"top_left_y":247,"width":1501,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e19275a586894a18b890f33e5c986e95","type":"text","conversion_output":true,"text":"The Blinded Review Committee will review radiographs and reports of those subjects for","text_display":"\n\nThe Blinded Review Committee will review radiographs and reports of those subjects for","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[370,314],[1863,314],[1863,367],[370,367]],"region":{"top_left_x":369,"top_left_y":313,"width":1494,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3075607476f24271ba3f2959e0c4a7f6","type":"text","conversion_output":true,"text":"whom the local investigator cannot easily confirm a clinical fracture and for cases where","text_display":" whom the local investigator cannot easily confirm a clinical fracture and for cases where","confidence":1,"confidence_rate":1},{"cnt":[[370,378],[1841,378],[1841,432],[370,432]],"region":{"top_left_x":369,"top_left_y":378,"width":1473,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd4179f16324404dbecf95a3f6157f95","type":"text","conversion_output":true,"text":"the link between symptom locality and fracture is ambiguous. Details of the processes","text_display":" the link between symptom locality and fracture is ambiguous. Details of the processes","confidence":1,"confidence_rate":1},{"cnt":[[370,447],[1745,447],[1745,501],[370,501]],"region":{"top_left_x":369,"top_left_y":446,"width":1376,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8586115d3004b45a87bf6f65de67bd8","type":"text","conversion_output":true,"text":"followed by the Blinded Review Committee will be included in a separate charter.","text_display":" followed by the Blinded Review Committee will be included in a separate charter.","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[370,533],[1749,533],[1749,587],[370,587]],"region":{"top_left_x":369,"top_left_y":532,"width":1380,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"392989539f0f48bcb492d8c28ae77398","type":"text","conversion_output":true,"text":"If the subject reports symptoms between study visits that would suggest a clinical","text_display":"\n\nIf the subject reports symptoms between study visits that would suggest a clinical","confidence":1,"confidence_rate":1},{"cnt":[[367,597],[1644,597],[1644,651],[367,651]],"region":{"top_left_x":367,"top_left_y":597,"width":1277,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b29354c8aeb450abadb9a9cd22abd9a","type":"text","conversion_output":true,"text":"fracture then the same procedures as described above should be followed.","text_display":" fracture then the same procedures as described above should be followed.","confidence":1,"confidence_rate":1},{"cnt":[[367,687],[1850,687],[1850,741],[367,741]],"region":{"top_left_x":367,"top_left_y":687,"width":1483,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"037bdf2533b349f388e9bc5389a041ce","type":"text","conversion_output":true,"text":"A copy of any radiographs or radiologist reports must be included in the subject's study","text_display":"\n\nA copy of any radiographs or radiologist reports must be included in the subject's study","confidence":1,"confidence_rate":1},{"cnt":[[370,752],[1846,752],[1846,806],[370,806]],"region":{"top_left_x":369,"top_left_y":751,"width":1477,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"984c5df56e094f9ca7148442636c8af5","type":"text","conversion_output":true,"text":"records. For the purpose of the study, all clinical fractures must be confirmed by x-ray.","text_display":" records. For the purpose of the study, all clinical fractures must be confirmed by x-ray.","confidence":0.986328125,"confidence_rate":0.9998535618320075},{"cnt":[[363,829],[1706,829],[1706,896],[363,896]],"region":{"top_left_x":363,"top_left_y":829,"width":1343,"height":67},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cbc02f4ce6f4caa8e7854f39bbeec19","type":"section_header","conversion_output":false,"children_ids":["07c72959dc824aa5b27f1fea2c1ea340"],"text":"","text_display":""},{"cnt":[[370,838],[1699,838],[1699,892],[370,892]],"region":{"top_left_x":369,"top_left_y":837,"width":1331,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07c72959dc824aa5b27f1fea2c1ea340","type":"text","conversion_output":true,"parent_id":"1cbc02f4ce6f4caa8e7854f39bbeec19","text":"7.7.1 Assessment of Clinical Fractures During Open-label Phase","text_display":"\n\n\\subsection*{7.7.1 Assessment of Clinical Fractures During Open-label Phase}","confidence":1,"confidence_rate":1},{"cnt":[[370,902],[1760,902],[1760,956],[370,956]],"region":{"top_left_x":369,"top_left_y":902,"width":1391,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f1c21c66cb04d82a677bd2f5d4f5d8e","type":"text","conversion_output":true,"text":"Clinical fractures identified by the site will be recorded on the CRF for all subjects.","text_display":"\n\nClinical fractures identified by the site will be recorded on the CRF for all subjects.","confidence":0.9985356330871582,"confidence_rate":0.9999840714296225},{"cnt":[[365,984],[982,984],[982,1046],[365,1046]],"region":{"top_left_x":365,"top_left_y":983,"width":617,"height":64},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5da335f7463548168a0ec7706d5b7993","type":"section_header","conversion_output":false,"children_ids":["b520669a36824c2ba82be04cac666b3b"],"text":"","text_display":""},{"cnt":[[370,988],[978,988],[978,1042],[370,1042]],"region":{"top_left_x":369,"top_left_y":988,"width":609,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b520669a36824c2ba82be04cac666b3b","type":"text","conversion_output":true,"parent_id":"5da335f7463548168a0ec7706d5b7993","text":"7.8 Lateral Spine X-ray","text_display":"\n\n\\subsection*{7.8 Lateral Spine X-ray}","confidence":0.8316249847412109,"confidence_rate":0.9934368578595281},{"cnt":[[370,1053],[1811,1053],[1811,1106],[370,1106]],"region":{"top_left_x":369,"top_left_y":1052,"width":1443,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ae64403abe84dde958d8ee9b180a6e6","type":"text","conversion_output":true,"text":"X-rays of the lateral thoracic and lumbar spine will be acquired according to separate","text_display":"\n\nX-rays of the lateral thoracic and lumbar spine will be acquired according to separate","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[370,1119],[1755,1119],[1755,1173],[370,1173]],"region":{"top_left_x":369,"top_left_y":1119,"width":1387,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bd2f15910e74b99b8b90abc3cb6d451","type":"text","conversion_output":true,"text":"instructions per the schedule outlined in Appendix A. Sites will be pre-qualified to","text_display":" instructions per the schedule outlined in Appendix A. Sites will be pre-qualified to","confidence":1,"confidence_rate":1},{"cnt":[[370,1186],[1790,1186],[1790,1240],[370,1240]],"region":{"top_left_x":369,"top_left_y":1185,"width":1421,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4d253fed2054dcaa6d991bdb82ccfc2","type":"text","conversion_output":true,"text":"conduct these x-rays based on pre-defined criteria. Any site that does not meet the","text_display":" conduct these x-rays based on pre-defined criteria. 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Assessment of vertebral fractures will be performed by an","text_display":" on-study vertebral x-rays. Assessment of vertebral fractures will be performed by an","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[370,1384],[1824,1384],[1824,1437],[370,1437]],"region":{"top_left_x":369,"top_left_y":1383,"width":1456,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1914d7056154b82a2b7c500be1c7a3a","type":"text","conversion_output":true,"text":"expert radiologist at the central imaging center using a semiquantitative grading scale","text_display":" expert radiologist at the central imaging center using a semiquantitative grading scale","confidence":1,"confidence_rate":1},{"cnt":[[370,1448],[1751,1448],[1751,1502],[370,1502]],"region":{"top_left_x":369,"top_left_y":1448,"width":1382,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc84d5af3b344b6ca7c138b32cc673f6","type":"text","conversion_output":true,"text":"(Genant et al, 1993): Grade \\(1,20 \\%\\) to \\(25 \\%\\) reduction in vertebral height (anterior,","text_display":" (Genant et al, 1993): Grade \\(1,20 \\%\\) to \\(25 \\%\\) reduction in vertebral height (anterior,","confidence":0.7209061821358808,"confidence_rate":0.9964492940222214},{"cnt":[[370,1517],[1815,1517],[1815,1571],[370,1571]],"region":{"top_left_x":369,"top_left_y":1516,"width":1447,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"520431a84312425dbe8c87abf311f492","type":"text","conversion_output":true,"text":"middle, or posterior); Grade \\(2,25 \\%\\) to \\(40 \\%\\) reduction in height; Grade 3 , greater than","text_display":" middle, or posterior); Grade \\(2,25 \\%\\) to \\(40 \\%\\) reduction in height; Grade 3 , greater than","confidence":0.8870972295849242,"confidence_rate":0.9987906239413029},{"cnt":[[370,1581],[788,1581],[788,1635],[370,1635]],"region":{"top_left_x":369,"top_left_y":1581,"width":420,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc88fa5eb7ca4baf986f867fcfdb80e5","type":"text","conversion_output":true,"text":"\\(40 \\%\\) reduction in height.","text_display":" \\(40 \\%\\) reduction in height.","confidence":0.5866274833679199,"confidence_rate":0.9811315213991381},{"cnt":[[370,1669],[1674,1669],[1674,1717],[370,1717]],"region":{"top_left_x":369,"top_left_y":1669,"width":1305,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acb06c7a91374431bfd0766536ea929d","type":"text","conversion_output":true,"text":"Prevalent vertebral fractures will be assessed and recorded at baseline. For","text_display":"\n\nPrevalent vertebral fractures will be assessed and recorded at baseline. For","confidence":1,"confidence_rate":1},{"cnt":[[370,1736],[1824,1736],[1824,1785],[370,1785]],"region":{"top_left_x":369,"top_left_y":1735,"width":1456,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d973c2ed5e5415b9861af6491086322","type":"text","conversion_output":true,"text":"assessment of incident vertebral fracture, x -rays will be reviewed blinded to treatment","text_display":" assessment of incident vertebral fracture, x -rays will be reviewed blinded to treatment","confidence":0.909700870513916,"confidence_rate":0.9990445027660438},{"cnt":[[370,1800],[1781,1800],[1781,1852],[370,1852]],"region":{"top_left_x":369,"top_left_y":1800,"width":1413,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf303c2a48b341319bf05578cd9c28e5","type":"text","conversion_output":true,"text":"but not to sequence. The semiquantitative scale will be used. For the study a new","text_display":" but not to sequence. The semiquantitative scale will be used. For the study a new","confidence":0.9990236759185791,"confidence_rate":0.9999886419133848},{"cnt":[[370,1867],[1717,1867],[1717,1919],[370,1919]],"region":{"top_left_x":369,"top_left_y":1866,"width":1348,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e6803a3941d43f087c8883d960c65c2","type":"text","conversion_output":true,"text":"vertebral fracture is defined as a fracture in a previously undeformed vertebrae.","text_display":" vertebral fracture is defined as a fracture in a previously undeformed vertebrae.","confidence":1,"confidence_rate":1},{"cnt":[[370,1931],[1661,1931],[1661,1983],[370,1983]],"region":{"top_left_x":369,"top_left_y":1931,"width":1292,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0733c3190f95441883ed2cdb269f5caf","type":"text","conversion_output":true,"text":"Vertebral fractures will include new compression fractures, defined as those","text_display":" Vertebral fractures will include new compression fractures, defined as those","confidence":1,"confidence_rate":1},{"cnt":[[370,1998],[1841,1998],[1841,2052],[370,2052]],"region":{"top_left_x":369,"top_left_y":1998,"width":1473,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"771b7c7683ed43fb808d74fa2c5592a3","type":"text","conversion_output":true,"text":"compression fractures having a decrease in total anterior or posterior height of at least","text_display":" compression fractures having a decrease in total anterior or posterior height of at least","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[370,2062],[1738,2062],[1738,2112],[370,2112]],"region":{"top_left_x":369,"top_left_y":2062,"width":1370,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e76d5c412f424e988489a8b0d434dc71","type":"text","conversion_output":true,"text":"\\(25 \\%\\) from baseline. New vertebral fractures will be classified as either clinical or","text_display":" \\(25 \\%\\) from baseline. New vertebral fractures will be classified as either clinical or","confidence":1,"confidence_rate":1},{"cnt":[[370,2131],[1811,2131],[1811,2185],[370,2185]],"region":{"top_left_x":369,"top_left_y":2131,"width":1443,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cca3d37dd1864290b13f64729405d391","type":"text","conversion_output":true,"text":"morphometric depending on whether or not in the investigator's opinion the symptom","text_display":" morphometric depending on whether or not in the investigator's opinion the symptom","confidence":1,"confidence_rate":1},{"cnt":[[370,2196],[1803,2196],[1803,2247],[370,2247]],"region":{"top_left_x":369,"top_left_y":2195,"width":1434,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83e70b6edc77439781413fdc35a4acd7","type":"text","conversion_output":true,"text":"locality can be linked to the fracture. Worsening of pre-existing fractures will also be","text_display":" locality can be linked to the fracture. Worsening of pre-existing fractures will also be","confidence":1,"confidence_rate":1},{"cnt":[[370,2262],[1830,2262],[1830,2314],[370,2314]],"region":{"top_left_x":369,"top_left_y":2262,"width":1462,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b28cfc34fb443e68fca5f0f09a2906a","type":"text","conversion_output":true,"text":"assessed. Worsening is defined as an increase in fracture severity of at least 1 grade","text_display":" assessed. Worsening is defined as an increase in fracture severity of at least 1 grade","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[370,2329],[883,2329],[883,2378],[370,2378]],"region":{"top_left_x":369,"top_left_y":2328,"width":515,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"934bc634731c4ffeb872eb2bbb9fabc6","type":"text","conversion_output":true,"text":"on the semiquantitative scale.","text_display":" on the semiquantitative scale.","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[370,2415],[1876,2415],[1876,2469],[370,2469]],"region":{"top_left_x":369,"top_left_y":2414,"width":1507,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e58d20cc6094102923d250798a1d3de","type":"text","conversion_output":true,"text":"If a subject has acute back pain at a time point other than when a scheduled spinal x-ray","text_display":"\n\nIf a subject has acute back pain at a time point other than when a scheduled spinal x-ray","confidence":0.94970703125,"confidence_rate":0.9994511960723906},{"cnt":[[370,2479],[1850,2479],[1850,2533],[370,2533]],"region":{"top_left_x":369,"top_left_y":2479,"width":1481,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76fc591b6b884b99906e325e4d05e7c7","type":"text","conversion_output":true,"text":"is obtained, and occurrence of a vertebral fracture is suspected, the investigator should","text_display":" is obtained, and occurrence of a vertebral fracture is suspected, the investigator should","confidence":0.9970703125,"confidence_rate":0.9999687878548241},{"cnt":[[370,2647],[638,2647],[638,2690],[370,2690]],"region":{"top_left_x":369,"top_left_y":2646,"width":270,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6c715bbd8724b4293414cad0c2a1350","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1886,2612],[1886,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":259,"height":72},"line":41,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"37bcc32ca9124ed0b2b785abd5afa576","type":"page_info","conversion_output":false,"text":"AMGEN \\({ }^{\\circ}\\)","text_display":"","confidence":0.5012664794921875,"confidence_rate":0.962359079284112}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-044","page":44,"lines":[{"cnt":[[370,64],[922,64],[922,105],[370,105]],"region":{"top_left_x":369,"top_left_y":64,"width":553,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0691f3f89c87448e89e53ac7aed6179e","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,103],[1033,103],[1033,144],[370,144]],"region":{"top_left_x":369,"top_left_y":103,"width":665,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04b2451d6574413baf3544a04718dc4a","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e81489d2338b4e2f9a83670019902cdb","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.966940022772178,"confidence_rate":0.998656151395401},{"cnt":[[1629,142],[1884,142],[1884,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":257,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d2f72d8b0cf4a9298e63cbeeb3a56ad","type":"page_info","conversion_output":false,"text":"Page 44 of 104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[1824,249],[1824,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":1456,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0dc9349911946018a53c7bb6b188d18","type":"text","conversion_output":true,"text":"obtain a lateral spinal x-ray to confirm the presence of clinical fracture as described in","text_display":"\nobtain a lateral spinal x-ray to confirm the presence of clinical fracture as described in","confidence":0.9931671619415283,"confidence_rate":0.9999278311434465},{"cnt":[[370,314],[1811,314],[1811,367],[370,367]],"region":{"top_left_x":369,"top_left_y":313,"width":1443,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d23759270f7e4e89be7c82473d1b0ca4","type":"text","conversion_output":true,"text":"Section 7.7. A copy of any radiographs or radiologist reports must be included in the","text_display":" Section 7.7. A copy of any radiographs or radiologist reports must be included in the","confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[370,380],[780,380],[780,432],[370,432]],"region":{"top_left_x":369,"top_left_y":380,"width":411,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"570269d210ae473f8624927f155254fd","type":"text","conversion_output":true,"text":"subject's study records.","text_display":" subject's study records.","confidence":0.99951171875,"confidence_rate":0.999983158745329},{"cnt":[[363,460],[1618,460],[1618,526],[363,526]],"region":{"top_left_x":363,"top_left_y":459,"width":1255,"height":68},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"046a64a4148b43c38098eb2f6b36542e","type":"section_header","conversion_output":false,"children_ids":["c12ffb0877be446ea10c3277e315db1a"],"text":"","text_display":""},{"cnt":[[370,468],[1611,468],[1611,522],[370,522]],"region":{"top_left_x":369,"top_left_y":468,"width":1243,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c12ffb0877be446ea10c3277e315db1a","type":"text","conversion_output":true,"parent_id":"046a64a4148b43c38098eb2f6b36542e","text":"7.9 Dual Energy X-ray Absorptiometry (DXA) Assessment","text_display":"\n\n\\subsection*{7.9 Dual Energy X-ray Absorptiometry (DXA) Assessment}","confidence":0.77978515625,"confidence_rate":0.9957206165967888},{"cnt":[[370,533],[1828,533],[1828,582],[370,582]],"region":{"top_left_x":369,"top_left_y":532,"width":1460,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fddb5bcd9709478a9c094898cfe495b2","type":"text","conversion_output":true,"text":"All subjects will be required to undergo bone densitometry assessments of the lumbar","text_display":"\n\nAll subjects will be required to undergo bone densitometry assessments of the lumbar","confidence":1,"confidence_rate":1},{"cnt":[[370,597],[1828,597],[1828,651],[370,651]],"region":{"top_left_x":369,"top_left_y":597,"width":1460,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4345b6a5f1034022addcbf9ad735e7be","type":"text","conversion_output":true,"text":"spine and proximal femur performed by DXA per the schedule outlined in Appendix A.","text_display":" spine and proximal femur performed by DXA per the schedule outlined in Appendix A.","confidence":1,"confidence_rate":1},{"cnt":[[370,683],[1837,683],[1837,737],[370,737]],"region":{"top_left_x":369,"top_left_y":683,"width":1468,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c638d9618634515b1d127ec00925153","type":"text","conversion_output":true,"text":"The same DXA machine must be used for all study procedures for a particular subject.","text_display":"\n\nThe same DXA machine must be used for all study procedures for a particular subject.","confidence":1,"confidence_rate":1},{"cnt":[[370,750],[1798,750],[1798,801],[370,801]],"region":{"top_left_x":369,"top_left_y":749,"width":1430,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ab03eb42cd742c8a3582d306e5093df","type":"text","conversion_output":true,"text":"The left side should be used for the proximal femur scans, unless prohibited, eg, hip","text_display":" The left side should be used for the proximal femur scans, unless prohibited, eg, hip","confidence":0.982421875,"confidence_rate":0.9998029699136467},{"cnt":[[370,816],[513,816],[513,870],[370,870]],"region":{"top_left_x":369,"top_left_y":816,"width":145,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbc04590b45f4d588f2144ce5c1f3ed4","type":"text","conversion_output":true,"text":"implant.","text_display":" implant.","confidence":1,"confidence_rate":1},{"cnt":[[370,902],[1751,902],[1751,956],[370,956]],"region":{"top_left_x":369,"top_left_y":902,"width":1382,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"707752175f154bb6ba83463d78b2cf87","type":"text","conversion_output":true,"text":"Lumbar spine scans must include L1 through L4. Vertebrae that are unevaluable","text_display":"\n\nLumbar spine scans must include L1 through L4. 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Table 1 outlines the specific analytes for each assessment.","text_display":" Appendix A. 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described","confidence":1,"confidence_rate":1},{"cnt":[[370,881],[1708,881],[1708,935],[370,935]],"region":{"top_left_x":369,"top_left_y":880,"width":1340,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afb4444a83454734954afa82b2c60bb0","type":"text","conversion_output":true,"text":"in Section 7.7. 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Data on fractures","text_display":" 6 months after PADCD will be considered an end of treatment visit. Data on fractures","confidence":1,"confidence_rate":1},{"cnt":[[370,2065],[1807,2065],[1807,2116],[370,2116]],"region":{"top_left_x":369,"top_left_y":2064,"width":1438,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54bc10e79c4c4fdaa74a4903e2588c4c","type":"text","conversion_output":true,"text":"occurring between the last visit prior to PADCD and PADCD have to be collected via","text_display":" occurring between the last visit prior to PADCD and PADCD have to be collected via","confidence":0.98291015625,"confidence_rate":0.9998018867474869},{"cnt":[[370,2131],[1588,2131],[1588,2185],[370,2185]],"region":{"top_left_x":369,"top_left_y":2131,"width":1219,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1ef638dc0a14431a7cb0b5382678813","type":"text","conversion_output":true,"text":"telephone or physical visits within six months after PADCD at the latest.","text_display":" telephone or physical visits within six months after PADCD at the latest.","confidence":0.9990234375,"confidence_rate":0.9999874739291208},{"cnt":[[370,2217],[1815,2217],[1815,2271],[370,2271]],"region":{"top_left_x":369,"top_left_y":2217,"width":1447,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"748e8fa98bb445f8b86cc21f962b9731","type":"text","conversion_output":true,"text":"Subjects who withdraw from IP prior to the PADCD will continue to attend Q6M study","text_display":"\n\nSubjects who withdraw from IP prior to the PADCD will continue to attend Q6M study","confidence":1,"confidence_rate":1},{"cnt":[[370,2282],[1777,2282],[1777,2335],[370,2335]],"region":{"top_left_x":369,"top_left_y":2281,"width":1408,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5553189eb68348b1ac08108312984ebf","type":"text","conversion_output":true,"text":"visits for assessment of the primary and secondary end-point and safety. 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Following regulatory and IRB/IEC approval of Protocol","text_display":" 66 months after the PADCD. Following regulatory and IRB/IEC approval of Protocol","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[370,1164],[1433,1164],[1433,1218],[370,1218]],"region":{"top_left_x":369,"top_left_y":1164,"width":1065,"height":55},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43cd73bef18d4d34a47b4598dd0dfbb6","type":"text","conversion_output":true,"text":"Amendment 4, further data will be assessed (see Section 3.1).","text_display":" Amendment 4, further data will be assessed (see Section 3.1).","confidence":0.99951171875,"confidence_rate":0.9999926000198329},{"cnt":[[370,1250],[1880,1250],[1880,1304],[370,1304]],"region":{"top_left_x":369,"top_left_y":1250,"width":1511,"height":55},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"697e84ce44b04b08b8f867570ab34ac9","type":"text","conversion_output":true,"text":"Subjects who do not receive open-label denosumab will be followed for DFS, BMFS, and","text_display":"\n\nSubjects who do not receive open-label denosumab will be followed for DFS, BMFS, and","confidence":1,"confidence_rate":1},{"cnt":[[370,1317],[1665,1317],[1665,1371],[370,1371]],"region":{"top_left_x":369,"top_left_y":1316,"width":1297,"height":55},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23909413dca44fddbb38c9cdd5214af3","type":"text","conversion_output":true,"text":"OS once a year (Q12M study visit) by clinic visits or telephone contacts until","text_display":" OS once a year (Q12M study visit) by clinic visits or telephone contacts until","confidence":1,"confidence_rate":1},{"cnt":[[370,1384],[1858,1384],[1858,1437],[370,1437]],"region":{"top_left_x":369,"top_left_y":1383,"width":1490,"height":55},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc3cb5d010b24007af3c1d2242075891","type":"text","conversion_output":true,"text":"approximately 66 months after PADCD. 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Additionally, further data will be assessed (see","confidence":1,"confidence_rate":1},{"cnt":[[370,1448],[595,1448],[595,1502],[370,1502]],"region":{"top_left_x":369,"top_left_y":1448,"width":227,"height":54},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96435feb524240f4ac50f4b263d6b273","type":"text","conversion_output":true,"text":"Section 3.1).","text_display":" Section 3.1).","confidence":1,"confidence_rate":1},{"cnt":[[370,1534],[1671,1534],[1671,1590],[370,1590]],"region":{"top_left_x":369,"top_left_y":1533,"width":1303,"height":57},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3856d1b38b2143ce911e86b3910805e8","type":"text","conversion_output":true,"text":"Subjects who receive open-label denosumab will have Q6M on-site visits for","text_display":"\n\nSubjects who receive open-label denosumab will have Q6M on-site visits for","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[370,1603],[1738,1603],[1738,1656],[370,1656]],"region":{"top_left_x":369,"top_left_y":1602,"width":1370,"height":55},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"016824ae5bfb41b496e64601e296f434","type":"text","conversion_output":true,"text":"administration of denosumab ( \\(60 mg SC Q6M\\) ) and (S)AE monitoring and will be","text_display":" administration of denosumab ( \\(60 mg SC Q6M\\) ) and (S)AE monitoring and will be","confidence":0.3893589524757358,"confidence_rate":0.9892165671500308},{"cnt":[[370,1667],[1852,1667],[1852,1721],[370,1721]],"region":{"top_left_x":369,"top_left_y":1667,"width":1483,"height":54},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3344f4834bf1451c916f2184545690ee","type":"text","conversion_output":true,"text":"followed Q12M only for DFS, BMFS, and OS until either approximately 66 months after","text_display":" followed Q12M only for DFS, BMFS, and OS until either approximately 66 months after","confidence":1,"confidence_rate":1},{"cnt":[[370,1732],[1880,1732],[1880,1790],[370,1790]],"region":{"top_left_x":369,"top_left_y":1731,"width":1511,"height":59},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ef4373248314344be8a19f354eacd77","type":"text","conversion_output":true,"text":"PADCD or completion of treatment, whichever is longer. 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At the end of study, the EOS CRF has to be","text_display":" withdrawal) and per protocol EOS. 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minimum of an overnight stay in a health care facility excluding","confidence":1,"confidence_rate":1},{"cnt":[[370,662],[1863,662],[1863,711],[370,711]],"region":{"top_left_x":369,"top_left_y":661,"width":1494,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"305b37768d5a4e1ebac9468a79fc719a","type":"text","conversion_output":true,"text":"hospitalizations for anticipated protocol-specified procedures. However, prolongation of","text_display":" hospitalizations for anticipated protocol-specified procedures. However, prolongation of","confidence":1,"confidence_rate":1},{"cnt":[[370,726],[1871,726],[1871,778],[370,778]],"region":{"top_left_x":369,"top_left_y":726,"width":1503,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f96f021223f46cfb3c63b1d268dda26","type":"text","conversion_output":true,"text":"hospitalization or re-admission after a subject has been discharged would be considered","text_display":" hospitalization or re-admission after a subject has been discharged would be considered","confidence":1,"confidence_rate":1},{"cnt":[[370,793],[496,793],[496,836],[370,836]],"region":{"top_left_x":369,"top_left_y":792,"width":128,"height":44},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3d88ef09ba24e85beea0c298c6cbf54","type":"text","conversion_output":true,"text":"a SAE.","text_display":" a SAE.","confidence":1,"confidence_rate":1},{"cnt":[[370,881],[1841,881],[1841,930],[370,930]],"region":{"top_left_x":369,"top_left_y":880,"width":1473,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccfa26cc9f454f24b00b6243bc6bb091","type":"text","conversion_output":true,"text":"Any adverse event that does not meet one of the definitions of serious (eg, emergency","text_display":"\n\nAny adverse event that does not meet one of the definitions of serious (eg, emergency","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[370,945],[1876,945],[1876,995],[370,995]],"region":{"top_left_x":369,"top_left_y":945,"width":1507,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d199090b14d4debb89785d76d1a146c","type":"text","conversion_output":true,"text":"room visit, outpatient surgery, or requires urgent investigation) may be considered by the","text_display":" room visit, outpatient surgery, or requires urgent investigation) may be considered by the","confidence":1,"confidence_rate":1},{"cnt":[[370,1010],[1863,1010],[1863,1059],[370,1059]],"region":{"top_left_x":369,"top_left_y":1009,"width":1494,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6210a5b3b12c4a35bbf76a8e4d46bb0b","type":"text","conversion_output":true,"text":"investigator to meet the \"other significant medical hazard\" criterion for classification as a","text_display":" investigator to meet the \"other significant medical hazard\" criterion for classification as a","confidence":1,"confidence_rate":1},{"cnt":[[370,1076],[1790,1076],[1790,1128],[370,1128]],"region":{"top_left_x":369,"top_left_y":1076,"width":1421,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b63919489e9413585279bd6c5de952d","type":"text","conversion_output":true,"text":"SAE. Examples include allergic bronchospasm, convulsions, and blood dyscrasias.","text_display":" SAE. Examples include allergic bronchospasm, convulsions, and blood dyscrasias.","confidence":1,"confidence_rate":1},{"cnt":[[365,1158],[1656,1158],[1656,1257],[365,1257]],"region":{"top_left_x":365,"top_left_y":1158,"width":1292,"height":99},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6d1c725237c4bf7a9a110b3655a8fbc","type":"section_header","conversion_output":false,"children_ids":["96762c233e9f44099d95068fb11f1a40","7721df80b8ae4c53b84ae4438dd0e2a7"],"text":"","text_display":""},{"cnt":[[370,1164],[1652,1164],[1652,1214],[370,1214]],"region":{"top_left_x":369,"top_left_y":1164,"width":1284,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96762c233e9f44099d95068fb11f1a40","type":"text","conversion_output":true,"parent_id":"e6d1c725237c4bf7a9a110b3655a8fbc","text":"9.2 Reporting Procedures for All Adverse Events During the","text_display":"\n\n\\subsection*{9.2 Reporting Procedures for All Adverse Events During the","confidence":0.9965834617614746,"confidence_rate":0.9999456778575185},{"cnt":[[619,1212],[986,1212],[986,1253],[619,1253]],"region":{"top_left_x":618,"top_left_y":1211,"width":369,"height":42},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7721df80b8ae4c53b84ae4438dd0e2a7","type":"text","conversion_output":true,"parent_id":"e6d1c725237c4bf7a9a110b3655a8fbc","text":"Double-blind Phase","text_display":" Double-blind Phase}","confidence":1,"confidence_rate":1},{"cnt":[[370,1274],[1740,1274],[1740,1321],[370,1321]],"region":{"top_left_x":369,"top_left_y":1274,"width":1372,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1029855546e34226bc9210288dbd1078","type":"text","conversion_output":true,"text":"The investigator is responsible for ensuring that all adverse events (as defined in","text_display":"\n\nThe investigator is responsible for ensuring that all adverse events (as defined in","confidence":1,"confidence_rate":1},{"cnt":[[370,1341],[1861,1341],[1861,1390],[370,1390]],"region":{"top_left_x":369,"top_left_y":1340,"width":1492,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1a404c46994419d84a63c7c764bbb30","type":"text","conversion_output":true,"text":"Section 9.1) observed by the investigator or reported by subjects after the signing of the","text_display":" Section 9.1) observed by the investigator or reported by subjects after the signing of the","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[370,1405],[1708,1405],[1708,1454],[370,1454]],"region":{"top_left_x":369,"top_left_y":1405,"width":1340,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"303fea9c106440978b82fe781abc0a65","type":"text","conversion_output":true,"text":"informed consent through 30 days after the last dose of investigational product","text_display":" informed consent through 30 days after the last dose of investigational product","confidence":1,"confidence_rate":1},{"cnt":[[370,1472],[1867,1472],[1867,1521],[370,1521]],"region":{"top_left_x":369,"top_left_y":1471,"width":1498,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b341a64c6af746f2985c6494e68604d4","type":"text","conversion_output":true,"text":"administration are reported using the applicable CRF. Adverse events that occur before","text_display":" administration are reported using the applicable CRF. Adverse events that occur before","confidence":1,"confidence_rate":1},{"cnt":[[370,1536],[1869,1536],[1869,1586],[370,1586]],"region":{"top_left_x":369,"top_left_y":1536,"width":1501,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50cb684738e7436e8a8c1f4f563b0196","type":"text","conversion_output":true,"text":"randomization and are deemed by the investigator to be unrelated to study screening do","text_display":" randomization and are deemed by the investigator to be unrelated to study screening do","confidence":1,"confidence_rate":1},{"cnt":[[370,1603],[986,1603],[986,1648],[370,1648]],"region":{"top_left_x":369,"top_left_y":1602,"width":618,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77647e2f315f49d9b9ac56353f17dfc4","type":"text","conversion_output":true,"text":"not have to be recorded in the CRF.","text_display":" not have to be recorded in the CRF.","confidence":1,"confidence_rate":1},{"cnt":[[370,1689],[1820,1689],[1820,1738],[370,1738]],"region":{"top_left_x":369,"top_left_y":1688,"width":1451,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75119a06fd7e4786bd0fe54c1166fd7f","type":"text","conversion_output":true,"text":"The following adverse event attributes must be assigned by the investigator: adverse","text_display":"\n\nThe following adverse event attributes must be assigned by the investigator: adverse","confidence":1,"confidence_rate":1},{"cnt":[[370,1755],[1760,1755],[1760,1807],[370,1807]],"region":{"top_left_x":369,"top_left_y":1755,"width":1391,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05ea1d7f706847f79ef6ef6dd8587f1c","type":"text","conversion_output":true,"text":"event diagnosis or syndrome(s) (if known, signs or symptoms if not known); event","text_display":" event diagnosis or syndrome(s) (if known, signs or symptoms if not known); event","confidence":1,"confidence_rate":1},{"cnt":[[370,1822],[1858,1822],[1858,1871],[370,1871]],"region":{"top_left_x":369,"top_left_y":1821,"width":1490,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec8d617b33a04c4a966e778c98601958","type":"text","conversion_output":true,"text":"description (with detail appropriate to the event); dates of onset and resolution; severity;","text_display":" description (with detail appropriate to the event); dates of onset and resolution; severity;","confidence":1,"confidence_rate":1},{"cnt":[[370,1886],[1876,1886],[1876,1936],[370,1936]],"region":{"top_left_x":369,"top_left_y":1886,"width":1507,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"923f30bfc1e5486d9d304358fdd2ec61","type":"text","conversion_output":true,"text":"assessment of relatedness to investigational product; and action taken. The investigator","text_display":" assessment of relatedness to investigational product; and action taken. The investigator","confidence":1,"confidence_rate":1},{"cnt":[[370,1955],[1858,1955],[1858,2004],[370,2004]],"region":{"top_left_x":369,"top_left_y":1955,"width":1490,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9373fa7259fe4c289d1e255b5131d752","type":"text","conversion_output":true,"text":"may be asked to provide follow-up information, discharge summaries, and extracts from","text_display":" may be asked to provide follow-up information, discharge summaries, and extracts from","confidence":1,"confidence_rate":1},{"cnt":[[370,2020],[810,2020],[810,2065],[370,2065]],"region":{"top_left_x":369,"top_left_y":2019,"width":441,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cce91e131cf4a33b074925c50791ceb","type":"text","conversion_output":true,"text":"medical records or CRFs.","text_display":" medical records or CRFs.","confidence":1,"confidence_rate":1},{"cnt":[[370,2105],[1835,2105],[1835,2157],[370,2157]],"region":{"top_left_x":369,"top_left_y":2105,"width":1466,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bb044107dfe4b149224a0c243d7cc5c","type":"text","conversion_output":true,"text":"If applicable, the relationship of the adverse event to the investigational product will be","text_display":"\n\nIf applicable, the relationship of the adverse event to the investigational product will be","confidence":1,"confidence_rate":1},{"cnt":[[370,2172],[1803,2172],[1803,2221],[370,2221]],"region":{"top_left_x":369,"top_left_y":2172,"width":1434,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ebb2fc7504a44cbb468dadc324b3d57","type":"text","conversion_output":true,"text":"assessed by means of the question: \"Is there a reasonable possibility that the event","text_display":" assessed by means of the question: \"Is there a reasonable possibility that the event","confidence":1,"confidence_rate":1},{"cnt":[[370,2239],[1880,2239],[1880,2288],[370,2288]],"region":{"top_left_x":369,"top_left_y":2238,"width":1511,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3b1bf1650be4b30ac5781820bab2d9a","type":"text","conversion_output":true,"text":"may have been caused by the investigational product?\" The investigator should respond","text_display":" may have been caused by the investigational product?\" The investigator should respond","confidence":1,"confidence_rate":1},{"cnt":[[370,2303],[1010,2303],[1010,2353],[370,2353]],"region":{"top_left_x":369,"top_left_y":2303,"width":641,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"440a81332e9c4f2b97b2692f11bf8019","type":"text","conversion_output":true,"text":"to this question with either Yes or No.","text_display":" to this question with either Yes or No.","confidence":1,"confidence_rate":1},{"cnt":[[370,2389],[1858,2389],[1858,2438],[370,2438]],"region":{"top_left_x":369,"top_left_y":2389,"width":1490,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30c1d47616e64adcbd99f34a56f8059a","type":"text","conversion_output":true,"text":"If the adverse event occurred before initiation of investigational product, the relationship","text_display":"\n\nIf the adverse event occurred before initiation of investigational product, the relationship","confidence":1,"confidence_rate":1},{"cnt":[[370,2458],[1863,2458],[1863,2507],[370,2507]],"region":{"top_left_x":369,"top_left_y":2457,"width":1494,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7311723ac4c3405a8a9f235a5afeeca6","type":"text","conversion_output":true,"text":"of the adverse event to study screening is to be assessed by means of the question: \"Is","text_display":" of the adverse event to study screening is to be assessed by means of the question: \"Is","confidence":1,"confidence_rate":1},{"cnt":[[370,2649],[638,2649],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2649,"width":270,"height":39},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d23729f23e8845f188bd95e87aef63a3","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1884,2612],[1884,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":257,"height":72},"line":40,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"f54511c85cc5418bbbd7e90dbc9162af","type":"page_info","conversion_output":false,"text":"AMGEN \\({ 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18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d81a266e82947ae9a62c5fbc5ff03a8","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9659682237543166,"confidence_rate":0.9986159850343261},{"cnt":[[1629,142],[1884,142],[1884,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":257,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"669632fccdf54625baace5b2ce337570","type":"page_info","conversion_output":false,"text":"Page 52 of 104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[1755,249],[1755,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":1387,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf7a9c038b87460d9302ef814fb9f53a","type":"text","conversion_output":true,"text":"there a reasonable possibility that the event may have occurred because of study","text_display":"\nthere a reasonable possibility that the event may have occurred because of study","confidence":1,"confidence_rate":1},{"cnt":[[370,314],[1833,314],[1833,367],[370,367]],"region":{"top_left_x":369,"top_left_y":313,"width":1464,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28157f2b37094c0e96ea6c543cb25224","type":"text","conversion_output":true,"text":"screening?\" The investigator should respond to this question with either Yes or No. If","text_display":" screening?\" The investigator should respond to this question with either Yes or No. If","confidence":1,"confidence_rate":1},{"cnt":[[370,380],[1594,380],[1594,432],[370,432]],"region":{"top_left_x":369,"top_left_y":380,"width":1226,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df98edfba7814c1196617636ffe67fd1","type":"text","conversion_output":true,"text":"the answer is Yes, record what part of the study screening is suspected.","text_display":" the answer is Yes, record what part of the study screening is suspected.","confidence":1,"confidence_rate":1},{"cnt":[[370,468],[1603,468],[1603,522],[370,522]],"region":{"top_left_x":369,"top_left_y":468,"width":1234,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"966a99c2a3b14947a7620bf5396ecb17","type":"text","conversion_output":true,"text":"The severity grading scale used in this study is described in Appendix B.","text_display":"\n\nThe severity grading scale used in this study is described in Appendix B.","confidence":1,"confidence_rate":1},{"cnt":[[370,554],[1865,554],[1865,608],[370,608]],"region":{"top_left_x":369,"top_left_y":554,"width":1496,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"274764f6092b4d20a6065ecd20905d46","type":"text","conversion_output":true,"text":"Medically significant adverse events considered related to the investigational product by","text_display":"\nMedically significant adverse events considered related to the investigational product by","confidence":1,"confidence_rate":1},{"cnt":[[367,619],[1760,619],[1760,672],[367,672]],"region":{"top_left_x":367,"top_left_y":618,"width":1393,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f6b5ea023f749868a04192f936f2d57","type":"text","conversion_output":true,"text":"the investigator or the sponsor will be followed until resolved or considered stable.","text_display":" the investigator or the sponsor will be followed until resolved or considered stable.","confidence":1,"confidence_rate":1},{"cnt":[[370,705],[1781,705],[1781,758],[370,758]],"region":{"top_left_x":369,"top_left_y":704,"width":1413,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c25a65293a8b4eed8d97f0b7dee35cb5","type":"text","conversion_output":true,"text":"It will be left to the investigator's clinical judgment to determine whether an adverse","text_display":"\n\nIt will be left to the investigator's clinical judgment to determine whether an adverse","confidence":1,"confidence_rate":1},{"cnt":[[370,773],[1869,773],[1869,827],[370,827]],"region":{"top_left_x":369,"top_left_y":773,"width":1501,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d43aab516dc74fae9ab92cb17efd83b0","type":"text","conversion_output":true,"text":"event is related and of sufficient severity to require the subject's removal from treatment.","text_display":" 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experienced a clinical","text_display":" which will conclude once approximately 247 subjects have experienced a clinical","confidence":1,"confidence_rate":1},{"cnt":[[370,2647],[638,2647],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2646,"width":270,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad116aa84ed5481a87617887931a9f42","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1884,2612],[1884,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":257,"height":72},"line":41,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"c7815da0b9ea4b83b04b814745c39ce1","type":"page_info","conversion_output":false,"text":"AMGEN \\({ 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18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d73de68f4a14c75b00325083a8bfd8d","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9674137807451189,"confidence_rate":0.9986757186930738},{"cnt":[[1629,142],[1884,142],[1884,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":257,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"daab361ab37d4ed58a795f69c9b4f498","type":"page_info","conversion_output":false,"text":"Page 57 of 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This assumes based on current recruitment and recruitment projections that","text_display":"\nfracture. This assumes based on current recruitment and recruitment projections that","confidence":1,"confidence_rate":1},{"cnt":[[367,314],[1749,314],[1749,367],[367,367]],"region":{"top_left_x":367,"top_left_y":313,"width":1382,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e51aa3c4ede448c943e49aee8d4b58f","type":"text","conversion_output":true,"text":"there will be an 82 -month accrual period and on a drop-out rate of \\(3.6 \\%\\) per year.","text_display":" there will be an 82 -month accrual period and on a drop-out rate of \\(3.6 \\%\\) per year.","confidence":0.9931697845458984,"confidence_rate":0.9999263075741642},{"cnt":[[370,400],[1798,400],[1798,453],[370,453]],"region":{"top_left_x":369,"top_left_y":399,"width":1430,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13b9b77b334f444387054e8ac72adbaa","type":"text","conversion_output":true,"text":"Approximately 247 subjects must experience a clinical fracture for this study to have","text_display":"\n\nApproximately 247 subjects must experience a clinical fracture for this study to have","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[370,466],[1818,466],[1818,520],[370,520]],"region":{"top_left_x":369,"top_left_y":466,"width":1449,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14d4eada68fb4f049a7e8e466205e961","type":"text","conversion_output":true,"text":"\\(80 \\%\\) power to detect a fracture ratio of 0.70 (denosumab vs. control) with a two-sided","text_display":" \\(80 \\%\\) power to detect a fracture ratio of 0.70 (denosumab vs. control) with a two-sided","confidence":1,"confidence_rate":1},{"cnt":[[370,533],[1815,533],[1815,587],[370,587]],"region":{"top_left_x":369,"top_left_y":532,"width":1447,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0df401287d7f4dd585a9275977b18810","type":"text","conversion_output":true,"text":"significance level of 0.05 . A hazard ratio of 0.70 indicates that the fracture rate in the","text_display":" significance level of 0.05 . A hazard ratio of 0.70 indicates that the fracture rate in the","confidence":0.9980475902557373,"confidence_rate":0.9999808402013884},{"cnt":[[370,597],[1669,597],[1669,655],[370,655]],"region":{"top_left_x":369,"top_left_y":597,"width":1301,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"062b3160778946158cbbeec7357683a2","type":"text","conversion_output":true,"text":"denosumab group is \\(30 \\%\\) less than in the control group (ie, \\(1.39 \\%\\) per year).","text_display":" denosumab group is \\(30 \\%\\) less than in the control group (ie, \\(1.39 \\%\\) per year).","confidence":0.998535871389322,"confidence_rate":0.9999829629184545},{"cnt":[[370,683],[1794,683],[1794,741],[370,741]],"region":{"top_left_x":369,"top_left_y":683,"width":1425,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"911c02a511294688bbd5f28e359d51f8","type":"text","conversion_output":true,"text":"The incidence of clinical fracture in the ATAC trial (Jakesz et al, 2005) was 22.6 per","text_display":"\n\nThe incidence of clinical fracture in the ATAC trial (Jakesz et al, 2005) was 22.6 per","confidence":0.99072265625,"confidence_rate":0.9999008491037157},{"cnt":[[370,748],[1858,748],[1858,806],[370,806]],"region":{"top_left_x":369,"top_left_y":747,"width":1490,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a826d3dffc74b3681947c4f9b9002a7","type":"text","conversion_output":true,"text":"1000 subject-years. 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All subjects will be","text_display":" this fracture rate, 247 fractures will be reached after 103 months. All subjects will be","confidence":1,"confidence_rate":1},{"cnt":[[367,1079],[1669,1079],[1669,1137],[367,1137]],"region":{"top_left_x":367,"top_left_y":1078,"width":1303,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e85778c6e1064f2f83933e5208fa6aec","type":"text","conversion_output":true,"text":"followed until they have had the opportunity to receive at least 2 doses of IP.","text_display":" followed until they have had the opportunity to receive at least 2 doses of IP.","confidence":1,"confidence_rate":1},{"cnt":[[367,1164],[1867,1164],[1867,1222],[367,1222]],"region":{"top_left_x":367,"top_left_y":1164,"width":1500,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bcf00be85b84935858468ed6b316698","type":"text","conversion_output":true,"text":"All clinical fractures, except those of the skull, face, fingers, and toes, which are typically","text_display":"\n\nAll clinical fractures, except those of the skull, face, fingers, and toes, which are typically","confidence":1,"confidence_rate":1},{"cnt":[[370,1233],[1803,1233],[1803,1287],[370,1287]],"region":{"top_left_x":369,"top_left_y":1233,"width":1434,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a7da3d1ef154b92b426010dec644123","type":"text","conversion_output":true,"text":"not associated with osteoporosis, will be included in the analysis of clinical fractures.","text_display":" not associated with osteoporosis, will be included in the analysis of clinical fractures.","confidence":1,"confidence_rate":1},{"cnt":[[370,1319],[1841,1319],[1841,1373],[370,1373]],"region":{"top_left_x":369,"top_left_y":1319,"width":1473,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1877ede731c8453383c46072177f262c","type":"text","conversion_output":true,"text":"The key secondary endpoint analysis is a comparison of the percent change of lumbar","text_display":"\n\nThe key secondary endpoint analysis is a comparison of the percent change of lumbar","confidence":1,"confidence_rate":1},{"cnt":[[370,1386],[1841,1386],[1841,1442],[370,1442]],"region":{"top_left_x":369,"top_left_y":1385,"width":1473,"height":57},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d25346589ef54a75b0c5b78bc0d6802f","type":"text","conversion_output":true,"text":"spine BMD between the denosumab treatment and placebo groups. 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Authorized site staff will be","text_display":" investigational product will be contained in the IVRS. Authorized site staff will be","confidence":1,"confidence_rate":1},{"cnt":[[370,2436],[1772,2436],[1772,2490],[370,2490]],"region":{"top_left_x":369,"top_left_y":2436,"width":1404,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"289350fe73b24f7fb9a5621d0ac5fd62","type":"text","conversion_output":true,"text":"provided with a unique Personal Identification Number (PIN) to access the IVRS to","text_display":" provided with a unique Personal Identification Number (PIN) to access the IVRS to","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[370,2647],[640,2647],[640,2692],[370,2692]],"region":{"top_left_x":369,"top_left_y":2646,"width":272,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0c44e244d804dba80bae22ae953f1b6","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1886,2612],[1886,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":259,"height":72},"line":40,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"a6390bebe8c14114bbe9e1950865dd38","type":"page_info","conversion_output":false,"text":"AMGEN \\({ }^{\\circ}\\)","text_display":"","confidence":0.5017375946044922,"confidence_rate":0.9624093054864471}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-058","page":58,"lines":[{"cnt":[[370,64],[922,64],[922,105],[370,105]],"region":{"top_left_x":369,"top_left_y":64,"width":553,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1519ba08651348c285365ffac13e67f2","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,103],[1033,103],[1033,144],[370,144]],"region":{"top_left_x":369,"top_left_y":103,"width":665,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26f46d5ae13f413dac31e2f8772e2070","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f4fde69ab77403d8a769a42ef54b597","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9659682237543166,"confidence_rate":0.9986159850343261},{"cnt":[[1629,142],[1884,142],[1884,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":257,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98e1afdd7c1a40aebf5abc023e24ae90","type":"page_info","conversion_output":false,"text":"Page 58 of 104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[1772,249],[1772,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":1404,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f1a5ede8bf74176b93db30cb17b93e0","type":"text","conversion_output":true,"text":"obtain unblinding information. This PIN is unique to the individual and must not be","text_display":"\nobtain unblinding information. This PIN is unique to the individual and must not be","confidence":1,"confidence_rate":1},{"cnt":[[370,316],[505,316],[505,363],[370,363]],"region":{"top_left_x":369,"top_left_y":315,"width":136,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"759ab568cd08444e8542b7331ea5fce3","type":"text","conversion_output":true,"text":"shared.","text_display":" shared.","confidence":1,"confidence_rate":1},{"cnt":[[370,400],[1777,400],[1777,453],[370,453]],"region":{"top_left_x":369,"top_left_y":399,"width":1408,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96499a3e1ab343509b5f2bd69762c5ea","type":"text","conversion_output":true,"text":"A subject's treatment assignment should only be unblinded when knowledge of the","text_display":"\n\nA subject's treatment assignment should only be unblinded when knowledge of the","confidence":1,"confidence_rate":1},{"cnt":[[370,468],[1876,468],[1876,522],[370,522]],"region":{"top_left_x":369,"top_left_y":468,"width":1507,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82ce73e2659f4000864a7b3a7504b802","type":"text","conversion_output":true,"text":"treatment is essential for the further management of the subject. Unblinding at the study","text_display":" treatment is essential for the further management of the subject. Unblinding at the study","confidence":1,"confidence_rate":1},{"cnt":[[370,533],[1699,533],[1699,587],[370,587]],"region":{"top_left_x":369,"top_left_y":532,"width":1331,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fb9816617304b32b001a4f5c96ae9e5","type":"text","conversion_output":true,"text":"site for any other reason will be considered a protocol deviation. The principal","text_display":" site for any other reason will be considered a protocol deviation. The principal","confidence":1,"confidence_rate":1},{"cnt":[[370,597],[1732,597],[1732,655],[370,655]],"region":{"top_left_x":369,"top_left_y":597,"width":1363,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f6052ece3464feb93af2a26cab681b0","type":"text","conversion_output":true,"text":"investigator is strongly encouraged to contact the Amgen Study Manager before","text_display":" investigator is strongly encouraged to contact the Amgen Study Manager before","confidence":1,"confidence_rate":1},{"cnt":[[370,664],[1880,664],[1880,718],[370,718]],"region":{"top_left_x":369,"top_left_y":663,"width":1511,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c37bffe67cc4dce8ff6763efe1dedc6","type":"text","conversion_output":true,"text":"unblinding any subject's treatment assignment, but must do so within 1 working day after","text_display":" unblinding any subject's treatment assignment, but must do so within 1 working day after","confidence":1,"confidence_rate":1},{"cnt":[[370,730],[1497,730],[1497,784],[370,784]],"region":{"top_left_x":369,"top_left_y":730,"width":1129,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b38239c1c4b640bea2c01876b7b6c9e8","type":"text","conversion_output":true,"text":"the event and must document the unblinding in the subject's CRF.","text_display":" the event and must document the unblinding in the subject's CRF.","confidence":1,"confidence_rate":1},{"cnt":[[370,816],[1764,816],[1764,870],[370,870]],"region":{"top_left_x":369,"top_left_y":816,"width":1395,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ec5abb4f3bc47f684a101446041db2a","type":"text","conversion_output":true,"text":"Subjects eligible to receive denosumab in the OLP will be unblinded as detailed in","text_display":"\n\nSubjects eligible to receive denosumab in the OLP will be unblinded as detailed in","confidence":1,"confidence_rate":1},{"cnt":[[370,881],[552,881],[552,930],[370,930]],"region":{"top_left_x":369,"top_left_y":880,"width":184,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cff2847610c4709ae9f63e64b7c4bd2","type":"text","conversion_output":true,"text":"Section 5.","text_display":" Section 5.","confidence":1,"confidence_rate":1},{"cnt":[[365,962],[1798,962],[1798,1072],[365,1072]],"region":{"top_left_x":365,"top_left_y":962,"width":1434,"height":111},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2474acba57f64323bb2a8f3719257f82","type":"section_header","conversion_output":false,"children_ids":["d664424e81c64c76872a5eb3c635c39f","9af40d62f30c4480a498a49ca5e17aa2"],"text":"","text_display":""},{"cnt":[[372,969],[1790,969],[1790,1023],[372,1023]],"region":{"top_left_x":371,"top_left_y":968,"width":1419,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d664424e81c64c76872a5eb3c635c39f","type":"text","conversion_output":true,"parent_id":"2474acba57f64323bb2a8f3719257f82","text":"10.5 Interim Analysis, Early Stopping Guidelines, and Time-points of","text_display":"\n\n\\subsection*{10.5 Interim Analysis, Early Stopping Guidelines, and Time-points of","confidence":0.8876833915710449,"confidence_rate":0.9983692743599348},{"cnt":[[619,1018],[797,1018],[797,1068],[619,1068]],"region":{"top_left_x":618,"top_left_y":1018,"width":180,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9af40d62f30c4480a498a49ca5e17aa2","type":"text","conversion_output":true,"parent_id":"2474acba57f64323bb2a8f3719257f82","text":"Analyses","text_display":" Analyses}","confidence":0.990234375,"confidence_rate":0.9992453909031958},{"cnt":[[370,1079],[1854,1079],[1854,1132],[370,1132]],"region":{"top_left_x":369,"top_left_y":1078,"width":1486,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51391197b4d14efe89b8c4e32247a55b","type":"text","conversion_output":true,"text":"An external DMC will be formed with members consisting of individuals chosen for their","text_display":"\n\nAn external DMC will be formed with members consisting of individuals chosen for their","confidence":1,"confidence_rate":1},{"cnt":[[370,1145],[1854,1145],[1854,1199],[370,1199]],"region":{"top_left_x":369,"top_left_y":1145,"width":1486,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df4806b4b8114fdeae947d6ddf50216e","type":"text","conversion_output":true,"text":"expertise in oncology and bone disease. Selected ABCSG and Amgen staff may serve","text_display":" expertise in oncology and bone disease. Selected ABCSG and Amgen staff may serve","confidence":1,"confidence_rate":1},{"cnt":[[370,1210],[1712,1210],[1712,1263],[370,1263]],"region":{"top_left_x":369,"top_left_y":1209,"width":1344,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5aee1d86f3ed4b9fb98a03031a38b945","type":"text","conversion_output":true,"text":"as liaisons to the external DMC, but will not be voting members, and will not be","text_display":" as liaisons to the external DMC, but will not be voting members, and will not be","confidence":1,"confidence_rate":1},{"cnt":[[370,1276],[1807,1276],[1807,1330],[370,1330]],"region":{"top_left_x":369,"top_left_y":1276,"width":1438,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a371f4ef45f4b989c1f874b117c9d3c","type":"text","conversion_output":true,"text":"unblinded to the results. 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Members of this","confidence":1,"confidence_rate":1},{"cnt":[[370,1474],[1861,1474],[1861,1532],[370,1532]],"region":{"top_left_x":369,"top_left_y":1473,"width":1492,"height":59},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bb3933fff8a44dba86615e67152cc8e","type":"text","conversion_output":true,"text":"external DMC will include, at a minimum, physicians external to Amgen and appropriate","text_display":" external DMC will include, at a minimum, physicians external to Amgen and appropriate","confidence":1,"confidence_rate":1},{"cnt":[[370,1538],[1880,1538],[1880,1594],[370,1594]],"region":{"top_left_x":369,"top_left_y":1538,"width":1511,"height":57},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae06961d16334455a064b5a2cfecb7bd","type":"text","conversion_output":true,"text":"statistical representation external to Amgen. 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The DMC will communicate major safety","confidence":1,"confidence_rate":1},{"cnt":[[370,1671],[1833,1671],[1833,1725],[370,1725]],"region":{"top_left_x":369,"top_left_y":1671,"width":1464,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b923fb9d66c418d9afbaa81c817b02a","type":"text","conversion_output":true,"text":"concerns and recommendations regarding study modification or termination to Amgen","text_display":" concerns and recommendations regarding study modification or termination to Amgen","confidence":1,"confidence_rate":1},{"cnt":[[369,1738],[1807,1736],[1807,1794],[370,1796]],"region":{"top_left_x":369,"top_left_y":1735,"width":1438,"height":61},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84cca9116b6d4b179a4f098fe86d53c7","type":"text","conversion_output":true,"text":"senior management. Details regarding the DMC will be provided in a separate DMC","text_display":" senior management. 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Safety analyses provided to the DMC will","confidence":1,"confidence_rate":1},{"cnt":[[370,1955],[786,1955],[786,2013],[370,2013]],"region":{"top_left_x":369,"top_left_y":1955,"width":418,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"184dea8bee304ba9ba4762ede6419499","type":"text","conversion_output":true,"text":"be descriptive in nature.","text_display":" be descriptive in nature.","confidence":1,"confidence_rate":1},{"cnt":[[370,2041],[1863,2041],[1863,2099],[370,2099]],"region":{"top_left_x":369,"top_left_y":2041,"width":1494,"height":59},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5e6e45315ac4c99a4300dfefb7b0821","type":"text","conversion_output":true,"text":"There will be no interim analysis based on the primary endpoint. An interim analysis for","text_display":"\n\nThere will be no interim analysis based on the primary endpoint. An interim analysis for","confidence":0.9917092323303223,"confidence_rate":0.9999104843590932},{"cnt":[[367,2105],[1852,2105],[1852,2163],[367,2163]],"region":{"top_left_x":367,"top_left_y":2105,"width":1485,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faf554f4b222416d950b6b8702eacbb2","type":"text","conversion_output":true,"text":"futility for the secondary endpoint DFS was performed after PADCD by an independent","text_display":" futility for the secondary endpoint DFS was performed after PADCD by an independent","confidence":1,"confidence_rate":1},{"cnt":[[370,2174],[1869,2174],[1869,2230],[370,2230]],"region":{"top_left_x":369,"top_left_y":2174,"width":1501,"height":57},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d5010bfc85045bd88546462edd8ce93","type":"text","conversion_output":true,"text":"statistician. This interim analysis used an informal futility bound. 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Study termination may","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[370,2239],[1876,2239],[1876,2295],[370,2295]],"region":{"top_left_x":369,"top_left_y":2238,"width":1507,"height":57},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34677f6722fb46acb612b21dc2a620b0","type":"text","conversion_output":true,"text":"be recommended by the DMC if the observed hazard ratio exceeded the hazard ratio for","text_display":" be recommended by the DMC if the observed hazard ratio exceeded the hazard ratio for","confidence":1,"confidence_rate":1},{"cnt":[[367,2305],[1871,2305],[1871,2361],[367,2361]],"region":{"top_left_x":367,"top_left_y":2305,"width":1505,"height":57},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d22e9c35e2f412b83617a8ac8be8b03","type":"text","conversion_output":true,"text":"futility ( 0.85 ). Following review of the interim DFS analysis results, the DMC determined","text_display":" futility ( 0.85 ). 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The primary analysis includes the primary","text_display":" study visit (considered as EOT visit). The primary analysis includes the primary","confidence":1,"confidence_rate":1},{"cnt":[[370,533],[1824,533],[1824,587],[370,587]],"region":{"top_left_x":369,"top_left_y":532,"width":1456,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76d543f27c0548909fb7fa56dfd20888","type":"text","conversion_output":true,"text":"endpoint and the first three secondary endpoints concerning the changes in BMD and","text_display":" endpoint and the first three secondary endpoints concerning the changes in BMD and","confidence":1,"confidence_rate":1},{"cnt":[[370,597],[698,597],[698,647],[370,647]],"region":{"top_left_x":369,"top_left_y":597,"width":330,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c78129c5b448451e92491afedacbcc9a","type":"text","conversion_output":true,"text":"vertebral fractures.","text_display":" vertebral fractures.","confidence":1,"confidence_rate":1},{"cnt":[[367,683],[1721,683],[1721,741],[367,741]],"region":{"top_left_x":367,"top_left_y":683,"width":1354,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aa37573d7d34119972cc09acdc3df49","type":"text","conversion_output":true,"text":"A final exploratory analysis as well as the main analyses for efficacy of the","text_display":"\n\nA final exploratory analysis as well as the main analyses for efficacy of the","confidence":1,"confidence_rate":1},{"cnt":[[370,752],[1790,752],[1790,806],[370,806]],"region":{"top_left_x":369,"top_left_y":751,"width":1421,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9439e2800d5545aea1db8b2a73bbcea6","type":"text","conversion_output":true,"text":"secondary endpoints BMFS and OS will be performed at the end of the main study.","text_display":" secondary endpoints BMFS and OS will be performed at the end of the main study.","confidence":0.99755859375,"confidence_rate":0.999970900526472},{"cnt":[[370,838],[587,838],[587,892],[370,892]],"region":{"top_left_x":369,"top_left_y":837,"width":218,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7eac7d33557f4738b7930e35c69e23c1","type":"text","conversion_output":true,"text":"Additionally,","text_display":"\n\nAdditionally,","confidence":1,"confidence_rate":1},{"cnt":[[1388,907],[1835,907],[1835,954],[1388,954]],"region":{"top_left_x":1387,"top_left_y":906,"width":448,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"581bacfc0b74414b93ce096c7d1980d7","type":"text","conversion_output":true,"text":"will be evaluated in a final","text_display":" will be evaluated in a final","confidence":1,"confidence_rate":1},{"cnt":[[370,967],[1880,967],[1880,1025],[370,1025]],"region":{"top_left_x":369,"top_left_y":966,"width":1511,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7dedf6172fa94fb4a473bfb3918b562c","type":"text","conversion_output":true,"text":"exploratory analysis at this time point. Only data collected up to the EOS visit (end of","text_display":" exploratory analysis at this time point. 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Any data collected from the ZA substudy will be excluded.","text_display":" analysis. Any data collected from the ZA substudy will be excluded.","confidence":1,"confidence_rate":1},{"cnt":[[365,1182],[1164,1182],[1164,1246],[365,1246]],"region":{"top_left_x":365,"top_left_y":1181,"width":800,"height":66},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4165c61a5f14bb69129837493449da1","type":"section_header","conversion_output":false,"children_ids":["6d4004aa2d6b409087e3c75fffb64251"],"text":"","text_display":""},{"cnt":[[372,1188],[1158,1188],[1158,1240],[372,1240]],"region":{"top_left_x":371,"top_left_y":1188,"width":788,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d4004aa2d6b409087e3c75fffb64251","type":"text","conversion_output":true,"parent_id":"c4165c61a5f14bb69129837493449da1","text":"10.6 Planned Methods of Analysis","text_display":"\n\n\\subsection*{10.6 Planned Methods of Analysis}","confidence":0.9931640625,"confidence_rate":0.9998146277362402},{"cnt":[[365,1250],[1257,1250],[1257,1308],[365,1308]],"region":{"top_left_x":365,"top_left_y":1250,"width":892,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae8e7abbfefe4bbb9d26cbcd2ee9dcc8","type":"section_header","conversion_output":false,"children_ids":["803ef56f25e040b0b96caab05a70078c"],"text":"","text_display":""},{"cnt":[[372,1255],[1248,1255],[1248,1304],[372,1304]],"region":{"top_left_x":371,"top_left_y":1254,"width":878,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"803ef56f25e040b0b96caab05a70078c","type":"text","conversion_output":true,"parent_id":"ae8e7abbfefe4bbb9d26cbcd2ee9dcc8","text":"10.6.1 General Approach/Considerations","text_display":"\n\n\\subsection*{10.6.1 General Approach/Considerations}","confidence":0.9936642581596971,"confidence_rate":0.9998521993460772},{"cnt":[[370,1319],[1828,1319],[1828,1371],[370,1371]],"region":{"top_left_x":369,"top_left_y":1319,"width":1460,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d58af1bcc4134e3abf02f7ccfd2ded80","type":"text","conversion_output":true,"text":"The principal analysis for the efficacy endpoints will be conducted on the FAS and the","text_display":"\n\nThe principal analysis for the efficacy endpoints will be conducted on the FAS and the","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[370,1384],[1858,1384],[1858,1437],[370,1437]],"region":{"top_left_x":369,"top_left_y":1383,"width":1490,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"876c57699901448c820baeaef917b98b","type":"text","conversion_output":true,"text":"per protocol population approach will be considered supportive. Safety analyses will be","text_display":" per protocol population approach will be considered supportive. 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Median and other selected percentiles will be substituted for","text_display":" minimum, and maximum. 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Analysis of the disease outcome-related secondary endpoints BMFS","text_display":" interim analysis). 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The primary analysis of this","confidence":1,"confidence_rate":1},{"cnt":[[370,314],[1687,314],[1687,365],[370,365]],"region":{"top_left_x":369,"top_left_y":313,"width":1318,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0ad88571a9d48569452584b39ee1c47","type":"text","conversion_output":true,"text":"endpoint will use logistic regression models including treatment groups as the","text_display":" endpoint will use logistic regression models including treatment groups as the","confidence":1,"confidence_rate":1},{"cnt":[[370,380],[1678,380],[1678,432],[370,432]],"region":{"top_left_x":369,"top_left_y":380,"width":1309,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef69ad6859fb4b679fc8ad1f0f29d963","type":"text","conversion_output":true,"text":"independent variable and stratified by the randomization stratification factors.","text_display":" independent variable and stratified by the randomization stratification factors.","confidence":1,"confidence_rate":1},{"cnt":[[370,597],[1828,597],[1828,651],[370,651]],"region":{"top_left_x":369,"top_left_y":597,"width":1460,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02934cbf2ce84389a771f643cf56ff5c","type":"text","conversion_output":true,"text":"The percent change in lumbar spine, total hip and femoral neck BMD from baseline to","text_display":"\n\nThe percent change in lumbar spine, total hip and femoral neck BMD from baseline to","confidence":1,"confidence_rate":1},{"cnt":[[370,666],[1846,666],[1846,715],[370,715]],"region":{"top_left_x":369,"top_left_y":666,"width":1477,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47eef07f051e41b58cb3994850e0afd2","type":"text","conversion_output":true,"text":"36 months will be calculated for subjects at pre-selected sites. The primary analysis of","text_display":" 36 months will be calculated for subjects at pre-selected sites. The primary analysis of","confidence":0.98779296875,"confidence_rate":0.9998665072914702},{"cnt":[[370,730],[1858,730],[1858,784],[370,784]],"region":{"top_left_x":369,"top_left_y":730,"width":1490,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68ac8e6123634ea89ef7ac16955c9baf","type":"text","conversion_output":true,"text":"these endpoints will employ a mixed effects model (Longford, 1993) including treatment","text_display":" these endpoints will employ a mixed effects model (Longford, 1993) including treatment","confidence":1,"confidence_rate":1},{"cnt":[[370,797],[1785,797],[1785,849],[370,849]],"region":{"top_left_x":369,"top_left_y":797,"width":1417,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e57a53fa1ef4e3b81801b4c2b7128e6","type":"text","conversion_output":true,"text":"groups as the independent variable and stratified by the randomization stratification","text_display":" groups as the independent variable and stratified by the randomization stratification","confidence":1,"confidence_rate":1},{"cnt":[[370,864],[505,864],[505,909],[370,909]],"region":{"top_left_x":369,"top_left_y":863,"width":136,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d0a164cebd84605be2b51d02a7be0e2","type":"text","conversion_output":true,"text":"factors.","text_display":" factors.","confidence":1,"confidence_rate":1},{"cnt":[[370,950],[1837,950],[1837,1001],[370,1001]],"region":{"top_left_x":369,"top_left_y":949,"width":1468,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f431a034fda84c108283afc2562780cb","type":"text","conversion_output":true,"text":"Disease-free survival is defined as time to any evidence of local or distant metastases,","text_display":"\n\nDisease-free survival is defined as time to any evidence of local or distant metastases,","confidence":1,"confidence_rate":1},{"cnt":[[370,1014],[1783,1014],[1783,1068],[370,1068]],"region":{"top_left_x":369,"top_left_y":1014,"width":1415,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f8c614947d248ac8a552306aa34beba","type":"text","conversion_output":true,"text":"contra-lateral breast cancer, secondary carcinoma, or death from any cause. Bone","text_display":" contra-lateral breast cancer, secondary carcinoma, or death from any cause. Bone","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[370,1083],[1682,1083],[1682,1132],[370,1132]],"region":{"top_left_x":369,"top_left_y":1082,"width":1314,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94f63f1150aa4ee29ead43e83f8a9f98","type":"text","conversion_output":true,"text":"metastases-free survival is determined by the time to first occurrence of bone","text_display":" metastases-free survival is determined by the time to first occurrence of bone","confidence":0.99169921875,"confidence_rate":0.9998995782404457},{"cnt":[[370,1147],[1783,1147],[1783,1197],[370,1197]],"region":{"top_left_x":369,"top_left_y":1147,"width":1415,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7395445625a54ec8aa91cb7533faf6d5","type":"text","conversion_output":true,"text":"metastases (either symptomatic or asymptomatic) or death from any cause. These","text_display":" metastases (either symptomatic or asymptomatic) or death from any cause. These","confidence":0.9990234375,"confidence_rate":0.9999882285072625},{"cnt":[[370,1214],[1835,1214],[1835,1265],[370,1265]],"region":{"top_left_x":369,"top_left_y":1213,"width":1466,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94adb4beff86473eb27d1fe872b36b24","type":"text","conversion_output":true,"text":"endpoints and OS will be analyzed using the same methods as used in the analysis of","text_display":" endpoints and OS will be analyzed using the same methods as used in the analysis of","confidence":1,"confidence_rate":1},{"cnt":[[370,1280],[737,1280],[737,1330],[370,1330]],"region":{"top_left_x":369,"top_left_y":1280,"width":368,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c906bb4098145dab9f84d619f6baca6","type":"text","conversion_output":true,"text":"the primary endpoint.","text_display":" the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[370,1362],[926,1362],[926,1420],[370,1420]],"region":{"top_left_x":369,"top_left_y":1362,"width":557,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75059856f64a430285dbab365894a791","type":"section_header","conversion_output":false,"children_ids":["611047985dec4b3b973dc76efa36ba1c"],"text":"","text_display":""},{"cnt":[[374,1366],[922,1366],[922,1416],[374,1416]],"region":{"top_left_x":373,"top_left_y":1366,"width":549,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"611047985dec4b3b973dc76efa36ba1c","type":"text","conversion_output":true,"parent_id":"75059856f64a430285dbab365894a791","text":"10.6.2.2 Safety Analyses","text_display":"\n\n\\subsection*{10.6.2.2 Safety Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[370,1431],[1682,1431],[1682,1480],[370,1480]],"region":{"top_left_x":369,"top_left_y":1430,"width":1314,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3141b2c14ed041cd80301b46d1fac55f","type":"text","conversion_output":true,"text":"Safety data will be summarized for all subjects who receive at least 1 dose of","text_display":"\n\nSafety data will be summarized for all subjects who receive at least 1 dose of","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[370,1497],[1710,1497],[1710,1549],[370,1549]],"region":{"top_left_x":369,"top_left_y":1497,"width":1342,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cca8e1e535e04ea58a87a12d6fb2c59d","type":"text","conversion_output":true,"text":"investigational products. All AEs will be coded using the Medical Dictionary for","text_display":" investigational products. All AEs will be coded using the Medical Dictionary for","confidence":1,"confidence_rate":1},{"cnt":[[370,1560],[1790,1560],[1790,1613],[370,1613]],"region":{"top_left_x":369,"top_left_y":1559,"width":1421,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79dbea64acab4e2c918ff1d0fec18d60","type":"text","conversion_output":true,"text":"Regulatory Activities (MedDRA). Any adverse events will be analyzed as treatment","text_display":" Regulatory Activities (MedDRA). Any adverse events will be analyzed as treatment","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[370,1629],[1745,1629],[1745,1680],[370,1680]],"region":{"top_left_x":369,"top_left_y":1628,"width":1376,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d239a0d22d864ab083110c3c5e9e4cb8","type":"text","conversion_output":true,"text":"emergent if the indicator of \"Did event start before the first dose of investigational","text_display":" emergent if the indicator of \"Did event start before the first dose of investigational","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[370,1693],[1848,1693],[1848,1747],[370,1747]],"region":{"top_left_x":369,"top_left_y":1692,"width":1479,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec4fd10ef337458e8b79c5bfad5f0a2a","type":"text","conversion_output":true,"text":"product\" is checked as \"No\" on Adverse Events Summary CRF pages. The analysis of","text_display":" product\" is checked as \"No\" on Adverse Events Summary CRF pages. The analysis of","confidence":1,"confidence_rate":1},{"cnt":[[370,1762],[1837,1762],[1837,1811],[370,1811]],"region":{"top_left_x":369,"top_left_y":1761,"width":1468,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15f9d4874f98495a91ff7b57822ee520","type":"text","conversion_output":true,"text":"adverse events will be descriptive. The subject incidence rates of treatment-emergent","text_display":" adverse events will be descriptive. The subject incidence rates of treatment-emergent","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[370,1826],[1863,1826],[1863,1876],[370,1876]],"region":{"top_left_x":369,"top_left_y":1826,"width":1494,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5199e5c33d364471b0981d62d5a57b79","type":"text","conversion_output":true,"text":"adverse events reported during the study period will be tabulated by system organ class","text_display":" adverse events reported during the study period will be tabulated by system organ class","confidence":1,"confidence_rate":1},{"cnt":[[370,1893],[1828,1893],[1828,1944],[370,1944]],"region":{"top_left_x":369,"top_left_y":1892,"width":1460,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b77b7bf7ba14fcb89cfe480a81424cd","type":"text","conversion_output":true,"text":"and preferred term. Additional summary tables will be provided separately for serious","text_display":" and preferred term. Additional summary tables will be provided separately for serious","confidence":1,"confidence_rate":1},{"cnt":[[370,1955],[1850,1955],[1850,2009],[370,2009]],"region":{"top_left_x":369,"top_left_y":1955,"width":1481,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b6c169326814b36a1f3a8fcb681253d","type":"text","conversion_output":true,"text":"adverse events, CTCAE grade 3,4 , or 5 AEs, adverse events leading to investigational","text_display":" adverse events, CTCAE grade 3,4 , or 5 AEs, adverse events leading to investigational","confidence":0.854633535258472,"confidence_rate":0.9983650617652626},{"cnt":[[370,2024],[1850,2024],[1850,2075],[370,2075]],"region":{"top_left_x":369,"top_left_y":2023,"width":1481,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3db7852cc578497b903bc5f247654061","type":"text","conversion_output":true,"text":"product discontinuation, and adverse events leading to study withdrawal. Narratives of","text_display":" product discontinuation, and adverse events leading to study withdrawal. Narratives of","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[370,2090],[1794,2090],[1794,2142],[370,2142]],"region":{"top_left_x":369,"top_left_y":2090,"width":1425,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21c1fd5f0a5642ebb0d3a385b1eea980","type":"text","conversion_output":true,"text":"deaths and serious adverse events will also be provided. All investigational product","text_display":" deaths and serious adverse events will also be provided. All investigational product","confidence":1,"confidence_rate":1},{"cnt":[[370,2155],[1794,2155],[1794,2206],[370,2206]],"region":{"top_left_x":369,"top_left_y":2154,"width":1425,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc5a7958f0f74dd6a4cf2d75a4c25d4e","type":"text","conversion_output":true,"text":"related adverse events, SAEs, CTCAE grade 3 , 4 or 5 adverse events, and adverse","text_display":" related adverse events, SAEs, CTCAE grade 3 , 4 or 5 adverse events, and adverse","confidence":0.9766995906829834,"confidence_rate":0.9997492212841721},{"cnt":[[370,2221],[1697,2221],[1697,2273],[370,2273]],"region":{"top_left_x":369,"top_left_y":2221,"width":1329,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bef1234ab80842f4abea42a91876b74b","type":"text","conversion_output":true,"text":"events leading to study withdrawal will be summarized in the same manner as","text_display":" events leading to study withdrawal will be summarized in the same manner as","confidence":1,"confidence_rate":1},{"cnt":[[370,2286],[1751,2286],[1751,2340],[370,2340]],"region":{"top_left_x":369,"top_left_y":2285,"width":1382,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b819c76e7ea14d7dbdcdd5977c7e7226","type":"text","conversion_output":true,"text":"treatment-emergent adverse events. All adverse events, CTCAE grade 3,4 , or 5","text_display":" treatment-emergent adverse events. All adverse events, CTCAE grade 3,4 , or 5","confidence":0.9212918931152672,"confidence_rate":0.9990245431830522},{"cnt":[[370,2355],[1777,2355],[1777,2404],[370,2404]],"region":{"top_left_x":369,"top_left_y":2354,"width":1408,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cf50455c3de46e1a23b12f1ba3d83b1","type":"text","conversion_output":true,"text":"adverse events, serious adverse events, all investigational product related adverse","text_display":" adverse events, serious adverse events, all investigational product related adverse","confidence":1,"confidence_rate":1},{"cnt":[[370,2419],[1850,2419],[1850,2471],[370,2471]],"region":{"top_left_x":369,"top_left_y":2419,"width":1481,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19e0273c16d444cf9c72689b3aac3017","type":"text","conversion_output":true,"text":"events, investigational product related CTCAE grade 3,4 , or 5 AEs, and investigational","text_display":" events, investigational product related CTCAE grade 3,4 , or 5 AEs, and investigational","confidence":0.9902536764275283,"confidence_rate":0.9999000648932193},{"cnt":[[370,2486],[1463,2486],[1463,2537],[370,2537]],"region":{"top_left_x":369,"top_left_y":2485,"width":1095,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8f11f521edf459eafebb9ce8244cc99","type":"text","conversion_output":true,"text":"product related serious adverse events will also be summarized.","text_display":" product related serious adverse events will also be 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18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[372,142],[690,142],[690,187],[372,187]],"region":{"top_left_x":371,"top_left_y":141,"width":319,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35559411b3894451bd02cd0b27140871","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9892718747723848,"confidence_rate":0.9995686495991648},{"cnt":[[1629,142],[1880,142],[1880,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":252,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"399a82417a064f9ab981b438e2d8d26b","type":"page_info","conversion_output":false,"text":"Page 63 of 104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[887,249],[887,299],[370,299]],"region":{"top_left_x":369,"top_left_y":249,"width":519,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8114a9d4a3b47f49064c0bd43377151","type":"text","conversion_output":true,"text":"The subject incidence rates of","text_display":"\n\nThe subject incidence rates of","confidence":1,"confidence_rate":1},{"cnt":[[864,316],[1807,316],[1807,367],[864,367]],"region":{"top_left_x":863,"top_left_y":315,"width":944,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf50f23d8528478b886b72d19c8af303","type":"text","conversion_output":true,"text":"reported during the OLP will be tabulated separately by","text_display":"\nreported during the OLP will be tabulated separately by","confidence":1,"confidence_rate":1},{"cnt":[[370,382],[1042,382],[1042,432],[370,432]],"region":{"top_left_x":369,"top_left_y":382,"width":673,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3bdd5919c2744d882900e3109fb9f0f","type":"text","conversion_output":true,"text":"system organ class and preferred term.","text_display":" system organ class and preferred term.","confidence":1,"confidence_rate":1},{"cnt":[[370,468],[1777,468],[1777,518],[370,518]],"region":{"top_left_x":369,"top_left_y":468,"width":1408,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdd44f38ac7e4f98ac710cd4a5305bee","type":"text","conversion_output":true,"text":"Laboratory parameters will be summarized over time using descriptive statistics for","text_display":"\n\nLaboratory parameters will be summarized over time using descriptive statistics for","confidence":1,"confidence_rate":1},{"cnt":[[370,535],[1828,535],[1828,582],[370,582]],"region":{"top_left_x":369,"top_left_y":534,"width":1460,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1385f17e24b04dec99b320939cc05996","type":"text","conversion_output":true,"text":"recorded values and change from baseline and shifts tables, in which the incidence of","text_display":" recorded values and change from baseline and shifts tables, in which the incidence of","confidence":1,"confidence_rate":1},{"cnt":[[370,602],[1824,602],[1824,651],[370,651]],"region":{"top_left_x":369,"top_left_y":601,"width":1456,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46c46b5a240f4bd49777a878397a8438","type":"text","conversion_output":true,"text":"shift of toxicity grade (CTCAE version 3.0 ) in recorded values from baseline to \"worst\"","text_display":" shift of toxicity grade (CTCAE version 3.0 ) in recorded values from baseline to \"worst\"","confidence":0.84814453125,"confidence_rate":0.9982858019611802},{"cnt":[[370,666],[1833,666],[1833,715],[370,715]],"region":{"top_left_x":369,"top_left_y":666,"width":1464,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5937e58f05e4f60ae1728201333d041","type":"text","conversion_output":true,"text":"on-study value is displayed. 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care within 30 days","confidence":0.99951171875,"confidence_rate":0.9999960292721264},{"cnt":[[826,466],[1284,466],[1284,500],[826,500]],"region":{"top_left_x":826,"top_left_y":466,"width":458,"height":35},"line":24,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"01974e985fc4413e9ebe2561261815fb","type":"text","conversion_output":false,"parent_id":"5136993ae0654b3abcfbfc08b40dc5d5","text":"prior to signing informed consent","text_display":" prior to signing informed 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baseline, \\(12 M , 24 M , 36 M\\) and EOT visits. Between the 36 M and the EOT visit, vertebral X-rays may be performed based on the investigator's decision and according to local routine practice. Unscheduled X -rays may be performed when significant clinical symptoms (e.g. back pain) are reported","text_display":"X-rays are performed at baseline, \\(12 M , 24 M , 36 M\\) and EOT visits. Between the 36 M and the EOT visit, vertebral X-rays may be performed based on the investigator's decision and according to local routine practice. Unscheduled X -rays may be performed when significant clinical symptoms (e.g. back pain) are reported","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9426656907889992,"confidence_rate":0.9998462525082081},{"cnt":[[825,515],[2477,515],[2477,549],[825,549]],"region":{"top_left_x":824,"top_left_y":514,"width":1653,"height":35},"line":27,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"be626d73a4964c858ebc422cb0bb2ed9","type":"text","conversion_output":false,"parent_id":"5dd5199b39b24fdab5de43a8ec0f30ff","text":"X-rays are performed at baseline, \\(12 M , 24 M , 36 M\\) and EOT visits. Between the 36 M and the EOT visit, vertebral X-rays may","text_display":"X-rays are performed at baseline, \\(12 M , 24 M , 36 M\\) and EOT visits. Between the 36 M and the EOT visit, vertebral X-rays may","confidence":1,"confidence_rate":1},{"cnt":[[826,553],[2430,553],[2430,587],[826,587]],"region":{"top_left_x":826,"top_left_y":552,"width":1605,"height":35},"line":28,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"0ea3bd1718ae452c8da8bc405d711389","type":"text","conversion_output":false,"parent_id":"5dd5199b39b24fdab5de43a8ec0f30ff","text":"be performed based on the investigator's decision and according to local routine practice. Unscheduled X -rays may be","text_display":" be performed based on the investigator's decision and according to local routine practice. Unscheduled X -rays may be","confidence":0.9426656907889992,"confidence_rate":0.9995388284358638},{"cnt":[[826,592],[1849,592],[1849,625],[826,625]],"region":{"top_left_x":826,"top_left_y":592,"width":1023,"height":33},"line":29,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c459c076568745d6b0b08f744bfff253","type":"text","conversion_output":false,"parent_id":"5dd5199b39b24fdab5de43a8ec0f30ff","text":"performed when significant clinical symptoms (e.g. back pain) are reported","text_display":" performed when significant clinical symptoms (e.g. back pain) are reported","confidence":1,"confidence_rate":1},{"cnt":[[2477,590],[2478,593],[2484,628],[2484,732],[2482,739],[2459,741],[471,741],[468,739],[466,631],[466,624],[468,620],[486,619],[2473,590]],"region":{"top_left_x":466,"top_left_y":590,"width":2018,"height":151},"line":30,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"b11d36ddc51144b4940acfd7fb923abe","type":"table_spanning_cell","conversion_output":false,"parent_id":"ff211db158b74798b692752f16c474cc","text":"","text_display":"","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1},{"cnt":[[495,819],[526,819],[526,851],[495,851]],"region":{"top_left_x":495,"top_left_y":819,"width":31,"height":33},"line":31,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"12dc526d618b4f89a72e20cb7af1de02","type":"simple_cell","conversion_output":false,"parent_id":"ff211db158b74798b692752f16c474cc","text":"5","text_display":"5","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[821,743],[2461,743],[2461,857],[821,857]],"region":{"top_left_x":821,"top_left_y":743,"width":1640,"height":114},"line":32,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2b234c968d5a41e587184cd97e9a1453","type":"complex_cell","conversion_output":false,"parent_id":"ff211db158b74798b692752f16c474cc","children_ids":["4b520d1cd8494732a85ddfad60313439","bb82f640d75f4f0b993ed9fcb3912dfb","fa045c2b1fc646e299b6caa5fd72df81"],"text":"A pregnancy test, where applicable, must be performed within 7 days prior to randomization. Where post-menopausal status is clearly documented, a pregnancy test is not required (see inclusion and exclusion criteria for definition of postmenopausal status).","text_display":"A pregnancy test, where applicable, must be performed within 7 days prior to randomization. Where post-menopausal status is clearly documented, a pregnancy test is not required (see inclusion and exclusion criteria for definition of postmenopausal status).","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[825,745],[2443,745],[2443,778],[825,778]],"region":{"top_left_x":824,"top_left_y":745,"width":1619,"height":33},"line":33,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4b520d1cd8494732a85ddfad60313439","type":"text","conversion_output":false,"parent_id":"2b234c968d5a41e587184cd97e9a1453","text":"A pregnancy test, where applicable, must be performed within 7 days prior to randomization. Where post-menopausal","text_display":"A pregnancy test, where applicable, must be performed within 7 days prior to randomization. Where post-menopausal","confidence":1,"confidence_rate":1},{"cnt":[[825,783],[2455,783],[2455,817],[825,817]],"region":{"top_left_x":824,"top_left_y":783,"width":1632,"height":35},"line":34,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bb82f640d75f4f0b993ed9fcb3912dfb","type":"text","conversion_output":false,"parent_id":"2b234c968d5a41e587184cd97e9a1453","text":"status is clearly documented, a pregnancy test is not required (see inclusion and exclusion criteria for definition of post-","text_display":" status is clearly documented, a pregnancy test is not required (see inclusion and exclusion criteria for definition of 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Subjects will undergo EOT assessments as follows: For subjects, whose last regular study visit within 6 months (+45 days time window) prior to the PADCD was a yearly visit (eg, month 12, 24, etc), this visit will be considered an EOT visit. An antibody sample will be taken during the first visit of the Long-Term Follow-Up. All subjects, whose last regular study visit within 6 months ( +45 days time window) prior to the PADCD was a 6 months visit (eg, month 6,18 , etc), will have to attend the next regularly scheduled yearly study visit (eg, Q12M) within 6 months after PADCD at the latest and perform all corresponding assessments, including antibody sampling. Subjects who withdraw from IP prior tot he PADCD will continue to attend Q6M study visits for assessment of the primary and secondary end-point and safety until PADCD and will then enter the Long-Term Follow-Up; and subjects who withdraw full consent (=EOS) will have no further study assessments from that date forward. All adverse events and serious adverse events must be reported from signing of the ICF through 30 days after the last dose of Investigational Product.","text_display":"Treatment phase, Q12M visits: At PADCD, the last yearly visit will be considered the End of Treatment (EOT) visit. Subjects will undergo EOT assessments as follows: For subjects, whose last regular study visit within 6 months (+45 days time window) prior to the PADCD was a yearly visit (eg, month 12, 24, etc), this visit will be considered an EOT visit. An antibody sample will be taken during the first visit of the Long-Term Follow-Up. All subjects, whose last regular study visit within 6 months ( +45 days time window) prior to the PADCD was a 6 months visit (eg, month 6,18 , etc), will have to attend the next regularly scheduled yearly study visit (eg, Q12M) within 6 months after PADCD at the latest and perform all corresponding assessments, including antibody sampling. Subjects who withdraw from IP prior tot he PADCD will continue to attend Q6M study visits for assessment of the primary and secondary end-point and safety until PADCD and will then enter the Long-Term Follow-Up; and subjects who withdraw full consent (=EOS) will have no further study assessments from that date forward. All adverse events and serious adverse events must be reported from signing of the ICF through 30 days after the last dose of Investigational Product.","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.579315185546875,"confidence_rate":0.9994909985038938},{"cnt":[[825,1118],[2356,1118],[2356,1152],[825,1152]],"region":{"top_left_x":824,"top_left_y":1117,"width":1533,"height":35},"line":44,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9d87cd42338640438955a3a3f9fa01d1","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"Treatment phase, Q12M visits: At PADCD, the last yearly visit will be considered the End of Treatment (EOT) visit.","text_display":"Treatment phase, Q12M visits: At PADCD, the last yearly visit will be considered the End of Treatment (EOT) visit.","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[826,1154],[2457,1154],[2457,1192],[826,1192]],"region":{"top_left_x":826,"top_left_y":1153,"width":1632,"height":39},"line":45,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"a715c1005cb445c6bbcd3736c8f66cc9","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"Subjects will undergo EOT assessments as follows: For subjects, whose last regular study visit within 6 months (+45 days","text_display":" Subjects will undergo EOT assessments as follows: For subjects, whose last regular study visit within 6 months (+45 days","confidence":0.579315185546875,"confidence_rate":0.9957441709759136},{"cnt":[[825,1193],[2436,1193],[2436,1228],[825,1228]],"region":{"top_left_x":824,"top_left_y":1193,"width":1612,"height":35},"line":46,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"9133eb43489f48678c5669ecf35731c3","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"time window) prior to the PADCD was a yearly visit (eg, month 12, 24, etc), this visit will be considered an EOT visit. An","text_display":" time window) prior to the PADCD was a yearly visit (eg, month 12, 24, etc), this visit will be considered an EOT visit. An","confidence":0.8469021320343018,"confidence_rate":0.9986924293361333},{"cnt":[[826,1229],[2425,1229],[2425,1267],[826,1267]],"region":{"top_left_x":826,"top_left_y":1229,"width":1599,"height":39},"line":47,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"61adab87dc1c47f7883f829fd994ab8b","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"antibody sample will be taken during the first visit of the Long-Term Follow-Up. All subjects, whose last regular study","text_display":" antibody sample will be taken during the first visit of the Long-Term Follow-Up. 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Subjects who withdraw from IP prior tot he PADCD will","text_display":" all corresponding assessments, including antibody sampling. Subjects who withdraw from IP prior tot he PADCD will","confidence":1,"confidence_rate":1},{"cnt":[[826,1388],[2446,1388],[2446,1422],[826,1422]],"region":{"top_left_x":826,"top_left_y":1387,"width":1621,"height":35},"line":51,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e77571e9040540c4a01d580dd376afae","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"continue to attend Q6M study visits for assessment of the primary and secondary end-point and safety until PADCD and","text_display":" continue to attend Q6M study visits for assessment of the primary and secondary end-point and safety until PADCD and","confidence":1,"confidence_rate":1},{"cnt":[[826,1424],[2396,1424],[2396,1460],[826,1460]],"region":{"top_left_x":826,"top_left_y":1423,"width":1570,"height":37},"line":52,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"88beb077f2cd49dea0972d7243a428e5","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"will then enter the Long-Term Follow-Up; and subjects who withdraw full consent (=EOS) will have no further study","text_display":" will then enter the Long-Term Follow-Up; and subjects who withdraw full consent (=EOS) will have no further study","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[826,1463],[2477,1463],[2477,1498],[826,1498]],"region":{"top_left_x":826,"top_left_y":1463,"width":1651,"height":35},"line":53,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cdae79c36c904337abeadf4c9cb939d5","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"assessments from that date forward. All adverse events and serious adverse events must be reported from signing of the","text_display":" assessments from that date forward. All adverse events and serious adverse events must be reported from signing of the","confidence":1,"confidence_rate":1},{"cnt":[[826,1503],[1710,1503],[1710,1537],[826,1537]],"region":{"top_left_x":826,"top_left_y":1503,"width":885,"height":35},"line":54,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e10bf2ce0b18480ea24e16c2bf7a652d","type":"text","conversion_output":false,"parent_id":"e2e2538ed3484898a1382e07e9dd2bd1","text":"ICF through 30 days after the last dose of Investigational Product.","text_display":" ICF through 30 days after the last dose of Investigational Product.","confidence":1,"confidence_rate":1},{"cnt":[[200,1707],[200,1530],[2490,1533],[2490,1710]],"region":{"top_left_x":199,"top_left_y":1529,"width":2291,"height":182},"line":55,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cd0247eef7404477808b5390c425eafe","type":"table_spanning_cell","conversion_output":false,"parent_id":"ff211db158b74798b692752f16c474cc","children_ids":["4feb514ca89240f2b2f11ebde576697d"],"text":"","text_display":"\\begin{tabular}{l}\nLong-Term Follow-Up (LTFU): Subjects will be followed-up once a year (Q12M) for overall survival (OS) and disease-free survival (DFS) by clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until either approximately 66 months post PADCD, depending on an interim DFS analysis at PADCD. To avoid extensive simultaneous \\\\\n11 visits or contacts each year.\n\\end{tabular}","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[495,1542],[2472,1542],[2472,1691],[495,1691]],"region":{"top_left_x":495,"top_left_y":1542,"width":1977,"height":149},"line":56,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"4feb514ca89240f2b2f11ebde576697d","type":"complex_cell","conversion_output":false,"parent_id":"cd0247eef7404477808b5390c425eafe","children_ids":["1b2cf3f34e8d454ba16887ef87841678","5d77cbdcba774cdfbbac0b25dfec2b91","61010a6d61c946178ea0c0779834dbff","cb3abf2727ff451d9bbf823bc6e14422","fcfd2b6817b5475192aa61bb2ab247b2"],"text":"\\begin{tabular}{l}\nLong-Term Follow-Up (LTFU): Subjects will be followed-up once a year (Q12M) for overall survival (OS) and disease-free survival (DFS) by clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until either approximately 66 months post PADCD, depending on an interim DFS analysis at PADCD. To avoid extensive simultaneous \\\\\n11 visits or contacts each year.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nLong-Term Follow-Up (LTFU): Subjects will be followed-up once a year (Q12M) for overall survival (OS) and disease-free survival (DFS) by clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until either approximately 66 months post PADCD, depending on an interim DFS analysis at PADCD. To avoid extensive simultaneous \\\\\n11 visits or contacts each year.\n\\end{tabular}","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.9956073760986328,"confidence_rate":0.9999920411640292},{"cnt":[[826,1543],[2450,1543],[2450,1575],[826,1575]],"region":{"top_left_x":826,"top_left_y":1542,"width":1624,"height":33},"line":57,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"1b2cf3f34e8d454ba16887ef87841678","type":"text","conversion_output":false,"parent_id":"4feb514ca89240f2b2f11ebde576697d","text":"Long-Term Follow-Up (LTFU): Subjects will be followed-up once a year (Q12M) for overall survival (OS) and disease-free","text_display":"Long-Term Follow-Up (LTFU): Subjects will be followed-up once a year (Q12M) for overall survival (OS) and disease-free","confidence":0.9956073760986328,"confidence_rate":0.9999642095850512},{"cnt":[[826,1579],[2468,1579],[2468,1613],[826,1613]],"region":{"top_left_x":826,"top_left_y":1578,"width":1642,"height":35},"line":58,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"5d77cbdcba774cdfbbac0b25dfec2b91","type":"text","conversion_output":false,"parent_id":"4feb514ca89240f2b2f11ebde576697d","text":"survival (DFS) by clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until either","text_display":" survival (DFS) by clinic visits or telephone contacts starting from their last study visit (considered as EOT visit) until either","confidence":1,"confidence_rate":1},{"cnt":[[826,1618],[2472,1618],[2472,1652],[826,1652]],"region":{"top_left_x":826,"top_left_y":1618,"width":1646,"height":35},"line":59,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"61010a6d61c946178ea0c0779834dbff","type":"text","conversion_output":false,"parent_id":"4feb514ca89240f2b2f11ebde576697d","text":"approximately 66 months post PADCD, depending on an interim DFS analysis at PADCD. To avoid extensive simultaneous","text_display":" approximately 66 months post PADCD, depending on an interim DFS analysis at PADCD. To avoid extensive simultaneous","confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[495,1658],[533,1658],[533,1690],[495,1690]],"region":{"top_left_x":495,"top_left_y":1657,"width":38,"height":34},"line":60,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"cb3abf2727ff451d9bbf823bc6e14422","type":"text","conversion_output":false,"parent_id":"4feb514ca89240f2b2f11ebde576697d","text":"11","text_display":"\n11","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[826,1658],[1201,1658],[1201,1690],[826,1690]],"region":{"top_left_x":826,"top_left_y":1657,"width":375,"height":34},"line":61,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fcfd2b6817b5475192aa61bb2ab247b2","type":"text","conversion_output":false,"parent_id":"4feb514ca89240f2b2f11ebde576697d","text":"visits or contacts each year.","text_display":" visits or contacts each year.","confidence":1,"confidence_rate":1},{"cnt":[[495,1784],[533,1784],[533,1822],[495,1822]],"region":{"top_left_x":495,"top_left_y":1783,"width":38,"height":39},"line":62,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"bb04f488b9744f80a5054bdf80984437","type":"simple_cell","conversion_output":false,"parent_id":"ff211db158b74798b692752f16c474cc","text":"12","text_display":"12","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[825,1701],[2448,1701],[2448,1818],[825,1818]],"region":{"top_left_x":824,"top_left_y":1701,"width":1625,"height":117},"line":63,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e15cebf5cd2e44e4a1a7c7372bf215cb","type":"complex_cell","conversion_output":false,"parent_id":"ff211db158b74798b692752f16c474cc","children_ids":["f31d92224817491eb2aa620107181412","2f01a1b73ed24730a31d3acd9c1050fd","f506581c691f426292351b607bec8fff"],"text":"Early End of Study (EOS): the last formal visit or contact for a subject, or an unscheduled study visit in case of early withdrawal from study (withdrawal of informed consent). If a subject reaches EOS per protocol, the EOS visit will occur during the LTFU, and only a survival assessment (DFS, OS, BMFS) is required.","text_display":"Early End of Study (EOS): the last formal visit or contact for a subject, or an unscheduled study visit in case of early withdrawal from study (withdrawal of informed consent). If a subject reaches EOS per protocol, the EOS visit will occur during the LTFU, and only a survival assessment (DFS, OS, BMFS) is required.","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99658203125,"confidence_rate":0.9999908698460813},{"cnt":[[826,1705],[2367,1705],[2367,1739],[826,1739]],"region":{"top_left_x":826,"top_left_y":1704,"width":1542,"height":35},"line":64,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f31d92224817491eb2aa620107181412","type":"text","conversion_output":false,"parent_id":"e15cebf5cd2e44e4a1a7c7372bf215cb","text":"Early End of Study (EOS): the last formal visit or contact for a subject, or an unscheduled study visit in case of early","text_display":"Early End of Study (EOS): the last formal visit or contact for a subject, or an unscheduled study visit in case of early","confidence":0.99658203125,"confidence_rate":0.9999726097883223},{"cnt":[[826,1742],[2443,1742],[2443,1778],[826,1778]],"region":{"top_left_x":826,"top_left_y":1742,"width":1617,"height":37},"line":65,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"2f01a1b73ed24730a31d3acd9c1050fd","type":"text","conversion_output":false,"parent_id":"e15cebf5cd2e44e4a1a7c7372bf215cb","text":"withdrawal from study (withdrawal of informed consent). If a subject reaches EOS per protocol, the EOS visit will occur","text_display":" withdrawal from study (withdrawal of informed consent). If a subject reaches EOS per protocol, the EOS visit will occur","confidence":1,"confidence_rate":1},{"cnt":[[825,1782],[1858,1782],[1858,1814],[825,1814]],"region":{"top_left_x":824,"top_left_y":1782,"width":1034,"height":33},"line":66,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"f506581c691f426292351b607bec8fff","type":"text","conversion_output":false,"parent_id":"e15cebf5cd2e44e4a1a7c7372bf215cb","text":"during the LTFU, and only a survival assessment (DFS, OS, BMFS) is required.","text_display":" during the LTFU, and only a survival assessment (DFS, OS, BMFS) is 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\\multirow[b]{2}{*}{Study Assessments} & \\multicolumn{5}{|c|}{Open Label Phase - Subjects receiving open label denosumab} & \\multicolumn{2}{|c|}{Long Term Follow up - Subjects not receiving open label denosumab} \\\\\n\\hline & Visit 1 & Q6M Visits & Q12M visits & End of open label treatment & Q12M visits (after End of treatment) \\({ }^{ 1 }\\) & \\multirow[b]{3}{*}{\\begin{tabular}{l}\nStudy Assessments \\\\\nConcomitant Medications \\({ }^{3}\\)\n\\end{tabular}} & \\multirow[b]{2}{*}{Q12M visits} \\\\\n\\hline Investigational product administration \\({ }^{2}\\) & x & x & x & & & & \\\\\n\\hline Concomitant Medications \\({ }^{3}\\) & & & x & & x & & X \\\\\n\\hline Collection of (S)AEs of special interest (oral events) and SAEs \\({ }^{4}\\) & & x & x & x & & Clinical Fracture Recording \\({ }^{5}\\) & X \\\\\n\\hline Clinical Fracture Recording \\({ }^{5}\\) & & & x & & x & \\multirow[b]{3}{*}{\\begin{tabular}{l}\nSurvival (DFS, OS, BMFS) \\\\\nDXA \\({ }^{6}\\)\n\\end{tabular}} 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Adverse Event Assessments","text_display":"\n\n\\section*{Appendix B. Adverse Event Assessments}","confidence":1,"confidence_rate":1},{"cnt":[[365,363],[887,363],[887,421],[365,421]],"region":{"top_left_x":365,"top_left_y":363,"width":523,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32d65ccfa3094e4d92ceecf82bf4f88f","type":"section_header","conversion_output":false,"children_ids":["9e37011329ab448f8c3def97f1e3bf01"],"text":"","text_display":""},{"cnt":[[369,370],[883,365],[883,415],[370,420]],"region":{"top_left_x":369,"top_left_y":364,"width":515,"height":56},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e37011329ab448f8c3def97f1e3bf01","type":"text","conversion_output":true,"parent_id":"32d65ccfa3094e4d92ceecf82bf4f88f","text":"Adverse Event Relatedness","text_display":"\n\n\\section*{Adverse Event Relatedness}","confidence":1,"confidence_rate":1},{"cnt":[[370,453],[1867,453],[1867,505],[370,505]],"region":{"top_left_x":369,"top_left_y":453,"width":1498,"height":52},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d67a868947a481887531bec2e0fcdfc","type":"text","conversion_output":true,"text":"Is there a reasonable possibility that the event may have been caused by investigational","text_display":"\n\nIs there a reasonable possibility that the event may have been caused by investigational","confidence":1,"confidence_rate":1},{"cnt":[[370,520],[595,520],[595,569],[370,569]],"region":{"top_left_x":369,"top_left_y":519,"width":227,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ddbdbe3f8d64bd6a7d9088b8af9d1a4","type":"text","conversion_output":true,"text":"product? 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Moribund; fatal processes progressing rapidly.","text_display":"\n\\(10 \\%\\) - Moribund; fatal processes progressing rapidly.","confidence":0.5299301147460938,"confidence_rate":0.9887245826419608},{"cnt":[[434,1719],[728,1719],[728,1760],[434,1760]],"region":{"top_left_x":433,"top_left_y":1718,"width":296,"height":42},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2241845cab94fd1a9570a4105ea2576","type":"text","conversion_output":true,"text":"0\\% - Dead.","text_display":"\n0\\% - Dead.","confidence":0.996584415435791,"confidence_rate":0.9997719306124709},{"cnt":[[698,1848],[1665,1848],[1665,1897],[698,1897]],"region":{"top_left_x":698,"top_left_y":1847,"width":968,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59a09d5877874cda84499dcae7be1618","type":"text","conversion_output":true,"text":"Karnofsky Score of \\(100 \\%-90 \\%\\) corresponds to ECOG 0","text_display":"\n\nKarnofsky Score of \\(100 \\%-90 \\%\\) corresponds to ECOG 0","confidence":0.37127203097211403,"confidence_rate":0.9824623872062871},{"cnt":[[700,1895],[1663,1895],[1663,1940],[700,1940]],"region":{"top_left_x":700,"top_left_y":1894,"width":963,"height":47},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06ef05eff1364650b6f19aeb2feb437d","type":"text","conversion_output":true,"text":"Karnofsky Score of 80\\%-70\\% corresponds to ECOG 1","text_display":"\nKarnofsky Score of 80\\%-70\\% corresponds to ECOG 1","confidence":0.45130783796776086,"confidence_rate":0.9848163441993598},{"cnt":[[700,1938],[1669,1938],[1669,1983],[700,1983]],"region":{"top_left_x":700,"top_left_y":1937,"width":970,"height":47},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2d932befcff4099bdf8215a6f63c594","type":"text","conversion_output":true,"text":"Karnofsky Score of 60\\% - 50\\% corresponds to ECOG 2","text_display":"\nKarnofsky Score of 60\\% - 50\\% corresponds to ECOG 2","confidence":0.4843869209289551,"confidence_rate":0.9866661519503604},{"cnt":[[700,1981],[1669,1981],[1669,2026],[700,2026]],"region":{"top_left_x":700,"top_left_y":1980,"width":970,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6226c591608345309e41f21913086cfa","type":"text","conversion_output":true,"text":"Karnofsky Score of \\(40 \\%-30 \\%\\) corresponds to ECOG 3","text_display":"\nKarnofsky Score of \\(40 \\%-30 \\%\\) corresponds to ECOG 3","confidence":0.5169820785522461,"confidence_rate":0.9880762567557868},{"cnt":[[698,2024],[1669,2024],[1669,2073],[698,2073]],"region":{"top_left_x":698,"top_left_y":2023,"width":972,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a6aa0bebd1b4dbe9f03752756a78513","type":"text","conversion_output":true,"text":"Karnofsky Score of \\(20 \\%-10 \\%\\) corresponds to ECOG 4","text_display":"\nKarnofsky Score of \\(20 \\%-10 \\%\\) corresponds to ECOG 4","confidence":0.7127865552902222,"confidence_rate":0.9938630310522399},{"cnt":[[696,2071],[1669,2071],[1669,2116],[696,2116]],"region":{"top_left_x":696,"top_left_y":2071,"width":974,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67ed7e232e80416c851143aae5ba79de","type":"text","conversion_output":true,"text":"Karnofsky Score of 0\\% corresponds to ECOG 5","text_display":"\nKarnofsky Score of 0\\% corresponds to ECOG 5","confidence":0.9946331977844238,"confidence_rate":0.999885511762092},{"cnt":[[370,2649],[638,2649],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2649,"width":270,"height":39},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f619676863540fbaecd55ecda98caf4","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1884,2612],[1884,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":257,"height":72},"line":46,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"214ceb54b90d4c1fbb2690fb07da89f6","type":"page_info","conversion_output":false,"text":"","text_display":""}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-088","page":88,"lines":[{"cnt":[[372,64],[922,64],[922,105],[372,105]],"region":{"top_left_x":371,"top_left_y":64,"width":551,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be22be27f0c84ba791bcdc0720a7c606","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[372,105],[1029,105],[1029,142],[372,142]],"region":{"top_left_x":371,"top_left_y":105,"width":659,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a25b35e0a9064678846a2539998cfca4","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999871474379078},{"cnt":[[370,144],[690,144],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":143,"width":321,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"efbfb2f0bdc047eeb9485d25bcbcfb66","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9926898427074775,"confidence_rate":0.9997065627641366},{"cnt":[[1629,142],[1880,142],[1880,187],[1629,187]],"region":{"top_left_x":1628,"top_left_y":141,"width":252,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"821f53d129b44d079477e63a0e79673b","type":"page_info","conversion_output":false,"text":"Page 88 of 104","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[735,246],[1515,243],[1515,303],[735,305]],"region":{"top_left_x":734,"top_left_y":243,"width":781,"height":63},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49bff4a09d144984a7eca2742e30cbae","type":"section_header","conversion_output":false,"children_ids":["430a657d67234d5eb6b91698e0c82dde"],"text":"","text_display":""},{"cnt":[[739,251],[1510,251],[1510,299],[739,299]],"region":{"top_left_x":739,"top_left_y":251,"width":772,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"430a657d67234d5eb6b91698e0c82dde","type":"text","conversion_output":true,"parent_id":"49bff4a09d144984a7eca2742e30cbae","text":"Appendix F. Serious Adverse Event Form","text_display":"\n\n\\section*{Appendix F. Serious Adverse Event Form}","confidence":1,"confidence_rate":1},{"cnt":[[387,344],[1858,344],[1858,483],[387,483]],"region":{"top_left_x":386,"top_left_y":343,"width":1473,"height":141},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a60a75be9c044fbf864d00eedce8084f","type":"table","conversion_output":true,"text":"\\begin{tabular}{|c|c|c|l|}\n\\hline \\begin{tabular}{c} \nAMGEN \\\\\nABCSG-18 \\\\\n20050209\n\\end{tabular} & \\begin{tabular}{c} \nClinical Trial Serious Adverse Event Report - Phase 1-4 \\\\\nNothy Amern Windn 24 Hours of knowdedge of the event\n\\end{tabular} & \\begin{tabular}{l} \n- New \\\\\n- Follow-up\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|c|c|c|l|}\n\\hline \\begin{tabular}{c} \nAMGEN \\\\\nABCSG-18 \\\\\n20050209\n\\end{tabular} & \\begin{tabular}{c} \nClinical Trial Serious Adverse Event Report - Phase 1-4 \\\\\nNothy Amern Windn 24 Hours of knowdedge of the event\n\\end{tabular} & \\begin{tabular}{l} \n- New \\\\\n- Follow-up\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.031768461165422174,"confidence_rate":0.9853052549983204},{"cnt":[[385,507],[1861,507],[1861,2355],[385,2355]],"region":{"top_left_x":384,"top_left_y":507,"width":1477,"height":1848},"line":8,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e3d7fd0c30c140a289318b77ded72faf","type":"table","conversion_output":true,"children_ids":["65801598ad73487397ba07d8fb2ed465","0e0f60d1170c4e6f81ddafa48edddbd1","02f1066b36704c9e8bcd7a1c1c114483","c1697d5663e2416c999d5a8e41f91815","76f019153272420580f2e8d139a26d50","2425c750f0174d23a328a4129301adf5","d8a9fd78b3aa44bbbb075d0fe36c4406","a67e64c268bd4172b5d48c58c4f67327","e73904b3188b4a0bb67e3aa9d1d3f59a","627db381368d42c49fac33750c61b238","4548ca38fbd44e739f2206a921e35478","05c86949a2ab429187898b08e5ba922c","5b38c9453daa4515899d5b89e3183b3e","73520ea72d9347c990d8ed506ee44901","f4fe01d5bdd243d1acfc483d1274f75a","6bc2e06917ee485a967276c3a596df12","d39f53e278ff4737a8f1315d9253fe2b","e43c1e044ab44584aff2d69f558ae270","bb4e37c941394e83a06b083b939cc7f7","817f8ce86d06480fb635214b27969b00","790295d1270d4251ba6652c9306a4fe3","a244263dd4b449df96fe0834488cdc34","268ae6d3ba5748309ed610945c6fd317","6261fa7317184178bb9f3d3bc1996776","2dd00e16a5b04c54af4987c37da127c6","2a4f7c8007db4d89b7e768df9ce2a5cc","64f7965faecf4fc292b63bc14d7d20b9","51fc848945a14826aec14cd9d8e20efd","049264fe413c45dabbbf37c44ab0b10c","521e6a02378b46768defcf1024719edd","5c9ced977ec34408974350e709152290","fa59e18989b24578a88f651b8bb5fab0","ec4ff4a345764db0955676dc7219ca27","fa0cb147fe6149afb83721370454be85","e6e26dad437343178b7e50d8afa85bfa","aed462dc1f62464480baae6e115f00a3","ab788444792d486eaa9f2c2153846ab6","1088c845509e48ed9ad7f7febe905b40","8ddd3015a73c4db193cd6293cb02912a","5620e4b8a73a4dd08d687530dcd2d981","6bc154b08050466292e5f0d9e47015fd","6496bd2ca397431f8f1f1de347a08c68","bb9bf1a1d3a542abb3305555606bd457","7f91eb4cbbec4bedaa479d66e6f09d33","5338655a41d5409b8a5042f56082f765","b461f81da20446ff9123df30785fe380","3af2aa0da55a49d1a4d7a97ff679ee5b","96cef1c39005420ebf29efd9739e781c","7b6480b93db747b6ba919b9235a088bd","9fbf1b61ba0744108928ce4a4aac7dbf","5328a481781543dabc5b939c07378652","82a7671bcae44854a42c9cfd8f2e8d2f","afde0be4dfb0420cb53d80d34a6f23dd","c42d92664ef4437199e12a6f8bbbc859","7d34fbbc83894679a7929f5ac2f1e8bd","98fabcf354fc4c109a66c829a658d0e2","8457ce93a592475d8ba7cdd88aea5f14","804c16f49f7a4c43b54f5e196aec9fed","06c5a873b7004e61a6043617db3085c0","8e9651402edc45e39b2596e3be72bfc6","1da8bc11abcd404fae11b7d7ab42df7e","f514d3253ccb4fd8898ed3de8670d322","3cbe4948f4c04c2ea8414a882d02d8c9","63b688f35b2f457f9350440f3325925a","cc898468274e4834bd2e4ebc488ca55b","758ccbd6ed2844e4be4b31e4f7fccd0d","fd56194ccb664ebf916f964b1d766d74","656aec6ffad64687b50fd8368a345a65","a135ce1fd2964bb68d42a9d7ee212662","245b6f3dec7044d5b666b57aa0529a4c","78672989d2484268bbb1e82db2504a1d","7b344d191c8544cd8f03e9ba877c47f8","07abf217bd4b41938ce0e47f8d27690c","5135132c83eb433db6912bde22f864be","4ae7d5dabc8c4db1a929567694007cff","8d36494a43474a77977859ef65ac9b57","8bd8f52e21374003ada5cbdeecef3f79","eba77e86e3e648a49ef4cbecae6e55b4","3ce5567ca302441b8d22755161d05786","e76035799c234d1db7963dc4a729ce8c","b3cce57e83d64d99ba6a28a2e319a006","7c645ea2879c4eba9f51df659a4b889b","e4b01910c1c04fa6b06bfa49f26ce31a","61a198afacbc46ffbb4b7722cd02e2bb","7588a9f7484b4659b73bcd03d177f744","e0ab03dc8e70443999e7463a4fbc98ed","67a86cfffaa743bab82b39a702d53fe7","e2e543e20bb7408395d54dd882da137b","a4db03ab8bff4822a86cdd3a9a648be8","9aa5820b20f247309b6c3e72c1af1c32","6ca234345d8f47a7b201bd46e7ca2293","09daf74aad7b486aaedaa5e155b7329f","f42441645210449dad67b82b905d2758","e2fed228ca614aab9c2aaf1b5a238b87","158f5fdd8b424b6fb5178adfa1a01111","9962b37321af4bdf94b0fa5adc07b5cb","c7d460fa443041e3a9573d094edb1bde","1f7fac8b56b74d798c061d6335be2419","f684fd818ca640aa98ea75dfbedb9188","8770238c37cb49358e72ac2756677671","ca39ccf4a82f440aa098b46c4fde440f","ee64a69de10c4a2d9f3d26d2dc978985","87e89532a03345378b4a75fda3e54d36","00fde8a028f24ad3a7cfe7b40b09827a","4f1046602c88430491c51a9a71319ba2","0872eceb0ed5474abbb7637b7f5f08a7","2173beff1f3c4177bb4cefba55313be1","1c72a47f8f5c4f68a62681e21517d097","5e98bd5b5dd5405c80e15c30fb13ddef","0f465add04884406bb3d2a61ccc179be","c13b467a1953452d8957bb1f53cae944","a8cb8e92e3fe4f259d59028d0bad4ac5","1921fda5adbc4138835306ac70e97ccd"],"text":"\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multicolumn{14}{|c|}{SELECT OR TYPE in A FAX\\#} \\\\\n\\hline \\multicolumn{14}{|c|}{1. SITE INFORMATION} \\\\\n\\hline Ste Number & \\multicolumn{3}{|c|}{\\multirow[t]{2}{*}{Investigato}} & \\multicolumn{5}{|c|}{\\multirow[t]{2}{*}{Country}} & \\multicolumn{5}{|c|}{Dete of Report} \\\\\n\\hline □\n□ & & & & & & & & & \\multicolumn{5}{|c|}{Dey Nath Yer} \\\\\n\\hline \\multicolumn{2}{|c|}{\\multirow[t]{2}{*}{Reporte}} & \\multicolumn{7}{|c|}{Phane Number} & \\multicolumn{5}{|c|}{Fex Number} \\\\\n\\hline & & ( ) & \\multicolumn{6}{|c|}{} & \\multicolumn{5}{|c|}{)} \\\\\n\\hline \\multicolumn{14}{|c|}{2 SUBJECT INFORMATION} \\\\\n\\hline Bulject ID Number & \\multicolumn{4}{|c|}{Dese of Birth} & & \\multicolumn{2}{|l|}{\\multirow{2}{*}{Bex\nD= DM}} & \\multicolumn{6}{|c|}{\\multirow[t]{2}{*}{Race}} \\\\\n\\hline & \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nDey \\\\\nMarth \\\\\nYer\n\\end{tabular}} & & & & & & & & & \\\\\n\\hline \\multicolumn{14}{|r|}{3. SERIOU SADVER SE EVENT - Information in Dis Secrion must also be entered on the Serious Adverse Event Summary CRF} \\\\\n\\hline \\multicolumn{14}{|c|}{Provide the date the Investigator became aware of this Serious Adverse Event Intormatom: Day ___ Wombi___ Year__} \\\\\n\\hline \\begin{tabular}{l}\nBenous Adverse Bvent Daynons of Syndmme \\\\\nIt diagnosis is unknown, enter Signs / Symptoms \\\\\nWhen Final Diagnosis is known, enter 20 Adverse Event \\\\\nLos one evert perine. It evert is tras, enter the Cause of Deech. Entryof Death\" is not excepteble, esthis is an outcome\n\\end{tabular} & \\begin{tabular}{l}\nDey Warth Yer \\\\\nDate Started\n\\end{tabular} & \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nDate Ended \\\\\nDate Ended \\\\\nDey Warth Yer\n\\end{tabular}} & Chad: tnyr wart cammente batere Hytch तार & \\begin{tabular}{l}\nBTE Bloou can ade ade \\\\\n[m' ==181 sincers.\n\\end{tabular} & \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nRawartc I Trave monerable gembilly hat ha \"\n    want want rassbaer mayrawbaen auaichy P7: Pyss nection 10 NO No 1 - \\\\\nin\n\\end{tabular}} & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nRamokic I Rewerraxiable genelily hat he want may havebancidue \\(b_{y}\\) an ingunteria? i \\\\\n![](https://cdn.mathpix.com/cropped/88940421-b913-44fa-bdb0-aad11fa7af25-088.jpg?height=64\\&width=48\\&top_left_y=1136\\&top_left_x=1607)\n\\end{tabular}} & \\begin{tabular}{l}\nOuthoume \\\\\nOutwome of Event of Event \\\\\n01 Raxiac \\\\\nOT Resiac C Ruriving 02 Resiry OrNat 03, Nat \" ила B4Fral 04Falal\n\\end{tabular} & ![](https://cdn.mathpix.com/cropped/88940421-b913-44fa-bdb0-aad11fa7af25-088.jpg?height=178\\&width=99\\&top_left_y=933\\&top_left_x=1669) & Chabanion \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{14}{|c|}{\\multirow[t]{2}{*}{\\begin{tabular}{l}\n01 Fess immediately lie-treatening 04 Frolonged hospital zatton \\\\\nCrilarila: 02 immediately life-treatening 04 Frolonged hosptal zetion \\\\\n08 Congenlital aromay/bith defect. significant \\\\\nmedical hazed\n\\end{tabular}}} \\\\\n\\hline \\multicolumn{14}{|c|}{4. HOSPITALIZATION} \\\\\n\\hline \\multicolumn{4}{|c|}{} & Day & & \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nDate Admitted\nMonth \\\\\nMonth Year\n\\end{tabular}} & Dey & \\multicolumn{3}{|r|}{\\begin{tabular}{l}\nDate Discharged \\\\\nMonth \\\\\nYear\n\\end{tabular}} \\\\\n\\hline \\multicolumn{14}{|c|}{Wes subject hosplitallzed? TNo TYes, if yes, please complete dates):} \\\\\n\\hline \\multicolumn{14}{|c|}{5. INVESTIGATIONAL PRODUCT (IP)} \\\\\n\\hline & \\begin{tabular}{l}\nInitial Stat Date \\\\\nDay \\\\\nMonth \\\\\nYeer\n\\end{tabular} & & & & & & & & & & \\multicolumn{3}{|c|}{Adtion Taken with Product 01 8til being Admintetered 02 Pemenetly Iecartinued 08 Whined} \\\\\n\\hline <<|MP>>>\n-'r'Binded -V'Open Label & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{14}{|l|}{6. CONCOMITANT MEDICATIONS (eg, chemotherapy) Any Concomixt Medcatons? = No = Yes, Hyes, pease complexe:} \\\\\n\\hline Medioation Name(c) & \\begin{tabular}{l}\nStat Date \\\\\nDay Vet Vur\n\\end{tabular} & \\begin{tabular}{l}\nStop Date \\\\\nDay Vat Var\n\\end{tabular} & \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nCo-cispedt \\\\\nNC | Nor\n\\end{tabular}} & \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nContinuing \\\\\nno | |r|\n\\end{tabular}} & \\multicolumn{2}{|r|}{Dose} & \\multicolumn{2}{|c|}{Route} & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nTreatment \\\\\nFreq. \\\\\nMed \\\\\nH0-1900\n\\end{tabular}} \\\\\n\\hline & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{3}{|c|}{} & & & & & & & & & & & \\\\\n\\hline \\multicolumn{3}{|c|}{} & & & & & & & & & & & \\\\\n\\hline \\multicolumn{3}{|c|}{} & & & & & & & & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multicolumn{14}{|c|}{SELECT OR TYPE in A FAX\\#} \\\\\n\\hline \\multicolumn{14}{|c|}{1. SITE INFORMATION} \\\\\n\\hline Ste Number & \\multicolumn{3}{|c|}{\\multirow[t]{2}{*}{Investigato}} & \\multicolumn{5}{|c|}{\\multirow[t]{2}{*}{Country}} & \\multicolumn{5}{|c|}{Dete of Report} \\\\\n\\hline □\n□ & & & & & & & & & \\multicolumn{5}{|c|}{Dey Nath Yer} \\\\\n\\hline \\multicolumn{2}{|c|}{\\multirow[t]{2}{*}{Reporte}} & \\multicolumn{7}{|c|}{Phane Number} & \\multicolumn{5}{|c|}{Fex Number} \\\\\n\\hline & & ( ) & \\multicolumn{6}{|c|}{} & \\multicolumn{5}{|c|}{)} \\\\\n\\hline \\multicolumn{14}{|c|}{2 SUBJECT INFORMATION} \\\\\n\\hline Bulject ID Number & \\multicolumn{4}{|c|}{Dese of Birth} & & \\multicolumn{2}{|l|}{\\multirow{2}{*}{Bex\nD= DM}} & \\multicolumn{6}{|c|}{\\multirow[t]{2}{*}{Race}} \\\\\n\\hline & \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nDey \\\\\nMarth \\\\\nYer\n\\end{tabular}} & & & & & & & & & \\\\\n\\hline \\multicolumn{14}{|r|}{3. SERIOU SADVER SE EVENT - Information in Dis Secrion must also be entered on the Serious Adverse Event Summary CRF} \\\\\n\\hline \\multicolumn{14}{|c|}{Provide the date the Investigator became aware of this Serious Adverse Event Intormatom: Day ___ Wombi___ Year__} \\\\\n\\hline \\begin{tabular}{l}\nBenous Adverse Bvent Daynons of Syndmme \\\\\nIt diagnosis is unknown, enter Signs / Symptoms \\\\\nWhen Final Diagnosis is known, enter 20 Adverse Event \\\\\nLos one evert perine. It evert is tras, enter the Cause of Deech. Entryof Death\" is not excepteble, esthis is an outcome\n\\end{tabular} & \\begin{tabular}{l}\nDey Warth Yer \\\\\nDate Started\n\\end{tabular} & \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nDate Ended \\\\\nDate Ended \\\\\nDey Warth Yer\n\\end{tabular}} & Chad: tnyr wart cammente batere Hytch तार & \\begin{tabular}{l}\nBTE Bloou can ade ade \\\\\n[m' ==181 sincers.\n\\end{tabular} & \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nRawartc I Trave monerable gembilly hat ha \"\n    want want rassbaer mayrawbaen auaichy P7: Pyss nection 10 NO No 1 - \\\\\nin\n\\end{tabular}} & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nRamokic I Rewerraxiable genelily hat he want may havebancidue \\(b_{y}\\) an ingunteria? i \\\\\n![](https://cdn.mathpix.com/cropped/88940421-b913-44fa-bdb0-aad11fa7af25-088.jpg?height=64\\&width=48\\&top_left_y=1136\\&top_left_x=1607)\n\\end{tabular}} & \\begin{tabular}{l}\nOuthoume \\\\\nOutwome of Event of Event \\\\\n01 Raxiac \\\\\nOT Resiac C Ruriving 02 Resiry OrNat 03, Nat \" ила B4Fral 04Falal\n\\end{tabular} & ![](https://cdn.mathpix.com/cropped/88940421-b913-44fa-bdb0-aad11fa7af25-088.jpg?height=178\\&width=99\\&top_left_y=933\\&top_left_x=1669) & Chabanion \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{4}{|c|}{} & & & & & & & & & & \\\\\n\\hline \\multicolumn{14}{|c|}{\\multirow[t]{2}{*}{\\begin{tabular}{l}\n01 Fess immediately lie-treatening 04 Frolonged hospital zatton \\\\\nCrilarila: 02 immediately life-treatening 04 Frolonged hosptal zetion \\\\\n08 Congenlital aromay/bith defect. significant \\\\\nmedical hazed\n\\end{tabular}}} \\\\\n\\hline \\multicolumn{14}{|c|}{4. HOSPITALIZATION} \\\\\n\\hline \\multicolumn{4}{|c|}{} & Day & & \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nDate Admitted\nMonth \\\\\nMonth Year\n\\end{tabular}} & Dey & \\multicolumn{3}{|r|}{\\begin{tabular}{l}\nDate Discharged \\\\\nMonth \\\\\nYear\n\\end{tabular}} \\\\\n\\hline \\multicolumn{14}{|c|}{Wes subject hosplitallzed? TNo TYes, if yes, please complete dates):} \\\\\n\\hline \\multicolumn{14}{|c|}{5. INVESTIGATIONAL PRODUCT (IP)} \\\\\n\\hline & \\begin{tabular}{l}\nInitial Stat Date \\\\\nDay \\\\\nMonth \\\\\nYeer\n\\end{tabular} & & & & & & & & & & \\multicolumn{3}{|c|}{Adtion Taken with Product 01 8til being Admintetered 02 Pemenetly Iecartinued 08 Whined} \\\\\n\\hline <<|MP>>>\n-'r'Binded -V'Open Label & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{14}{|l|}{6. CONCOMITANT MEDICATIONS (eg, chemotherapy) Any Concomixt Medcatons? = No = Yes, Hyes, pease complexe:} \\\\\n\\hline Medioation Name(c) & \\begin{tabular}{l}\nStat Date \\\\\nDay Vet Vur\n\\end{tabular} & \\begin{tabular}{l}\nStop Date \\\\\nDay Vat Var\n\\end{tabular} & \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nCo-cispedt \\\\\nNC | Nor\n\\end{tabular}} & \\multicolumn{2}{|r|}{\\begin{tabular}{l}\nContinuing \\\\\nno | |r|\n\\end{tabular}} & \\multicolumn{2}{|r|}{Dose} & \\multicolumn{2}{|c|}{Route} & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nTreatment \\\\\nFreq. \\\\\nMed \\\\\nH0-1900\n\\end{tabular}} \\\\\n\\hline & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{3}{|c|}{} & & & & & & & & & & & \\\\\n\\hline \\multicolumn{3}{|c|}{} & & & & & & & & & & & \\\\\n\\hline \\multicolumn{3}{|c|}{} & & & & & & & & & & & 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30 sites in Austria are anticipated to participate in the ZA","text_display":"\n\nApproximately 30 sites in Austria are anticipated to participate in the ZA","confidence":0.9975607387024183,"confidence_rate":0.999970217014959},{"cnt":[[370,2054],[569,2054],[569,2099],[370,2099]],"region":{"top_left_x":369,"top_left_y":2053,"width":201,"height":47},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1d923d9f7ca40d9a15bc5e57aaf5267","type":"text","conversion_output":true,"text":"extension.","text_display":" 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Based on this study, a","confidence":0.7624949903426957,"confidence_rate":0.9971794088986835},{"cnt":[[370,1298],[1790,1298],[1790,1347],[370,1347]],"region":{"top_left_x":369,"top_left_y":1297,"width":1421,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc652ff688a04bab9f6f19d1140eac28","type":"text","conversion_output":true,"text":"\\(5 \\%\\) (SD \\(-4.3 \\%\\) ), \\(5.2 \\%\\) (SD \\(-2.6 \\%\\) ), and \\(3.9 \\%\\) (SD \\(-3.8 \\%\\) ) decrease in the lumbar","text_display":" \\(5 \\%\\) (SD \\(-4.3 \\%\\) ), \\(5.2 \\%\\) (SD \\(-2.6 \\%\\) ), and \\(3.9 \\%\\) (SD \\(-3.8 \\%\\) ) decrease in the lumbar","confidence":0.2883792738666759,"confidence_rate":0.9871306242604598},{"cnt":[[370,1362],[1824,1362],[1824,1412],[370,1412]],"region":{"top_left_x":369,"top_left_y":1362,"width":1456,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8c5d48622954758958c29e4e19859d9","type":"text","conversion_output":true,"text":"spine, total hip, and femoral neck BMD was seen during the 2 years after denesumab","text_display":" spine, total hip, and femoral neck BMD was seen during the 2 years after denesumab","confidence":0.5155492506422437,"confidence_rate":0.9926656680007784},{"cnt":[[370,1431],[870,1431],[870,1480],[370,1480]],"region":{"top_left_x":369,"top_left_y":1430,"width":502,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"46088c1344e4455baa7bf6ff5ec12289","type":"text","conversion_output":true,"text":"discontinuation (data on file).","text_display":" discontinuation (data on file).","confidence":0.9500928146645077,"confidence_rate":0.9985789107185489},{"cnt":[[370,1517],[1858,1517],[1858,1566],[370,1566]],"region":{"top_left_x":369,"top_left_y":1516,"width":1490,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cab7d0989c94aac921f333194e6e21d","type":"text","conversion_output":true,"text":"A paper reporting 22 case studies of postmenopausal women who received 5 injections","text_display":"\n\nA paper reporting 22 case studies of postmenopausal women who received 5 injections","confidence":0.8747076346014312,"confidence_rate":0.9985769116334028},{"cnt":[[370,1581],[1867,1581],[1867,1631],[370,1631]],"region":{"top_left_x":369,"top_left_y":1581,"width":1498,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a999ed1c10eb4b66a3ec3b99fa8cfe60","type":"text","conversion_output":true,"text":"(approximately 2.5 years) of denosumab 60 mg Q6M and were then given a single dese","text_display":" (approximately 2.5 years) of denosumab 60 mg Q6M and were then given a single dese","confidence":0.6111797473897695,"confidence_rate":0.9948306266201647},{"cnt":[[1925,1119],[2052,1119],[2052,1635],[1925,1635]],"region":{"top_left_x":1925,"top_left_y":1119,"width":127,"height":516},"line":23,"column":0,"font_size":88,"is_printed":true,"is_handwritten":false,"id":"a0106ff5e8594ea3a58bddca7081abf3","type":"page_info","conversion_output":false,"text":"","text_display":""},{"cnt":[[370,1646],[1785,1646],[1785,1697],[370,1697]],"region":{"top_left_x":369,"top_left_y":1645,"width":1417,"height":53},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"60995337245b4babbc3557ecbfb31b7e","type":"text","conversion_output":true,"text":"of ZA 6 months after the fifth injection (Lehmann and Aeberli, 2017). A \\(3.8 \\%\\) (SD =","text_display":" of ZA 6 months after the fifth injection (Lehmann and Aeberli, 2017). A \\(3.8 \\%\\) (SD =","confidence":0.9142827730241396,"confidence_rate":0.9990368579290375},{"cnt":[[370,1710],[1850,1710],[1850,1764],[370,1764]],"region":{"top_left_x":369,"top_left_y":1710,"width":1481,"height":54},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"481cf234b6804d589a88b200f96a83be","type":"text","conversion_output":true,"text":"\\(2.8 \\%), 1.7 \\%(S D=3.3 \\%)\\), and \\(0.6 \\%(S D=5 \\%)\\) decrease in the lumbar spine, total hip,","text_display":" \\(2.8 \\%), 1.7 \\%(S D=3.3 \\%)\\), and \\(0.6 \\%(S D=5 \\%)\\) decrease in the lumbar spine, total hip,","confidence":0.975237872918661,"confidence_rate":0.9997050568511507},{"cnt":[[370,1779],[1867,1779],[1867,1830],[370,1830]],"region":{"top_left_x":369,"top_left_y":1778,"width":1498,"height":53},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"003da1a62b0a48f5bf47843288e94895","type":"text","conversion_output":true,"text":"and femeral neck BMD was seen during the 2.5 years after denesumab discontinuation.","text_display":" and femeral neck BMD was seen during the 2.5 years after denesumab discontinuation.","confidence":0.7579410122867682,"confidence_rate":0.9969590318578336},{"cnt":[[370,1865],[1835,1865],[1835,1916],[370,1916]],"region":{"top_left_x":369,"top_left_y":1864,"width":1466,"height":53},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96a39187cafe4ce89cf50802651d1c08","type":"text","conversion_output":true,"text":"A table showing the level of precision (ie, half width of \\(95 \\%\\) CI) for each treatment arm","text_display":"\n\nA table showing the level of precision (ie, half width of \\(95 \\%\\) CI) for each treatment arm","confidence":0.3367011993007747,"confidence_rate":0.988724885652156},{"cnt":[[370,1934],[1738,1934],[1738,1983],[370,1983]],"region":{"top_left_x":369,"top_left_y":1933,"width":1370,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fcfa6164cb494a7ebb2abb00c84aa7ca","type":"text","conversion_output":true,"text":"and each BMD type for different sample sizes, calculated based on the standard","text_display":" and each BMD type for different sample sizes, calculated based on the standard","confidence":0.9819733832318889,"confidence_rate":0.9997808544297925},{"cnt":[[370,1998],[1699,1998],[1699,2047],[370,2047]],"region":{"top_left_x":369,"top_left_y":1998,"width":1331,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"413eeae579714b659592b1093bd91f32","type":"text","conversion_output":true,"text":"deviations estimated from the 2 studies mentioned above, is presented below.","text_display":" deviations estimated from the 2 studies mentioned above, is presented below.","confidence":0.9340202035395031,"confidence_rate":0.9991877442276428},{"cnt":[[370,2647],[638,2647],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2646,"width":270,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d76c419d6e574368979b30d5827323d8","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2617],[1878,2617],[1878,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2616,"width":250,"height":68},"line":31,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"03c706ee357542dfaa4ffc3cd33e57c5","type":"page_info","conversion_output":false,"text":"","text_display":""}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-156","page":156,"lines":[{"cnt":[[372,64],[922,64],[922,105],[372,105]],"region":{"top_left_x":371,"top_left_y":64,"width":551,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"844ec222a8fa408ea48cfa502cdfde22","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,103],[1029,103],[1029,144],[370,144]],"region":{"top_left_x":369,"top_left_y":103,"width":661,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fda8c583a0e2467489ddddf7e501551e","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.998046875,"confidence_rate":0.9999485530382876},{"cnt":[[372,142],[690,142],[690,187],[372,187]],"region":{"top_left_x":371,"top_left_y":141,"width":319,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21ce2060c70d406094f4bb7621e614b0","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.934207632089965,"confidence_rate":0.9972814395446233},{"cnt":[[1650,142],[1876,142],[1876,187],[1650,187]],"region":{"top_left_x":1650,"top_left_y":141,"width":226,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d66f6be8ad7b45f880c76a14aa7a31ea","type":"page_info","conversion_output":false,"text":"Page 52 of 71","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[920,279],[1330,279],[1330,331],[920,331]],"region":{"top_left_x":919,"top_left_y":279,"width":411,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fa9819204f14792aa2e5fd8cec73094","type":"figure_label","conversion_output":false,"text":"Table 2. 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Sample Sizes}\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline \\multirow[b]{3}{*}{Number of subjects in each arm} & \\multicolumn{6}{|c|}{Precision (half width of \\(95 \\%\\) confidence interval)} \\\\\n\\hline & \\multicolumn{3}{|c|}{Standard of Gare} & \\multicolumn{3}{|c|}{IV zoledronio acid} \\\\\n\\hline & Lumbar Spine & Fotal Hip & Femeral Neck & Lumbar Spine & Fotal Hip & Femeral Neck \\\\\n\\hline 75 & \\(\\pm 1.0 \\%\\) & \\(\\pm 0.6 \\%\\) & ± 0.9\\% & \\(\\pm 0.6 \\%\\) & \\(\\pm 0.8 \\%\\) & \\(\\pm 1.1 \\%\\) \\\\\n\\hline 100 & \\(\\pm 0.9 \\%\\) & \\(\\pm 0.5 \\%\\) & \\(\\pm 0.7 \\%\\) & \\(\\pm 0.5 \\%\\) & \\(\\pm 0.7 \\%\\) & \\#1.0\\% \\\\\n\\hline 125 & \\(\\pm 0.8 \\%\\) & \\(\\pm 0.5 \\%\\) & \\(\\pm 0.7 \\%\\) & \\(\\pm 0.5 \\%\\) & \\(\\pm 0.6 \\%\\) & \\(\\pm 0.9 \\%\\) 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Subjects who have undergone a hysterectomy do","text_display":" \\(7\\) days prior to randomization. Subjects who have undergone a hysterectomy do","confidence":0.8407492637634277,"confidence_rate":0.9979122810694372},{"cnt":[[370,1482],[904,1482],[904,1532],[370,1532]],"region":{"top_left_x":369,"top_left_y":1482,"width":536,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9883c64ff88a48eaac39631dc023e2e1","type":"text","conversion_output":true,"text":"not require a pregnancy test.","text_display":" not require a pregnancy test.","confidence":1,"confidence_rate":1},{"cnt":[[367,2157],[1729,2157],[1729,2206],[367,2206]],"region":{"top_left_x":367,"top_left_y":2157,"width":1363,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05a763f6129744efa7e7b4c0c990e637","type":"text","conversion_output":true,"text":"Additionally, subjects will have lab assessments to determine eligibility as","text_display":"\n\nAdditionally, subjects will have lab assessments to determine eligibility as","confidence":1,"confidence_rate":1},{"cnt":[[370,2221],[724,2221],[724,2267],[370,2267]],"region":{"top_left_x":369,"top_left_y":2221,"width":356,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"061d33afbf2446dca7262659a4a4f501","type":"text","conversion_output":true,"text":"outlined in Table 2.","text_display":" outlined in Table 2.","confidence":1,"confidence_rate":1},{"cnt":[[370,2647],[638,2647],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2646,"width":270,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0220c91ddd54c8687ef2be9c8c696b5","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1880,2612],[1880,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":252,"height":72},"line":18,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"3cbedff8f63c4505abace0edd3fe6890","type":"page_info","conversion_output":false,"text":"AMGEN \\({ }^{\\circ}\\)","text_display":"","confidence":0.6495602719951421,"confidence_rate":0.9763150177715401}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-169","page":169,"lines":[{"cnt":[[370,64],[922,64],[922,105],[370,105]],"region":{"top_left_x":369,"top_left_y":64,"width":553,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71ac0de539df46118a2a62af15b9f09e","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[372,103],[1029,103],[1029,144],[372,144]],"region":{"top_left_x":371,"top_left_y":103,"width":659,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d66253d9894b4891bafdb12ecaed29e4","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999742887608599},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"830c330f02f84838a7431197ed2ceb7f","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9089791867882013,"confidence_rate":0.9961899534407793},{"cnt":[[1650,142],[1876,142],[1876,187],[1650,187]],"region":{"top_left_x":1650,"top_left_y":141,"width":226,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04b8215a7d9d4efeaed1e42ffb882df9","type":"page_info","conversion_output":false,"text":"Page 65 of 71","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[507,245],[1742,245],[1742,303],[507,303]],"region":{"top_left_x":507,"top_left_y":244,"width":1236,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d84a7e2ad19643f89a47fd30db1b40ac","type":"figure_label","conversion_output":false,"text":"Table 2. 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Based on this study, a 5\\% (SD = 4.3\\%), 5.2\\% (SD = 2.6\\%), and 3.9\\%","text_display":" 24 months. Based on this study, a 5\\% (SD = 4.3\\%), 5.2\\% (SD = 2.6\\%), and 3.9\\%","confidence":0.5608541582512098,"confidence_rate":0.9927973843802061},{"cnt":[[370,2402],[1811,2402],[1811,2456],[370,2456]],"region":{"top_left_x":369,"top_left_y":2401,"width":1443,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3ed5e6f9fa143b7a46d2b95abfbbe61","type":"text","conversion_output":true,"text":"(SD \\(=3.8 \\%\\) ) decrease in the lumbar spine, total hip, and femoral neck BMD was","text_display":" (SD \\(=3.8 \\%\\) ) decrease in the lumbar spine, total hip, and femoral neck BMD was","confidence":0.8979761444993528,"confidence_rate":0.9987347801701485},{"cnt":[[370,2471],[1669,2471],[1669,2520],[370,2520]],"region":{"top_left_x":369,"top_left_y":2470,"width":1301,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08d1726154d7429d97563b153a6cf0fa","type":"text","conversion_output":true,"text":"seen during the \\(2\\) years after denosumab discontinuation (data on file).","text_display":" seen during the \\(2\\) years after denosumab discontinuation (data on file).","confidence":0.9951193332672119,"confidence_rate":0.99994033573019},{"cnt":[[370,2647],[638,2647],[638,2688],[370,2688]],"region":{"top_left_x":369,"top_left_y":2646,"width":270,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98f0156479264654b8b627c10e6614be","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2612],[1884,2612],[1884,2683],[1629,2683]],"region":{"top_left_x":1628,"top_left_y":2612,"width":257,"height":72},"line":27,"column":0,"font_size":70,"is_printed":true,"is_handwritten":false,"id":"8a5561c92931457a8afe7a4a100717b8","type":"page_info","conversion_output":false,"text":"AMGEN \\({ }^{\\circ}\\)","text_display":"","confidence":0.8537760209292173,"confidence_rate":0.9912558769419763}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"88940421-b913-44fa-bdb0-aad11fa7af25-171","page":171,"lines":[{"cnt":[[370,64],[922,64],[922,105],[370,105]],"region":{"top_left_x":369,"top_left_y":64,"width":553,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52fd05ed545f4a7ead335ab6345e5754","type":"page_info","conversion_output":false,"text":"Product: Denosumab (AMG 162)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,103],[1033,103],[1033,144],[370,144]],"region":{"top_left_x":369,"top_left_y":103,"width":665,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f07d7a77c7454f2a8b79c738e9412097","type":"page_info","conversion_output":false,"text":"Protocol Number: 20050209/ABCSG 18","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999356759809369},{"cnt":[[370,142],[690,142],[690,187],[370,187]],"region":{"top_left_x":369,"top_left_y":141,"width":321,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14a28592695f42bfa8580a9f350024f0","type":"page_info","conversion_output":false,"text":"Date: 15 July 2019","text_display":"","confidence":0.9113596491515636,"confidence_rate":0.9962941765905982},{"cnt":[[1650,142],[1876,142],[1876,187],[1650,187]],"region":{"top_left_x":1650,"top_left_y":141,"width":226,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d234765a7efb48238f34d88aa6bdf1ba","type":"page_info","conversion_output":false,"text":"Page 67 of 71","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,249],[1749,249],[1749,301],[370,301]],"region":{"top_left_x":369,"top_left_y":249,"width":1380,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7841d9a2bc024bd9a36fd5d172ab06c8","type":"text","conversion_output":true,"text":"A paper reporting 22 case studies of postmenopausal women who received","text_display":"\n\nA paper reporting 22 case studies of postmenopausal women who received","confidence":1,"confidence_rate":1},{"cnt":[[370,314],[1813,314],[1813,367],[370,367]],"region":{"top_left_x":369,"top_left_y":313,"width":1445,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ecd65c9a4c64315af6daafd4ca450ad","type":"text","conversion_output":true,"text":"5 injections (approximately 2.5 years) of denosumab 60 mg Q6M and were then","text_display":" 5 injections (approximately 2.5 years) of denosumab 60 mg Q6M and were then","confidence":0.9878253936767578,"confidence_rate":0.9998592130849695},{"cnt":[[370,382],[1433,382],[1433,434],[370,434]],"region":{"top_left_x":369,"top_left_y":382,"width":1065,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f22a48249b2345ceb762cf7b3d24392d","type":"text","conversion_output":true,"text":"given a single dose of ZA 6 months after the fifth injection","text_display":" given a single dose of ZA 6 months after the fifth injection","confidence":1,"confidence_rate":1},{"cnt":[[370,447],[1695,447],[1695,501],[370,501]],"region":{"top_left_x":369,"top_left_y":446,"width":1327,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3a8a7eb0a37450cbde4a02a522b2b1c","type":"text","conversion_output":true,"text":"(Lehmann and Aeberli, 2017). A 3.8\\% (SD = 2.8\\%), 1.7\\% (SD = 3.3\\%), and","text_display":" (Lehmann and Aeberli, 2017). A 3.8\\% (SD = 2.8\\%), 1.7\\% (SD = 3.3\\%), and","confidence":0.6405877447332387,"confidence_rate":0.9940793409529775},{"cnt":[[370,511],[1876,511],[1876,565],[370,565]],"region":{"top_left_x":369,"top_left_y":511,"width":1507,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d5ebbf2ce6241a1825528ee57796d71","type":"text","conversion_output":true,"text":"\\(0 . 6 \\% ( S D = 5 \\% )\\) decrease in the lumbar spine, total hip, and femoral neck BMD was","text_display":" \\(0 . 6 \\% ( S D = 5 \\% )\\) decrease in the lumbar spine, total hip, and femoral neck BMD was","confidence":0.5884550504738912,"confidence_rate":0.9946582099392186},{"cnt":[[370,580],[1463,580],[1463,629],[370,629]],"region":{"top_left_x":369,"top_left_y":580,"width":1095,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebb99ce190704f50a219e50b883a2212","type":"text","conversion_output":true,"text":"seen during the \\(2 . 5\\) years after denosumab discontinuation.","text_display":" seen during the \\(2 . 5\\) years after denosumab discontinuation.","confidence":0.99951171875,"confidence_rate":0.9999929217569623},{"cnt":[[370,666],[1858,666],[1858,715],[370,715]],"region":{"top_left_x":369,"top_left_y":666,"width":1490,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f613be4012a478aaf49b9f115e95ece","type":"text","conversion_output":true,"text":"A table showing the level of precision (ie, half width of \\(9 5 \\% C I\\) ) for each treatment","text_display":"\n\nA table showing the level of precision (ie, half width of \\(9 5 \\% C I\\) ) for each treatment","confidence":0.6595337024560659,"confidence_rate":0.9956282974641555},{"cnt":[[370,730],[1738,730],[1738,784],[370,784]],"region":{"top_left_x":369,"top_left_y":730,"width":1370,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ada06e80fad4caa968eb0189a80150d","type":"text","conversion_output":true,"text":"arm and each BMD type for different sample sizes, calculated based on the","text_display":" arm and each BMD type for different sample sizes, calculated based on the","confidence":1,"confidence_rate":1},{"cnt":[[370,797],[1841,797],[1841,849],[370,849]],"region":{"top_left_x":369,"top_left_y":797,"width":1473,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9797586ddc7f44be963bb8c9dffb2488","type":"text","conversion_output":true,"text":"standard deviations estimated from the 2 studies mentioned above, is presented","text_display":" standard deviations estimated from the 2 studies mentioned above, is presented","confidence":0.92822265625,"confidence_rate":0.9991342860668254},{"cnt":[[370,864],[501,864],[501,909],[370,909]],"region":{"top_left_x":369,"top_left_y":863,"width":132,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b50c78575de4b78a0703b90c38be296","type":"text","conversion_output":true,"text":"below.","text_display":" below.","confidence":1,"confidence_rate":1},{"cnt":[[913,980],[1334,980],[1334,1033],[913,1033]],"region":{"top_left_x":913,"top_left_y":979,"width":422,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39f507ae2a4b40c19149c385a6099e84","type":"figure_label","conversion_output":false,"text":"Table 3. 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Sample Sizes}\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline \\multirow[b]{3}{*}{Number of subjects in each arm} & \\multicolumn{6}{|c|}{Precision (half width of 95\\% confidence interval)} \\\\\n\\hline & \\multicolumn{3}{|c|}{Standard of care} & \\multicolumn{3}{|c|}{IV zoledronic acid} \\\\\n\\hline & Lumbar Spine & Total Hip & Femoral Neck & Lumbar Spine & Total Hip & Femoral Neck \\\\\n\\hline 75 & \\(\\pm 1.0 \\%\\) & \\(\\pm 0 . 6 \\%\\) & \\(\\pm 0.9 \\%\\) & \\(\\pm 0.6 \\%\\) & \\(\\pm 0.8 \\%\\) & \\(\\pm 1.1 \\%\\) \\\\\n\\hline 100 & \\(\\pm 0.9 \\%\\) & \\(\\pm 0.5 \\%\\) & \\(\\pm 0.7 \\%\\) & \\(\\pm 0.5 \\%\\) & \\(\\pm 0.7 \\%\\) & \\(\\pm 1 . 0 \\%\\) \\\\\n\\hline 125 & \\(\\pm 0.8 \\%\\) & \\(\\pm 0 . 5 \\%\\) & \\(\\pm 0.7 \\%\\) & \\(\\pm 0 . 5 \\%\\) & \\(\\pm 0.6 \\%\\) & \\(\\pm 0 . 9 \\%\\) 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Given the change in hazard ratio and the increase in","text_display":" from 128 subjects to 247 subjects. Given the change in hazard ratio and the increase in","confidence":1,"confidence_rate":1},{"cnt":[[370,1435],[1850,1435],[1850,1485],[370,1485]],"region":{"top_left_x":369,"top_left_y":1435,"width":1481,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"163f87c97bf04da68c2d6fee6e86f857","type":"text","conversion_output":true,"text":"the study duration the number of subjects to be enrolled has been increased from 2800","text_display":" the study duration the number of subjects to be enrolled has been increased from 2800","confidence":1,"confidence_rate":1},{"cnt":[[370,1480],[1706,1480],[1706,1528],[370,1528]],"region":{"top_left_x":369,"top_left_y":1480,"width":1337,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4e49be3ec3146f686548db2a23bd81b","type":"text","conversion_output":true,"text":"to 3400 . Based on the recruitment figures to date and the predictions of future","text_display":" to 3400 . Based on the recruitment figures to date and the predictions of future","confidence":1,"confidence_rate":1},{"cnt":[[370,1523],[1841,1523],[1841,1573],[370,1573]],"region":{"top_left_x":369,"top_left_y":1523,"width":1473,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"093101ad7a344d11b388f0d858af6427","type":"text","conversion_output":true,"text":"recruitment, the overall study duration is estimated to be 96 months, which includes an","text_display":" recruitment, the overall study duration is estimated to be 96 months, which includes an","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[370,1568],[1164,1568],[1164,1618],[370,1618]],"region":{"top_left_x":369,"top_left_y":1568,"width":796,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82672abfdd3e400aa8e17ff30d350582","type":"text","conversion_output":true,"text":"enrollment period of approximately 71 months.","text_display":" enrollment period of approximately 71 months.","confidence":0.99951171875,"confidence_rate":0.9999907849387211},{"cnt":[[365,1624],[675,1624],[675,1687],[365,1687]],"region":{"top_left_x":365,"top_left_y":1624,"width":310,"height":63},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d65bb7b83a648aabb94d4a54386df68","type":"section_header","conversion_output":false,"children_ids":["8bfdec4e8026437089e96fb024fff1bc"],"text":"","text_display":""},{"cnt":[[370,1633],[668,1633],[668,1682],[370,1682]],"region":{"top_left_x":369,"top_left_y":1632,"width":300,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bfdec4e8026437089e96fb024fff1bc","type":"text","conversion_output":true,"parent_id":"4d65bb7b83a648aabb94d4a54386df68","text":"Interim analysis","text_display":"\n\n\\section*{Interim analysis}","confidence":1,"confidence_rate":1},{"cnt":[[370,1697],[1553,1697],[1553,1747],[370,1747]],"region":{"top_left_x":369,"top_left_y":1697,"width":1185,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8190aac6b5e449e085e87263668e107d","type":"text","conversion_output":true,"text":"The interim analysis will be removed based on the following rationale:","text_display":"\n\nThe interim analysis will be removed based on the following rationale:","confidence":0.93603515625,"confidence_rate":0.9991190250449828},{"cnt":[[370,1764],[1876,1764],[1876,1815],[370,1815]],"region":{"top_left_x":369,"top_left_y":1763,"width":1507,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59885d6d21a741d8ac032038e0e1b492","type":"text","conversion_output":true,"text":"- Since this trial was started in December 2006, new data have emerged from phase 3","text_display":"\n- Since this trial was started in December 2006, new data have emerged from phase 3","confidence":1,"confidence_rate":1},{"cnt":[[432,1809],[1751,1809],[1751,1858],[432,1858]],"region":{"top_left_x":431,"top_left_y":1808,"width":1320,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f803f96eb0c0477698f1fc577292f752","type":"text","conversion_output":true,"text":"studies evaluating denosumab for impact on bone mineral density (BMD) and","text_display":" studies evaluating denosumab for impact on bone mineral density (BMD) and","confidence":0.99853515625,"confidence_rate":0.9999812063601604},{"cnt":[[430,1852],[1669,1852],[1669,1899],[430,1899]],"region":{"top_left_x":429,"top_left_y":1851,"width":1241,"height":49},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9512fbe96f454763a03d0cb9e2848c41","type":"text","conversion_output":true,"text":"fracture rate. These studies have demonstrated a consistent and similar","text_display":" fracture rate. These studies have demonstrated a consistent and similar","confidence":1,"confidence_rate":1},{"cnt":[[432,1895],[1781,1895],[1781,1944],[432,1944]],"region":{"top_left_x":431,"top_left_y":1894,"width":1351,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd5006d2da6242abb3801ee0826b4ca7","type":"text","conversion_output":true,"text":"improvement in BMD and/or in clinical fracture rate across all study populations","text_display":" improvement in BMD and/or in clinical fracture rate across all study populations","confidence":1,"confidence_rate":1},{"cnt":[[432,1938],[1790,1938],[1790,1987],[432,1987]],"region":{"top_left_x":431,"top_left_y":1937,"width":1359,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"551a517d7077443f84f5699e35b3895f","type":"text","conversion_output":true,"text":"(J Clin Oncol 2008;26:4875-82; N Engl J Med 2009;361:745-55; N Engl J Med","text_display":" (J Clin Oncol 2008;26:4875-82; N Engl J Med 2009;361:745-55; N Engl J Med","confidence":0.9603138724341989,"confidence_rate":0.9994809668276177},{"cnt":[[432,1985],[1863,1985],[1863,2035],[432,2035]],"region":{"top_left_x":431,"top_left_y":1985,"width":1432,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44d7357273734f70b451e38e49e53a5e","type":"text","conversion_output":true,"text":"2009;361:756-65). Therefore we anticipate that BMD and fracture rate will display a","text_display":" 2009;361:756-65). Therefore we anticipate that BMD and fracture rate will display a","confidence":0.9819650650024414,"confidence_rate":0.9997932083546311},{"cnt":[[432,2028],[1813,2028],[1813,2078],[432,2078]],"region":{"top_left_x":431,"top_left_y":2028,"width":1383,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ea3abd4f68840da9ca692bc563cb33d","type":"text","conversion_output":true,"text":"similar effect in this population and consequently the interim analysis is no longer","text_display":" similar effect in this population and consequently the interim analysis is no longer","confidence":0.900390625,"confidence_rate":0.9988217443289155},{"cnt":[[434,2073],[593,2073],[593,2121],[434,2121]],"region":{"top_left_x":433,"top_left_y":2073,"width":160,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fe8dcd76d7a44598093ff69aba42484","type":"text","conversion_output":true,"text":"required.","text_display":" 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fracture","text_display":" are typically based on a primary endpoint of subject incidence of new vertebral fracture","confidence":1,"confidence_rate":1},{"cnt":[[370,2402],[1794,2402],[1794,2449],[370,2449]],"region":{"top_left_x":369,"top_left_y":2401,"width":1425,"height":49},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f610b5dec757429a88284e1d7692eb10","type":"text","conversion_output":true,"text":"over a 36 months period (N Engl J Med 2009;361:745-55), and also recognizing the","text_display":" over a 36 months period (N Engl J Med 2009;361:745-55), and also recognizing the","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[370,2445],[1772,2445],[1772,2494],[370,2494]],"region":{"top_left_x":369,"top_left_y":2444,"width":1404,"height":51},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbf0311331304c1aa9820f4d69eb252c","type":"text","conversion_output":true,"text":"clinical importance of 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to","confidence":0.9990236759185791,"confidence_rate":0.9999886419133848},{"cnt":[[370,296],[1182,296],[1182,346],[370,346]],"region":{"top_left_x":369,"top_left_y":296,"width":813,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b039cedb00754079bfe929963a7a4781","type":"text","conversion_output":true,"text":"account for these clinically important outcomes:","text_display":" account for these clinically important outcomes:","confidence":0.99951171875,"confidence_rate":0.9999907849387211},{"cnt":[[370,361],[1807,361],[1807,410],[370,410]],"region":{"top_left_x":369,"top_left_y":360,"width":1438,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6e572f5e33a4fabb25113cc8cfe57b0","type":"text","conversion_output":true,"text":"- The endpoints \"subject incidence of new vertebral fracture at 12 and 24 months\",","text_display":"\n- The endpoints \"subject incidence of new vertebral fracture at 12 and 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