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inflammation markers) and the response to the drug \\\\\n- To evaluate potential associations of biomarkers (e.g., genetic variations or protein biomarkers measured at baseline) with drug response, and/or disease severity or disease progression \\\\\n- To explore the relationship between dosing (dose and regimen), cartilage structure, and clinical scores as a function of time, by means of modelling\n\\end{tabular} \\\\\n\\hline Trial Endpoints & \\begin{tabular}{l}\nPrimary \\\\\nChange from baseline in cartilage thickness in the total femorotibial joint as evaluated by MRI at 2 years \\\\\nSecondary \\\\\n- Changes from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and in the WOMAC pain, function, and stiffness index scores over 2 years \\\\\n- Change from baseline in the 20 -meter walk test over 2 years \\\\\n- Change from baseline in the Patient's Global Assessment (PGA) over 2 years \\\\\n- Change from baseline in minimal Joint Space Width (JSW) in the medial and lateral compartments as evaluated by X-ray over 2 years \\\\\n- Change from baseline in cartilage thickness in the medial and lateral compartments over 2 years \\\\\n- Change from baseline in cartilage volume in the medial and lateral compartments over 2 years \\\\\n- Synovial fluid levels of sprifermin/FGF-18 \\\\\n- Serum levels of sprifermin/FGF-18 \\\\\nSafety endpoints \\\\\n- Nature, incidence and severity of local and systemic Adverse Events (AEs). \\\\\n- Incidence of acute inflammatory reactions (AIRs), defined as increase of pain by 30 mm on a 100 mm visual analogue scale (VAS) and a self-\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n- To evaluate changes in quality of life (QOL) \\\\\n- To explore treatment effect on the knee joint and bone structures by MRI \\\\\n- To evaluate long-term treatment effects \\\\\n- To explore the relationship between the change 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synovial fluid effusion (i.e., joint swelling) within 3 days following i.a. injection (see Section 7.4.1.1 of the protocol) \\\\\n- Changes in laboratory safety parameters, vital signs, 12-lead electrocardiogram (ECG) parameters, weight, and physical examinations \\\\\n- Occurrence of binding and neutralizing antibodies to sprifermin/FGF-18 \\\\\nExploratory \\\\\n- Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) responder rate at 2 years \\\\\n- Patient Global Impression of Change (PGIC) over 2 years \\\\\n- Changes from baseline in the scores of the Knee Injury and Osteoarthritis Outcome Score quality of life subscale (KOOS QOL) and the SF-36 Medical Outcomes Study Short Form-36 General Health Survey (MOS SF-36 questionnaire) over 2 years \\\\\n- Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Index over 2 years \\\\\n- Change from baseline in Numerical Rating Scale (NRS) pain score in the target and 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Please see below for specification of dose groups (Trial Product).\n\\end{tabular} \\\\\n\\hline Number of Subjects & The trial will randomize approximately 545 subjects ( 109 per treatment group). \\\\\n\\hline Trial Product & \\begin{tabular}{l}\nSprifermin (also known as: recombinant human fibroblast growth factor 18 [rhFGF-18]; AS902330) 30 mcg or 100 mcg , administered intra-articularly (i.a.). \\\\\nSubjects will receive 4 cycles of treatment (each consisting of 3 once-weekly i.a. injections over 3 consecutive weeks) at intervals of 6 months. \\\\\nSubjects will be randomized in equal allocation to one of 5 treatment groups: \\\\\n- 4 cycles of sprifermin ( 100 mcg per injection, total dose 1200 mcg ) \\\\\n- 2 cycles of sprifermin ( 100 mcg per injection) alternating with 2 cycles of placebo (total dose 600 mcg ) \\\\\n- 4 cycles of sprifermin ( 30 mcg per injection, total dose 360 mcg ) \\\\\n- 2 cycles of sprifermin ( 30 mcg per injection) alternating with 2 cycles of placebo (total dose 180 mcg ) \\\\\n- 4 cycles of placebo (total dose 0 mcg )\n\\end{tabular} \\\\\n\\hline Treatment and Trial Duration & \\begin{tabular}{l}\nPlanned treatment duration is 2 years. \\\\\nFollow-up duration is 3 years.\n\\end{tabular} \\\\\n\\hline Trial Periods (if applicable) & \\begin{tabular}{l}\nThe screening period will comprise a period of 4 to 42 days during which a subject's eligibility will be determined, beginning at signature of the Informed Consent Form (ICF). \\\\\nDuring the screening visits, eligibility will be assessed and the target knee will be defined. At the baseline visit, eligibility will be confirmed, randomization will occur, and the first IMP injection will be given (Week 0/Visit 2). The last of the four cycles of 3 injections of IMP will begin on Week 78/Visit 17, and the last dose of IMP is scheduled to be administered at Week 80/Visit 19.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Trial Design & \\begin{tabular}{l}\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of sprifermin administered i.a. in subjects with primary OA of the knee and Kellgren-Lawrence (KL) grade 2 or 3. \\\\\nThe trial consists of a screening period lasting up to 42 days, a 2-year (104week) double-blind placebo-controlled (DBPC) treatment phase, which will start at randomization (Week 0/Visit 2) and a 3-year extended follow-up phase. Please see table 5 and 6 (Appendix E) in the clinical trial protocol. Please see below for specification of dose groups (Trial Product).\n\\end{tabular} \\\\\n\\hline Number of Subjects & The trial will randomize approximately 545 subjects ( 109 per treatment group). \\\\\n\\hline Trial Product & \\begin{tabular}{l}\nSprifermin (also known as: recombinant human fibroblast growth factor 18 [rhFGF-18]; AS902330) 30 mcg or 100 mcg , administered intra-articularly (i.a.). \\\\\nSubjects will receive 4 cycles of treatment (each consisting of 3 once-weekly i.a. injections over 3 consecutive weeks) at intervals of 6 months. \\\\\nSubjects will be randomized in equal allocation to one of 5 treatment groups: \\\\\n- 4 cycles of sprifermin ( 100 mcg per injection, total dose 1200 mcg ) \\\\\n- 2 cycles of sprifermin ( 100 mcg per injection) alternating with 2 cycles of placebo (total dose 600 mcg ) \\\\\n- 4 cycles of sprifermin ( 30 mcg per injection, total dose 360 mcg ) \\\\\n- 2 cycles of sprifermin ( 30 mcg per injection) alternating with 2 cycles of placebo (total dose 180 mcg ) \\\\\n- 4 cycles of placebo (total dose 0 mcg )\n\\end{tabular} \\\\\n\\hline Treatment and Trial Duration & \\begin{tabular}{l}\nPlanned treatment duration is 2 years. \\\\\nFollow-up duration is 3 years.\n\\end{tabular} \\\\\n\\hline Trial Periods (if applicable) & \\begin{tabular}{l}\nThe screening period will comprise a period of 4 to 42 days during which a subject's eligibility will be determined, beginning at signature of the Informed Consent Form (ICF). \\\\\nDuring the screening visits, eligibility will be assessed and the target knee will be defined. At the baseline visit, eligibility will be confirmed, randomization will occur, and the first IMP injection will be given (Week 0/Visit 2). 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Please see table 5 and 6 (Appendix E) in the clinical trial protocol. Please see below for specification of dose groups (Trial Product).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of sprifermin administered i.a. in subjects with primary OA of the knee and Kellgren-Lawrence (KL) grade 2 or 3. \\\\\nThe trial consists of a screening period lasting up to 42 days, a 2-year (104week) double-blind placebo-controlled (DBPC) treatment phase, which will start at randomization (Week 0/Visit 2) and a 3-year extended follow-up phase. Please see table 5 and 6 (Appendix E) in the clinical trial protocol. Please see below for specification of dose groups (Trial Product).\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.7512187957763672,"confidence_rate":0.999231424511665},{"cnt":[[582,324],[1848,324],[1848,373],[582,373]],"region":{"top_left_x":582,"top_left_y":324,"width":1267,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"191c22a7f638450c82ae6df89e30a21d","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"This is a multicenter, randomized, double-blind, placebo-controlled,","text_display":"This is a multicenter, randomized, double-blind, placebo-controlled,","confidence":1,"confidence_rate":1},{"cnt":[[582,373],[1848,373],[1848,420],[582,420]],"region":{"top_left_x":582,"top_left_y":373,"width":1267,"height":47},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9e4b1686d6d498e8644a12da4148bec","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"parallel-group Phase II trial of sprifermin administered i.a. in subjects with","text_display":" parallel-group Phase II trial of sprifermin administered i.a. in subjects with","confidence":1,"confidence_rate":1},{"cnt":[[582,422],[1704,422],[1704,469],[582,469]],"region":{"top_left_x":582,"top_left_y":422,"width":1122,"height":47},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c54cee55e3c4c34a87e5de544d9e02a","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"primary OA of the knee and Kellgren-Lawrence (KL) grade 2 or 3.","text_display":" primary OA of the knee and Kellgren-Lawrence (KL) grade 2 or 3.","confidence":0.8395251464253306,"confidence_rate":0.9977010827663355},{"cnt":[[582,510],[1846,510],[1846,559],[582,559]],"region":{"top_left_x":582,"top_left_y":509,"width":1264,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7c2ad0e265746f5810e0e6b9ca35f02","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"The trial consists of a screening period lasting up to 42 days, a 2-year (104-","text_display":"\nThe trial consists of a screening period lasting up to 42 days, a 2-year (104","confidence":0.99267578125,"confidence_rate":0.9999145249028433},{"cnt":[[582,559],[1846,559],[1846,605],[582,605]],"region":{"top_left_x":582,"top_left_y":558,"width":1264,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18dff734d48c45c5a3b5e88f6731a54c","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"week) double-blind placebo-controlled (DBPC) treatment phase, which will","text_display":"week) double-blind placebo-controlled (DBPC) treatment phase, which will","confidence":1,"confidence_rate":1},{"cnt":[[582,608],[1846,608],[1846,654],[582,654]],"region":{"top_left_x":582,"top_left_y":607,"width":1264,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b84471afdb8e488bae310078cecee14a","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"start at randomization (Week 0/Visit 2) and a 3-year extended follow-up","text_display":" start at randomization (Week 0/Visit 2) and a 3-year extended follow-up","confidence":0.7512187957763672,"confidence_rate":0.9962431492882313},{"cnt":[[582,657],[1846,657],[1846,703],[582,703]],"region":{"top_left_x":582,"top_left_y":656,"width":1264,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92080ccc486c4f9087da3aabf56e6c5d","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"phase. Please see table 5 and 6 (Appendix E) in the clinical trial protocol.","text_display":" phase. Please see table 5 and 6 (Appendix E) in the clinical trial protocol.","confidence":1,"confidence_rate":1},{"cnt":[[582,703],[1676,703],[1676,750],[582,750]],"region":{"top_left_x":582,"top_left_y":703,"width":1095,"height":47},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4637adf4e914dbf9e49cd015c7e4317","type":"text","conversion_output":false,"parent_id":"6a60a5108ac7439a97fc6e3e1cb584ab","text":"Please see below for specification of dose groups (Trial Product).","text_display":" Please see below for specification of dose groups (Trial 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alternating with 2 cycles of","text_display":"\n- 2 cycles of sprifermin ( 30 mcg per injection) alternating with 2 cycles of","confidence":0.9582220560405403,"confidence_rate":0.9995412263806782},{"cnt":[[631,1639],[1120,1639],[1120,1686],[631,1686]],"region":{"top_left_x":631,"top_left_y":1639,"width":489,"height":47},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1b566e2cc64401593f193a7e4bb8e4b","type":"text","conversion_output":false,"parent_id":"d388fcb8d12e414bb3fb14280f6c470c","text":"placebo (total dose 180 mcg )","text_display":" placebo (total dose 180 mcg )","confidence":1,"confidence_rate":1},{"cnt":[[582,1710],[1273,1710],[1273,1756],[582,1756]],"region":{"top_left_x":582,"top_left_y":1710,"width":691,"height":47},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78ac68f8f3424759b960d7e3bae10141","type":"text","conversion_output":false,"parent_id":"d388fcb8d12e414bb3fb14280f6c470c","text":"- 4 cycles of placebo (total dose 0 mcg )","text_display":"\n- 4 cycles of placebo (total dose 0 mcg )","confidence":0.984375,"confidence_rate":0.9997084062815639},{"cnt":[[260,1803],[541,1803],[541,1893],[260,1893]],"region":{"top_left_x":260,"top_left_y":1802,"width":282,"height":91},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea7b4e912abe43a184f37d93df8d120c","type":"complex_cell","conversion_output":false,"parent_id":"0d8981f8e8d0481ca8a8f3efbe9ce5c8","children_ids":["a9e2102b21f9459898020161019db390","8d837b649ed14b07a47d78bf99fcc6dc"],"text":"Treatment and Trial Duration","text_display":"Treatment and Trial Duration","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[266,1806],[539,1806],[539,1844],[266,1844]],"region":{"top_left_x":265,"top_left_y":1805,"width":274,"height":39},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9e2102b21f9459898020161019db390","type":"text","conversion_output":false,"parent_id":"ea7b4e912abe43a184f37d93df8d120c","text":"Treatment and","text_display":"Treatment and","confidence":1,"confidence_rate":1},{"cnt":[[266,1852],[536,1852],[536,1893],[266,1893]],"region":{"top_left_x":265,"top_left_y":1851,"width":271,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d837b649ed14b07a47d78bf99fcc6dc","type":"text","conversion_output":false,"parent_id":"ea7b4e912abe43a184f37d93df8d120c","text":"Trial Duration","text_display":" Trial 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years.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[582,1803],[1218,1803],[1218,1849],[582,1849]],"region":{"top_left_x":582,"top_left_y":1802,"width":637,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e01740f35ca449288f56fa2e985ab00","type":"text","conversion_output":false,"parent_id":"d72c65d6db464296ba79824807f4f7c6","text":"Planned treatment duration is 2 years.","text_display":"Planned treatment duration is 2 years.","confidence":1,"confidence_rate":1},{"cnt":[[582,1893],[1087,1893],[1087,1942],[582,1942]],"region":{"top_left_x":582,"top_left_y":1892,"width":506,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e4b5189aa60414996e0420d7ebb5d50","type":"text","conversion_output":false,"parent_id":"d72c65d6db464296ba79824807f4f7c6","text":"Follow-up duration is 3 years.","text_display":"\nFollow-up duration is 3 years.","confidence":1,"confidence_rate":1},{"cnt":[[260,1983],[525,1983],[525,2084],[260,2084]],"region":{"top_left_x":260,"top_left_y":1982,"width":266,"height":102},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80e868eefebc4bde80a12f9a1d6ce8f1","type":"complex_cell","conversion_output":false,"parent_id":"0d8981f8e8d0481ca8a8f3efbe9ce5c8","children_ids":["bf5f1f2da3214a709c8cb6109c9441f8","4841395f45114a4093311a035f859a6d"],"text":"Trial Periods (if applicable)","text_display":"Trial Periods (if applicable)","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[266,1988],[509,1988],[509,2024],[266,2024]],"region":{"top_left_x":265,"top_left_y":1988,"width":244,"height":36},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf5f1f2da3214a709c8cb6109c9441f8","type":"text","conversion_output":false,"parent_id":"80e868eefebc4bde80a12f9a1d6ce8f1","text":"Trial 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target knee will be defined. At the baseline visit, eligibility will be confirmed, randomization will occur, and the first IMP injection will be given (Week 0/Visit 2). The last of the four cycles of 3 injections of IMP will begin on Week 78/Visit 17, and the last dose of IMP is scheduled to be administered at Week 80/Visit 19.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe screening period will comprise a period of 4 to 42 days during which a subject's eligibility will be determined, beginning at signature of the Informed Consent Form (ICF). \\\\\nDuring the screening visits, eligibility will be assessed and the target knee will be defined. At the baseline visit, eligibility will be confirmed, randomization will occur, and the first IMP injection will be given (Week 0/Visit 2). The last of the four cycles of 3 injections of IMP will begin on Week 78/Visit 17, and the last dose of IMP is scheduled to be administered at Week 80/Visit 19.\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990236759185791,"confidence_rate":0.9999987079360249},{"cnt":[[582,1983],[1848,1983],[1848,2029],[582,2029]],"region":{"top_left_x":582,"top_left_y":1982,"width":1267,"height":48},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f90d924d0f245abaa2e1623dee53703","type":"text","conversion_output":false,"parent_id":"7f6ecc475c624056b174d338eeacf1b0","text":"The screening period will comprise a period of 4 to 42 days during which a","text_display":"The screening period will comprise a period of 4 to 42 days during which a","confidence":1,"confidence_rate":1},{"cnt":[[582,2032],[1848,2032],[1848,2078],[582,2078]],"region":{"top_left_x":582,"top_left_y":2032,"width":1267,"height":47},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"492eaff5e3154f54816f657ee9cf82e4","type":"text","conversion_output":false,"parent_id":"7f6ecc475c624056b174d338eeacf1b0","text":"subject's eligibility will be determined, beginning at signature of the","text_display":" subject's eligibility will be determined, beginning at signature of the","confidence":1,"confidence_rate":1},{"cnt":[[582,2081],[1103,2081],[1103,2128],[582,2128]],"region":{"top_left_x":582,"top_left_y":2081,"width":522,"height":47},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90effe626164404eb81d11901e3832ec","type":"text","conversion_output":false,"parent_id":"7f6ecc475c624056b174d338eeacf1b0","text":"Informed Consent Form (ICF).","text_display":" Informed Consent Form (ICF).","confidence":1,"confidence_rate":1},{"cnt":[[582,2168],[1846,2168],[1846,2215],[582,2215]],"region":{"top_left_x":582,"top_left_y":2168,"width":1264,"height":47},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5537c6b21ce1415bbba7debc296bfdcd","type":"text","conversion_output":false,"parent_id":"7f6ecc475c624056b174d338eeacf1b0","text":"During the screening visits, eligibility will be assessed and the target knee","text_display":"\nDuring the screening visits, eligibility will be assessed and the target knee","confidence":1,"confidence_rate":1},{"cnt":[[582,2215],[1846,2215],[1846,2264],[582,2264]],"region":{"top_left_x":582,"top_left_y":2214,"width":1264,"height":50},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71ffbfd5f4ee4800b888ee07d8d30cee","type":"text","conversion_output":false,"parent_id":"7f6ecc475c624056b174d338eeacf1b0","text":"will be defined. At the baseline visit, eligibility will be confirmed,","text_display":" will be defined. At the baseline visit, eligibility will be confirmed,","confidence":1,"confidence_rate":1},{"cnt":[[582,2264],[1846,2264],[1846,2313],[582,2313]],"region":{"top_left_x":582,"top_left_y":2263,"width":1264,"height":51},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be13ec557cdf477a96061c4360d60060","type":"text","conversion_output":false,"parent_id":"7f6ecc475c624056b174d338eeacf1b0","text":"randomization will occur, and the first IMP injection will be given (Week","text_display":" randomization will occur, and the first IMP injection will be given (Week","confidence":1,"confidence_rate":1},{"cnt":[[582,2313],[1846,2313],[1846,2359],[582,2359]],"region":{"top_left_x":582,"top_left_y":2313,"width":1264,"height":47},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0af594ca2fc74759b0b268503e1fa41c","type":"text","conversion_output":false,"parent_id":"7f6ecc475c624056b174d338eeacf1b0","text":"0/Visit 2). 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Moreover, the variability of the measure is","text_display":" to that of a lower dose \\((30 mcg )\\) given twice a year. Moreover, the variability of the measure is","confidence":0.5670395221095532,"confidence_rate":0.9946621624961981},{"cnt":[[245,1633],[1439,1633],[1439,1682],[245,1682]],"region":{"top_left_x":244,"top_left_y":1632,"width":1196,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e17151765c3243bf91bbc878403ecfca","type":"text","conversion_output":true,"text":"large, and therefore a deviation from perfect linearity may be expected.","text_display":" large, and therefore a deviation from perfect linearity may be expected.","confidence":1,"confidence_rate":1},{"cnt":[[245,1723],[683,1723],[683,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1723,"width":440,"height":41},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e97a2fb8d464cce93679bf741f0e8b6","type":"text","conversion_output":true,"text":"Calculations showed that:","text_display":"\n\nCalculations showed that:","confidence":1,"confidence_rate":1},{"cnt":[[245,1792],[1880,1792],[1880,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1791,"width":1636,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44310a2fea744e4b966d232fa20a19de","type":"text","conversion_output":true,"text":"- 55 evaluable subjects in each group (total 275 subjects) will ensure a power of \\(90 \\%\\) for detecting","text_display":"\n- 55 evaluable subjects in each group (total 275 subjects) will ensure a power of \\(90 \\%\\) for detecting","confidence":1,"confidence_rate":1},{"cnt":[[294,1843],[1128,1843],[1128,1893],[294,1893]],"region":{"top_left_x":294,"top_left_y":1843,"width":834,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33d072e0511f468fa6e5d2caed2803ff","type":"text","conversion_output":true,"text":"a linear dose relationship using a linear trend test,","text_display":" a linear dose relationship using a linear trend test,","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[1880,1912],[1880,1966],[245,1966]],"region":{"top_left_x":244,"top_left_y":1912,"width":1636,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da5aa0a6b85f4e6c8bb3309cd6d43186","type":"text","conversion_output":true,"text":"- 76 evaluable subjects in each group (total 380 subjects) will ensure a power of \\(90 \\%\\) for detecting","text_display":"\n- 76 evaluable subjects in each group (total 380 subjects) will ensure a power of \\(90 \\%\\) for detecting","confidence":1,"confidence_rate":1},{"cnt":[[294,1962],[1880,1962],[1880,2013],[294,2013]],"region":{"top_left_x":294,"top_left_y":1961,"width":1586,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a069a08ef5f94692b73192e4d740b0d8","type":"text","conversion_output":true,"text":"an overall treatment effect (meaning that at least one group differs from the other groups) as","text_display":" an overall treatment effect (meaning that at least one group differs from the other groups) as","confidence":1,"confidence_rate":1},{"cnt":[[292,2011],[385,2011],[385,2052],[292,2052]],"region":{"top_left_x":292,"top_left_y":2010,"width":93,"height":42},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"141f6d84295e433ca21b80336b99d9b4","type":"text","conversion_output":true,"text":"well.","text_display":" well.","confidence":1,"confidence_rate":1},{"cnt":[[245,2099],[1880,2099],[1880,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2099,"width":1636,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd6d8141a25949f0bb74d6843ebff548","type":"text","conversion_output":true,"text":"Based on recent literature and other trial experience (see protocol references 45 and 46), the subject","text_display":"\n\nBased on recent literature and other trial experience (see protocol references 45 and 46), the subject","confidence":0.9638845920562744,"confidence_rate":0.9996656585470894},{"cnt":[[245,2148],[1880,2148],[1880,2198],[245,2198]],"region":{"top_left_x":244,"top_left_y":2148,"width":1636,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e38dd6381625483c9b4fde1f91ecde03","type":"text","conversion_output":true,"text":"discontinuation rate is estimated to be close to \\(30 \\%\\) at two years. Assuming a \\(30 \\%\\) drop-out rate,","text_display":" discontinuation rate is estimated to be close to \\(30 \\%\\) at two years. Assuming a \\(30 \\%\\) drop-out rate,","confidence":0.98095703125,"confidence_rate":0.9998203280929825},{"cnt":[[245,2196],[1880,2196],[1880,2245],[245,2245]],"region":{"top_left_x":244,"top_left_y":2195,"width":1636,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c08656d18d64d7b8af6a1d77409acec","type":"text","conversion_output":true,"text":"a total of 545 subjects should be randomized ( 109 subjects per group) in order to detect an overall","text_display":" a total of 545 subjects should be randomized ( 109 subjects per group) in order to detect an overall","confidence":0.9058976173400879,"confidence_rate":0.9991100450336076},{"cnt":[[245,2243],[526,2243],[526,2288],[245,2288]],"region":{"top_left_x":244,"top_left_y":2242,"width":283,"height":47},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ae499fa01254b2d8419969b99aba89b","type":"text","conversion_output":true,"text":"treatment effect.","text_display":" treatment effect.","confidence":1,"confidence_rate":1},{"cnt":[[245,2333],[1880,2333],[1880,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2333,"width":1636,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"066214061d7a4f8fb6cca89e4d53d1dd","type":"text","conversion_output":true,"text":"In order to be able to demonstrate that structural improvement translates into symptomatic benefit,","text_display":"\n\nIn order to be able to demonstrate that structural improvement translates into symptomatic benefit,","confidence":1,"confidence_rate":1},{"cnt":[[245,2380],[1880,2380],[1880,2430],[245,2430]],"region":{"top_left_x":244,"top_left_y":2380,"width":1636,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f5492c984d64487b69ea1b1af4075af","type":"text","conversion_output":true,"text":"it is important that the study be adequately powered to detect significant differences in normalized","text_display":" it is important that the study be adequately powered to detect significant differences in normalized","confidence":1,"confidence_rate":1},{"cnt":[[245,2428],[1880,2428],[1880,2479],[245,2479]],"region":{"top_left_x":244,"top_left_y":2427,"width":1636,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73ab05cb07ec47c4b4e714ccdf02af74","type":"text","conversion_output":true,"text":"WOMAC scores. With 76 evaluable subjects per treatment group, the power to show a statistically","text_display":" WOMAC scores. 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(Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8630b7da5e8643bdb5d3a26b3713c90a","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,331],[245,331]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"806b6ef7cd4f46c49971f7ced1e3c802","type":"text","conversion_output":true,"text":"significant difference between at least one active treatment group and the placebo group for the","text_display":"\nsignificant difference between at least one active treatment group and the placebo group for the","confidence":1,"confidence_rate":1},{"cnt":[[245,329],[1880,329],[1880,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1636,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e550c1cc596422cb370638d264957cc","type":"text","conversion_output":true,"text":"secondary WOMAC endpoints ranges from \\(69 \\%\\) to \\(87 \\%\\) for the total score, from \\(80 \\%\\) to \\(99 \\%\\) for","text_display":" secondary WOMAC endpoints ranges from \\(69 \\%\\) to \\(87 \\%\\) for the total score, from \\(80 \\%\\) to \\(99 \\%\\) for","confidence":0.9990234375,"confidence_rate":0.9999907826873115},{"cnt":[[245,378],[1880,378],[1880,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7be46b88d55341b0b3c74265f41dfba8","type":"text","conversion_output":true,"text":"the pain score and from \\(53 \\%\\) to \\(83 \\%\\) for the function score, depending on the expected mean","text_display":" the pain score and from \\(53 \\%\\) to \\(83 \\%\\) for the function score, depending on the expected mean","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[892,425],[892,475],[245,475]],"region":{"top_left_x":244,"top_left_y":425,"width":648,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb46b07f174b4150a9f05d69765764ed","type":"text","conversion_output":true,"text":"difference from placebo (see Table 1).","text_display":" difference from placebo (see Table 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The SAP has to be approved prior to database partial lock and breaking the","text_display":" Management plan. The SAP has to be approved prior to database partial lock and breaking the","confidence":1,"confidence_rate":1},{"cnt":[[296,666],[1109,666],[1109,715],[296,715]],"region":{"top_left_x":296,"top_left_y":666,"width":813,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a57f5bf78d584af58eabb68d2cf5d180","type":"text","conversion_output":true,"text":"blind. This will be referred to as 2 -year analysis.","text_display":" blind. 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Subjects will","text_display":" readers, and subjects will remain blinded during the extended follow-up phase. Subjects will","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[294,975],[1880,975],[1880,1025],[294,1025]],"region":{"top_left_x":294,"top_left_y":975,"width":1586,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"261eaf75dcab4b10a764a42020a17a74","type":"text","conversion_output":true,"text":"maintain their subject number from treatment phase to follow-up. X-ray and MRI readers will","text_display":" maintain their subject number from treatment phase to follow-up. X-ray and MRI readers will","confidence":1,"confidence_rate":1},{"cnt":[[294,1023],[1360,1023],[1360,1074],[294,1074]],"region":{"top_left_x":294,"top_left_y":1022,"width":1066,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d5d461cbb9441f8a51c5dbc8aaf887e","type":"text","conversion_output":true,"text":"remain blinded during the study and after the study completion.","text_display":" remain blinded during the study and after the study completion.","confidence":1,"confidence_rate":1},{"cnt":[[269,1104],[587,1104],[587,1162],[269,1162]],"region":{"top_left_x":268,"top_left_y":1104,"width":319,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc1856a208b64c239313fc15e3a5e99d","type":"section_header","conversion_output":false,"children_ids":["1b3199a9626a413f8cb307bc089e4c51"],"text":"","text_display":""},{"cnt":[[271,1109],[582,1109],[582,1158],[271,1158]],"region":{"top_left_x":270,"top_left_y":1108,"width":313,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b3199a9626a413f8cb307bc089e4c51","type":"text","conversion_output":true,"parent_id":"dc1856a208b64c239313fc15e3a5e99d","text":"Study Design","text_display":"\n\n\\section*{Study Design}","confidence":1,"confidence_rate":1},{"cnt":[[243,1158],[1882,1158],[1882,2004],[243,2004]],"region":{"top_left_x":242,"top_left_y":1158,"width":1641,"height":847},"line":21,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d2394c1cf675499cb097cd30f544d0d1","type":"diagram","conversion_output":true,"text":"","text_display":"\n![](https://cdn.mathpix.com/cropped/7d3f1047-18ef-437a-aee6-86ac05993601-19.jpg?height=847&width=1641&top_left_y=1158&top_left_x=242)"},{"cnt":[[245,2030],[1880,2030],[1880,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2030,"width":1636,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a9ea7a0a660423b81451697605b7c2f","type":"text","conversion_output":true,"text":"- In addition, a Year-3 analysis, repeating Year-2 analysis for primary and secondary efficacy","text_display":"\n- In addition, a Year-3 analysis, repeating Year-2 analysis for primary and secondary efficacy","confidence":1,"confidence_rate":1},{"cnt":[[294,2080],[1106,2080],[1106,2127],[294,2127]],"region":{"top_left_x":294,"top_left_y":2079,"width":813,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e89cbe6bb714fcc9aa8041a22ec5475","type":"text","conversion_output":true,"text":"endpoints as well as safety endpoints is planned.","text_display":" endpoints as well as safety endpoints is planned.","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1880,2170],[1880,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1636,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9960b478359441ae97c7edf54be468da","type":"text","conversion_output":true,"text":"No interim analysis is planned before the primary analysis defined at 2 years; however, an","text_display":"\n\nNo interim analysis is planned before the primary analysis defined at 2 years; however, an","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1880,2217],[1880,2264],[245,2264]],"region":{"top_left_x":244,"top_left_y":2217,"width":1636,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d6e0c1044c64fa38c952f68fdc446c4","type":"text","conversion_output":true,"text":"Independent Data Monitoring Committee (IDMC) will perform periodic reviews of semi-un-","text_display":" Independent Data Monitoring Committee (IDMC) will perform periodic reviews of semi-un","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[1880,2264],[1880,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2264,"width":1636,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8271aa3fb084b3583bc4e32a9448e7c","type":"text","conversion_output":true,"text":"blinded data to evaluate the safety of the subjects on an ongoing basis. Detailed description of the","text_display":"blinded data to evaluate the safety of the subjects on an ongoing basis. Detailed description of the","confidence":1,"confidence_rate":1},{"cnt":[[245,2312],[1302,2312],[1302,2361],[245,2361]],"region":{"top_left_x":244,"top_left_y":2311,"width":1058,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e83d62f79fb24757b858ef35e19ff8c0","type":"text","conversion_output":true,"text":"safety monitoring is specified in a dedicated IDMC charter [2].","text_display":" safety monitoring is specified in a dedicated IDMC charter [2].","confidence":1,"confidence_rate":1},{"cnt":[[1543,2561],[1616,2561],[1616,2595],[1543,2595]],"region":{"top_left_x":1542,"top_left_y":2560,"width":74,"height":36},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c442e6951b346408b30ae7b03c9bf26","type":"page_info","conversion_output":false,"text":"19/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-20","page":20,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"32df84b667354e9994c83a4237aae832","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[640,172],[640,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":397,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2e2b0b9848049fb95846610c626924c","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,277],[1551,277],[1551,346],[241,346]],"region":{"top_left_x":240,"top_left_y":277,"width":1312,"height":69},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afcd7a39e95d4914add00674401bbaff","type":"section_header","conversion_output":false,"children_ids":["0278b2f1c81b463fae81c466ec4361f0"],"text":"","text_display":""},{"cnt":[[245,284],[1545,284],[1545,342],[245,342]],"region":{"top_left_x":244,"top_left_y":283,"width":1301,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0278b2f1c81b463fae81c466ec4361f0","type":"text","conversion_output":true,"parent_id":"afcd7a39e95d4914add00674401bbaff","text":"8.1 Analysis of data from DBPC treatment phase","text_display":"\n\n\\subsection*{8.1 Analysis of data from DBPC treatment phase}","confidence":0.9951221942901611,"confidence_rate":0.9999041273209408},{"cnt":[[245,378],[1880,378],[1880,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecca5b967c914da4a51e3f9b6142336b","type":"text","conversion_output":true,"text":"An overview of endpoints and type of analysis for the DBPC treatment phase is provided in","text_display":"\n\nAn overview of endpoints and type of analysis for the DBPC treatment phase is provided in","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[1880,425],[1880,475],[245,475]],"region":{"top_left_x":244,"top_left_y":425,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1bd079de3de4701b9cef5417ec36b45","type":"text","conversion_output":true,"text":"Section19.1. The analysis will report all data collected from the DBPC treatment phase up to 24","text_display":" Section19.1. The analysis will report all data collected from the DBPC treatment phase up to 24","confidence":1,"confidence_rate":1},{"cnt":[[245,475],[1880,475],[1880,524],[245,524]],"region":{"top_left_x":244,"top_left_y":474,"width":1636,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9a4cfd2a4574fd1b49e19af1b782449","type":"text","conversion_output":true,"text":"months (day 819), i.e. disposition, demographics, baseline characteristics, concomitant medication","text_display":" months (day 819), i.e. disposition, demographics, baseline characteristics, concomitant medication","confidence":0.994631290435791,"confidence_rate":0.9999477375514105},{"cnt":[[245,522],[1880,522],[1880,574],[245,574]],"region":{"top_left_x":244,"top_left_y":522,"width":1636,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d88a07ca8b774d368327b9f63fd543d3","type":"text","conversion_output":true,"text":"during and prior to DBPC treatment phase, compliance and exposure, all efficacy endpoints and","text_display":" during and prior to DBPC treatment phase, compliance and exposure, all efficacy endpoints and","confidence":1,"confidence_rate":1},{"cnt":[[245,571],[1008,571],[1008,621],[245,621]],"region":{"top_left_x":244,"top_left_y":571,"width":764,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b4fa2550a87425187ea7e9ea9021684","type":"text","conversion_output":true,"text":"safety parameters up to 24 months (day 819).","text_display":" safety parameters up to 24 months (day 819).","confidence":1,"confidence_rate":1},{"cnt":[[245,660],[1880,660],[1880,711],[245,711]],"region":{"top_left_x":244,"top_left_y":659,"width":1636,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7047dabcdaf4c0f9836527296030ede","type":"text","conversion_output":true,"text":"Moreover, PK-related analysis will be provided by Merck Serono Quantitative Pharmacology and","text_display":"\n\nMoreover, PK-related analysis will be provided by Merck Serono Quantitative Pharmacology and","confidence":1,"confidence_rate":1},{"cnt":[[245,709],[1880,709],[1880,758],[245,758]],"region":{"top_left_x":244,"top_left_y":708,"width":1636,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce1ddfa521e24b81b9d0ef56a1a872b9","type":"text","conversion_output":true,"text":"Drug Disposition (QPD) and Enabling Clinical Sciences (ECS) and will be incorporated in the","text_display":" Drug Disposition (QPD) and Enabling Clinical Sciences (ECS) and will be incorporated in the","confidence":1,"confidence_rate":1},{"cnt":[[245,756],[1880,756],[1880,806],[245,806]],"region":{"top_left_x":244,"top_left_y":756,"width":1636,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ad7c180b0114296b9c19fc8671a229a","type":"text","conversion_output":true,"text":"CTR (if at least one sample show sprifermin concentration). PK analyses and biomarker subgroups","text_display":" CTR (if at least one sample show sprifermin concentration). PK analyses and biomarker subgroups","confidence":1,"confidence_rate":1},{"cnt":[[245,804],[1880,804],[1880,853],[245,853]],"region":{"top_left_x":244,"top_left_y":803,"width":1636,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"585133cfddf44bc29d31fed41ac72357","type":"text","conversion_output":true,"text":"(genetic markers - Single nucleotide polymorphism [SNP] and subgroups based on biochemical","text_display":" (genetic markers - Single nucleotide polymorphism [SNP] and subgroups based on biochemical","confidence":1,"confidence_rate":1},{"cnt":[[245,851],[1880,851],[1880,900],[245,900]],"region":{"top_left_x":244,"top_left_y":850,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9181100822734edca89191ffe97a11b5","type":"text","conversion_output":true,"text":"marker cutoffs) are included in this SAP in Section 16.3 and Section 16.4, respectively. Additional","text_display":" marker cutoffs) are included in this SAP in Section 16.3 and Section 16.4, respectively. Additional","confidence":1,"confidence_rate":1},{"cnt":[[245,900],[1880,897],[1880,947],[245,950]],"region":{"top_left_x":244,"top_left_y":897,"width":1636,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2426d15674a466ba407b22ced732725","type":"text","conversion_output":true,"text":"analyses of other exploratory biomarkers will be described in the BSAP and will be reported","text_display":" analyses of other exploratory biomarkers will be described in the BSAP and will be reported","confidence":1,"confidence_rate":1},{"cnt":[[245,945],[1880,945],[1880,999],[245,999]],"region":{"top_left_x":244,"top_left_y":945,"width":1636,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2de3106b0ce241edabb86f0f4be67397","type":"text","conversion_output":true,"text":"separately in an Exploratory Biomarkers Report. Any modeling of the data will be further","text_display":" separately in an Exploratory Biomarkers Report. 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A Blind Data Review Meeting will be arranged to discuss the","text_display":" sent to Merck Serono for review. 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In general, the same endpoints (for efficacy and safety) will be presented as for the treatment","text_display":" 19.1. 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Clarification on time points, scored regions, scoring system and analyses for Whole Organ","confidence":1,"confidence_rate":1},{"cnt":[[245,1534],[1880,1534],[1880,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1533,"width":1636,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf6f9ecd458448d2a561e5110637172d","type":"text","conversion_output":true,"text":"Magnetic Resonance Imaging Score (WORMS) and (Boston-Leeds Osteoarthritis Knee Score)","text_display":" Magnetic Resonance Imaging Score (WORMS) and (Boston-Leeds Osteoarthritis Knee Score)","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[245,1581],[1394,1581],[1394,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1581,"width":1151,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f3847dd20384bdfb78dee895b5208ed","type":"text","conversion_output":true,"text":"BLOKS are provided in Section 16.5 (Section 8.5.5 of the protocol).","text_display":" BLOKS are provided in Section 16.5 (Section 8.5.5 of the protocol).","confidence":0.99658203125,"confidence_rate":0.999954350063996},{"cnt":[[241,1669],[445,1669],[445,1721],[241,1721]],"region":{"top_left_x":240,"top_left_y":1669,"width":205,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe86f1081d2749d29f442d7bf53fcc37","type":"section_header","conversion_output":false,"children_ids":["d0b3217a5ec144a29a60ceead6ef4547"],"text":"","text_display":""},{"cnt":[[245,1676],[440,1676],[440,1717],[245,1717]],"region":{"top_left_x":244,"top_left_y":1675,"width":197,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0b3217a5ec144a29a60ceead6ef4547","type":"text","conversion_output":true,"parent_id":"fe86f1081d2749d29f442d7bf53fcc37","text":"Additions:","text_display":"\n\n\\section*{Additions:}","confidence":1,"confidence_rate":1},{"cnt":[[245,1762],[1880,1762],[1880,1811],[245,1811]],"region":{"top_left_x":244,"top_left_y":1761,"width":1636,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cbb3585007d486f975e09746dadec7a","type":"text","conversion_output":true,"text":"1. Analysis sets. The following additional analysis set is specified in Section 10. For the long term","text_display":"\n1. Analysis sets. The following additional analysis set is specified in Section 10. For the long term","confidence":1,"confidence_rate":1},{"cnt":[[245,1809],[1880,1809],[1880,1858],[245,1858]],"region":{"top_left_x":244,"top_left_y":1808,"width":1636,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebd2d449d93c464ea2ce4dcfcb16c962","type":"text","conversion_output":true,"text":"follow-up phase (following day 819), a separate analysis set is defined consisting of subjects from","text_display":" follow-up phase (following day 819), a separate analysis set is defined consisting of subjects from","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,1856],[1880,1856],[1880,1906],[245,1906]],"region":{"top_left_x":244,"top_left_y":1856,"width":1636,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8087b59e5700451f9baea170cc306cc2","type":"text","conversion_output":true,"text":"the ITT population who have at least one post-treatment quantitative MRI assessment or at least","text_display":" the ITT population who have at least one post-treatment quantitative MRI assessment or at least","confidence":1,"confidence_rate":1},{"cnt":[[245,1904],[1880,1904],[1880,1953],[245,1953]],"region":{"top_left_x":244,"top_left_y":1903,"width":1636,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf11b5ba8c834998a3fc2f71fc39ffa1","type":"text","conversion_output":true,"text":"one WOMAC measurement in the follow-up period, i.e., the Second ITT (ITT2). The ITT2","text_display":" one WOMAC measurement in the follow-up period, i.e., the Second ITT (ITT2). 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Year-3 Analysis: A Year-3 Analysis is planned and described in Section 8.","text_display":"\n2. Year-3 Analysis: A Year-3 Analysis is planned and described in Section 8.","confidence":1,"confidence_rate":1},{"cnt":[[245,2226],[1880,2226],[1880,2277],[245,2277]],"region":{"top_left_x":244,"top_left_y":2225,"width":1636,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f517ea868fa4d52a769c52ede01f883","type":"text","conversion_output":true,"text":"3. Sensitivity analysis using LOCF. The LOCF method as imputation for missing data on post","text_display":"\n3. Sensitivity analysis using LOCF. The LOCF method as imputation for missing data on post","confidence":1,"confidence_rate":1},{"cnt":[[245,2273],[1880,2273],[1880,2327],[245,2327]],"region":{"top_left_x":244,"top_left_y":2273,"width":1636,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdca13c71d184054972c2f717f16d438","type":"text","conversion_output":true,"text":"baseline observations will be used as sensitivity evaluation with potential to be utilized in future","text_display":" baseline observations will be used as sensitivity evaluation with potential to be utilized in future","confidence":0.9985356330871582,"confidence_rate":0.9999860435245741},{"cnt":[[245,2322],[913,2322],[913,2368],[245,2368]],"region":{"top_left_x":244,"top_left_y":2322,"width":670,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18c36ea1ca014e2fa81250782beee28a","type":"text","conversion_output":true,"text":"studies. This is described in Section 11.","text_display":" studies. This is described in Section 11.","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1620,2561],[1620,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":82,"height":36},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c230e5c2dddb43a889f5afd5824f067c","type":"page_info","conversion_output":false,"text":"21/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-22","page":22,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d21df5d4941f46deb1e31e79a899c78d","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73721836586d4dda8397fc330f8db581","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,329],[245,329]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31545d90e01241a0872e3a0ab87b3057","type":"text","conversion_output":true,"text":"4. Adverse events of special interest: Injection site reactions, Neoplasms, Musculoskeletal","text_display":"\n4. Adverse events of special interest: Injection site reactions, Neoplasms, Musculoskeletal","confidence":1,"confidence_rate":1},{"cnt":[[245,329],[1880,329],[1880,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1636,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dbc4935f1b1496b9f184a87ac628e33","type":"text","conversion_output":true,"text":"disorders will be identified using pre-specified rules and will be summarized (as specified in","text_display":" disorders will be identified using pre-specified rules and will be summarized (as specified in","confidence":1,"confidence_rate":1},{"cnt":[[245,378],[483,378],[483,425],[245,425]],"region":{"top_left_x":244,"top_left_y":378,"width":240,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98db914d87fb46bfaa14ef3759c6384f","type":"text","conversion_output":true,"text":"Section 17.1).","text_display":" Section 17.1).","confidence":1,"confidence_rate":1},{"cnt":[[245,466],[1880,466],[1880,518],[245,518]],"region":{"top_left_x":244,"top_left_y":466,"width":1636,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed9e8eacf6fb463f94433541879d02da","type":"text","conversion_output":true,"text":"5. Key efficacy endpoints will be summarized by baseline biomarker subgroups (as specified in","text_display":"\n5. Key efficacy endpoints will be summarized by baseline biomarker subgroups (as specified in","confidence":1,"confidence_rate":1},{"cnt":[[245,516],[1880,516],[1880,565],[245,565]],"region":{"top_left_x":244,"top_left_y":515,"width":1636,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e768a0ccdb54e5f81ee6c51e982df76","type":"text","conversion_output":true,"text":"Section 16.4) and by clinical subgroups. Some of the subgroups (as specified in Section 10, last","text_display":" Section 16.4) and by clinical subgroups. Some of the subgroups (as specified in Section 10, last","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,563],[1880,563],[1880,612],[245,612]],"region":{"top_left_x":244,"top_left_y":562,"width":1636,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a66623f443c14f338b59eb95e05d6832","type":"text","conversion_output":true,"text":"part), were not pre-specified in the protocol. For countries with low accrual, pooling of subjects","text_display":" part), were not pre-specified in the protocol. For countries with low accrual, pooling of subjects","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,610],[1880,610],[1880,660],[245,660]],"region":{"top_left_x":244,"top_left_y":610,"width":1636,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2c45910fcbb46079398e0e3f27e745c","type":"text","conversion_output":true,"text":"will be done by similarity. As of September 2014 (when study was fully enrolled) there were only","text_display":" will be done by similarity. As of September 2014 (when study was fully enrolled) there were only","confidence":1,"confidence_rate":1},{"cnt":[[245,657],[1880,657],[1880,707],[245,707]],"region":{"top_left_x":244,"top_left_y":657,"width":1636,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b35ae9f55e5b4f27bc081b5647e90bd3","type":"text","conversion_output":true,"text":"11 randomized subjects from the USA and one from Poland. Therefore, for the primary analysis","text_display":" 11 randomized subjects from the USA and one from Poland. 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Czech","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[1880,752],[1880,804],[245,804]],"region":{"top_left_x":244,"top_left_y":751,"width":1636,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba48e2bd78de4ec8a9cd776861a961e3","type":"text","conversion_output":true,"text":"Republic and Estonia, as well as Hong Kong, are counted separately, and the USA will be pooled","text_display":" Republic and Estonia, as well as Hong Kong, are counted separately, and the USA will be pooled","confidence":1,"confidence_rate":1},{"cnt":[[245,801],[1880,801],[1880,853],[245,853]],"region":{"top_left_x":244,"top_left_y":801,"width":1636,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4919c3df85347e799f1ef446f9d622d","type":"text","conversion_output":true,"text":"with Denmark as USA+ Western Europe. For subgroup analyses there will be 3 regions: (1)","text_display":" with Denmark as USA+ Western Europe. For subgroup analyses there will be 3 regions: (1)","confidence":1,"confidence_rate":1},{"cnt":[[245,851],[1880,851],[1880,900],[245,900]],"region":{"top_left_x":244,"top_left_y":850,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de23e63c568e491c8e603bc81cbf2129","type":"text","conversion_output":true,"text":"Eastern European, (2) USA+ Western Europe, and (3) Hong Kong. This is specified in sections 10","text_display":" Eastern European, (2) USA+ Western Europe, and (3) Hong Kong. This is specified in sections 10","confidence":0.9829773399978876,"confidence_rate":0.9998248193154711},{"cnt":[[245,898],[1880,898],[1880,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":1636,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd891b2b58244336abb58cf41ccedc92","type":"text","conversion_output":true,"text":"and 16.1. Among these subgroups, 3 subgroups have been identified to have higher priority and","text_display":" and 16.1. Among these subgroups, 3 subgroups have been identified to have higher priority and","confidence":0.98388671875,"confidence_rate":0.9998391761832534},{"cnt":[[245,945],[666,945],[666,995],[245,995]],"region":{"top_left_x":244,"top_left_y":945,"width":423,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d198539a268c4869b33bf2787e043821","type":"text","conversion_output":true,"text":"described in Section 10).","text_display":" described in Section 10).","confidence":1,"confidence_rate":1},{"cnt":[[245,1036],[1880,1036],[1880,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1035,"width":1636,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a131738152ff4d79b3eed4f7f7f36b99","type":"text","conversion_output":true,"text":"6. Responder variables: subjects with at least 10 -point improvement on WOMAC Total score, and","text_display":"\n6. 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In case of deviations from","text_display":" Subjects will be analyzed according to the actual treatment they receive. 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Please","text_display":" conservatively be allocated to the lowest of the possible planned Sprifermin dose groups. Please","confidence":1,"confidence_rate":1},{"cnt":[[245,885],[1171,885],[1171,935],[245,935]],"region":{"top_left_x":244,"top_left_y":885,"width":927,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8316f042a8c24998b23e5cdd68b5da94","type":"text","conversion_output":true,"text":"refer to the \"Analysis Sets\" document for more details.","text_display":" refer to the \"Analysis Sets\" document for more 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Prior to unblinding this list may be updated.","text_display":" was provided in Appendix 19.2. Prior to unblinding this list may be updated.","confidence":0.9941492080688477,"confidence_rate":0.9999275584898206},{"cnt":[[245,597],[1880,597],[1880,647],[245,647]],"region":{"top_left_x":244,"top_left_y":597,"width":1636,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcb0326a08c143b2acd420fd6540de2c","type":"text","conversion_output":true,"text":"Subgroups will be defined by individual listing prior to database lock and prior to breaking the","text_display":"\n\nSubgroups will be defined by individual listing prior to database lock and prior to breaking the","confidence":1,"confidence_rate":1},{"cnt":[[245,645],[1012,645],[1012,694],[245,694]],"region":{"top_left_x":244,"top_left_y":644,"width":768,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bea9828db424510a0a79a37e13e75a5","type":"text","conversion_output":true,"text":"blind for the reporting of the treatment phase.","text_display":" blind for the reporting of the treatment phase.","confidence":1,"confidence_rate":1},{"cnt":[[245,735],[1562,735],[1562,797],[245,797]],"region":{"top_left_x":244,"top_left_y":734,"width":1318,"height":64},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c0b7e5ff1ea4a5bb67bc8dd626e4332","type":"section_header","conversion_output":false,"children_ids":["1b893c05ef9c46009e7c7fa63f73e3ad","a786dd4e335640ae973a963abf5ec86b"],"text":"","text_display":""},{"cnt":[[243,739],[301,739],[301,786],[243,786]],"region":{"top_left_x":242,"top_left_y":739,"width":59,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b893c05ef9c46009e7c7fa63f73e3ad","type":"text","conversion_output":true,"parent_id":"5c0b7e5ff1ea4a5bb67bc8dd626e4332","text":"11","text_display":"\n\n\\section*{11","confidence":1,"confidence_rate":1},{"cnt":[[595,739],[1558,739],[1558,793],[595,793]],"region":{"top_left_x":595,"top_left_y":739,"width":963,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a786dd4e335640ae973a963abf5ec86b","type":"text","conversion_output":true,"parent_id":"5c0b7e5ff1ea4a5bb67bc8dd626e4332","text":"General Specifications for Statistical Analyses","text_display":" General Specifications for Statistical Analyses}","confidence":0.99853515625,"confidence_rate":0.9999718096726914},{"cnt":[[245,834],[1880,834],[1880,883],[245,883]],"region":{"top_left_x":244,"top_left_y":833,"width":1636,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40f60baceab94410a6657aaea9cfb517","type":"text","conversion_output":true,"text":"It is planned to perform the statistical analysis in two steps. Approximately one month after the","text_display":"\n\nIt is planned to perform the statistical analysis in two steps. Approximately one month after the","confidence":1,"confidence_rate":1},{"cnt":[[245,881],[1880,881],[1880,930],[245,930]],"region":{"top_left_x":244,"top_left_y":880,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c314d2abcf8e4946941b189163e1f2f9","type":"text","conversion_output":true,"text":"last subject reaches day 819 of the 2 -year DBPC treatment phase, the database will be partially","text_display":" last subject reaches day 819 of the 2 -year DBPC treatment phase, the database will be partially","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[245,928],[1878,928],[1878,978],[245,978]],"region":{"top_left_x":244,"top_left_y":928,"width":1634,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"347eefec6e394fa38744427a77574e2a","type":"text","conversion_output":true,"text":"locked, the treatment code will be un-blinded. Thereafter, complete analyses will be performed,","text_display":" locked, the treatment code will be un-blinded. Thereafter, complete analyses will be performed,","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1880,975],[1880,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1636,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c16cf65d6f845e387d8d4a523910a23","type":"text","conversion_output":true,"text":"and a detailed CTR will be written based on the data collected up to the end of the DBPC treatment","text_display":" and a detailed CTR will be written based on the data collected up to the end of the DBPC treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1880,1023],[1880,1074],[245,1074]],"region":{"top_left_x":244,"top_left_y":1022,"width":1636,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7e3676729804d8d93a0e567949acf58","type":"text","conversion_output":true,"text":"phase (day 819). Long term follow-up data (from Year 2 to Year 5) will be integrated and analyzed","text_display":" phase (day 819). Long term follow-up data (from Year 2 to Year 5) will be integrated and analyzed","confidence":1,"confidence_rate":1},{"cnt":[[245,1072],[1880,1072],[1880,1121],[245,1121]],"region":{"top_left_x":244,"top_left_y":1072,"width":1636,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7b708e6084e44ada634edf6501f5c5c","type":"text","conversion_output":true,"text":"with the DBPC treatment phase data but reported separately from the DBPC treatment phase","text_display":" with the DBPC treatment phase data but reported separately from the DBPC treatment phase","confidence":1,"confidence_rate":1},{"cnt":[[245,1119],[1880,1119],[1880,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1119,"width":1636,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba2c4f1ecf8e41c68652b325fabcb8b8","type":"text","conversion_output":true,"text":"results. Investigators, other site staff, study monitors, and subjects will remain blinded to study","text_display":" results. Investigators, other site staff, study monitors, and subjects will remain blinded to study","confidence":1,"confidence_rate":1},{"cnt":[[245,1169],[1878,1169],[1878,1218],[245,1218]],"region":{"top_left_x":244,"top_left_y":1168,"width":1634,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dfd7560ea7549048347be8c8b2f6ad3","type":"text","conversion_output":true,"text":"treatment during the extended follow-up phase as described in Section 8. X-ray and MRI readers","text_display":" treatment during the extended follow-up phase as described in Section 8. X-ray and MRI readers","confidence":1,"confidence_rate":1},{"cnt":[[245,1216],[1850,1216],[1850,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1216,"width":1606,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef888807e0d045ea8384d3eaec5ec53a","type":"text","conversion_output":true,"text":"will remain blinded to study treatment until completion of the extended follow-up phase results.","text_display":" will remain blinded to study treatment until completion of the extended follow-up phase results.","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1560,1306],[1560,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":1316,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e591dfd2a7854711bc68c1939a657904","type":"text","conversion_output":true,"text":"A list of endpoints according to treatment phase is provided in Appendix 19.1.","text_display":"\n\nA list of endpoints according to treatment phase is provided in Appendix 19.1.","confidence":1,"confidence_rate":1},{"cnt":[[241,1392],[604,1392],[604,1446],[241,1446]],"region":{"top_left_x":240,"top_left_y":1392,"width":364,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f24eac125fe2400cb797b37ef3bd83f7","type":"section_header","conversion_output":false,"children_ids":["0badfac41c6a4b7ba0d72e40184baf6b"],"text":"","text_display":""},{"cnt":[[245,1396],[599,1396],[599,1446],[245,1446]],"region":{"top_left_x":244,"top_left_y":1396,"width":356,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0badfac41c6a4b7ba0d72e40184baf6b","type":"text","conversion_output":true,"parent_id":"f24eac125fe2400cb797b37ef3bd83f7","text":"Summary Statistics","text_display":"\n\n\\section*{Summary Statistics}","confidence":1,"confidence_rate":1},{"cnt":[[245,1487],[1876,1487],[1876,1534],[245,1534]],"region":{"top_left_x":244,"top_left_y":1486,"width":1632,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a03a3c9d49d41d4acf5a44582720142","type":"text","conversion_output":true,"text":"Summary statistics will be presented per treatment group and where relevant for 'all subjects'.","text_display":"\n\nSummary statistics will be presented per treatment group and where relevant for 'all subjects'.","confidence":1,"confidence_rate":1},{"cnt":[[245,1534],[1880,1534],[1880,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1533,"width":1636,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb59fd919fa447b88577ea5d275f58b7","type":"text","conversion_output":true,"text":"Summary statistics will be presented also per country. The summary statistics presented for","text_display":" Summary statistics will be presented also per country. The summary statistics presented for","confidence":1,"confidence_rate":1},{"cnt":[[245,1581],[1880,1581],[1880,1631],[245,1631]],"region":{"top_left_x":244,"top_left_y":1581,"width":1636,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00ca9babcb2344679e717e67e850e15d","type":"text","conversion_output":true,"text":"quantitative variables will be the number of observations ( n ), the number of missing values","text_display":" quantitative variables will be the number of observations ( n ), the number of missing values","confidence":0.9965834617614746,"confidence_rate":0.9999670929651705},{"cnt":[[245,1629],[1880,1629],[1880,1678],[245,1678]],"region":{"top_left_x":244,"top_left_y":1628,"width":1636,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b9edeaceb8445c6a796a3b5c525b29b","type":"text","conversion_output":true,"text":"(missing), mean, standard deviation (SD), median, first and third quartiles (Q1, Q3), and minimum","text_display":" (missing), mean, standard deviation (SD), median, first and third quartiles (Q1, Q3), and minimum","confidence":1,"confidence_rate":1},{"cnt":[[245,1676],[1880,1676],[1880,1725],[245,1725]],"region":{"top_left_x":244,"top_left_y":1675,"width":1636,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d146bb85ea374a5f81af74d703a6c036","type":"text","conversion_output":true,"text":"(min) and maximum (max) values. The mean, SD, median, first and third quartiles values will be","text_display":" (min) and maximum (max) values. The mean, SD, median, first and third quartiles values will be","confidence":0.90966796875,"confidence_rate":0.9990441377785483},{"cnt":[[245,1723],[1880,1723],[1880,1775],[245,1775]],"region":{"top_left_x":244,"top_left_y":1723,"width":1636,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7667c35f13d45a9bccd35ff3997642e","type":"text","conversion_output":true,"text":"presented with one more decimal places as the raw data. The minimum and maximum values will","text_display":" presented with one more decimal places as the raw data. The minimum and maximum values will","confidence":1,"confidence_rate":1},{"cnt":[[245,1772],[1880,1772],[1880,1820],[245,1820]],"region":{"top_left_x":244,"top_left_y":1772,"width":1636,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fd6e0c6fa5c4fddbb136e97b0d17948","type":"text","conversion_output":true,"text":"be reported to the same number of decimal places as the raw data. In general, the maximum number","text_display":" be reported to the same number of decimal places as the raw data. In general, the maximum number","confidence":1,"confidence_rate":1},{"cnt":[[245,1818],[1308,1818],[1308,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1817,"width":1065,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"830aab8b88374eac86f534723a007bfe","type":"text","conversion_output":true,"text":"of decimal places reported shall be four for any summary statistic.","text_display":" of decimal places reported shall be four for any summary statistic.","confidence":1,"confidence_rate":1},{"cnt":[[245,1908],[1880,1908],[1880,1957],[245,1957]],"region":{"top_left_x":244,"top_left_y":1907,"width":1636,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fcccc6011124afe844cacc45830af4a","type":"text","conversion_output":true,"text":"The summary statistics presented for categorical data will be the number of observations ( n ), the","text_display":"\n\nThe summary statistics presented for categorical data will be the number of observations ( n ), the","confidence":0.7173467054963112,"confidence_rate":0.9969845918210656},{"cnt":[[245,1955],[1880,1955],[1880,2004],[245,2004]],"region":{"top_left_x":244,"top_left_y":1955,"width":1636,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f8fec504bb14f209048021945f08d93","type":"text","conversion_output":true,"text":"number of missing values (missing), and the count and percentage of subjects in each category at","text_display":" number of missing values (missing), and the count and percentage of subjects in each category at","confidence":0.998046875,"confidence_rate":0.9999806434067887},{"cnt":[[245,2002],[1493,2002],[1493,2054],[245,2054]],"region":{"top_left_x":244,"top_left_y":2002,"width":1250,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d8141bae1b94c3bbc22d437ba969a09","type":"text","conversion_output":true,"text":"the relevant time point(s). Percentage will be given with one decimal place.","text_display":" the relevant time point(s). Percentage will be given with one decimal place.","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[1880,2093],[1880,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2092,"width":1636,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"377bce1c9dfd47ddb0f80b96bbd238e3","type":"text","conversion_output":true,"text":"The summary statistics presented for adverse events will be number of observations ( n ), the","text_display":"\n\nThe summary statistics presented for adverse events will be number of observations ( n ), the","confidence":0.984375,"confidence_rate":0.9998485849551061},{"cnt":[[245,2140],[1549,2140],[1549,2189],[245,2189]],"region":{"top_left_x":244,"top_left_y":2139,"width":1306,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dd488d779e2412aa23718c41f4d894e","type":"text","conversion_output":true,"text":"percentage of subjects (\\%), overall and per system organ class (SOC) and PT.","text_display":" percentage of subjects (\\%), overall and per system organ class (SOC) and PT.","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[245,2230],[1880,2230],[1880,2279],[245,2279]],"region":{"top_left_x":244,"top_left_y":2230,"width":1636,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3016f4bce674aaea1075c363dbe79ff","type":"text","conversion_output":true,"text":"Apart from the trend test for AIRs, all confidence intervals (CI) and statistical tests will be two-","text_display":"\n\nApart from the trend test for AIRs, all confidence intervals (CI) and statistical tests will be two","confidence":1,"confidence_rate":1},{"cnt":[[245,2277],[1880,2277],[1880,2327],[245,2327]],"region":{"top_left_x":244,"top_left_y":2277,"width":1636,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"492535cc666a4157aacd1090e175739d","type":"text","conversion_output":true,"text":"sided. Calculation of differences between treatment groups of continuous endpoints and","text_display":"sided. Calculation of differences between treatment groups of continuous endpoints and","confidence":1,"confidence_rate":1},{"cnt":[[245,2325],[1880,2325],[1880,2376],[245,2376]],"region":{"top_left_x":244,"top_left_y":2324,"width":1636,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cbc69d275c040728b8a0d488a1fe89d","type":"text","conversion_output":true,"text":"corresponding CIs, will be normal based using unequal variances. CIs will be presented with one","text_display":" corresponding CIs, will be normal based using unequal variances. 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However, if a p -value is only presented with four decimal","text_display":" presented with three decimal places. 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Sex will","text_display":"\n\nAge, sex and race will be reported on all by-subject listings unless otherwise specified. Sex will","confidence":1,"confidence_rate":1},{"cnt":[[245,700],[1880,700],[1880,750],[245,750]],"region":{"top_left_x":244,"top_left_y":700,"width":1636,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9ae79fb7714404092958c70af18fec6","type":"text","conversion_output":true,"text":"be abbreviated as: female (F) and male (M). Race will be abbreviated as: American Indian or","text_display":" be abbreviated as: female (F) and male (M). Race will be abbreviated as: American Indian or","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[245,748],[1880,748],[1880,797],[245,797]],"region":{"top_left_x":244,"top_left_y":747,"width":1636,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f89b87d11cd4dbf8ef641165c530fee","type":"text","conversion_output":true,"text":"Alaska Native (AI), Asian (AS), Black or African American (BL), Native Hawaiian or other","text_display":" Alaska Native (AI), Asian (AS), Black or African American (BL), Native Hawaiian or other","confidence":1,"confidence_rate":1},{"cnt":[[245,795],[1096,795],[1096,844],[245,844]],"region":{"top_left_x":244,"top_left_y":794,"width":852,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5efaf7a395a464d988d047deae5fcf8","type":"text","conversion_output":true,"text":"Pacific Islander (NH), White (WH) and Other (O).","text_display":" Pacific Islander (NH), White (WH) and Other (O).","confidence":0.933410273049958,"confidence_rate":0.9987006479186623},{"cnt":[[245,885],[1880,885],[1880,935],[245,935]],"region":{"top_left_x":244,"top_left_y":885,"width":1636,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45f1945cff09413aaeaad0ab33da4479","type":"text","conversion_output":true,"text":"All report outputs will be produced using SAS® version 9.4 (or later) in a secure and validated","text_display":"\n\nAll report outputs will be produced using SAS® version 9.4 (or later) in a secure and validated","confidence":0.9951221942901611,"confidence_rate":0.9999525279129318},{"cnt":[[245,932],[1880,932],[1880,982],[245,982]],"region":{"top_left_x":244,"top_left_y":932,"width":1636,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f48ae961851548dcb63cf9301ee32fd0","type":"text","conversion_output":true,"text":"environment. All report outputs will be provided to the Sponsor in PDF and true MS Word","text_display":" environment. All report outputs will be provided to the Sponsor in PDF and true MS Word","confidence":1,"confidence_rate":1},{"cnt":[[245,980],[445,980],[445,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":979,"width":201,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4142a367ea1b44ba8a1c062bda2cbe2f","type":"text","conversion_output":true,"text":"documents.","text_display":" documents.","confidence":1,"confidence_rate":1},{"cnt":[[241,1070],[406,1070],[406,1119],[241,1119]],"region":{"top_left_x":240,"top_left_y":1069,"width":167,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6af0314b7d1f4b23bf2ef73bbb53f92c","type":"section_header","conversion_output":false,"children_ids":["78c32358712c46c5b83b39d6e2060795"],"text":"","text_display":""},{"cnt":[[245,1074],[402,1074],[402,1115],[245,1115]],"region":{"top_left_x":244,"top_left_y":1074,"width":158,"height":42},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78c32358712c46c5b83b39d6e2060795","type":"text","conversion_output":true,"parent_id":"6af0314b7d1f4b23bf2ef73bbb53f92c","text":"Baseline","text_display":"\n\n\\section*{Baseline}","confidence":1,"confidence_rate":1},{"cnt":[[245,1160],[1880,1160],[1880,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1160,"width":1636,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"713faf88d1e34ea0af20708813469a01","type":"text","conversion_output":true,"text":"Baseline value is defined as the last non-missing measurement taken before first treatment","text_display":"\n\nBaseline value is defined as the last non-missing measurement taken before first treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1207],[1880,1207],[1880,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1207,"width":1636,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"575ab8f38e1e455fb844b6eb60d37faf","type":"text","conversion_output":true,"text":"(including unscheduled visits). This will typically be measurements taken at Baseline visit (week","text_display":" (including unscheduled visits). This will typically be measurements taken at Baseline visit (week","confidence":1,"confidence_rate":1},{"cnt":[[245,1255],[1880,1255],[1880,1306],[245,1306]],"region":{"top_left_x":244,"top_left_y":1254,"width":1636,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b589a16b716c474393516c6d8c34fa33","type":"text","conversion_output":true,"text":"0 ) but if this measurement is missing the measurement taken at the Screening visit (day-42 to -4)","text_display":" 0 ) but if this measurement is missing the measurement taken at the Screening visit (day-42 to -4)","confidence":0.9021367907490685,"confidence_rate":0.9989908123403543},{"cnt":[[245,1302],[1880,1302],[1880,1354],[245,1354]],"region":{"top_left_x":244,"top_left_y":1301,"width":1636,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba694e415adb44d2bc9b9bda608cb430","type":"text","conversion_output":true,"text":"will be used if available. See schedule of trial procedures in the protocol, Appendix E. For subjects","text_display":" will be used if available. See schedule of trial procedures in the protocol, Appendix E. For subjects","confidence":0.9990234375,"confidence_rate":0.9999907826873115},{"cnt":[[245,1351],[1502,1351],[1502,1399],[245,1399]],"region":{"top_left_x":244,"top_left_y":1351,"width":1258,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b870799a16ac4aca956e79502f067bbc","type":"text","conversion_output":true,"text":"randomized but not treated, date of randomization will be used as baseline.","text_display":" randomized but not treated, date of randomization will be used as baseline.","confidence":1,"confidence_rate":1},{"cnt":[[245,1439],[1880,1439],[1880,1491],[245,1491]],"region":{"top_left_x":244,"top_left_y":1439,"width":1636,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c0629eed8514c9f87333ac684a1f6aa","type":"text","conversion_output":true,"text":"If date of assessment is same as injection day and time is not collected, assessment is assumed to","text_display":"\n\nIf date of assessment is same as injection day and time is not collected, assessment is assumed to","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,1489],[754,1489],[754,1540],[245,1540]],"region":{"top_left_x":244,"top_left_y":1488,"width":511,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2605d9d053034f8091bd0e7e0f9dbb29","type":"text","conversion_output":true,"text":"be collected prior to injection.","text_display":" be collected prior to injection.","confidence":0.99951171875,"confidence_rate":0.9999868000736574},{"cnt":[[245,1577],[1880,1577],[1880,1629],[245,1629]],"region":{"top_left_x":244,"top_left_y":1576,"width":1636,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5179a15e0a484ffab7b6132e3e7bb8a0","type":"text","conversion_output":true,"text":"Time windows for Analysis Visit (AVISIT) to be used in Analysis Dataset Model (ADaM) datasets","text_display":"\n\nTime 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the mapping to AVISIT, any reference to visits throughout the rest","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[831,1766],[831,1815],[245,1815]],"region":{"top_left_x":244,"top_left_y":1766,"width":588,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dd9d2a3f2a043c49a42a0cf4f49e11b","type":"text","conversion_output":true,"text":"of the SAP, refers to this mapping.","text_display":" of the SAP, refers to this 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Study week window & Questionnaires/20 M/Labs (for 2-5 years part) /NRS/SF36/Pain in other joints target day \\(( \\operatorname { m i n } , \\operatorname { m a x } ) \\sim\\) & qMRI and SF36/Pain in other joints and Labs (for the year-2 part) target day (min, max)~ & X-ray, sqMRI, ECG target day (min, max) & AVISIT N for ADQS & AVISIT N for MRI & AVISIT N for XRAY \\\\\n\\hline Baseline * & \\(1(-42,1)\\) & \\(1(-42,1)\\) & \\(1(-42,1)\\) & 1 & 1 & 1 \\\\\n\\hline Month 3/Week 12~ & \\(85(2,133)\\) & \\multirow{2}{*}{183 \\((2,224)\\)} & \\multirow[t]{4}{*}{365 \\((2,406)\\) \\&} & 2 & \\multirow[t]{2}{*}{3} & \\multirow[t]{4}{*}{5} \\\\\n\\hline Month 6/Week 26 * & \\(183(134,224)\\) & & & 3 & & \\\\\n\\hline Month 9/Week 38~ & \\(267(225,315)\\) & \\multirow{2}{*}{365 \\((225,406)\\)} & & 4 & \\multirow[t]{2}{*}{5} & \\\\\n\\hline Month 12/Week 52 * & \\(365(316,406)\\) & & & 5 & & \\\\\n\\hline Month 15/Week 64 \\({ }^{\\sim}\\) & \\(449(407,497)\\) & \\multirow{2}{*}{547 \\((407,588)\\)} & \\multirow[t]{4}{*}{729 \\((407,819)\\)} & 6 & \\multirow[t]{2}{*}{7} & \\multirow[t]{4}{*}{9} \\\\\n\\hline Month 18/Week 78 * & \\(547(498,588)\\) & & & 7 & & \\\\\n\\hline Month 21/Week 90~ & \\(631(589,679)\\) & \\multirow{2}{*}{729 \\((589,819)\\)} & & 8 & \\multirow[t]{2}{*}{9} & \\\\\n\\hline Month 24/Week 104 & \\(729(680,819)\\) & & & 9 & & \\\\\n\\hline Month 30/Week 130 & \\(911(820,1001)\\) & \\multirow{2}{*}{1093 \\((820,1183)\\)} & \\multirow{2}{*}{1093 \\((820,1183)\\)} & 10 & \\multirow[t]{2}{*}{11} & \\multirow[t]{2}{*}{11} \\\\\n\\hline Month 36/Week 156 & \\(1093(1002,1183)\\) & & & 11 & & \\\\\n\\hline Month 42/Week 182 & \\(1275(1184,1365)\\) & \\multirow{2}{*}{1457 \\((1184,1547)\\)} & \\multirow{2}{*}{1457 \\((1184,1547)\\)} & 12 & \\multirow[t]{2}{*}{13} & \\multirow[t]{2}{*}{13} \\\\\n\\hline Month 48/Week 208 & \\(1457(1366,1547)\\) & & & 13 & & \\\\\n\\hline Month 54/Week 234 & \\(1639(1548,1729)\\) & \\multirow{2}{*}{1821 \\((1548,1849)\\)} & \\multirow{2}{*}{1821 \\((1548,1849)\\)} & 14 & \\multirow[t]{2}{*}{15} & \\multirow[t]{2}{*}{15} \\\\\n\\hline Month 60/Week 260 & \\(1821(1730,1849)\\) & & & 15 & & \\\\\n\\hline LOCF1 (up to Month 24) & \\multicolumn{3}{|l|}{Last post-baseline measurement in DBPC \\((2,819)\\)} & \\multicolumn{3}{|l|}{20 (for 2 years)} \\\\\n\\hline LOCF2 (Up to Month 60) & \\multicolumn{3}{|c|}{Last post-baseline measurement in Follow-up period \\((2,1849)\\)} & \\multicolumn{3}{|l|}{50 (for 5 years)} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 3 Target days for AVISIT}\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline Study week window & Questionnaires/20 M/Labs (for 2-5 years part) /NRS/SF36/Pain in other joints target day \\(( \\operatorname { m i n } , \\operatorname { m a x } ) \\sim\\) & qMRI and SF36/Pain in other joints and Labs (for the year-2 part) target day (min, max)~ & X-ray, sqMRI, ECG target day 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Study week window & To be used relative to injection visit independent of ADY & AVISITN for injection related ADVS \\\\\n\\hline Cycle 1/Week 0/pre-injection assessment/Baseline & Yes & 1 \\\\\n\\hline Cycle 1/Week 1/pre-injection assessment & Yes & 2 \\\\\n\\hline Cycle 1/Week 2/pre-injection assessment & Yes & 3 \\\\\n\\hline Cycle 1/Week 3 & Yes & 4 \\\\\n\\hline & & \\\\\n\\hline Cycle 2/Week 0/pre-injection assessment & Yes & 5 \\\\\n\\hline Cycle 2/Week 1/pre-injection assessment & Yes & 6 \\\\\n\\hline Cycle 2/Week 2/pre-injection assessment & Yes & 7 \\\\\n\\hline Cycle 2/Week 3 & Yes & 8 \\\\\n\\hline & & \\\\\n\\hline Cycle 3/Week 0/pre-injection assessment & Yes & 9 \\\\\n\\hline Cycle 3/Week 1/pre-injection assessment & Yes & 10 \\\\\n\\hline Cycle 3/Week 2/pre-injection assessment & Yes & 11 \\\\\n\\hline Cycle 3/Week 3 & Yes & 12 \\\\\n\\hline & & \\\\\n\\hline Cycle 4/Week 0/pre-injection assessment & Yes & 13 \\\\\n\\hline Cycle 4/Week 1/pre-injection assessment & Yes & 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(AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[640,172],[640,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":397,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1924a32ac9f49f4b961e14d3101a576","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,281],[333,281],[333,320],[245,320]],"region":{"top_left_x":244,"top_left_y":281,"width":90,"height":40},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9eca2e8b702843288cf51fa8e6af9b3f","type":"text","conversion_output":true,"text":"run;","text_display":"\nrun;","confidence":1,"confidence_rate":1},{"cnt":[[241,357],[1538,357],[1538,428],[241,428]],"region":{"top_left_x":240,"top_left_y":356,"width":1299,"height":72},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a79568fa4a75453c9e36c24108f45711","type":"section_header","conversion_output":false,"children_ids":["e3b7684825a74885a3084da33072fa52","c56685e01bc34c8ebfd2f3cf83686a6f"],"text":"","text_display":""},{"cnt":[[243,363],[305,363],[305,412],[243,412]],"region":{"top_left_x":242,"top_left_y":363,"width":64,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3b7684825a74885a3084da33072fa52","type":"text","conversion_output":true,"parent_id":"a79568fa4a75453c9e36c24108f45711","text":"12","text_display":"\n\n\\section*{12","confidence":1,"confidence_rate":1},{"cnt":[[593,365],[1528,365],[1528,419],[593,419]],"region":{"top_left_x":592,"top_left_y":365,"width":936,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c56685e01bc34c8ebfd2f3cf83686a6f","type":"text","conversion_output":true,"parent_id":"a79568fa4a75453c9e36c24108f45711","text":"Disposition of Subjects and Discontinuations","text_display":" Disposition of Subjects and Discontinuations}","confidence":0.991706371307373,"confidence_rate":0.9998300509291251},{"cnt":[[245,460],[1880,460],[1880,509],[245,509]],"region":{"top_left_x":244,"top_left_y":459,"width":1636,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f085e6f879f478badfb57717525ef0f","type":"text","conversion_output":true,"text":"This section presents specifications for reporting subject disposition and treatment/trial","text_display":"\n\nThis section presents specifications for reporting subject disposition and treatment/trial","confidence":1,"confidence_rate":1},{"cnt":[[245,507],[1742,507],[1742,556],[245,556]],"region":{"top_left_x":244,"top_left_y":507,"width":1499,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd194ffb6ab3456b952a63a7272e546d","type":"text","conversion_output":true,"text":"discontinuations. Additionally, procedures for reporting protocol deviations are provided.","text_display":" discontinuations. Additionally, procedures for reporting protocol deviations are provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,597],[1721,597],[1721,647],[245,647]],"region":{"top_left_x":244,"top_left_y":597,"width":1477,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec407a0f19234d419fe0c200feeed56b","type":"text","conversion_output":true,"text":"Subject disposition will be presented for all subjects and by treatment group in terms of:","text_display":"\n\nSubject disposition will be presented for all subjects and by treatment group in terms of:","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1609,670],[1609,720],[245,720]],"region":{"top_left_x":244,"top_left_y":670,"width":1366,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a32468127448421682c21085f9e74a16","type":"text","conversion_output":true,"text":"- Total number of subjects screened (i.e. subjects who signed informed consent)","text_display":"\n- Total number of subjects screened (i.e. subjects who signed informed consent)","confidence":0.986328125,"confidence_rate":0.9998361301452251},{"cnt":[[245,741],[1880,741],[1880,793],[245,793]],"region":{"top_left_x":244,"top_left_y":741,"width":1636,"height":52},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bd932b9a3e345a597d61137b527ef63","type":"text","conversion_output":true,"text":"- Number and percentages of subjects discontinuing the trial prior to randomization divided by","text_display":"\n- Number and percentages of subjects discontinuing the trial prior to randomization divided by","confidence":1,"confidence_rate":1},{"cnt":[[294,791],[1876,791],[1876,838],[294,838]],"region":{"top_left_x":294,"top_left_y":790,"width":1582,"height":48},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d131f710484041b89f2db3d1c058078a","type":"text","conversion_output":true,"text":"main reason for discontinuation (did not meet all eligibility criteria, withdrew consent, other),","text_display":" main reason for discontinuation (did not meet all eligibility criteria, withdrew consent, other),","confidence":1,"confidence_rate":1},{"cnt":[[294,838],[836,838],[836,887],[294,887]],"region":{"top_left_x":294,"top_left_y":837,"width":542,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44aec56e42a8452ca7a7ad46b8ae4324","type":"text","conversion_output":true,"text":"by country and site, and overall.","text_display":" by country and site, and overall.","confidence":1,"confidence_rate":1},{"cnt":[[245,907],[1124,907],[1124,958],[245,958]],"region":{"top_left_x":244,"top_left_y":906,"width":880,"height":53},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58365e2ab5e34cfc8611e6a2080c8551","type":"text","conversion_output":true,"text":"- Number and percentages of randomized subjects.","text_display":"\n- Number and percentages of randomized subjects.","confidence":1,"confidence_rate":1},{"cnt":[[245,980],[1055,980],[1055,1029],[245,1029]],"region":{"top_left_x":244,"top_left_y":979,"width":811,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93a0b9f5af634fc48e958cfe1e82fc60","type":"text","conversion_output":true,"text":"- Number and percentages of exposed subjects","text_display":"\n- Number and percentages of exposed subjects","confidence":1,"confidence_rate":1},{"cnt":[[245,1053],[1878,1053],[1878,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1052,"width":1634,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28b5ae0d2fa24a4d9c3ee435961aa149","type":"text","conversion_output":true,"text":"- Number and percentages of randomized subjects who completed the DBPC treatment phase.","text_display":"\n- Number and percentages of randomized subjects who completed the DBPC treatment 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and during extended follow up phase (grouped","confidence":0.9912109375,"confidence_rate":0.9999089947172777},{"cnt":[[292,1315],[1390,1315],[1390,1364],[292,1364]],"region":{"top_left_x":292,"top_left_y":1314,"width":1099,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1655dbca63de47d7b6f99a84d5222b9a","type":"text","conversion_output":true,"text":"by treatment) and main reason (AE, death, lost to follow-up, etc).","text_display":" by treatment) and main reason (AE, death, lost to follow-up, etc).","confidence":1,"confidence_rate":1},{"cnt":[[245,1388],[1880,1388],[1880,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1387,"width":1636,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92dafcd281344053b94ad04cedf62b71","type":"text","conversion_output":true,"text":"- Number and percentages of randomized subjects who discontinued treatment after","text_display":"\n- Number and percentages of randomized subjects who discontinued treatment after","confidence":1,"confidence_rate":1},{"cnt":[[292,1435],[1880,1435],[1880,1485],[292,1485]],"region":{"top_left_x":292,"top_left_y":1435,"width":1588,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d63cd0413bf84a7995d76ce4c0cc262d","type":"text","conversion_output":true,"text":"randomization, during DPBC and during extended follow up phase (grouped by treatment) and","text_display":" randomization, during DPBC and during extended follow up phase (grouped by treatment) and","confidence":1,"confidence_rate":1},{"cnt":[[292,1482],[1087,1482],[1087,1532],[292,1532]],"region":{"top_left_x":292,"top_left_y":1482,"width":796,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aceb0135e8864821a7d7f5b50bb35673","type":"text","conversion_output":true,"text":"main reason (AE, death, lost to follow-up, etc).","text_display":" main reason 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completing the extended follow up phase.","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[1880,1714],[1880,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1714,"width":1636,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5459208bf9d4c45aa6129f08d785f2b","type":"text","conversion_output":true,"text":"For subjects who discontinued the trial summary statistics will also be presented for time to study","text_display":"\n\nFor subjects who discontinued the trial summary statistics will also be presented for time to study","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[1880,1766],[1880,1813],[245,1813]],"region":{"top_left_x":244,"top_left_y":1766,"width":1636,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87b1ddff9b36400fbf505ff2385abbfa","type":"text","conversion_output":true,"text":"termination for the 2-year analysis this corresponds only to early discontinuation i.e. before day","text_display":" termination for the 2-year analysis this corresponds only to early discontinuation i.e. before day","confidence":0.7002902281237766,"confidence_rate":0.9965471358806978},{"cnt":[[245,1813],[324,1813],[324,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1813,"width":81,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"552b6f1eafc945b1aed3bf2f9c2dfa46","type":"text","conversion_output":true,"text":"819.","text_display":" 819.","confidence":1,"confidence_rate":1},{"cnt":[[245,1901],[1154,1901],[1154,1951],[245,1951]],"region":{"top_left_x":244,"top_left_y":1901,"width":910,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d712147aae2f4d738900f3246333ee75","type":"text","conversion_output":true,"text":"Subject disposition will also be presented per country.","text_display":"\n\nSubject disposition will also be presented per country.","confidence":1,"confidence_rate":1},{"cnt":[[245,1989],[1313,1989],[1313,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1989,"width":1069,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5b553b2ba8c40bf965f6c5174247d10","type":"text","conversion_output":true,"text":"Time to study termination in days will be calculated as follows:","text_display":"\nTime to study termination in days will be calculated as follows:","confidence":1,"confidence_rate":1},{"cnt":[[370,2075],[1317,2075],[1317,2133],[370,2133]],"region":{"top_left_x":369,"top_left_y":2075,"width":948,"height":59},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"208f3fd5d58343a9939ae3221700fe8e","type":"math","conversion_output":true,"text":"\\[\n=\\text { Date of study termination - Date of Randomization }+1\n\\]","text_display":"\n\\[\n=\\text { Date of study termination - Date of Randomization }+1\n\\]","confidence":0.6118856063112617,"confidence_rate":0.9914193079955577},{"cnt":[[245,2170],[1878,2170],[1878,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1634,"height":51},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85838163a112455f97f24e0aeb9b94c0","type":"text","conversion_output":true,"text":"A by-subject listing of Analysis Set details will be presented by treatment group including: center,","text_display":"\n\nA by-subject listing of Analysis Set details will be presented by treatment group including: center,","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1880,2217],[1880,2267],[245,2267]],"region":{"top_left_x":244,"top_left_y":2217,"width":1636,"height":50},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38be778381b34797ae370a2a00eafa95","type":"text","conversion_output":true,"text":"subject identifier, inclusion/exclusion flag for each Analysis Set and reason for exclusion from","text_display":" subject identifier, inclusion/exclusion flag for each Analysis Set and reason for exclusion from","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[556,2264],[556,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2264,"width":313,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2462cd6cb3fe4707af06feff9c2c043d","type":"text","conversion_output":true,"text":"each Analysis Set.","text_display":" each Analysis 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v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,277],[1016,277],[1016,337],[243,337]],"region":{"top_left_x":242,"top_left_y":277,"width":775,"height":61},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32e5c6ae02334f60bbb8621e0ceaa680","type":"section_header","conversion_output":false,"children_ids":["9ed76b76c4274554bcdfa926b28d30e8"],"text":"","text_display":""},{"cnt":[[247,284],[1010,284],[1010,333],[247,333]],"region":{"top_left_x":247,"top_left_y":283,"width":763,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ed76b76c4274554bcdfa926b28d30e8","type":"text","conversion_output":true,"parent_id":"32e5c6ae02334f60bbb8621e0ceaa680","text":"12.1 Protocol Deviations","text_display":"\n\n\\subsection*{12.1 Protocol Deviations}","confidence":0.83544921875,"confidence_rate":0.9938196699755514},{"cnt":[[245,378],[1878,378],[1878,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1634,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6e6829afa4a43519c065aeb92566bab","type":"text","conversion_output":true,"text":"A table will be produced summarizing, by treatment group, the number and percentage of subjects","text_display":"\n\nA table will be produced summarizing, by treatment group, the number and percentage of subjects","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[1858,425],[1858,475],[245,475]],"region":{"top_left_x":244,"top_left_y":425,"width":1615,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80e574fa77f244e2b0dc6c187d3d27c0","type":"text","conversion_output":true,"text":"with a major protocol deviation, overall and by type of deviation (ITT and mITT Analysis 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Major","text_display":"\n\nAll protocol deviations will be listed and each will be marked whether it is major or minor. 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Subjects who have (actual total dose)/(planned total dose)* 100 within \\(75-100 \\%\\) will","text_display":" document). Subjects who have (actual total dose)/(planned total dose)* 100 within \\(75-100 \\%\\) will","confidence":0.8639192804067428,"confidence_rate":0.9986078657287369},{"cnt":[[245,842],[1880,842],[1880,896],[245,896]],"region":{"top_left_x":244,"top_left_y":842,"width":1636,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cff94cfae4a04125b9b7fe6aaa198818","type":"text","conversion_output":true,"text":"be considered treatment compliant. If subject was randomized to placebo group but instead","text_display":" be considered treatment compliant. If subject was randomized to placebo group but instead","confidence":1,"confidence_rate":1},{"cnt":[[245,889],[1880,889],[1880,943],[245,943]],"region":{"top_left_x":244,"top_left_y":889,"width":1636,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4de80a41458141269fab61c1ad0e7a19","type":"text","conversion_output":true,"text":"received at least one dose of sprifermin, then this subject will be classified as having major protocol","text_display":" received at least one dose of sprifermin, then this subject will be classified as having major protocol","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,939],[1880,939],[1880,990],[245,990]],"region":{"top_left_x":244,"top_left_y":938,"width":1636,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a24c6a47345749e2b02e3f2a26d61573","type":"text","conversion_output":true,"text":"deviation. Additionally subjects identified in the Note To File: \"NTF_QC of primary endpoint","text_display":" deviation. Additionally subjects identified in the Note To File: \"NTF_QC of primary endpoint","confidence":1,"confidence_rate":1},{"cnt":[[245,988],[1338,988],[1338,1038],[245,1038]],"region":{"top_left_x":244,"top_left_y":988,"width":1095,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e076eaf3be0d493081a4a9cc210a46b8","type":"text","conversion_output":true,"text":"MRI_FORWARD_17MAY2016\", will be excluded from the PP.","text_display":" MRI_FORWARD_17MAY2016\", will be excluded from the PP.","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[243,1164],[1648,1164],[1648,1231],[243,1231]],"region":{"top_left_x":242,"top_left_y":1164,"width":1406,"height":68},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9da41e675f9845f6a19c07d6c77d1ccf","type":"section_header","conversion_output":false,"children_ids":["1933d1248a6e4306be515a154c46d611","6fe27b6b7123424092a82929e9c03772"],"text":"","text_display":""},{"cnt":[[243,1173],[305,1173],[305,1220],[243,1220]],"region":{"top_left_x":242,"top_left_y":1173,"width":64,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1933d1248a6e4306be515a154c46d611","type":"text","conversion_output":true,"parent_id":"9da41e675f9845f6a19c07d6c77d1ccf","text":"13","text_display":"\n\n\\section*{13","confidence":0.99951171875,"confidence_rate":0.9997558295653994},{"cnt":[[593,1173],[1644,1173],[1644,1227],[593,1227]],"region":{"top_left_x":592,"top_left_y":1173,"width":1052,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fe27b6b7123424092a82929e9c03772","type":"text","conversion_output":true,"parent_id":"9da41e675f9845f6a19c07d6c77d1ccf","text":"Demographics and Other Baseline Characteristics","text_display":" Demographics and Other Baseline Characteristics}","confidence":1,"confidence_rate":1},{"cnt":[[245,1263],[1880,1263],[1880,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1263,"width":1636,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39053b589d1d4a8fabab92c04b154a75","type":"text","conversion_output":true,"text":"Demographics and other baseline characteristics will be presented descriptively for the analysis","text_display":"\n\nDemographics and other baseline characteristics will be presented descriptively for the analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,1315],[1800,1315],[1800,1364],[245,1364]],"region":{"top_left_x":244,"top_left_y":1314,"width":1557,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cadf5ad81ee74d8888db1980aa3a92c1","type":"text","conversion_output":true,"text":"sets described in table 2 (Section 10). Moreover, demographics will be presented by country.","text_display":" sets described in table 2 (Section 10). Moreover, demographics will be presented by country.","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,1401],[1880,1401],[1880,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1400,"width":1636,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aafb8b81cdda44a2bb50b27b675f0ddb","type":"text","conversion_output":true,"text":"By-subject listings accompanying each demographic and baseline characteristics table will be","text_display":"\n\nBy-subject listings accompanying each demographic and baseline characteristics table will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[419,1452],[419,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":175,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"affc617ecd5343e69dc38704526107ae","type":"text","conversion_output":true,"text":"produced.","text_display":" produced.","confidence":1,"confidence_rate":1},{"cnt":[[243,1538],[909,1538],[909,1605],[243,1605]],"region":{"top_left_x":242,"top_left_y":1538,"width":667,"height":67},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6197fce9aec74cb9bf96c923dfcb9a4f","type":"section_header","conversion_output":false,"children_ids":["2d7c47c2b46145e691bc5f643df20285"],"text":"","text_display":""},{"cnt":[[249,1543],[902,1543],[902,1601],[249,1601]],"region":{"top_left_x":249,"top_left_y":1542,"width":654,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d7c47c2b46145e691bc5f643df20285","type":"text","conversion_output":true,"parent_id":"6197fce9aec74cb9bf96c923dfcb9a4f","text":"13.1 Demographics","text_display":"\n\n\\subsection*{13.1 Demographics}","confidence":0.99169921875,"confidence_rate":0.9996031537843453},{"cnt":[[245,1637],[1764,1637],[1764,1691],[245,1691]],"region":{"top_left_x":244,"top_left_y":1637,"width":1520,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eeffc96a7efd421fa5fe5600a1a6fdc7","type":"text","conversion_output":true,"text":"Demographic variables include age, sex, height, weight, BMI, race, ethnicity, and country.","text_display":"\n\nDemographic variables include age, sex, height, weight, BMI, race, ethnicity, and country.","confidence":1,"confidence_rate":1},{"cnt":[[243,1727],[947,1727],[947,1794],[243,1794]],"region":{"top_left_x":242,"top_left_y":1727,"width":706,"height":67},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baad8385179e403ab69ac4c350edba6d","type":"section_header","conversion_output":false,"children_ids":["2ef07d6829474a32a7e84abc4bca0fa7"],"text":"","text_display":""},{"cnt":[[249,1732],[941,1732],[941,1785],[249,1785]],"region":{"top_left_x":249,"top_left_y":1731,"width":693,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ef07d6829474a32a7e84abc4bca0fa7","type":"text","conversion_output":true,"parent_id":"baad8385179e403ab69ac4c350edba6d","text":"13.2 Medical History","text_display":"\n\n\\subsection*{13.2 Medical History}","confidence":0.9541015625,"confidence_rate":0.9981223588355804},{"cnt":[[245,1824],[1880,1824],[1880,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1824,"width":1636,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a82667a32fcd4d0fa15e6f6a7c0b0234","type":"text","conversion_output":true,"text":"Medical history (other than knee OA) will be summarized descriptively by MedDRA SOC and","text_display":"\n\nMedical history (other than knee OA) will be summarized descriptively by MedDRA SOC and","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[243,1873],[312,1873],[312,1919],[243,1919]],"region":{"top_left_x":242,"top_left_y":1873,"width":70,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff31d86c1232427eb4b47058a74ca003","type":"text","conversion_output":true,"text":"PT.","text_display":" PT.","confidence":0.99951171875,"confidence_rate":0.9999389518012535},{"cnt":[[245,1959],[1248,1959],[1248,2020],[245,2020]],"region":{"top_left_x":244,"top_left_y":1959,"width":1005,"height":61},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cda20b8ff2ad4b24955326f7babe9c3a","type":"section_header","conversion_output":false,"children_ids":["1b041aa72bf545d98c8a8d9e4fe1f6e6"],"text":"","text_display":""},{"cnt":[[249,1966],[1240,1966],[1240,2013],[249,2013]],"region":{"top_left_x":249,"top_left_y":1965,"width":991,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b041aa72bf545d98c8a8d9e4fe1f6e6","type":"text","conversion_output":true,"parent_id":"cda20b8ff2ad4b24955326f7babe9c3a","text":"13.3 Other Baseline Characteristics","text_display":"\n\n\\subsection*{13.3 Other Baseline 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consumption","confidence":1,"confidence_rate":1},{"cnt":[[245,2204],[1878,2204],[1878,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2204,"width":1634,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fff8f5db23cf412f9b7fb979775e20d7","type":"text","conversion_output":true,"text":"- Specification of target knee OA: (KL Grade 2 or 3, target knee location (Left or Right knee),","text_display":"\n- Specification of target knee OA: (KL Grade 2 or 3, target knee location (Left or Right knee),","confidence":1,"confidence_rate":1},{"cnt":[[294,2252],[1880,2252],[1880,2301],[294,2301]],"region":{"top_left_x":294,"top_left_y":2251,"width":1586,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"637196316a7944c1896392c0577f9157","type":"text","conversion_output":true,"text":"medial and lateral mJSW, Anatomic axis angle (AAA) of knee alignment [in degrees calculated","text_display":" medial and lateral mJSW, Anatomic axis angle (AAA) of knee alignment [in degrees calculated","confidence":0.9951171875,"confidence_rate":0.9999490140875682},{"cnt":[[294,2299],[1880,2299],[1880,2350],[294,2350]],"region":{"top_left_x":294,"top_left_y":2298,"width":1586,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e49651c70d0d45248ebb0fc64ecf551d","type":"text","conversion_output":true,"text":"as 180 - ANGLE, where ANGLE is the value corresponding to xmtestcd = 'ANGLE'], response","text_display":" as 180 - ANGLE, where ANGLE is the value corresponding to xmtestcd = 'ANGLE'], response","confidence":0.9951212396845222,"confidence_rate":0.9999485202691547},{"cnt":[[294,2346],[1635,2346],[1635,2400],[294,2400]],"region":{"top_left_x":294,"top_left_y":2346,"width":1341,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39731a28a6704af990635c7353365aea","type":"text","conversion_output":true,"text":"to Question 1 of the WOMAC pain index at screening, and time since diagnosis","text_display":" to Question 1 of the WOMAC pain index at screening, and time since diagnosis","confidence":1,"confidence_rate":1},{"cnt":[[245,2419],[1424,2419],[1424,2469],[245,2469]],"region":{"top_left_x":244,"top_left_y":2419,"width":1181,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f0263ad6c744c1b98b36ec48dec1aef","type":"text","conversion_output":true,"text":"- Contralateral knee: KL Grade ( \\(0,1,2,3\\) ), medial and lateral mJSW","text_display":"\n- Contralateral knee: KL Grade ( \\(0,1,2,3\\) ), medial and lateral mJSW","confidence":0.822410948574543,"confidence_rate":0.9973965273098481},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d71acadf48da49b7bdea66576ac4eefc","type":"page_info","conversion_output":false,"text":"34/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-35","page":35,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7bdfdb1ff72455e87b6f2e890e23a4d","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43440ea7adbc4b63b223e1d34c5a9a08","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,284],[1734,284],[1734,333],[245,333]],"region":{"top_left_x":244,"top_left_y":283,"width":1490,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7cdbb50874a4b9fbf19a01092eac590","type":"text","conversion_output":true,"text":"- Pain in other joints (yes/no, and if yes, how many joints and which joints specifically)","text_display":"\n- Pain in other joints (yes/no, and if yes, how many joints and which joints specifically)","confidence":1,"confidence_rate":1},{"cnt":[[245,357],[1418,357],[1418,406],[245,406]],"region":{"top_left_x":244,"top_left_y":356,"width":1174,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b1d655dcb7e466a889e2abbf99ff56d","type":"text","conversion_output":true,"text":"- All other attributes defined in subgroups analysis set in Section 10.","text_display":"\n- All other attributes defined in subgroups analysis set in Section 10.","confidence":1,"confidence_rate":1},{"cnt":[[243,443],[1644,443],[1644,503],[243,503]],"region":{"top_left_x":242,"top_left_y":442,"width":1402,"height":61},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54844f0fc1464271aefbfe19a116617f","type":"section_header","conversion_output":false,"children_ids":["9ac2552a356940f9b776f7cc3380072a","37463e3825d04a8a8284f1cf051480eb"],"text":"","text_display":""},{"cnt":[[243,447],[305,447],[305,498],[243,498]],"region":{"top_left_x":242,"top_left_y":446,"width":64,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ac2552a356940f9b776f7cc3380072a","type":"text","conversion_output":true,"parent_id":"54844f0fc1464271aefbfe19a116617f","text":"14","text_display":"\n\n\\section*{14","confidence":1,"confidence_rate":1},{"cnt":[[593,449],[1639,449],[1639,496],[593,496]],"region":{"top_left_x":592,"top_left_y":449,"width":1048,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37463e3825d04a8a8284f1cf051480eb","type":"text","conversion_output":true,"parent_id":"54844f0fc1464271aefbfe19a116617f","text":"Previous or Concomitant Medications/Procedures","text_display":" Previous or Concomitant Medications/Procedures}","confidence":1,"confidence_rate":1},{"cnt":[[245,541],[1880,541],[1880,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":1636,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d66c08af290c41b292c9e5e13a8767a1","type":"text","conversion_output":true,"text":"Medication start and stop dates will be compared to the date of first dose of study medication, see","text_display":"\n\nMedication start and stop dates will be compared to the date of first dose of study medication, 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Medications that start and stop prior to","text_display":"\n\nAll medications categories will be summarized and listed. Medications that start and stop prior to","confidence":1,"confidence_rate":1},{"cnt":[[245,997],[1880,997],[1880,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":996,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a718be5126043909584a483971b0112","type":"text","conversion_output":true,"text":"the date of first dose of study medication will be classified as previous medication. If a medication","text_display":" the date of first dose of study medication will be classified as previous medication. If a medication","confidence":1,"confidence_rate":1},{"cnt":[[245,1044],[1880,1044],[1880,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1044,"width":1636,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d705651585fa4f0cbdfc390aa9c77369","type":"text","conversion_output":true,"text":"starts or stops on or after the date of first dose of study medication and prior to last dose, then","text_display":" starts or stops on or after the date of first dose of study medication and prior to last dose, then","confidence":1,"confidence_rate":1},{"cnt":[[245,1091],[1880,1091],[1880,1141],[245,1141]],"region":{"top_left_x":244,"top_left_y":1091,"width":1636,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35d091c1fdeb4c20bdc6d47cb32bb9b0","type":"text","conversion_output":true,"text":"the medication will be classified as Concomitant. Medications that start after last injection will","text_display":" the medication will be classified as Concomitant. Medications that start after last injection will","confidence":1,"confidence_rate":1},{"cnt":[[245,1141],[1882,1141],[1882,1188],[245,1188]],"region":{"top_left_x":244,"top_left_y":1140,"width":1639,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b417353700a4e91bfee643071bef53e","type":"text","conversion_output":true,"text":"not be considered concomitant and will be categorized as Post-treatment medications. If","text_display":" not be considered concomitant and will be categorized as Post-treatment medications. If","confidence":1,"confidence_rate":1},{"cnt":[[245,1188],[1880,1188],[1880,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1188,"width":1636,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fa6260178284891aeb0bdb46fa55395","type":"text","conversion_output":true,"text":"medication start and/or stop dates are missing or partial, the dates will be compared with the date","text_display":" medication start and/or stop dates are missing or partial, the dates will be compared with the date","confidence":1,"confidence_rate":1},{"cnt":[[245,1237],[1880,1237],[1880,1287],[245,1287]],"region":{"top_left_x":244,"top_left_y":1237,"width":1636,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66013fea927049da80599cc12c4b6e40","type":"text","conversion_output":true,"text":"of first dose of study medication. Medications will be assumed to be Concomitant, unless there is","text_display":" of first dose of study medication. Medications will be assumed to be Concomitant, unless there is","confidence":0.9970703125,"confidence_rate":0.9999712358310027},{"cnt":[[245,1285],[1880,1285],[1880,1334],[245,1334]],"region":{"top_left_x":244,"top_left_y":1284,"width":1636,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00a711cf4e3349d3b3950a8e65e6a57c","type":"text","conversion_output":true,"text":"clear evidence (through comparison of partial dates) to suggest that the medication stopped prior","text_display":" clear evidence (through comparison of partial dates) to suggest that the medication stopped prior","confidence":1,"confidence_rate":1},{"cnt":[[245,1332],[1880,1332],[1880,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":1636,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58d93c45a4824e74938261713cba5fa5","type":"text","conversion_output":true,"text":"to the first dose of study medication (in which case the medication will be assumed to be Previous","text_display":" to the first dose of study medication (in which case the medication will be assumed to be Previous","confidence":1,"confidence_rate":1},{"cnt":[[245,1379],[1880,1379],[1880,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1379,"width":1636,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08686aaec5304571b2bf30adb4c48fc2","type":"text","conversion_output":true,"text":"medication) or started after last injection (in which case the medication will be assumed to be Post-","text_display":" medication) or started after last injection (in which case the medication will be assumed to be Post","confidence":1,"confidence_rate":1},{"cnt":[[245,1429],[629,1429],[629,1480],[245,1480]],"region":{"top_left_x":244,"top_left_y":1428,"width":386,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a45a8604a834caabc97669532f82b5a","type":"text","conversion_output":true,"text":"treatment medication).","text_display":"treatment medication).","confidence":1,"confidence_rate":1},{"cnt":[[245,1517],[1880,1517],[1880,1566],[245,1566]],"region":{"top_left_x":244,"top_left_y":1516,"width":1636,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4041913c6a6f42a8b34573402e867df0","type":"text","conversion_output":true,"text":"Pain and other medication such as NSAIDs taken in each of the three categories ( \\(a , b , c\\) ) described","text_display":"\n\nPain and other medication such as NSAIDs taken in each of the three categories ( \\(a , b , c\\) ) described","confidence":0.4026126405224204,"confidence_rate":0.992120077015763},{"cnt":[[245,1566],[1772,1566],[1772,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1566,"width":1529,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25ece977cc8b489c9b0f9df56fbf5215","type":"text","conversion_output":true,"text":"above will be summarized and listed. List of pain medication is attached in Appendix 19.2.","text_display":" above will be summarized and listed. List of pain medication is attached in Appendix 19.2.","confidence":1,"confidence_rate":1},{"cnt":[[245,1654],[1880,1654],[1880,1706],[245,1706]],"region":{"top_left_x":244,"top_left_y":1654,"width":1636,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29cc34317e28455987200312693b0797","type":"text","conversion_output":true,"text":"All medications will be coded using the latest version of the WhoDrug Anatomic therapeutic class","text_display":"\n\nAll medications will be coded using the latest version of the WhoDrug Anatomic therapeutic class","confidence":1,"confidence_rate":1},{"cnt":[[245,1704],[1880,1704],[1880,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1703,"width":1636,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a61481dff4a44f796bd8666ee9644e1","type":"text","conversion_output":true,"text":"(ATC) Medications using the indication or using the secondary level of the ATC code. Coding","text_display":" (ATC) Medications using the indication or using the secondary level of the ATC code. Coding","confidence":1,"confidence_rate":1},{"cnt":[[245,1753],[900,1753],[900,1803],[245,1803]],"region":{"top_left_x":244,"top_left_y":1753,"width":657,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c328d030dc4847a089d71dcc966b4222","type":"text","conversion_output":true,"text":"will be updated for the 5 -year analysis.","text_display":" will be updated for the 5 -year analysis.","confidence":0.890864790417254,"confidence_rate":0.9976443582073967},{"cnt":[[245,1839],[758,1839],[758,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1839,"width":515,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4f45e27c58c427da75441653e5fd885","type":"text","conversion_output":true,"text":"Procedures will be listed only.","text_display":"\n\nProcedures will be listed only.","confidence":1,"confidence_rate":1},{"cnt":[[243,1927],[1394,1927],[1394,1996],[243,1996]],"region":{"top_left_x":242,"top_left_y":1927,"width":1153,"height":69},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31989e79f0924ab89ab2dafea84b79e3","type":"section_header","conversion_output":false,"children_ids":["67fc4ee7583f4332aebd04920ea74c01","c3bc0128c21840d296fdef577b5b141f"],"text":"","text_display":""},{"cnt":[[243,1934],[305,1934],[305,1987],[243,1987]],"region":{"top_left_x":242,"top_left_y":1933,"width":64,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67fc4ee7583f4332aebd04920ea74c01","type":"text","conversion_output":true,"parent_id":"31989e79f0924ab89ab2dafea84b79e3","text":"15","text_display":"\n\n\\section*{15","confidence":1,"confidence_rate":1},{"cnt":[[593,1934],[1386,1934],[1386,1989],[593,1989]],"region":{"top_left_x":592,"top_left_y":1933,"width":794,"height":57},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3bc0128c21840d296fdef577b5b141f","type":"text","conversion_output":true,"parent_id":"31989e79f0924ab89ab2dafea84b79e3","text":"Treatment Compliance and Exposure","text_display":" Treatment Compliance and Exposure}","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1403,2028],[1403,2078],[245,2078]],"region":{"top_left_x":244,"top_left_y":2028,"width":1159,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c4480ceafdd4362b57c43851237520c","type":"text","conversion_output":true,"text":"Exposure to sprifermin will be summarized descriptively in terms of:","text_display":"\n\nExposure to sprifermin will be summarized descriptively in terms of:","confidence":1,"confidence_rate":1},{"cnt":[[245,2101],[1482,2101],[1482,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2101,"width":1239,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57372b7ffbf94970a91b59d4abd0d525","type":"text","conversion_output":true,"text":"- Duration of exposure \\(=\\) date of last injection - date of first injection +1","text_display":"\n- Duration of exposure \\(=\\) date of last injection - date of first injection +1","confidence":0.9220606558956206,"confidence_rate":0.9990569069654791},{"cnt":[[245,2170],[1403,2170],[1403,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2169,"width":1159,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb5f41a1159642838d4f74b490c0ee69","type":"text","conversion_output":true,"text":"- Total dose \\((\\mu g )=\\) sum of (number of \\(X \\mu g\\) dose injections * \\(X \\mu g\\) )","text_display":"\n- Total dose \\((\\mu g )=\\) sum of (number of \\(X \\mu g\\) dose injections * \\(X \\mu g\\) )","confidence":0.5838666264518267,"confidence_rate":0.994230870210788},{"cnt":[[245,2243],[1880,2243],[1880,2292],[245,2292]],"region":{"top_left_x":244,"top_left_y":2242,"width":1636,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f7747cd69924de89c9b83d98368b463","type":"text","conversion_output":true,"text":"- Listing of treatment exposure including time between injections within a cycle and time","text_display":"\n- Listing of treatment exposure including time between injections within a cycle and time","confidence":1,"confidence_rate":1},{"cnt":[[292,2290],[1785,2290],[1785,2340],[292,2340]],"region":{"top_left_x":292,"top_left_y":2290,"width":1494,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e83fd87efa28439f94a0e2f360e281ec","type":"text","conversion_output":true,"text":"between last injection of previous cycle and first injection of next cycle will be provided.","text_display":" between last injection of previous cycle and first injection of next cycle will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,2380],[1394,2380],[1394,2430],[245,2430]],"region":{"top_left_x":244,"top_left_y":2380,"width":1151,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b882f83b1a4b8aab51837fc953e62e","type":"text","conversion_output":true,"text":"Treatment compliance will be summarized descriptively in terms of:","text_display":"\n\nTreatment compliance will be summarized descriptively in terms of:","confidence":1,"confidence_rate":1},{"cnt":[[245,2454],[1111,2454],[1111,2503],[245,2503]],"region":{"top_left_x":244,"top_left_y":2453,"width":867,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83c8850485df49dd83ed481ddf832560","type":"text","conversion_output":true,"text":"- Mean number of injections by cycle and overall;","text_display":"\n- Mean number of injections by cycle and overall;","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"330acbd457b848eeaa5b23a6ab7e8f79","type":"page_info","conversion_output":false,"text":"35/71","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1783,2531],[1906,2531],[1906,2643],[1783,2643]],"region":{"top_left_x":1783,"top_left_y":2530,"width":123,"height":113},"line":41,"column":0,"font_size":111,"is_printed":true,"is_handwritten":false,"id":"6d51b5550ada4b768ed2e539ef0bce13","type":"page_info","conversion_output":false,"text":"M","text_display":"","confidence":0.99755859375,"confidence_rate":0.999592684418561}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-36","page":36,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19b9cf06eda74f13883f568e0a9a4298","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"740298af571d49948a4d963ba88d24ee","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,284],[1528,284],[1528,333],[245,333]],"region":{"top_left_x":244,"top_left_y":283,"width":1284,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ff93b0ba72b43a986b455211e86d03c","type":"text","conversion_output":true,"text":"- Number of subjects (and percentage) receiving \\(1,2,3 \\ldots .12\\) injections; and","text_display":"\n- Number of subjects (and percentage) receiving \\(1,2,3 \\ldots .12\\) injections; and","confidence":0.9975600242614746,"confidence_rate":0.9999698404877662},{"cnt":[[245,357],[1880,357],[1880,406],[245,406]],"region":{"top_left_x":244,"top_left_y":356,"width":1636,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06c9dc3f3acb4db899b13ab15a46e39f","type":"text","conversion_output":true,"text":"- Number of subjects (and percentage) with \\(75-100 \\%\\) treatment compliance. Subjects who have","text_display":"\n- Number of subjects (and percentage) with \\(75-100 \\%\\) treatment compliance. Subjects who have","confidence":0.9697694571256648,"confidence_rate":0.9996868152893107},{"cnt":[[296,404],[1880,404],[1880,453],[296,453]],"region":{"top_left_x":296,"top_left_y":403,"width":1584,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae75a7cb58e3429494c5ac6b5f192113","type":"text","conversion_output":true,"text":"(actual total dose)/(planned total dose)*100 within 75-100\\% will be considered treatment","text_display":" (actual total dose)/(planned total dose)*100 within 75-100\\% will be considered treatment","confidence":0.6800052688922733,"confidence_rate":0.9958617611261908},{"cnt":[[296,451],[1644,451],[1644,501],[296,501]],"region":{"top_left_x":296,"top_left_y":451,"width":1348,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84edf0e2e4f147eb95fe7c687a0ec12a","type":"text","conversion_output":true,"text":"compliant. Treatment compliance will not be summarized for the placebo group.","text_display":" compliant. Treatment compliance will not be summarized for the placebo group.","confidence":0.9990234375,"confidence_rate":0.9999880849533282},{"cnt":[[245,524],[1381,524],[1381,574],[245,574]],"region":{"top_left_x":244,"top_left_y":524,"width":1138,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"529f181c7b63486f95e3b1c7285b960f","type":"text","conversion_output":true,"text":"- Listing of subjects receiving wrong medication will be provided.","text_display":"\n- Listing of subjects receiving wrong medication will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[243,612],[1042,612],[1042,677],[243,677]],"region":{"top_left_x":242,"top_left_y":612,"width":800,"height":65},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34df93cfcef1423ea548d6c9204771a8","type":"section_header","conversion_output":false,"children_ids":["3769ebd8da5649f6acd04fcf95dc3f22","00a173e8ce7c4aa0bc483caeae59101f"],"text":"","text_display":""},{"cnt":[[243,619],[305,619],[305,666],[243,666]],"region":{"top_left_x":242,"top_left_y":618,"width":64,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3769ebd8da5649f6acd04fcf95dc3f22","type":"text","conversion_output":true,"parent_id":"34df93cfcef1423ea548d6c9204771a8","text":"16","text_display":"\n\n\\section*{16","confidence":0.99951171875,"confidence_rate":0.9997558295653994},{"cnt":[[593,614],[1038,614],[1038,672],[593,672]],"region":{"top_left_x":592,"top_left_y":614,"width":446,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00a173e8ce7c4aa0bc483caeae59101f","type":"text","conversion_output":true,"parent_id":"34df93cfcef1423ea548d6c9204771a8","text":"Endpoint Evaluation","text_display":" Endpoint Evaluation}","confidence":1,"confidence_rate":1},{"cnt":[[245,709],[1880,709],[1880,761],[245,761]],"region":{"top_left_x":244,"top_left_y":708,"width":1636,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41ccb954e106411c8d6cc31124b5bcc9","type":"text","conversion_output":true,"text":"This section presents specifications for analyzing the trial endpoints specified in the Clinical Trial","text_display":"\n\nThis section presents specifications for analyzing the trial endpoints specified in the Clinical Trial","confidence":0.9980480668600649,"confidence_rate":0.9999817399737813},{"cnt":[[245,758],[1880,758],[1880,810],[245,810]],"region":{"top_left_x":244,"top_left_y":758,"width":1636,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a5e9abce9e449f1b717b81957529462","type":"text","conversion_output":true,"text":"Protocol to meet the trial objective. Endpoints not identified in the Clinical Trial Protocol are also","text_display":" Protocol to meet the trial objective. Endpoints not identified in the Clinical Trial Protocol are also","confidence":0.99853515625,"confidence_rate":0.9999862999285899},{"cnt":[[245,808],[505,808],[505,857],[245,857]],"region":{"top_left_x":244,"top_left_y":807,"width":261,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a18fc2dda2dc498c87a24a95b0ee30f4","type":"text","conversion_output":true,"text":"presented here.","text_display":" presented here.","confidence":1,"confidence_rate":1},{"cnt":[[245,894],[1369,894],[1369,960],[245,960]],"region":{"top_left_x":244,"top_left_y":893,"width":1125,"height":68},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e89aa4b0f84c48db9632b9886fa7d5c6","type":"section_header","conversion_output":false,"children_ids":["537ecc598b7141c18839f642fbac639a"],"text":"","text_display":""},{"cnt":[[249,898],[1364,898],[1364,956],[249,956]],"region":{"top_left_x":249,"top_left_y":898,"width":1116,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"537ecc598b7141c18839f642fbac639a","type":"text","conversion_output":true,"parent_id":"e89aa4b0f84c48db9632b9886fa7d5c6","text":"16.1 Primary Efficacy Endpoint Analyses","text_display":"\n\n\\subsection*{16.1 Primary Efficacy Endpoint Analyses}","confidence":0.7492270469665527,"confidence_rate":0.9933082296350481},{"cnt":[[245,993],[1880,993],[1880,1042],[245,1042]],"region":{"top_left_x":244,"top_left_y":992,"width":1636,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c59b28d880d8494fab08c963d4783f34","type":"text","conversion_output":true,"text":"The primary endpoint for the DBPC treatment phase is the change from baseline in cartilage","text_display":"\n\nThe primary endpoint for the DBPC treatment phase is the change from baseline in cartilage","confidence":1,"confidence_rate":1},{"cnt":[[245,1042],[1878,1042],[1878,1091],[245,1091]],"region":{"top_left_x":244,"top_left_y":1041,"width":1634,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee34ad2e412f49ff99d8fb7f7d337a5d","type":"text","conversion_output":true,"text":"thickness in the total femorotibial joint as evaluated by quantitative MRI at 2 years in the mITT.","text_display":" thickness in the total femorotibial joint as evaluated by quantitative MRI at 2 years in the mITT.","confidence":0.9970703125,"confidence_rate":0.9999723212563202},{"cnt":[[245,1089],[1592,1089],[1592,1139],[245,1139]],"region":{"top_left_x":244,"top_left_y":1089,"width":1348,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04e2808fce8b4ef18889d1df7a7af93c","type":"text","conversion_output":true,"text":"Cartilage thickness of the total femorotibial joint will be calculated in two ways:","text_display":" Cartilage thickness of the total femorotibial joint will be calculated in two ways:","confidence":1,"confidence_rate":1},{"cnt":[[312,1177],[1659,1177],[1659,1227],[312,1227]],"region":{"top_left_x":311,"top_left_y":1177,"width":1348,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eadda7f31b3c488a923c78a8da78be97","type":"text","conversion_output":true,"text":"1. 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Of these two (1) is considered the primary, and only this is","text_display":" be used as primary endpoint. Of these two (1) is considered the primary, and only this is","confidence":1,"confidence_rate":1},{"cnt":[[245,1598],[1880,1598],[1880,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1598,"width":1636,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46bd6ec8240448dea1db09589f5b098d","type":"text","conversion_output":true,"text":"summarized and analyzed, (2) is just derived in ADaM. Definitions of these variables are provided","text_display":" summarized and analyzed, (2) is just derived in ADaM. Definitions of these variables are provided","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[245,1646],[1055,1646],[1055,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1645,"width":811,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2ccdaef8cfd42629878e3552f40d10c","type":"text","conversion_output":true,"text":"in the imaging transfer specifications document.","text_display":" in the imaging transfer specifications 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presented both for the DBPC treatment phase and for the follow-up phase.","confidence":1,"confidence_rate":1},{"cnt":[[245,1962],[1467,1962],[1467,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1961,"width":1224,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f23a232b5c340de9c2c678c2772f7d8","type":"text","conversion_output":true,"text":"Summary statistics will be provided per timepoint (including LOCF) for:","text_display":"\n\nSummary statistics will be provided per timepoint (including LOCF) for:","confidence":1,"confidence_rate":1},{"cnt":[[245,2032],[1592,2032],[1592,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2032,"width":1348,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db711cf17f5043eca330f2d5ae54247f","type":"text","conversion_output":true,"text":"- Cartilage thickness in the femorotibial joint as evaluated by quantitative MRI","text_display":"\n- Cartilage thickness in the femorotibial joint as evaluated by quantitative MRI","confidence":1,"confidence_rate":1},{"cnt":[[245,2105],[1519,2105],[1519,2155],[245,2155]],"region":{"top_left_x":244,"top_left_y":2105,"width":1275,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd884d006f814c0fa213b52c8f6ad37e","type":"text","conversion_output":true,"text":"- absolute change from baseline in cartilage thickness by quantitative MRI","text_display":"\n- absolute change from baseline in cartilage thickness by quantitative MRI","confidence":1,"confidence_rate":1},{"cnt":[[245,2179],[1562,2179],[1562,2228],[245,2228]],"region":{"top_left_x":244,"top_left_y":2178,"width":1318,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e5b35f9354e4b4d92205547eada0040","type":"text","conversion_output":true,"text":"- percentage change from baseline in cartilage thickness by quantitative MRI","text_display":"\n- percentage change from baseline in cartilage thickness by quantitative MRI","confidence":1,"confidence_rate":1},{"cnt":[[243,2264],[1416,2264],[1416,2322],[243,2322]],"region":{"top_left_x":242,"top_left_y":2264,"width":1174,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c05fd740f2c8485b930d533942da7ae7","type":"section_header","conversion_output":false,"children_ids":["42c8aa9efb8147dfac81a3199cd20cfa"],"text":"","text_display":""},{"cnt":[[245,2269],[1412,2269],[1412,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2268,"width":1168,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42c8aa9efb8147dfac81a3199cd20cfa","type":"text","conversion_output":true,"parent_id":"c05fd740f2c8485b930d533942da7ae7","text":"Primary analyses of linear dose-relationship and treatment effect","text_display":"\n\n\\section*{Primary analyses of linear dose-relationship and treatment 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If some items are missing, imputation for Total score (and for sub scores) will be","text_display":" time point. If some items are missing, imputation for Total score (and for sub scores) will be","confidence":1,"confidence_rate":1},{"cnt":[[245,378],[1059,378],[1059,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":816,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31e02015f5924d33992283058df239b1","type":"text","conversion_output":true,"text":"performed using same principal used for KOOS.","text_display":" performed using same principal used for 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function and stiffness) will be tabulated descriptively as described above for","confidence":1,"confidence_rate":1},{"cnt":[[245,653],[449,653],[449,694],[245,694]],"region":{"top_left_x":244,"top_left_y":653,"width":206,"height":41},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"174835023a1f4705bab73db16aa969f8","type":"text","conversion_output":true,"text":"Total score.","text_display":" Total score.","confidence":1,"confidence_rate":1},{"cnt":[[245,741],[1878,741],[1878,793],[245,793]],"region":{"top_left_x":244,"top_left_y":741,"width":1634,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80d643f524d64611805e9618cc2bcc18","type":"text","conversion_output":true,"text":"Absolute change from baseline in pain, function, stiffness, and weight-bearing pain, over 2 years","text_display":"\n\nAbsolute change from baseline in pain, function, stiffness, and weight-bearing pain, over 2 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Mean score will be presented as described for","text_display":" LOCF) as well as absolute change from baseline. Mean score will be presented as described for","confidence":1,"confidence_rate":1},{"cnt":[[245,1667],[1880,1667],[1880,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1667,"width":1636,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e68c30528bcd49848e4771487b26720c","type":"text","conversion_output":true,"text":"continuous variables, and also number and percentages per score will be presented. No imputation","text_display":" continuous variables, and also number and percentages per score will be presented. No imputation","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[1012,1714],[1012,1766],[245,1766]],"region":{"top_left_x":244,"top_left_y":1714,"width":768,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba98340a45b64459a3e5478e8f6c0844","type":"text","conversion_output":true,"text":"for missing data will be done (except LOCF).","text_display":" for missing data will be done (except LOCF).","confidence":1,"confidence_rate":1},{"cnt":[[245,1805],[1364,1805],[1364,1869],[245,1869]],"region":{"top_left_x":244,"top_left_y":1804,"width":1121,"height":66},"line":30,"column":0,"font_size":40,"is_printed":true,"is_handwritten":false,"id":"d3843358e4d841cb863ef2b7179a293c","type":"section_header","conversion_output":false,"children_ids":["3e9a541129304e0bb652275242aa1750","f0f0f38d0ba54281bcd46be6a51e2122"],"text":"","text_display":""},{"cnt":[[243,1809],[337,1809],[337,1865],[243,1865]],"region":{"top_left_x":242,"top_left_y":1808,"width":96,"height":57},"line":31,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"3e9a541129304e0bb652275242aa1750","type":"text","conversion_output":true,"parent_id":"d3843358e4d841cb863ef2b7179a293c","text":"16.3","text_display":"\n\n\\section*{16.3","confidence":1,"confidence_rate":1},{"cnt":[[593,1809],[1360,1809],[1360,1865],[593,1865]],"region":{"top_left_x":592,"top_left_y":1808,"width":768,"height":57},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0f0f38d0ba54281bcd46be6a51e2122","type":"text","conversion_output":true,"parent_id":"d3843358e4d841cb863ef2b7179a293c","text":"Pharmacokinetic Endpoint Analyses","text_display":" Pharmacokinetic Endpoint Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[243,1901],[672,1901],[672,1957],[243,1957]],"region":{"top_left_x":242,"top_left_y":1901,"width":431,"height":57},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2674c76552b42b6a0b5cffe72b7a47c","type":"section_header","conversion_output":false,"children_ids":["a99dd22bbd0a44b4b49f7f19f1c39c0f"],"text":"","text_display":""},{"cnt":[[245,1904],[668,1904],[668,1953],[245,1953]],"region":{"top_left_x":244,"top_left_y":1903,"width":425,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a99dd22bbd0a44b4b49f7f19f1c39c0f","type":"text","conversion_output":true,"parent_id":"d2674c76552b42b6a0b5cffe72b7a47c","text":"Pharmacokinetics (PK)","text_display":"\n\n\\section*{Pharmacokinetics (PK)}","confidence":1,"confidence_rate":1},{"cnt":[[245,1994],[1880,1994],[1880,2043],[245,2043]],"region":{"top_left_x":244,"top_left_y":1993,"width":1636,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a507f4736eb4591a17f5eae809d7859","type":"text","conversion_output":true,"text":"Analyses relating to this endpoint will be conducted by Merck Serono QPD and ECS using the PK","text_display":"\n\nAnalyses relating to this endpoint will be conducted by Merck Serono QPD and ECS using the PK","confidence":1,"confidence_rate":1},{"cnt":[[245,2041],[471,2041],[471,2090],[245,2090]],"region":{"top_left_x":244,"top_left_y":2041,"width":227,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"671c8b726c404b16ae3ec6972ff8c786","type":"text","conversion_output":true,"text":"Analysis Set.","text_display":" Analysis Set.","confidence":1,"confidence_rate":1},{"cnt":[[245,2131],[1880,2131],[1880,2181],[245,2181]],"region":{"top_left_x":244,"top_left_y":2131,"width":1636,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb6246d9e04047968b2fcb6f07049f8a","type":"text","conversion_output":true,"text":"The data will be reviewed for implausible concentration data. Exclusion of implausible values will","text_display":"\n\nThe data will be reviewed for implausible concentration data. Exclusion of implausible values will","confidence":1,"confidence_rate":1},{"cnt":[[245,2179],[1880,2179],[1880,2228],[245,2228]],"region":{"top_left_x":244,"top_left_y":2178,"width":1636,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"756af7681e054e69a3305785aa2bcd87","type":"text","conversion_output":true,"text":"be decided by the responsible PK/Pharmacodynamic(s) (PD) representative and/or the Clinical","text_display":" be decided by the responsible PK/Pharmacodynamic(s) (PD) representative and/or the Clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,2226],[1880,2226],[1880,2275],[245,2275]],"region":{"top_left_x":244,"top_left_y":2225,"width":1636,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ba793683943405ba8caca132bd811c8","type":"text","conversion_output":true,"text":"Pharmacology Representative and will be documented in the CTR. If necessary, the subject will","text_display":" Pharmacology Representative and will be documented in the CTR. If necessary, the subject will","confidence":1,"confidence_rate":1},{"cnt":[[245,2273],[698,2273],[698,2322],[245,2322]],"region":{"top_left_x":244,"top_left_y":2273,"width":455,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6f72f8055fd4d4a84586c0b681db3b3","type":"text","conversion_output":true,"text":"be excluded from analysis.","text_display":" be excluded from analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,2363],[1880,2363],[1880,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2363,"width":1636,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fb0f00430b44129975c7ceb69238fab","type":"text","conversion_output":true,"text":"Quality control procedures for the pharmacokinetic analysis will be performed in accordance with","text_display":"\n\nQuality control procedures for the pharmacokinetic analysis will be performed in accordance with","confidence":1,"confidence_rate":1},{"cnt":[[245,2411],[1356,2411],[1356,2460],[245,2460]],"region":{"top_left_x":244,"top_left_y":2410,"width":1112,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63aa8c27f2034d448340618c98671e2a","type":"text","conversion_output":true,"text":"the QPD Standard Operating Procedures (SOPs) at Merck Serono.","text_display":" the QPD Standard Operating Procedures (SOPs) at Merck 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(Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3d094a151704a73afa6beed6010a1a1","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,329],[245,329]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85b70075360445c68bbcecab6f2411d2","type":"text","conversion_output":true,"text":"In case no measurable sprifermin could be detected either in serum or in synovial fluid this will be","text_display":"\n\nIn case no measurable sprifermin could be detected either in serum or in synovial fluid this will be","confidence":1,"confidence_rate":1},{"cnt":[[245,329],[1629,329],[1629,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1385,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a18377fd530a49a88bf911dbe33167c2","type":"text","conversion_output":true,"text":"described in the CTR but no Tables, Listings and Figures (TLFs) will be provided.","text_display":" described in the CTR but no Tables, Listings and Figures (TLFs) will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[241,412],[1433,412],[1433,466],[241,466]],"region":{"top_left_x":240,"top_left_y":412,"width":1194,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c4f8c6350d4483ca94c161e1cc241da","type":"section_header","conversion_output":false,"children_ids":["9fbd13d8e83a424b9a06a0d1a9fe4219"],"text":"","text_display":""},{"cnt":[[245,419],[1429,419],[1429,462],[245,462]],"region":{"top_left_x":244,"top_left_y":418,"width":1185,"height":44},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fbd13d8e83a424b9a06a0d1a9fe4219","type":"text","conversion_output":true,"parent_id":"1c4f8c6350d4483ca94c161e1cc241da","text":"Pharmacokinetics based on concentrations measured in the serum","text_display":"\n\n\\section*{Pharmacokinetics based on concentrations measured in the serum}","confidence":1,"confidence_rate":1},{"cnt":[[245,507],[1798,507],[1798,556],[245,556]],"region":{"top_left_x":244,"top_left_y":507,"width":1555,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10073156d8524a5cb6287b2cfe688f2f","type":"text","conversion_output":true,"text":"Blood samples for the quantification of sprifermin are collected pre-dose at the baseline visit","text_display":"\n\nBlood samples for the quantification of sprifermin are collected pre-dose at the baseline visit","confidence":1,"confidence_rate":1},{"cnt":[[245,554],[1824,554],[1824,604],[245,604]],"region":{"top_left_x":244,"top_left_y":554,"width":1581,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe0452f22f914b44ad361b96a6a68a2c","type":"text","conversion_output":true,"text":"Week 0/Visit 2, 2 hours after the last dose of each cycle and at the end of the DBPC treatment","text_display":" Week 0/Visit 2, 2 hours after the last dose of each cycle and at the end of the DBPC treatment","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,604],[526,604],[526,655],[245,655]],"region":{"top_left_x":244,"top_left_y":603,"width":283,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a2febdd08c54ad3bf605b98970f7ce6","type":"text","conversion_output":true,"text":"phase (Visit 22).","text_display":" phase (Visit 22).","confidence":1,"confidence_rate":1},{"cnt":[[245,692],[1858,692],[1858,741],[245,741]],"region":{"top_left_x":244,"top_left_y":691,"width":1615,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"785be7e7bfdc44c8aa0f0a1d463c178a","type":"text","conversion_output":true,"text":"Serum levels of sprifermin ( \\(pg / mL\\) ) will be determined under the responsibility of QPD and will","text_display":"\n\nSerum levels of sprifermin ( \\(pg / mL\\) ) will be determined under the responsibility of QPD and will","confidence":0.9810516041653727,"confidence_rate":0.9998261040565084},{"cnt":[[245,735],[587,735],[587,784],[245,784]],"region":{"top_left_x":244,"top_left_y":734,"width":343,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aa2100194404cd2863d09353b410aae","type":"text","conversion_output":true,"text":"be stored in the PPD","text_display":" be stored in the PPD","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[419,786],[419,840],[245,840]],"region":{"top_left_x":244,"top_left_y":786,"width":175,"height":55},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1a7d9cb20474ec7a1cfd0df16c946df","type":"form_field","conversion_output":true,"text":"","text_display":"\n□","subtype":"box"},{"cnt":[[415,786],[1837,786],[1837,840],[415,840]],"region":{"top_left_x":414,"top_left_y":786,"width":1423,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72bfa496d0ad4f1c9255de78c8ca05cc","type":"text","conversion_output":true,"text":". QPD will produce a separate bio-analytical report. The lower limit of quantification","text_display":" . QPD will produce a separate bio-analytical report. The lower limit of quantification","confidence":0.99755859375,"confidence_rate":0.9999731389174491},{"cnt":[[245,838],[569,838],[569,887],[245,887]],"region":{"top_left_x":244,"top_left_y":837,"width":326,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73978f33d28543aaabe5a141b2606825","type":"text","conversion_output":true,"text":"will be \\(100 pg / mL\\).","text_display":" will be \\(100 pg / mL\\).","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1760,924],[1760,975],[245,975]],"region":{"top_left_x":244,"top_left_y":923,"width":1516,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"928596826fde45be811b2a239fb21087","type":"text","conversion_output":true,"text":"Before DBPC database lock reconciliation of blinded data will be performed. After DBPC","text_display":"\n\nBefore DBPC database lock reconciliation of blinded data will be performed. After DBPC","confidence":1,"confidence_rate":1},{"cnt":[[245,973],[1682,973],[1682,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":973,"width":1439,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14e4989b81c846b39a1d32ad6512ae2a","type":"text","conversion_output":true,"text":"database lock final data will be mapped to SDTM and returned to Merck Serono Data","text_display":" database lock final data will be mapped to SDTM and returned to Merck Serono Data","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[479,1023],[479,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":236,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d187f39de584ffaa41ae542429dce88","type":"text","conversion_output":true,"text":"Management.","text_display":" Management.","confidence":1,"confidence_rate":1},{"cnt":[[245,1111],[1841,1111],[1841,1162],[245,1162]],"region":{"top_left_x":244,"top_left_y":1110,"width":1598,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc913ce942804ceb9dc7183769be5152","type":"text","conversion_output":true,"text":"QPD will be responsible for the descriptive statistics on the serum concentrations of sprifermin","text_display":"\n\nQPD will be responsible for the descriptive statistics on the serum concentrations of sprifermin","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,1160],[1156,1160],[1156,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1160,"width":912,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e4ad6adb8224092a9978b5be31f6172","type":"text","conversion_output":true,"text":"and TLFs will be provided for the CTR, as applicable.","text_display":" and TLFs will be provided for the CTR, as applicable.","confidence":1,"confidence_rate":1},{"cnt":[[245,1250],[1863,1250],[1863,1300],[245,1300]],"region":{"top_left_x":244,"top_left_y":1250,"width":1619,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ec688f38cab464f8838676bb2ae95cf","type":"text","conversion_output":true,"text":"The following descriptive statistics will be presented for the PK Analysis Set by treatment group","text_display":"\n\nThe following descriptive statistics will be presented for the PK Analysis Set by treatment group","confidence":0.7086381912231445,"confidence_rate":0.9966291237007429},{"cnt":[[245,1298],[1820,1298],[1820,1347],[245,1347]],"region":{"top_left_x":244,"top_left_y":1297,"width":1576,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88e04a1150174835b600cfc8011066cb","type":"text","conversion_output":true,"text":"and time-point: Number ( N ) of observations, mean, SD, median, min, max, and coefficient of","text_display":" and time-point: Number ( N ) of observations, mean, SD, median, min, max, and coefficient of","confidence":0.9277863445019174,"confidence_rate":0.9992725578705147},{"cnt":[[245,1345],[1850,1345],[1850,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1344,"width":1606,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8d1eb5cca9d40258267aa82258bb729","type":"text","conversion_output":true,"text":"variation (\\%CV), if applicable. Individual and mean concentrations will be plotted by treatment","text_display":" variation (\\%CV), if applicable. Individual and mean concentrations will be plotted by treatment","confidence":0.9975595474243164,"confidence_rate":0.9999755659451772},{"cnt":[[245,1392],[844,1392],[844,1446],[245,1446]],"region":{"top_left_x":244,"top_left_y":1392,"width":601,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54073a4669c64ffe8c7c01643f5fc308","type":"text","conversion_output":true,"text":"group and time-point, if applicable.","text_display":" group and time-point, if applicable.","confidence":1,"confidence_rate":1},{"cnt":[[241,1525],[1562,1525],[1562,1588],[241,1588]],"region":{"top_left_x":240,"top_left_y":1525,"width":1322,"height":63},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49616ca5374240bf8d1a9461a667c452","type":"section_header","conversion_output":false,"children_ids":["e0fcdf5953834002990da235aefdfd09"],"text":"","text_display":""},{"cnt":[[245,1530],[1558,1530],[1558,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1529,"width":1314,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0fcdf5953834002990da235aefdfd09","type":"text","conversion_output":true,"parent_id":"49616ca5374240bf8d1a9461a667c452","text":"Pharmacokinetics based on concentrations measured in the synovial fluid","text_display":"\n\n\\section*{Pharmacokinetics based on concentrations measured in the synovial fluid}","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[245,1626],[1807,1626],[1807,1678],[245,1678]],"region":{"top_left_x":244,"top_left_y":1626,"width":1563,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7c727b8f91a45a2939ce3a98c5ee064","type":"text","conversion_output":true,"text":"Synovial fluid for the quantification of sprifermin is collected at visits where IMP is injected.","text_display":"\n\nSynovial fluid for the quantification of sprifermin is collected at visits where IMP is injected.","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1676],[1794,1676],[1794,1725],[245,1725]],"region":{"top_left_x":244,"top_left_y":1675,"width":1550,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b6ddb8f3998449c96945f88e49a659d","type":"text","conversion_output":true,"text":"Synovial fluid will be collected as part of the i.a. injection procedure, thus pre-dose synovial","text_display":" Synovial fluid will be collected as part of the i.a. injection procedure, thus pre-dose synovial","confidence":1,"confidence_rate":1},{"cnt":[[245,1723],[1128,1723],[1128,1772],[245,1772]],"region":{"top_left_x":244,"top_left_y":1723,"width":884,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2124861178a34556b62f615e0d301e44","type":"text","conversion_output":true,"text":"fluid samples are collected prior each IMP injection.","text_display":" fluid samples are collected prior each IMP injection.","confidence":1,"confidence_rate":1},{"cnt":[[245,1770],[1841,1770],[1841,1820],[245,1820]],"region":{"top_left_x":244,"top_left_y":1770,"width":1598,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a7d41162647442a96294940a2f32482","type":"text","conversion_output":true,"text":"Synovial fluid levels of sprifermin will be determined under the responsibility of QPD and will","text_display":"\nSynovial fluid levels of sprifermin will be determined under the responsibility of QPD and will","confidence":1,"confidence_rate":1},{"cnt":[[245,1813],[587,1813],[587,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1813,"width":343,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bdfe2d0c67a4ef48a7b9bc75c990ab3","type":"text","conversion_output":true,"text":"be stored in the PPD","text_display":" be stored in the PPD","confidence":0.99560546875,"confidence_rate":0.999823846893383},{"cnt":[[1156,1822],[1665,1822],[1665,1869],[1156,1869]],"region":{"top_left_x":1155,"top_left_y":1821,"width":511,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f23af9c180643909a0a20dc46684e2f","type":"text","conversion_output":true,"text":". QPD will produce a separate","text_display":" . QPD will produce a separate","confidence":0.9347822666168213,"confidence_rate":0.9980183881451152},{"cnt":[[245,1865],[1474,1865],[1474,1919],[245,1919]],"region":{"top_left_x":244,"top_left_y":1864,"width":1230,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"080aac9647754c6eb3b5cf30beb4d4a4","type":"text","conversion_output":true,"text":"bioanalytical report. The lower limit of quantification will be \\(150 pg / mL\\).","text_display":" bioanalytical report. 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After DBPC","confidence":1,"confidence_rate":1},{"cnt":[[245,2011],[1682,2011],[1682,2060],[245,2060]],"region":{"top_left_x":244,"top_left_y":2010,"width":1439,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f670f05d021d416a80c35bd7a4669baf","type":"text","conversion_output":true,"text":"database lock final data will be mapped to SDTM and returned to Merck Serono Data","text_display":" database lock final data will be mapped to SDTM and returned to Merck Serono Data","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[1635,2058],[1635,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2058,"width":1391,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78a90481a1a143b4b6dff248f764c2bb","type":"text","conversion_output":true,"text":"Management. QPD will be responsible for the descriptive statistics on the synovial","text_display":" Management. 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The","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[245,2153],[1861,2153],[1861,2204],[245,2204]],"region":{"top_left_x":244,"top_left_y":2152,"width":1617,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"264607ac8c9241b1a1d1899943b251e3","type":"text","conversion_output":true,"text":"following descriptive statistics will be presented for the PK Analysis Set by treatment group and","text_display":" following descriptive statistics will be presented for the PK Analysis Set by treatment group and","confidence":0.99755859375,"confidence_rate":0.9999760356661515},{"cnt":[[245,2202],[1841,2202],[1841,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2202,"width":1598,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"082771c596bd4ec1a86f3b5831dc2519","type":"text","conversion_output":true,"text":"time point: Number ( N ) of observations, mean, SD, standard error of the mean (SEM), median,","text_display":" time point: Number ( N ) of observations, mean, SD, standard error of the mean (SEM), median,","confidence":0.9844558996761978,"confidence_rate":0.9998493750321278},{"cnt":[[245,2247],[1745,2247],[1745,2301],[245,2301]],"region":{"top_left_x":244,"top_left_y":2247,"width":1501,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83a4a3bb3c9e4d429d5658feced7b98d","type":"text","conversion_output":true,"text":"min, max, and \\(\\% CV\\), if applicable. Individual and mean concentrations will be plotted by","text_display":" min, max, and \\(\\% CV\\), if applicable. 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The data will","confidence":1,"confidence_rate":1},{"cnt":[[245,980],[1639,980],[1639,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":979,"width":1396,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b033700eb04d4a938423a7c47e3033fe","type":"text","conversion_output":true,"text":"be summarized by overall frequency and by treatment and time point, if applicable.","text_display":" be summarized by overall frequency and by treatment and time point, if applicable.","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[342,1070],[342,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1069,"width":98,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b52a73b201904f04bd25574ed2654a08","type":"section_header","conversion_output":false,"children_ids":["bd49337765b54b9681dda9223b5f04dc"],"text":"","text_display":""},{"cnt":[[249,1074],[337,1074],[337,1119],[249,1119]],"region":{"top_left_x":249,"top_left_y":1074,"width":89,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd49337765b54b9681dda9223b5f04dc","type":"text","conversion_output":true,"parent_id":"b52a73b201904f04bd25574ed2654a08","text":"16.4","text_display":"\n\n\\section*{16.4}","confidence":1,"confidence_rate":1},{"cnt":[[593,1070],[1061,1070],[1061,1132],[593,1132]],"region":{"top_left_x":592,"top_left_y":1069,"width":470,"height":64},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79b954ec0de640acb80da269f34bf1d3","type":"section_header","conversion_output":false,"children_ids":["1c8c9c44510f419fbaa8f133d14dee06"],"text":"","text_display":""},{"cnt":[[597,1074],[1059,1074],[1059,1128],[597,1128]],"region":{"top_left_x":597,"top_left_y":1074,"width":463,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c8c9c44510f419fbaa8f133d14dee06","type":"text","conversion_output":true,"parent_id":"79b954ec0de640acb80da269f34bf1d3","text":"Biomarker subgroups","text_display":"\n\n\\section*{Biomarker subgroups}","confidence":1,"confidence_rate":1},{"cnt":[[243,1164],[505,1164],[505,1214],[243,1214]],"region":{"top_left_x":242,"top_left_y":1164,"width":263,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7ed3dad96034edeb235f220ad924d5f","type":"section_header","conversion_output":false,"children_ids":["494b1af1701c4aa0b9a55ec203a06621"],"text":"","text_display":""},{"cnt":[[245,1169],[501,1169],[501,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1168,"width":257,"height":42},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"494b1af1701c4aa0b9a55ec203a06621","type":"text","conversion_output":true,"parent_id":"f7ed3dad96034edeb235f220ad924d5f","text":"PGX markers","text_display":"\n\n\\section*{PGX markers}","confidence":1,"confidence_rate":1},{"cnt":[[245,1257],[1878,1257],[1878,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1256,"width":1634,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b9647c5910b41818d1924436573b552","type":"text","conversion_output":true,"text":"SNPs located in the Interleukin 1 Receptor Antagonist (IL1RN) gene are known to be linked to","text_display":"\n\nSNPs located in the Interleukin 1 Receptor Antagonist (IL1RN) gene are known to be linked to","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1880,1306],[1880,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":1636,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14be8c6712d740f1879f36066b4f6f9e","type":"text","conversion_output":true,"text":"disease severity and predictive of progression [3,4]. Subgroups based on distinct genotypes","text_display":" disease severity and predictive of progression [3,4]. Subgroups based on distinct genotypes","confidence":0.91943359375,"confidence_rate":0.999125409162059},{"cnt":[[245,1354],[1880,1354],[1880,1403],[245,1403]],"region":{"top_left_x":244,"top_left_y":1353,"width":1636,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea5df16d672a43b7a1e948a46f967221","type":"text","conversion_output":true,"text":"resulting from the combination of the SNPs rs9005 and rs315952 in the IL1RN cluster will be","text_display":" resulting from the combination of the SNPs rs9005 and rs315952 in the IL1RN cluster will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1401],[1880,1401],[1880,1450],[245,1450]],"region":{"top_left_x":244,"top_left_y":1400,"width":1636,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84aa8f0a411d4cf3bf793d9ede81cbd3","type":"text","conversion_output":true,"text":"considered as exploratory objective based on a retrospective analysis of subjects with a defined","text_display":" considered as exploratory objective based on a retrospective analysis of subjects with a defined","confidence":1,"confidence_rate":1},{"cnt":[[245,1448],[1884,1448],[1884,1500],[245,1500]],"region":{"top_left_x":244,"top_left_y":1448,"width":1641,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f222275a6754a0d9a6c5d976bcdbb40","type":"text","conversion_output":true,"text":"haplotype in the sprifermin Phase 1b PoC study (28980), suggesting the potential identification of","text_display":" haplotype in the sprifermin Phase 1b PoC study (28980), suggesting the potential identification of","confidence":1,"confidence_rate":1},{"cnt":[[245,1497],[1878,1497],[1878,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1497,"width":1634,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c16c9c4d5dc4eb4ad4024ab1c42b66a","type":"text","conversion_output":true,"text":"subgroups of subjects who can be classified as progressors and/or responders to treatment.","text_display":" subgroups of subjects who can be classified as progressors and/or responders to treatment.","confidence":1,"confidence_rate":1},{"cnt":[[245,1543],[1880,1543],[1880,1594],[245,1594]],"region":{"top_left_x":244,"top_left_y":1542,"width":1636,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21e375c2b8cc41b28e9bf0b7b2ad31fd","type":"text","conversion_output":true,"text":"Considering these results, the following biomarker subgroups (as well as the subgroups in the","text_display":" Considering these results, the following biomarker subgroups (as well as the subgroups in the","confidence":1,"confidence_rate":1},{"cnt":[[245,1592],[990,1592],[990,1644],[245,1644]],"region":{"top_left_x":244,"top_left_y":1591,"width":747,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d63efcfdc1a843a7b97f0a306a6861b0","type":"text","conversion_output":true,"text":"single SNPs) will be evaluated in this study:","text_display":" single SNPs) will be evaluated in this study:","confidence":1,"confidence_rate":1},{"cnt":[[365,1678],[1338,1678],[1338,2004],[365,2004]],"region":{"top_left_x":365,"top_left_y":1677,"width":974,"height":328},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b4721ba0a6140db9a790469d769b84c","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& \\text { Subgroup A: rs9005 GG/rs315952 TT } \\\\\n& \\text { Subgroup B: rs9005 A carriers (AG or AA)/rs315952 TT } \\\\\n& \\text { Subgroup C: rs9005 GG/rs315952 C carriers (CT or CC) } \\\\\n& \\text { Subgroup D: rs9005 A carriers/rs315952 C carriers }\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& \\text { Subgroup A: rs9005 GG/rs315952 TT } \\\\\n& \\text { Subgroup B: rs9005 A carriers (AG or AA)/rs315952 TT } \\\\\n& \\text { Subgroup C: rs9005 GG/rs315952 C carriers (CT or CC) } \\\\\n& \\text { Subgroup D: rs9005 A carriers/rs315952 C carriers }\n\\end{aligned}\n\\]","confidence":0.8716294595910214,"confidence_rate":0.9993813136408589},{"cnt":[[245,2041],[1880,2041],[1880,2090],[245,2090]],"region":{"top_left_x":244,"top_left_y":2041,"width":1636,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db63ea5215504f79bf076bef95f14896","type":"text","conversion_output":true,"text":"These subgroups will be evaluated by summarizing structure (MRI and X-ray) and symptom","text_display":"\n\nThese subgroups will be evaluated by summarizing structure (MRI and X-ray) and symptom","confidence":1,"confidence_rate":1},{"cnt":[[245,2088],[1880,2088],[1880,2138],[245,2138]],"region":{"top_left_x":244,"top_left_y":2088,"width":1636,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"979988d9ce564051865c66264deabd0d","type":"text","conversion_output":true,"text":"(WOMAC) endpoints by treatment groups in the PGX population ( n , number of missing values,","text_display":" (WOMAC) endpoints by treatment groups in the PGX population ( n , number of missing values,","confidence":0.8516347408294678,"confidence_rate":0.9984267530483759},{"cnt":[[245,2136],[1880,2136],[1880,2187],[245,2187]],"region":{"top_left_x":244,"top_left_y":2135,"width":1636,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3e4c0287dde4267ab64b5a20f547b75","type":"text","conversion_output":true,"text":"mean, SD, median, Q1, Q3, min, and max). Supporting figures will also be provided. To facilitate","text_display":" mean, SD, median, Q1, Q3, min, and max). Supporting figures will also be provided. To facilitate","confidence":1,"confidence_rate":1},{"cnt":[[245,2183],[1880,2183],[1880,2237],[245,2237]],"region":{"top_left_x":244,"top_left_y":2182,"width":1636,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d184a4d39f2f483abc94137d8eabe053","type":"text","conversion_output":true,"text":"informal comparisons between active treatment groups and placebo group, the mean difference","text_display":" informal comparisons between active treatment groups and placebo group, the mean difference","confidence":1,"confidence_rate":1},{"cnt":[[245,2230],[1880,2230],[1880,2282],[245,2282]],"region":{"top_left_x":244,"top_left_y":2230,"width":1636,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6880eae8085745f599f842f8ffa716dc","type":"text","conversion_output":true,"text":"from placebo in absolute change including \\(95 \\%\\) CIs will be calculated and presented in tables and","text_display":" from placebo in absolute change including \\(95 \\%\\) CIs will be calculated and presented in tables and","confidence":0.99658203125,"confidence_rate":0.9999670791635416},{"cnt":[[245,2282],[1880,2282],[1880,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2281,"width":1636,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5042138848704378a176e66c7ad56b96","type":"text","conversion_output":true,"text":"figures by timepoint. If treatment effect seems consistent across treatment groups, analyses pooling","text_display":" figures by timepoint. If treatment effect seems consistent across treatment groups, analyses pooling","confidence":1,"confidence_rate":1},{"cnt":[[245,2329],[1880,2329],[1880,2378],[245,2378]],"region":{"top_left_x":244,"top_left_y":2328,"width":1636,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"119833857b324d96a9924b7e672330f0","type":"text","conversion_output":true,"text":"the different treatment groups will also be performed. The occurrences of AIRs (frequency and","text_display":" the different treatment groups will also be performed. The occurrences of AIRs (frequency and","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,2376],[1708,2376],[1708,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2376,"width":1465,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"862ad4166b634ab5a5258df23bd6e692","type":"text","conversion_output":true,"text":"\\(95 \\%\\) exact confidence interval) will be summarized by genetic groups described above.","text_display":" \\(95 \\%\\) exact confidence interval) will be summarized by genetic groups described above.","confidence":0.9912316717673093,"confidence_rate":0.9998999255052364},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb6eaeb02ca8496d925b14818b8561b1","type":"page_info","conversion_output":false,"text":"42/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-43","page":43,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"990020d51dee4f75bcfd9f3a0e135161","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[640,172],[640,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":397,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"524f8c4e185a4934ba9e4b2b6f358444","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,329],[245,329]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32c27fc0f5504c88ab6539c8229fba17","type":"text","conversion_output":true,"text":"Demographic and baseline characteristics as specified in Section 13 will be summarized for the","text_display":"\n\nDemographic and baseline characteristics as specified in Section 13 will be summarized for the","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,329],[535,329],[535,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":291,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1a98a2f9b634b8da4ef2057902de19d","type":"text","conversion_output":true,"text":"PGX population.","text_display":" PGX population.","confidence":0.99951171875,"confidence_rate":0.9999755802732609},{"cnt":[[241,415],[1137,415],[1137,475],[241,475]],"region":{"top_left_x":240,"top_left_y":414,"width":897,"height":61},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"633ee57c92ca46b5bde38a6cfbd6a3aa","type":"section_header","conversion_output":false,"children_ids":["4579415face446ff94fcc6efcb59dd3a"],"text":"","text_display":""},{"cnt":[[245,421],[1132,421],[1132,468],[245,468]],"region":{"top_left_x":244,"top_left_y":421,"width":889,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4579415face446ff94fcc6efcb59dd3a","type":"text","conversion_output":true,"parent_id":"633ee57c92ca46b5bde38a6cfbd6a3aa","text":"Biochemical markers of joint tissue inflammation","text_display":"\n\n\\section*{Biochemical markers of joint tissue inflammation}","confidence":1,"confidence_rate":1},{"cnt":[[245,507],[1880,507],[1880,556],[245,556]],"region":{"top_left_x":244,"top_left_y":507,"width":1636,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49c9b14a847141f5b2ef0df97e41376c","type":"text","conversion_output":true,"text":"The following blood-based biochemical markers are known to be linked to joint inflammation and","text_display":"\n\nThe following blood-based biochemical markers are known to be linked to joint inflammation and","confidence":1,"confidence_rate":1},{"cnt":[[245,554],[1876,554],[1876,604],[245,604]],"region":{"top_left_x":244,"top_left_y":554,"width":1632,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a1046b83485472fa3ff3ceb2872b004","type":"text","conversion_output":true,"text":"ECM turnover through the upregulation of MMP observed in OA: C1M, C3M, and CRPM [5].","text_display":" ECM turnover through the upregulation of MMP observed in OA: C1M, C3M, and CRPM [5].","confidence":1,"confidence_rate":1},{"cnt":[[245,604],[1830,604],[1830,655],[245,655]],"region":{"top_left_x":244,"top_left_y":603,"width":1587,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eabbf6d780c43ae9df124e6f65d3e29","type":"text","conversion_output":true,"text":"hsCRP is a measure of acute inflammation and a general marker of systemic inflammation [5].","text_display":" hsCRP is a measure of acute inflammation and a general marker of systemic inflammation [5].","confidence":0.9951171875,"confidence_rate":0.9999490140875682},{"cnt":[[245,694],[1880,694],[1880,743],[245,743]],"region":{"top_left_x":244,"top_left_y":693,"width":1636,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5f3ef05519a4211b4991e905dc463fc","type":"text","conversion_output":true,"text":"Two subgroups resulting from categorizing each of the inflammation markers at baseline (and all","text_display":"\n\nTwo subgroups resulting from categorizing each of the inflammation markers at baseline (and all","confidence":1,"confidence_rate":1},{"cnt":[[245,741],[1880,741],[1880,793],[245,793]],"region":{"top_left_x":244,"top_left_y":741,"width":1636,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"983e8f53cc1549738c029d2a65d2a553","type":"text","conversion_output":true,"text":"possible 2-way pairwise combinations of two of them [i.e. C1M, C3M, CRPM, C1M*C3M,","text_display":" possible 2-way pairwise combinations of two of them [i.e. C1M, C3M, CRPM, C1M*C3M,","confidence":0.9980475902557373,"confidence_rate":0.9999775368249376},{"cnt":[[245,786],[1880,786],[1880,838],[245,838]],"region":{"top_left_x":244,"top_left_y":786,"width":1636,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2be5bb297834724a15350e168a6d637","type":"text","conversion_output":true,"text":"C1M*CRPM, and C3M*CRPM], to support the hypothesis that subjects with high localized","text_display":" C1M*CRPM, and C3M*CRPM], to support the hypothesis that subjects with high localized","confidence":1,"confidence_rate":1},{"cnt":[[245,836],[1880,836],[1880,887],[245,887]],"region":{"top_left_x":244,"top_left_y":835,"width":1636,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5effe0fc563640038396f4c2ab6a007f","type":"text","conversion_output":true,"text":"inflammation show low structural and symptomatic response to Sprifermin) as marker falling into","text_display":" inflammation show low structural and symptomatic response to Sprifermin) as marker falling into","confidence":1,"confidence_rate":1},{"cnt":[[245,885],[1880,885],[1880,935],[245,935]],"region":{"top_left_x":244,"top_left_y":885,"width":1636,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fab1410d0f63486ebc15e92112acb6e5","type":"text","conversion_output":true,"text":"highest tertile ( \\(=33 \\%\\) of all subjects in FORWARD with highest marker at baseline), and marker","text_display":" highest tertile ( \\(=33 \\%\\) of all subjects in FORWARD with highest marker at baseline), and marker","confidence":1,"confidence_rate":1},{"cnt":[[245,932],[1880,932],[1880,982],[245,982]],"region":{"top_left_x":244,"top_left_y":932,"width":1636,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6e93c6ba88a4224b995d643a0bf13fe","type":"text","conversion_output":true,"text":"falling into the two lower tertiles will be evaluated separately for structure (MRI and X-ray) and","text_display":" falling into the two lower tertiles will be evaluated separately for structure (MRI and X-ray) and","confidence":1,"confidence_rate":1},{"cnt":[[245,980],[1880,980],[1880,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":979,"width":1636,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1dbdb905313486f86400c7a6bcc3c0b","type":"text","conversion_output":true,"text":"symptom (WOMAC) endpoints by treatment groups in the ITT population ( n , number of missing","text_display":" symptom (WOMAC) endpoints by treatment groups in the ITT population ( n , number of missing","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1027],[1880,1027],[1880,1079],[245,1079]],"region":{"top_left_x":244,"top_left_y":1026,"width":1636,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d41f28d694d349d587c85f326f5d4ca8","type":"text","conversion_output":true,"text":"values, mean, SD, median, Q1, Q3, min, and max). The general systemic inflammation marker","text_display":" values, mean, SD, median, Q1, Q3, min, and max). The general systemic inflammation marker","confidence":1,"confidence_rate":1},{"cnt":[[245,1076],[1880,1076],[1880,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1076,"width":1636,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f455de45424943d08f01f456e446bc99","type":"text","conversion_output":true,"text":"hsCRP will be used as a reference for the overall inflammation status and will be evaluated for its","text_display":" hsCRP will be used as a reference for the overall inflammation status and will be evaluated for its","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,1126],[836,1126],[836,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1125,"width":592,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75db5b4457d8494aa341ecb8d932954e","type":"text","conversion_output":true,"text":"association with the other markers.","text_display":" association with the other markers.","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1880,1212],[1880,1263],[245,1263]],"region":{"top_left_x":244,"top_left_y":1211,"width":1636,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed5629a2b51242ef99539bf80208d7a5","type":"text","conversion_output":true,"text":"In addition, Baseline CRPM will be analysed with cutoff of 10 (Baseline CRPM \\(\\leq 10 ng / mL\\), and","text_display":"\n\nIn addition, Baseline CRPM will be analysed with cutoff of 10 (Baseline CRPM \\(\\leq 10 ng / mL\\), and","confidence":1,"confidence_rate":1},{"cnt":[[245,1263],[462,1263],[462,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1263,"width":218,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fd1a3ece624466995304157fc9dc3eb","type":"text","conversion_output":true,"text":"\\(>10 ng / mL\\) ).","text_display":" \\(>10 ng / mL\\) ).","confidence":1,"confidence_rate":1},{"cnt":[[245,1351],[1880,1351],[1880,1403],[245,1403]],"region":{"top_left_x":244,"top_left_y":1351,"width":1636,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f268bd559bef4dc79b30737525e5fc12","type":"text","conversion_output":true,"text":"Supporting figures will also be provided. To facilitate informal comparisons between active","text_display":"\n\nSupporting figures will also be provided. To facilitate informal comparisons between active","confidence":1,"confidence_rate":1},{"cnt":[[245,1401],[1880,1401],[1880,1450],[245,1450]],"region":{"top_left_x":244,"top_left_y":1400,"width":1636,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"443c0f2254474d308543a41c15adad17","type":"text","conversion_output":true,"text":"treatment groups and placebo group, the mean difference from placebo in absolute change","text_display":" treatment groups and placebo group, the mean difference from placebo in absolute change","confidence":1,"confidence_rate":1},{"cnt":[[245,1448],[1880,1448],[1880,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1448,"width":1636,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cb4fd3011e94effa950772d32276ce6","type":"text","conversion_output":true,"text":"including 95\\% CIs will be calculated and presented in tables and figures by timepoint. If treatment","text_display":" including 95\\% CIs will be calculated and presented in tables and figures by timepoint. 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For marker proC2: proC2","confidence":1,"confidence_rate":1},{"cnt":[[245,2380],[1878,2380],[1878,2430],[245,2430]],"region":{"top_left_x":244,"top_left_y":2380,"width":1634,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2fbeea998f643929cc1a9161814faa0","type":"text","conversion_output":true,"text":"falling into highest tertile ( \\(=33 \\%\\) of all subjects in FORWARD with highest marker at baseline),","text_display":" falling into highest tertile ( \\(=33 \\%\\) of all subjects in FORWARD with highest marker at baseline),","confidence":0.97216796875,"confidence_rate":0.9997286264237104},{"cnt":[[245,2428],[1880,2428],[1880,2479],[245,2479]],"region":{"top_left_x":244,"top_left_y":2427,"width":1636,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6089d8be24564dbcad616a3db9d893cf","type":"text","conversion_output":true,"text":"and marker falling into the two lower tertiles) will be evaluated separately for structure (MRI and","text_display":" and marker falling into the two lower tertiles) will be evaluated separately for structure (MRI and","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8374adfc4054512baac61497c306e11","type":"page_info","conversion_output":false,"text":"43/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-44","page":44,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e5a7a947ced42eda6995130a304764d","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab60aec13c2343e485188299480da552","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,331],[245,331]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e8013d15b3e452baddb0d9bfbafb6ce","type":"text","conversion_output":true,"text":"X-ray) and symptom (WOMAC) endpoints by treatment groups in the ITT population ( n , number","text_display":"\n\nX-ray) and symptom (WOMAC) endpoints by treatment groups in the ITT population ( n , number","confidence":0.88720703125,"confidence_rate":0.9988273849356507},{"cnt":[[245,329],[1291,329],[1291,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1048,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d72b0c0d56bd435886090bf945a33ff9","type":"text","conversion_output":true,"text":"of missing values, mean, SD, median, Q1, Q3, min, and max).","text_display":" of missing values, mean, SD, median, Q1, Q3, min, and max).","confidence":0.99658203125,"confidence_rate":0.9999465041911151},{"cnt":[[245,417],[1878,417],[1878,468],[245,468]],"region":{"top_left_x":244,"top_left_y":416,"width":1634,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d562aff561945c88722717f76171830","type":"text","conversion_output":true,"text":"In addition, Baseline CTX-II will be anlaysed with cutoff of 350 (Baseline CTX-II \\(\\leq 350 ng / mmol\\),","text_display":"\n\nIn addition, Baseline CTX-II will be anlaysed with cutoff of 350 (Baseline CTX-II \\(\\leq 350 ng / mmol\\),","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[245,468],[582,468],[582,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":339,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78740c86feeb4dca8894522a6232b21c","type":"text","conversion_output":true,"text":"and \\(>350 ng / mmol\\) ).","text_display":" and \\(>350 ng / mmol\\) ).","confidence":1,"confidence_rate":1},{"cnt":[[245,554],[1880,554],[1880,606],[245,606]],"region":{"top_left_x":244,"top_left_y":554,"width":1636,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82edd74c86894543a44dee9c0a168025","type":"text","conversion_output":true,"text":"Supporting figures will also be provided. To facilitate informal comparisons between active","text_display":"\n\nSupporting figures will also be provided. To facilitate informal comparisons between active","confidence":1,"confidence_rate":1},{"cnt":[[245,606],[1880,606],[1880,655],[245,655]],"region":{"top_left_x":244,"top_left_y":605,"width":1636,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9534d6a42714acd9396502d32626023","type":"text","conversion_output":true,"text":"treatment groups and placebo group, the mean difference from placebo in absolute change","text_display":" treatment groups and placebo group, the mean difference from placebo in absolute change","confidence":1,"confidence_rate":1},{"cnt":[[245,653],[1880,653],[1880,703],[245,703]],"region":{"top_left_x":244,"top_left_y":653,"width":1636,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9006f74ebec4843aef3ce887f5f2ab3","type":"text","conversion_output":true,"text":"including 95\\% CIs will be calculated and presented in tables and figures by timepoint. If treatment","text_display":" including 95\\% CIs will be calculated and presented in tables and figures by timepoint. 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percent changes from baseline that correspond to \"high","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1008,1212],[1008,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":764,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"039b5d0310c8406c8f60696b0cb66fbf","type":"text","conversion_output":true,"text":"improvement\" and \"moderate improvement\".","text_display":" improvement\" and \"moderate improvement\".","confidence":1,"confidence_rate":1},{"cnt":[[245,1298],[1137,1298],[1137,1349],[245,1349]],"region":{"top_left_x":244,"top_left_y":1297,"width":893,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d84d6b1827444caa04a260dec1e2958","type":"text","conversion_output":true,"text":"OMERACT-OARSI response is defined [9] as either","text_display":"\n\nOMERACT-OARSI response is defined [9] as 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type3;","confidence":1,"confidence_rate":1},{"cnt":[[286,2282],[1416,2282],[1416,2325],[286,2325]],"region":{"top_left_x":285,"top_left_y":2281,"width":1131,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"913a2afda91a4c58a0dab9c433b0d2b5","type":"code","conversion_output":true,"parent_id":"09cb7352554b460a96cb9a679b6fbd83","text":"estimate '30\\mug x2 vs Placebo' grpn -1 1 0 0 0 / exp ;","text_display":"\n    estimate '30\\mug x2 vs Placebo' grpn -1 1 0 0 0 / exp ;","confidence":0.5791015625,"confidence_rate":0.9902924715358541},{"cnt":[[286,2363],[1416,2363],[1416,2408],[286,2408]],"region":{"top_left_x":285,"top_left_y":2363,"width":1131,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"008e7852f2f24a49864aa7c5d79ac54d","type":"code","conversion_output":true,"parent_id":"09cb7352554b460a96cb9a679b6fbd83","text":"estimate '30\\mug x4 vs Placebo' grpn -1 0 1 0 0 / exp ;","text_display":"\n    estimate '30\\mug x4 vs Placebo' grpn -1 0 1 0 0 / exp ;","confidence":0.67822265625,"confidence_rate":0.9930904166431764},{"cnt":[[288,2443],[1416,2443],[1416,2486],[288,2486]],"region":{"top_left_x":287,"top_left_y":2442,"width":1129,"height":44},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20da11ac78c845e181478237ac41bd3f","type":"code","conversion_output":true,"parent_id":"09cb7352554b460a96cb9a679b6fbd83","text":"estimate '100ug x2 vs Placebo' grpn -1 0 0 1 0 / exp ;","text_display":"\n    estimate '100ug x2 vs Placebo' grpn -1 0 0 1 0 / exp 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(PGIC)}","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1884,670],[1884,720],[245,720]],"region":{"top_left_x":244,"top_left_y":670,"width":1641,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c033e31f8e64ddf96df412166b1bd3d","type":"text","conversion_output":true,"text":"The PGIC score is based on subject's answer to the question: \"Since getting the first injection of","text_display":"\n\nThe PGIC score is based on subject's answer to the question: \"Since getting the first injection of","confidence":0.81298828125,"confidence_rate":0.997991935527261},{"cnt":[[245,718],[1880,718],[1880,767],[245,767]],"region":{"top_left_x":244,"top_left_y":717,"width":1636,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"539c5e0596c246139bbc8f9d108f400a","type":"text","conversion_output":true,"text":"study treatment in your knee how would you describe the change in overall symptoms for this","text_display":" study treatment in your knee how would you describe the change in overall symptoms for this","confidence":1,"confidence_rate":1},{"cnt":[[245,765],[1880,765],[1880,814],[245,814]],"region":{"top_left_x":244,"top_left_y":764,"width":1636,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf494dbc974345dca3f8999bff6b3fc7","type":"text","conversion_output":true,"text":"knee\" and can take on values between 'Very much improved' 'Very much Worse' with 7 possible","text_display":" knee\" and can take on values between 'Very much improved' 'Very much Worse' with 7 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The PGIC will be summarised by treatment and analysis timepoint (including LOCF). No","text_display":" choices. The PGIC will be summarised by treatment and analysis timepoint (including LOCF). 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Given","text_display":"\n\nAll items have five possible answers ranging from 0 (no problems) to 4 (extreme problems). Given","confidence":1,"confidence_rate":1},{"cnt":[[245,1323],[1880,1323],[1880,1373],[245,1373]],"region":{"top_left_x":244,"top_left_y":1323,"width":1636,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11defe04b3284983a385b3748d8b8af9","type":"text","conversion_output":true,"text":"items I1 to Ix as the answers to each questionnaire item on a given subscale and the raw score as","text_display":" items I1 to Ix as the answers to each questionnaire item on a given subscale and the raw score as","confidence":0.9239387512207031,"confidence_rate":0.999224717391932},{"cnt":[[245,1371],[1880,1371],[1880,1420],[245,1420]],"region":{"top_left_x":244,"top_left_y":1370,"width":1636,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be2f740b6742412e9f4da7e50eb0d3db","type":"text","conversion_output":true,"text":"the arithmetic mean of the respective non-missing answers of items I1 to Ix, the subscale summary","text_display":" the arithmetic mean of the respective non-missing answers of items I1 to Ix, the subscale summary","confidence":0.9404869079589844,"confidence_rate":0.9993986362776025},{"cnt":[[245,1418],[703,1418],[703,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1417,"width":459,"height":47},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"369c8ec2d66e4dd2a9a299c0e6e6bcde","type":"text","conversion_output":true,"text":"score will be calculated as:","text_display":" score will be calculated as:","confidence":1,"confidence_rate":1},{"cnt":[[801,1500],[1326,1500],[1326,1665],[801,1665]],"region":{"top_left_x":801,"top_left_y":1499,"width":525,"height":167},"line":25,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"0df0daaf3a224daf9a9dbc07836d5895","type":"math","conversion_output":true,"text":"\\[\n\\left[\\frac{(\\text { mean score })}{4}\\right] \\cdot 100\n\\]","text_display":"\n\\[\n\\left[\\frac{(\\text { mean score })}{4}\\right] \\cdot 100\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[245,1697],[1880,1697],[1880,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1697,"width":1636,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9fa4ddad4f9147a0a6e15ffd3ad6825d","type":"text","conversion_output":true,"text":"As long as at least \\(50 \\%\\) of the subscale items are answered for each subscale for a specific visit, a","text_display":"\n\nAs long as at least \\(50 \\%\\) of the subscale items are answered for each subscale for a specific visit, a","confidence":0.9907269477844238,"confidence_rate":0.9999137415480512},{"cnt":[[245,1745],[1880,1745],[1880,1794],[245,1794]],"region":{"top_left_x":244,"top_left_y":1744,"width":1636,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6fd141ec5ef04136a27330bccd9bf5b5","type":"text","conversion_output":true,"text":"mean score can be imputed using the mean of the non-missing items for that visit. If more than","text_display":" mean score can be imputed using the mean of the non-missing items for that visit. If more than","confidence":1,"confidence_rate":1},{"cnt":[[245,1792],[1880,1792],[1880,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1791,"width":1636,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90135fc7dd054959905d06c8accc8f1b","type":"text","conversion_output":true,"text":"\\(50 \\%\\) of the subscale items are omitted, the response is considered invalid and no subscale score","text_display":" \\(50 \\%\\) of the subscale items are omitted, the response is considered invalid and no subscale score","confidence":0.9819421768188477,"confidence_rate":0.9998159476928572},{"cnt":[[245,1839],[1880,1839],[1880,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1839,"width":1636,"height":54},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e9b072c1e93440d949986b2e27f6c5e","type":"text","conversion_output":true,"text":"should be calculated. For KOOS Symptoms, this means that 3 items must be answered; for KOOS","text_display":" should be calculated. For KOOS Symptoms, this means that 3 items must be answered; for KOOS","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1111,1886],[1111,1938],[245,1938]],"region":{"top_left_x":244,"top_left_y":1886,"width":867,"height":52},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"232b15f17a164b5693d908a427aa8eb7","type":"text","conversion_output":true,"text":"QOL, 2 items in order to calculate a subscale score.","text_display":" QOL, 2 items in order to calculate a subscale score.","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[245,1979],[1880,1979],[1880,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1978,"width":1636,"height":53},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c68e250bebe4be3bfd7ced2ac7fd3e2","type":"text","conversion_output":true,"text":"This imputation is equivalent to taking the arithmetic mean of the non-missing items. Summary","text_display":"\n\nThis imputation is equivalent to taking the arithmetic mean of the non-missing items. Summary","confidence":1,"confidence_rate":1},{"cnt":[[245,2028],[1880,2028],[1880,2078],[245,2078]],"region":{"top_left_x":244,"top_left_y":2028,"width":1636,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc27b8ac77ed481a9078ac79cf5a06cd","type":"text","conversion_output":true,"text":"scores range from 0 to 100, with zero representing no knee problems and 100 representing extreme","text_display":" scores range from 0 to 100, with zero representing no knee problems and 100 representing extreme","confidence":0.9609375,"confidence_rate":0.9996276776605059},{"cnt":[[245,2075],[1790,2075],[1790,2125],[245,2125]],"region":{"top_left_x":244,"top_left_y":2075,"width":1546,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10a63ba74837466d832c148f2079edde","type":"text","conversion_output":true,"text":"knee problems. An overall summary score (both subscales combined) will not be calculated.","text_display":" knee problems. An overall summary score (both subscales combined) will not be calculated.","confidence":1,"confidence_rate":1},{"cnt":[[245,2166],[1880,2166],[1880,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2165,"width":1636,"height":51},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a46200fae09b476ba3cc9fa416b390a0","type":"text","conversion_output":true,"text":"Summary statistics for summary scores, and its absolute change from baseline, will be presented","text_display":"\n\nSummary statistics for summary scores, and its absolute change from baseline, will be presented","confidence":1,"confidence_rate":1},{"cnt":[[245,2213],[1128,2213],[1128,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":884,"height":51},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"452b2b16a5f1483188bdc5f23e93ca27","type":"text","conversion_output":true,"text":"for each subscale, by treatment group and timepoint.","text_display":" for each subscale, by treatment group and timepoint.","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1878,2299],[1878,2350],[245,2350]],"region":{"top_left_x":244,"top_left_y":2298,"width":1634,"height":53},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d538ff6f9b1496296b5b2851f103017","type":"text","conversion_output":true,"text":"An accompanying by-subject listing will be provided including: treatment; country; age; sex; BMI;","text_display":"\n\nAn accompanying by-subject listing will be provided including: treatment; country; age; sex; BMI;","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,2346],[1880,2346],[1880,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2346,"width":1636,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3760a090164e4ce1b72049885718a254","type":"text","conversion_output":true,"text":"response for each KOOS item at each visit; each subscale summary score at each analysis time point;","text_display":" response for each KOOS item at each visit; each subscale summary score at each analysis time point;","confidence":1,"confidence_rate":1},{"cnt":[[245,2393],[1637,2393],[1637,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2393,"width":1394,"height":50},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22e4bbe30c144fd481abea0f9a6d20a4","type":"text","conversion_output":true,"text":"change from baseline in each subscale summary score at each visit (ITT Analysis Set).","text_display":" change from baseline in each subscale summary score at each visit (ITT Analysis Set).","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1620,2561],[1620,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":82,"height":36},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f45f9f9396b941a58548f475cdbd8efe","type":"page_info","conversion_output":false,"text":"45/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-46","page":46,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"792e47184cf34435af38d4e8504dca75","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"074f7c13eaf4487a992809922597c006","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,275],[1437,275],[1437,337],[241,337]],"region":{"top_left_x":240,"top_left_y":275,"width":1198,"height":63},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f5c354b23774779b1fb71bb253af38a","type":"section_header","conversion_output":false,"children_ids":["737783918be4434ba8d3cab8612ef7a8"],"text":"","text_display":""},{"cnt":[[245,281],[1433,281],[1433,333],[245,333]],"region":{"top_left_x":244,"top_left_y":281,"width":1190,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"737783918be4434ba8d3cab8612ef7a8","type":"text","conversion_output":true,"parent_id":"9f5c354b23774779b1fb71bb253af38a","text":"The Medical Outcomes Survey Short Form 36 (MOS SF-36) Score","text_display":"\n\n\\section*{The Medical Outcomes Survey Short Form 36 (MOS SF-36) Score}","confidence":1,"confidence_rate":1},{"cnt":[[245,370],[1880,370],[1880,419],[245,419]],"region":{"top_left_x":244,"top_left_y":369,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"375c59705544429dabd04dc7dcc2f828","type":"text","conversion_output":true,"text":"The MOS SF-36 consists of the following 8 sub-scores (with corresponding items within each sub-","text_display":"\n\nThe MOS SF-36 consists of the following 8 sub-scores (with corresponding items within each sub","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,419],[1880,419],[1880,468],[245,468]],"region":{"top_left_x":244,"top_left_y":418,"width":1636,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba70cf1b575545cca124b63b55fe43f2","type":"text","conversion_output":true,"text":"score are scored on 2-, 3-, 5-, or 6-point scale) and will be transformed to a 0-100 scale as described","text_display":"score are scored on 2-, 3-, 5-, or 6-point scale) and will be transformed to a 0-100 scale as described","confidence":0.8681757480427739,"confidence_rate":0.9986919570671835},{"cnt":[[245,468],[754,468],[754,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":511,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59de0010a49a41f48a32ab4c68a49b99","type":"text","conversion_output":true,"text":"in [10] and in the table below:","text_display":" in [10] and in the table below:","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1472,537],[1472,591],[245,591]],"region":{"top_left_x":244,"top_left_y":537,"width":1228,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c09c0de840744e189726dce34ba2dae","type":"text","conversion_output":true,"text":"- general health (GH, based on 5 items [Q1,Q11a, Q11b, Q11c, Q11d]),","text_display":"\n- general health (GH, based on 5 items [Q1,Q11a, Q11b, Q11c, Q11d]),","confidence":1,"confidence_rate":1},{"cnt":[[245,610],[1190,610],[1190,664],[245,664]],"region":{"top_left_x":244,"top_left_y":610,"width":947,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e898461b9ba4035965b70046dbb84e6","type":"text","conversion_output":true,"text":"- physical function (PF, based on 10 items [Q3a-Q3j]),","text_display":"\n- physical function (PF, based on 10 items [Q3a-Q3j]),","confidence":1,"confidence_rate":1},{"cnt":[[245,681],[1298,681],[1298,733],[245,733]],"region":{"top_left_x":244,"top_left_y":681,"width":1054,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bdb3656317b4678bc7bc9cdfeb70727","type":"text","conversion_output":true,"text":"- physical role limitations (RP, based on 4 items [Q4a-Q4d]),","text_display":"\n- physical role limitations (RP, based on 4 items [Q4a-Q4d]),","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[1051,752],[1051,806],[245,806]],"region":{"top_left_x":244,"top_left_y":751,"width":807,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"283593f68a954079be23cbcb208488d0","type":"text","conversion_output":true,"text":"- bodily pain (BP, based on 2 items [Q7, Q8]),","text_display":"\n- bodily pain (BP, based on 2 items [Q7, Q8]),","confidence":1,"confidence_rate":1},{"cnt":[[245,825],[1199,825],[1199,879],[245,879]],"region":{"top_left_x":244,"top_left_y":824,"width":955,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2e70112b3824e07bcaf2d4c0c156731","type":"text","conversion_output":true,"text":"- vitality (VT, based on 4 items [Q9a, Q9e, Q9g, Q9i]),","text_display":"\n- vitality (VT, based on 4 items [Q9a, Q9e, Q9g, Q9i]),","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1128,898],[1128,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":884,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7adaca455ddb40739fada35236baac3a","type":"text","conversion_output":true,"text":"- social function (SF, based on 2 items [Q6, Q10]),","text_display":"\n- social function (SF, based on 2 items [Q6, Q10]),","confidence":1,"confidence_rate":1},{"cnt":[[245,967],[1317,967],[1317,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":966,"width":1073,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17149dbcecb54bbfa16086a35d5c8070","type":"text","conversion_output":true,"text":"- emotional role limitations (RE, based on 3 items [Q5a-Q5c])","text_display":"\n- emotional role limitations (RE, based on 3 items [Q5a-Q5c])","confidence":1,"confidence_rate":1},{"cnt":[[245,1040],[1414,1040],[1414,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1039,"width":1170,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"246fe2d1530e4891b5f403681e363efb","type":"text","conversion_output":true,"text":"- mental health (MH, based on 5 items [Q9b, Q9c, Q9d, Q9f, Q9h]).","text_display":"\n- mental health (MH, based on 5 items [Q9b, Q9c, Q9d, Q9f, Q9h]).","confidence":1,"confidence_rate":1},{"cnt":[[245,1130],[1137,1130],[1137,1179],[245,1179]],"region":{"top_left_x":244,"top_left_y":1130,"width":893,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3a2698fa0064e1993524aad76cfc2d4","type":"text","conversion_output":true,"text":"and a total score (based on 36 items [all above+Q2]).","text_display":"\nand a total score (based on 36 items [all above+Q2]).","confidence":0.7690034655388445,"confidence_rate":0.9957033586803349},{"cnt":[[245,1220],[1880,1220],[1880,1270],[245,1270]],"region":{"top_left_x":244,"top_left_y":1220,"width":1636,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d12102ad5e2e4e828a55a3972cea8ddd","type":"text","conversion_output":true,"text":"Each scale is directly transformed into a \\(0-100\\) scale on the assumption that each question carries","text_display":"\nEach scale is directly transformed into a \\(0-100\\) scale on the assumption that each question carries","confidence":0.9990234375,"confidence_rate":0.9999907826873115},{"cnt":[[245,1268],[1880,1268],[1880,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1267,"width":1636,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c8c5ceadfd2413db4bf3b82e92a6d31","type":"text","conversion_output":true,"text":"equal weight. All of the scales are scored so that the least health has a value of 0 and the greatest health","text_display":" equal weight. All of the scales are scored so that the least health has a value of 0 and the greatest health","confidence":1,"confidence_rate":1},{"cnt":[[245,1317],[552,1317],[552,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1316,"width":309,"height":44},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"612570effe2f42d98293d28d29b42995","type":"text","conversion_output":true,"text":"has a value of 100 .","text_display":" has a value of 100 .","confidence":1,"confidence_rate":1},{"cnt":[[245,1405],[1308,1405],[1308,1457],[245,1457]],"region":{"top_left_x":244,"top_left_y":1405,"width":1065,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bc8b528061047f6aa85732e2e897c0b","type":"figure_label","conversion_output":false,"text":"Table 4 Scoring transformation for MOS 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Sub score & \\# of items and range of scale & Total possible score & Items need to be reversed (maxitem+1) & Normalizing Algorithm to 0-100= [(item[or average of items]min)/range]*100 \\\\\n\\hline GH & 5 items with 1-5 & 5-25 & Q1, Q11b, Q11d & 100*(average-1)/4 \\\\\n\\hline PF & 10 items with 1-3 & 10-30 & & 100* (average-1)/2 \\\\\n\\hline RP & 4 items with 1-5 & 4-20 & & 100* (average-1)/4 \\\\\n\\hline BP & 2 items with 1-6 and 1-5 & 2-11 & Q7, Q8 & 100* \\(\\{[( Q 7-1) / 5]+[( Q 8-1) / 4]\\} / 2\\) \\\\\n\\hline VT & 4 items with 1-5 & 4-20 & Q9a, Q9e & 100* (average-1)/4 \\\\\n\\hline SF & 2 items with 1-5 & 2-10 & Q6 & 100* (average-1)/4 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4 Scoring transformation for MOS SF-36}\n\\begin{tabular}{|l|l|l|l|l|}\n\\hline Sub score & \\# of items and range of scale & Total possible score & Items need to be reversed (maxitem+1) & Normalizing Algorithm to 0-100= 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If more than","confidence":1,"confidence_rate":1},{"cnt":[[245,1014],[1880,1014],[1880,1063],[245,1063]],"region":{"top_left_x":244,"top_left_y":1014,"width":1636,"height":50},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf04d3502f88475e9f92f49255bc4c53","type":"text","conversion_output":true,"text":"\\(50 \\%\\) of the sub score items are omitted, the response is considered invalid and no sub score should","text_display":" \\(50 \\%\\) of the sub score items are omitted, the response is considered invalid and no sub score should","confidence":0.9946331977844238,"confidence_rate":0.9999472439874045},{"cnt":[[245,1061],[1420,1061],[1420,1113],[245,1113]],"region":{"top_left_x":244,"top_left_y":1061,"width":1177,"height":52},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88bb30719e9842d3a66113987dff2cf4","type":"text","conversion_output":true,"text":"be calculated. Similarly, same principle will be applied to Total score.","text_display":" be calculated. Similarly, same principle will be applied to Total score.","confidence":1,"confidence_rate":1},{"cnt":[[245,1154],[1880,1154],[1880,1205],[245,1205]],"region":{"top_left_x":244,"top_left_y":1153,"width":1636,"height":53},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e33d5fcf5e1b4d779886250d2aa73ba9","type":"text","conversion_output":true,"text":"Sub scores and total score will be summarised by treatment and timepoint (including LOCF) along","text_display":"\n\nSub scores and total score will be summarised by treatment and timepoint (including LOCF) along","confidence":1,"confidence_rate":1},{"cnt":[[245,1199],[1880,1199],[1880,1250],[245,1250]],"region":{"top_left_x":244,"top_left_y":1198,"width":1636,"height":53},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b825fb4b1124a8285dd4a276c48de28","type":"text","conversion_output":true,"text":"with the absolute change from baseline. Individual items as well as derived sub scores will be","text_display":" with the absolute change from baseline. Individual items as well as derived sub scores will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1250],[595,1250],[595,1300],[245,1300]],"region":{"top_left_x":244,"top_left_y":1250,"width":352,"height":50},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a24154b891ba4aa7a172390f6c49f74c","type":"text","conversion_output":true,"text":"presented in listings.","text_display":" presented in listings.","confidence":1,"confidence_rate":1},{"cnt":[[241,1334],[1104,1334],[1104,1394],[241,1394]],"region":{"top_left_x":240,"top_left_y":1334,"width":865,"height":61},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ed971275e804ea59a9091f676ce1f28","type":"section_header","conversion_output":false,"children_ids":["7bb8b1ba43614e01915ef7dade4c5eed"],"text":"","text_display":""},{"cnt":[[245,1341],[1102,1341],[1102,1390],[245,1390]],"region":{"top_left_x":244,"top_left_y":1340,"width":859,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bb8b1ba43614e01915ef7dade4c5eed","type":"text","conversion_output":true,"parent_id":"6ed971275e804ea59a9091f676ce1f28","text":"The Numeric Rating Scale (NRS) for pain score","text_display":"\n\n\\section*{The Numeric Rating Scale (NRS) for pain score}","confidence":1,"confidence_rate":1},{"cnt":[[245,1427],[1880,1427],[1880,1476],[245,1476]],"region":{"top_left_x":244,"top_left_y":1426,"width":1636,"height":50},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c166165c8f2f49ab837c81c4ab37070e","type":"text","conversion_output":true,"text":"The NRS pain score in the target and contralateral knee is based on subject's answer to the question","text_display":"\n\nThe NRS pain score in the target and contralateral knee is based on subject's answer to the question","confidence":1,"confidence_rate":1},{"cnt":[[245,1474],[1880,1474],[1880,1523],[245,1523]],"region":{"top_left_x":244,"top_left_y":1473,"width":1636,"height":51},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01dec434561c4d8fa6164c79946138d1","type":"text","conversion_output":true,"text":"\"Please indicate the worst pain in the past 24 hours in the target (contralateral) knee\" and can take","text_display":" \"Please indicate the worst pain in the past 24 hours in the target (contralateral) knee\" and can take","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[1343,1521],[1343,1573],[245,1573]],"region":{"top_left_x":244,"top_left_y":1521,"width":1099,"height":52},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"064d75cd1c80425b855bd89093135224","type":"text","conversion_output":true,"text":"on values between 0-10 (0=No Pain, 10=Worst Pain imaginable).","text_display":" on values between 0-10 (0=No Pain, 10=Worst Pain imaginable).","confidence":0.7359032391377696,"confidence_rate":0.995364464723827},{"cnt":[[245,1611],[1880,1611],[1880,1663],[245,1663]],"region":{"top_left_x":244,"top_left_y":1611,"width":1636,"height":52},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92caf95184344a148a6afc2d2093a8cf","type":"text","conversion_output":true,"text":"The NRS will be presented with summary statistics by treatment and timepoint (including LOCF)","text_display":"\n\nThe NRS will be presented with summary statistics by treatment and timepoint (including LOCF)","confidence":1,"confidence_rate":1},{"cnt":[[245,1661],[1880,1661],[1880,1712],[245,1712]],"region":{"top_left_x":244,"top_left_y":1660,"width":1636,"height":53},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"524105c815b94613a13345151a28c291","type":"text","conversion_output":true,"text":"as well as absolute change from baseline for target knee and contralateral separately. No","text_display":" as well as absolute change from baseline for target knee and contralateral separately. No","confidence":1,"confidence_rate":1},{"cnt":[[245,1710],[1457,1710],[1457,1760],[245,1760]],"region":{"top_left_x":244,"top_left_y":1710,"width":1213,"height":50},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a10af263cec47cbba668318fc6026cf","type":"text","conversion_output":true,"text":"imputation for missing data will be done. Individual items will be listed.","text_display":" imputation for missing data will be done. Individual items will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[241,1796],[597,1796],[597,1852],[241,1852]],"region":{"top_left_x":240,"top_left_y":1796,"width":358,"height":56},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8540d1639a2e4001abd58e2845ce563d","type":"section_header","conversion_output":false,"children_ids":["7b48a9f3621549559f895398d5209a73"],"text":"","text_display":""},{"cnt":[[245,1800],[595,1800],[595,1848],[245,1848]],"region":{"top_left_x":244,"top_left_y":1800,"width":352,"height":48},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b48a9f3621549559f895398d5209a73","type":"text","conversion_output":true,"parent_id":"8540d1639a2e4001abd58e2845ce563d","text":"Pain in other joints","text_display":"\n\n\\section*{Pain in other joints}","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1880,1886],[1880,1938],[245,1938]],"region":{"top_left_x":244,"top_left_y":1886,"width":1636,"height":52},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"416419478afc476eb9266d6091dbeefe","type":"text","conversion_output":true,"text":"Pain in other joints will be summarised per joint and for number of subjects having pain in at least","text_display":"\n\nPain in other joints will be summarised per joint and for number of subjects having pain in at least","confidence":1,"confidence_rate":1},{"cnt":[[245,1936],[1880,1936],[1880,1987],[245,1987]],"region":{"top_left_x":244,"top_left_y":1935,"width":1636,"height":53},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85b2332fa7e3490e86fb2a7c475284e7","type":"text","conversion_output":true,"text":"one joint. Data will be summarised by treatment and timepoint (including LOCF). No imputation","text_display":" one joint. Data will be summarised by treatment and timepoint (including LOCF). No imputation","confidence":1,"confidence_rate":1},{"cnt":[[245,1985],[748,1985],[748,2035],[245,2035]],"region":{"top_left_x":244,"top_left_y":1985,"width":504,"height":50},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbcc77eca90845d5a8472df5f5c67215","type":"text","conversion_output":true,"text":"for missing data will be done.","text_display":" for missing data will be done.","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[241,2071],[1248,2071],[1248,2127],[241,2127]],"region":{"top_left_x":240,"top_left_y":2071,"width":1009,"height":56},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"858ff56b6f6f437499d8378066c2c3ca","type":"section_header","conversion_output":false,"children_ids":["679d3505e1a341c0a89910f389230cd0"],"text":"","text_display":""},{"cnt":[[245,2075],[1244,2075],[1244,2121],[245,2121]],"region":{"top_left_x":244,"top_left_y":2075,"width":1000,"height":46},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"679d3505e1a341c0a89910f389230cd0","type":"text","conversion_output":true,"parent_id":"858ff56b6f6f437499d8378066c2c3ca","text":"The Intermittent and Constant OA Pain (ICOAP) score","text_display":"\n\n\\section*{The Intermittent and Constant OA Pain (ICOAP) score}","confidence":0.998046875,"confidence_rate":0.99996508927304},{"cnt":[[245,2161],[1880,2161],[1880,2213],[245,2213]],"region":{"top_left_x":244,"top_left_y":2161,"width":1636,"height":52},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4849672a39e4e6f8e12d87a037a8274","type":"text","conversion_output":true,"text":"ICOAP is based on subject's response to 11 questions designed to assess OA knee pain that is","text_display":"\n\nICOAP is based on subject's response to 11 questions designed to assess OA knee pain that is","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,2209],[1025,2209],[1025,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2208,"width":781,"height":55},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36e8aeb3a7b54eeeb490878f7e347e23","type":"text","conversion_output":true,"text":"\"constant\" and pain that is \"intermittent\" [11].","text_display":" \"constant\" and pain that is \"intermittent\" [11].","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1880,2299],[1880,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2298,"width":1636,"height":51},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59a3d1188feb4fa5a5df1c7a073df82c","type":"text","conversion_output":true,"text":"To calculate the \"constant\" pain subscale, the sum of items 1 to 5 (each on the scale of 0 [not at","text_display":"\n\nTo calculate the \"constant\" pain subscale, the sum of items 1 to 5 (each on the scale of 0 [not at","confidence":0.99853515625,"confidence_rate":0.9999869115349181},{"cnt":[[245,2346],[1880,2346],[1880,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2346,"width":1636,"height":50},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c77f16720f44adaaa505c95af54e72","type":"text","conversion_output":true,"text":"all/I don't have pain] to 4 [Extremely]) will be derived as total pain score with a range of \\(0-20\\).","text_display":" all/I don't have pain] to 4 [Extremely]) will be derived as total pain score with a range of \\(0-20\\).","confidence":0.6220030784606934,"confidence_rate":0.9956928458101301},{"cnt":[[245,2393],[1878,2393],[1878,2445],[245,2445]],"region":{"top_left_x":244,"top_left_y":2393,"width":1634,"height":52},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62755f9b2e764771bbec430436bedfb1","type":"text","conversion_output":true,"text":"This score can be transformed to a score out of 100 using the following formula: (total/20) x 100 .","text_display":" This score can be transformed to a score out of 100 using the following formula: (total/20) x 100 .","confidence":0.9546427691764166,"confidence_rate":0.9995781065478065},{"cnt":[[245,2443],[1880,2443],[1880,2494],[245,2494]],"region":{"top_left_x":244,"top_left_y":2442,"width":1636,"height":53},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e251b3ccb6e4213aed1cddba2d42eab","type":"text","conversion_output":true,"text":"Similarly, to calculate the \"intermittent\" pain subscale the sum of items 6 to 11 (each on the scale","text_display":" Similarly, to calculate the \"intermittent\" pain subscale the sum of items 6 to 11 (each on the scale","confidence":0.9990234375,"confidence_rate":0.9999911978797494},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e8336f3f925433696d8609ad45d773a","type":"page_info","conversion_output":false,"text":"47/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-48","page":48,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"538e125212ed443ebfedd1bc20aaff8c","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"049d3cbc944e41f8bf09d19f9d1f9886","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,331],[245,331]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c3a0fce08404d978708ea7acd858683","type":"text","conversion_output":true,"text":"of 0 [not at all/I don't have pain] to 4 [Extremely/very often]) will be derived as total pain score","text_display":"\nof 0 [not at all/I don't have pain] to 4 [Extremely/very often]) will be derived as total pain score","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[245,329],[1880,329],[1880,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1636,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd4be1728878428f9c30aeb793778bae","type":"text","conversion_output":true,"text":"with a range of 0-24. This score can be transformed to a score out of 100 using the following","text_display":" with a range of 0-24. This score can be transformed to a score out of 100 using the following","confidence":0.85400390625,"confidence_rate":0.998438650758737},{"cnt":[[245,378],[1880,378],[1880,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86a6f9e5f3fd4bd19841edd1811c03a5","type":"text","conversion_output":true,"text":"formula: \\((\\) total \\(/ 24) \\times 100\\). Total pain score is the sum of \"constant\" pain subscale and \"intermittent\"","text_display":" formula: \\((\\) total \\(/ 24) \\times 100\\). Total pain score is the sum of \"constant\" pain subscale and \"intermittent\"","confidence":0.87042158600525,"confidence_rate":0.9987726334498778},{"cnt":[[245,425],[1880,425],[1880,475],[245,475]],"region":{"top_left_x":244,"top_left_y":425,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57239e4455d2440695a347061ac6f7c0","type":"text","conversion_output":true,"text":"pain subscale (range 0-44). Total pain score can be transformed to a score out of 100 using the","text_display":" pain subscale (range 0-44). Total pain score can be transformed to a score out of 100 using the","confidence":0.96630859375,"confidence_rate":0.9996673170934014},{"cnt":[[245,473],[849,473],[849,522],[245,522]],"region":{"top_left_x":244,"top_left_y":472,"width":605,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcb4f580eca947918a808a04717e869d","type":"text","conversion_output":true,"text":"following formula: \\((\\) total \\(/ 44) \\times 100\\).","text_display":" following formula: \\((\\) total \\(/ 44) \\times 100\\).","confidence":0.711658917306579,"confidence_rate":0.9929384563029847},{"cnt":[[245,563],[1880,563],[1880,612],[245,612]],"region":{"top_left_x":244,"top_left_y":562,"width":1636,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fd6cbc2eb9a452aac1920269c616b08","type":"text","conversion_output":true,"text":"If there are 3 or more items missing for each subscale for a visit, the response is considered invalid.","text_display":"\n\nIf there are 3 or more items missing for each subscale for a visit, the response is considered invalid.","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[245,610],[1880,610],[1880,660],[245,660]],"region":{"top_left_x":244,"top_left_y":610,"width":1636,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a91916056b64ce0bae653e55a1b8de2","type":"text","conversion_output":true,"text":"If there are less than 3 items missing, the missing item can be replaced with the mean of the","text_display":" If there are less than 3 items missing, the missing item can be replaced with the mean of the","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,657],[1072,657],[1072,707],[245,707]],"region":{"top_left_x":244,"top_left_y":657,"width":829,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"422d35f20d3a46d595f974ca8b516cbb","type":"text","conversion_output":true,"text":"response to other items within the same subscale.","text_display":" response to other items within the same subscale.","confidence":1,"confidence_rate":1},{"cnt":[[245,748],[1880,748],[1880,797],[245,797]],"region":{"top_left_x":244,"top_left_y":747,"width":1636,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e4fad805e614d98bd8b864eb0fe4285","type":"text","conversion_output":true,"text":"Total pain score and \"constant\" and \"intermittent\" pain subscores will be summarised by treatment","text_display":"\n\nTotal pain score and \"constant\" and \"intermittent\" pain subscores will be summarised by treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,795],[1442,795],[1442,844],[245,844]],"region":{"top_left_x":244,"top_left_y":794,"width":1198,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dc8640c275848e8ba0085125c9687e8","type":"text","conversion_output":true,"text":"and timepoint (including LOCF) as will absolute change from baseline.","text_display":" and timepoint (including LOCF) as will absolute change from baseline.","confidence":1,"confidence_rate":1},{"cnt":[[245,885],[761,885],[761,930],[245,930]],"region":{"top_left_x":244,"top_left_y":885,"width":517,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e56768082a34dda94486fafe45cfb31","type":"text","conversion_output":true,"text":"Individual items will be listed.","text_display":"\n\nIndividual items will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1880,975],[1880,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1636,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f0d7c1d050648e2adf63a687e95693c","type":"text","conversion_output":true,"text":"Change over time in structural features of the knee joint (e.g., synovium, menisci, bone, and","text_display":"\nChange over time in structural features of the knee joint (e.g., synovium, menisci, bone, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1240,1023],[1240,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":996,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bea7d337c9f487cad5a27a408978178","type":"text","conversion_output":true,"text":"other structures) as evaluated by semiquantitative MRI","text_display":" other structures) as evaluated by semiquantitative MRI","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1880,1113],[1880,1162],[245,1162]],"region":{"top_left_x":244,"top_left_y":1112,"width":1636,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"959a00e3377547a1ba40ca2092d9eb70","type":"text","conversion_output":true,"text":"The protocol specifies that both WORMS and BLOKS will be used for semi-quantitative","text_display":"\n\nThe protocol specifies that both WORMS and BLOKS will be used for semi-quantitative","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[245,1160],[1880,1160],[1880,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1160,"width":1636,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33ad07061caf4585b1bffcc7e6fdcfc3","type":"text","conversion_output":true,"text":"assessment of the target knee MRI, but does not specifically state at which of the 8 MRI-acquiring","text_display":" assessment of the target knee MRI, but does not specifically state at which of the 8 MRI-acquiring","confidence":1,"confidence_rate":1},{"cnt":[[245,1207],[1880,1207],[1880,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1207,"width":1636,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd3aa63da9a145fbaa4a5365458665e2","type":"text","conversion_output":true,"text":"timepoints WORMS and BLOKS will be used. Moreover, as many WORMS and BLOKS","text_display":" timepoints WORMS and BLOKS will be used. 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Femur posterior \\\\\nMTa: Medial Tibia anterior \\\\\nMTc: Medial Tibia central \\\\\nMTp: Medial Tibia posterior\n\\end{tabular} \\\\\n\\hline Lateral femoro-tibial joint (LFTJ) & \\begin{tabular}{l}\nLFc: Lateral Femur central \\\\\nLFp: Lateral Femur posterior \\\\\nLTa: Lateral Tibia anterior \\\\\nLTc: Lateral Tibia central \\\\\nLTp: Lateral Tibia posterior\n\\end{tabular} \\\\\n\\hline Patello-Femoral Joint (PFJ) & \\begin{tabular}{l}\nMP: Medial Patella \\\\\nLP: Lateral Patella \\\\\nMFa: Medial Femur anterior \\\\\nLFa: Lateral Femur anterior\n\\end{tabular} 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WORMS score & Variable & Compartment & Derivation \\\\\n\\hline Cartilage & \\begin{tabular}{l}\nCartilage signal, Cartilage morphology \\\\\n(only morphology in TLFs)\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Bone Marrow Edema & Bone Marrow Edema & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Subarticular cysts & Subarticular cysts & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Bone attrition & Bone attrition & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Osteophytes & Osteophytes & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nSum of the regions of each compartment as described below: \\\\\nMFTJ (central femur, central tibia, posterior femur, posterior tibia) \\\\\nLFTJ (central femur, central tibia, posterior femur, posterior tibia) \\\\\nPFJ (superior patella, inferior patella, lateral patella, medial patella, anterior femur medial, anterior femur lateral, anterior tibia medial, anterior tibia lateral) \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Ligaments & \\begin{tabular}{l}\nAnterior Cruciate \\\\\nLigament (ACL) \\\\\nPosterior Cruciate\n\\end{tabular} & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 6 WORMS scores}\n\\begin{tabular}{|l|l|l|l|}\n\\hline WORMS score & Variable & Compartment & Derivation \\\\\n\\hline Cartilage & \\begin{tabular}{l}\nCartilage signal, Cartilage morphology \\\\\n(only morphology in TLFs)\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Bone Marrow Edema & Bone Marrow Edema & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Subarticular cysts & Subarticular cysts & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Bone attrition & Bone attrition & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nMFTJ, LFTJ, PFJ \\\\\nSum of the regions of each compartment \\\\\nEntire knee \\\\\nSum of the 3 compartments\n\\end{tabular} \\\\\n\\hline Osteophytes & Osteophytes & \\begin{tabular}{l}\nMFTJ \\\\\nLFTJ \\\\\nPFJ \\\\\nEntire knee\n\\end{tabular} & \\begin{tabular}{l}\nSum of the regions of each compartment as described below: \\\\\nMFTJ (central femur, central tibia, posterior femur, posterior tibia) \\\\\nLFTJ (central femur, central tibia, posterior femur, posterior tibia) \\\\\nPFJ (superior patella, inferior patella, lateral patella, medial patella, anterior femur medial, anterior femur lateral, anterior tibia medial, anterior tibia 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Bursitis","confidence":1,"confidence_rate":1},{"cnt":[[520,1277],[864,1277],[864,1323],[520,1323]],"region":{"top_left_x":519,"top_left_y":1277,"width":346,"height":46},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5702a368af0d49fcb9edb001f43d3f07","type":"text","conversion_output":false,"parent_id":"d1cbcfc0b1f647289f425bea5bd81bf1","text":"Lateral Meniscal Cyst","text_display":" Lateral Meniscal Cyst","confidence":1,"confidence_rate":1},{"cnt":[[520,1323],[866,1323],[866,1366],[520,1366]],"region":{"top_left_x":519,"top_left_y":1322,"width":348,"height":45},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ca7de40a91d4aca8321a0de5784cb10","type":"text","conversion_output":false,"parent_id":"d1cbcfc0b1f647289f425bea5bd81bf1","text":"Medial Meniscal Cyst","text_display":" Medial Meniscal Cyst","confidence":1,"confidence_rate":1},{"cnt":[[520,1364],[795,1364],[795,1410],[520,1410]],"region":{"top_left_x":519,"top_left_y":1364,"width":276,"height":46},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47d08b39d90b4c159e6a680594167b60","type":"text","conversion_output":false,"parent_id":"d1cbcfc0b1f647289f425bea5bd81bf1","text":"Tibiofibular Cyst","text_display":" Tibiofibular Cyst","confidence":1,"confidence_rate":1},{"cnt":[[520,1412],[728,1412],[728,1457],[520,1457]],"region":{"top_left_x":519,"top_left_y":1411,"width":209,"height":47},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef613daea1de4fa6848ee4b2b8a78ad6","type":"text","conversion_output":false,"parent_id":"d1cbcfc0b1f647289f425bea5bd81bf1","text":"Baker's Cyst","text_display":" Baker's Cyst","confidence":1,"confidence_rate":1},{"cnt":[[1349,1169],[1425,1169],[1425,1208],[1349,1208]],"region":{"top_left_x":1349,"top_left_y":1169,"width":77,"height":40},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77b58279e6cf4bf3b25bf931310cd375","type":"simple_cell","conversion_output":false,"parent_id":"ce76ac92adfe40a785b0511f0ea266a1","text":"N/A","text_display":"N/A","cell_row":5,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[245,1543],[1880,1543],[1880,1592],[245,1592]],"region":{"top_left_x":244,"top_left_y":1542,"width":1636,"height":50},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72774286b50e4f188c9a550f238919dd","type":"text","conversion_output":true,"text":"Each of the WORMS scores for the entire knee and for each compartment will be tabulated per","text_display":"\n\nEach of the WORMS scores for the entire knee and for each compartment will be tabulated per","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,1590],[1880,1590],[1880,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1589,"width":1636,"height":51},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"518aa73d818540039e9793e419d38410","type":"text","conversion_output":true,"text":"time point, as well as the absolute change from baseline. Analyses will be performed on a whole","text_display":" time point, as well as the absolute change from baseline. Analyses will be performed on a whole","confidence":1,"confidence_rate":1},{"cnt":[[245,1637],[1878,1637],[1878,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1637,"width":1634,"height":50},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aeb26c9cc8974ddda9b2dd5282d31d40","type":"text","conversion_output":true,"text":"knee level and separately for the compartments given in table 6 for all subgroups. Synovial cysts","text_display":" knee level and separately for the compartments given in table 6 for all subgroups. Synovial cysts","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[245,1687],[1880,1687],[1880,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1686,"width":1636,"height":48},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"897169d5f0b14ed791b3a75ebe8e0914","type":"text","conversion_output":true,"text":"and bursae are summarized using shift tables. For all but Baker's cysts, the values are","text_display":" and bursae are summarized using shift tables. For all but Baker's cysts, the values are","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1880,1732],[1880,1783],[245,1783]],"region":{"top_left_x":244,"top_left_y":1731,"width":1636,"height":53},"line":67,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecaff8a7fe3d44058eac734fdf853411","type":"text","conversion_output":true,"text":"\"Present\"/\"Absent\". For Baker's cysts the possible values are \"0\", \"POP1\", \"POP2\", and \"POP3\"","text_display":" \"Present\"/\"Absent\". For Baker's cysts the possible values are \"0\", \"POP1\", \"POP2\", and \"POP3\"","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[245,1783],[1502,1783],[1502,1833],[245,1833]],"region":{"top_left_x":244,"top_left_y":1783,"width":1258,"height":50},"line":68,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"831f55f3b3a14f3791517414f44148ac","type":"text","conversion_output":true,"text":"( \\(1=\\) small size Baker's, \\(2=\\) medium size Baker's, and, \\(3=\\) large size Baker's).","text_display":" ( \\(1=\\) small size Baker's, \\(2=\\) medium size Baker's, and, \\(3=\\) large size Baker's).","confidence":0.7829011751809389,"confidence_rate":0.9973140662951712},{"cnt":[[245,1869],[1880,1869],[1880,1921],[245,1921]],"region":{"top_left_x":244,"top_left_y":1869,"width":1636,"height":52},"line":69,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4b3b29e2c4842cea91a0223f18a779f","type":"text","conversion_output":true,"text":"In addition, for the purpose of comparison of sprifermin doses vs. placebo, absolute differences","text_display":"\n\nIn addition, for the purpose of comparison of sprifermin doses vs. placebo, absolute differences","confidence":1,"confidence_rate":1},{"cnt":[[245,1919],[1880,1919],[1880,1968],[245,1968]],"region":{"top_left_x":244,"top_left_y":1918,"width":1636,"height":50},"line":70,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"843c1cf8311e4dacb72e9594f3da4163","type":"text","conversion_output":true,"text":"from placebo in mean change from baseline in WORMS scores for the entire knee, as well for each","text_display":" from placebo in mean change from baseline in WORMS scores for the entire knee, as well for each","confidence":1,"confidence_rate":1},{"cnt":[[245,1968],[1880,1968],[1880,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1967,"width":1636,"height":51},"line":71,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed8c47498e9440b4925657fe2f37433b","type":"text","conversion_output":true,"text":"compartment, for each sprifermin doses will also be tabulated at Week 52, Week 104 and Week","text_display":" compartment, for each sprifermin doses will also be tabulated at Week 52, Week 104 and Week","confidence":1,"confidence_rate":1},{"cnt":[[247,2015],[1880,2015],[1880,2065],[247,2065]],"region":{"top_left_x":247,"top_left_y":2015,"width":1633,"height":50},"line":72,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67749d810d2a46edbd24252ad5f27085","type":"text","conversion_output":true,"text":"156. For the WORMS scoring of the target knee joint, the following information will be listed, in","text_display":" 156. For the WORMS scoring of the target knee joint, the following information will be listed, in","confidence":1,"confidence_rate":1},{"cnt":[[245,2062],[1880,2062],[1880,2112],[245,2112]],"region":{"top_left_x":244,"top_left_y":2062,"width":1636,"height":50},"line":73,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec858903c0c249f0a64d5cbad46aca53","type":"text","conversion_output":true,"text":"addition to core variables: time point, date of the MRI, for each score: variables used for the","text_display":" addition to core variables: time point, date of the MRI, for each score: variables used for the","confidence":1,"confidence_rate":1},{"cnt":[[245,2110],[1377,2110],[1377,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2109,"width":1134,"height":51},"line":74,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be9848377a8a499bb31463a52b1673b3","type":"text","conversion_output":true,"text":"derivation, scores per compartment, absolute change from baseline.","text_display":" derivation, scores per compartment, absolute change from baseline.","confidence":1,"confidence_rate":1},{"cnt":[[245,2200],[965,2200],[965,2245],[245,2245]],"region":{"top_left_x":244,"top_left_y":2200,"width":721,"height":46},"line":75,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c4b0cc344224f0e97dbe1e8dcb24ad0","type":"text","conversion_output":true,"text":"For the calculation of the WORMS scores:","text_display":"\n\nFor the calculation of the WORMS scores:","confidence":1,"confidence_rate":1},{"cnt":[[309,2295],[1880,2295],[1880,2342],[309,2342]],"region":{"top_left_x":309,"top_left_y":2294,"width":1571,"height":48},"line":76,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"613b38c4fc0c4d1fa0a3e68b645de852","type":"text","conversion_output":true,"text":"- If a region is graded \" -9 \" (Unscorable) or \" 0.1 \" (Progression unscorable, coded as \"NA\" in","text_display":"\n- If a region is graded \" -9 \" (Unscorable) or \" 0.1 \" (Progression unscorable, coded as \"NA\" in","confidence":0.9902508163377206,"confidence_rate":0.999908443274703},{"cnt":[[370,2342],[1880,2342],[1880,2391],[370,2391]],"region":{"top_left_x":369,"top_left_y":2341,"width":1511,"height":51},"line":77,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9feab9f1a3d64417ac3bb9fa10efdba6","type":"text","conversion_output":true,"text":"the data), then the region's grade is set to missing. No imputation for missing data for","text_display":" the data), then the region's grade is set to missing. No imputation for missing data for","confidence":1,"confidence_rate":1},{"cnt":[[370,2389],[763,2389],[763,2432],[370,2432]],"region":{"top_left_x":369,"top_left_y":2389,"width":394,"height":44},"line":78,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37fe866d756d4e87b3efbb14a54c5505","type":"text","conversion_output":true,"text":"WORMS will be done.","text_display":" WORMS will be done.","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":79,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2a8a034907a04a128258661e0ef1eac5","type":"page_info","conversion_output":false,"text":"50/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-51","page":51,"lines":[{"cnt":[[245,129],[1167,129],[1167,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":923,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40ef2cf48b004c859d5b463f37e13610","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[640,172],[640,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":397,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"298e6fe5c72e4cdcadbc50c35c69e919","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,284],[1880,284],[1880,333],[309,333]],"region":{"top_left_x":309,"top_left_y":283,"width":1571,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de532d2eb5ef4e5f9e7ab9884d628118","type":"text","conversion_output":true,"text":"- If a region is graded \" 0.5 \" (Worsening (within grade), coded as \"+\") or \"- 0.5 \"","text_display":"\n- If a region is graded \" 0.5 \" (Worsening (within grade), coded as \"+\") or \"- 0.5 \"","confidence":0.9970703125,"confidence_rate":0.9999691163986473},{"cnt":[[370,331],[1880,331],[1880,380],[370,380]],"region":{"top_left_x":369,"top_left_y":330,"width":1511,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6512789f19b649c1ad0bed303572ee99","type":"text","conversion_output":true,"text":"(Improvement (within grade), coded as \"-\"), then the region's grade is set to the last","text_display":" (Improvement (within grade), coded as \"-\"), then the region's grade is set to the last","confidence":0.88671875,"confidence_rate":0.9986796918582848},{"cnt":[[370,380],[1880,380],[1880,432],[370,432]],"region":{"top_left_x":369,"top_left_y":380,"width":1511,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cba9c06f5e06466b8e2624317e6ec77a","type":"text","conversion_output":true,"text":"available existing grade within the previous visits, for the purpose of calculating change","text_display":" available existing grade within the previous visits, for the purpose of calculating change","confidence":1,"confidence_rate":1},{"cnt":[[370,430],[909,430],[909,473],[370,473]],"region":{"top_left_x":369,"top_left_y":429,"width":540,"height":44},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19f651be08e14d54b6c3b1e04fbaeaa0","type":"text","conversion_output":true,"text":"from baseline on numeric scale.","text_display":" from baseline on numeric scale.","confidence":1,"confidence_rate":1},{"cnt":[[245,518],[1880,518],[1880,569],[245,569]],"region":{"top_left_x":244,"top_left_y":517,"width":1636,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"691b39d4abe24580a8ef599959904bb4","type":"text","conversion_output":true,"text":"The partial BLOKS scoring system will be assessed using subregions for cartilage and menisci","text_display":"\n\nThe partial BLOKS scoring system will be assessed using subregions for cartilage and menisci","confidence":1,"confidence_rate":1},{"cnt":[[245,567],[1865,567],[1865,617],[245,617]],"region":{"top_left_x":244,"top_left_y":567,"width":1621,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6558b10774b04a1daa2d20762a9830ef","type":"text","conversion_output":true,"text":"defined in Table 7. The scoring approach of knee features to be analyzed is described in Table 7.","text_display":" defined in Table 7. The scoring approach of knee features to be analyzed is described in Table 7.","confidence":1,"confidence_rate":1},{"cnt":[[245,655],[868,655],[868,698],[245,698]],"region":{"top_left_x":244,"top_left_y":655,"width":624,"height":44},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac510e39af3e472faca9ed1d93e98efc","type":"figure_label","conversion_output":false,"text":"Table 7 BLOKS scores","text_display":"","confidence":0.9970703125,"confidence_rate":0.999895220224256},{"cnt":[[245,735],[1880,735],[1880,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":734,"width":1636,"height":1662},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec3e03a6366a4a0ea4803bacf1bffe26","type":"table","conversion_output":true,"children_ids":["cc162051dfbf42189b3fa1ceb22bde7e","646bd1a1a7fe4d189e7334c22f287e88","e338618f01d544378a14c4ed33cf6de7","6fdfc8fc14634cb2a08546e86e07b506","b00d18805cc14b62aa02ff34623d6f00","c16fbc4dc7954acab9837ccc5c465b89","f74c19f4429b469ebb9485cc88244885","26175ad6efe64910b6e783922079d1a1","92e7478112ce44ae8c68b5a5efab6bc8","8823314217f94d668237f9d915e1bfc8","5171e27c7c4c422cb5daa7aae4de4c32"],"selected_labels":["ac510e39af3e472faca9ed1d93e98efc"],"text":"\\begin{tabular}{|l|l|}\n\\hline Cartilage & 10 different scores possible ( \\(0.0,1.0,1.1,2.0,2.1,2.2\\), 3.0, 3.1, 3.2, 3.3), with the first number representing the score for the size of cartilage loss (\\% of surface area, 0 : none; \\(1:<10 \\% ; 2: 10-75 \\% ; 3:>75 \\%\\) ), and the second number representing the score for the full thickness cartilage loss (\\% full thickness, 0: none; 1: \\(<10 \\% ; 2\\) : 1075\\%; 3: >75\\%). Each score is therefore a categorical variable, and is derived for 14 different regions, matching the WORMS regions of table 5. \\\\\n\\hline Meniscal extrusion & \\begin{tabular}{l}\nScore of 0-3 applied for amount of extrusion in 2 locations: \\\\\nMedial meniscus (medial extrusion), Lateral meniscus (lateral extrusion)\n\\end{tabular} \\\\\n\\hline Meniscus tear & \\begin{tabular}{l}\nSignal change, type of tear and cyst are scored as present (score 1) or absent (score 0 ) in 6 regions and maceration is scored as absent/partial/progressive (follow-up only)/complete (38 variables in total): \\\\\n- Medial meniscus anterior (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Medial meniscus body (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Medial meniscus posterior horn (intrameniscal signal, vertical tear, horizontal tear, complex tear, root tear, maceration, meniscal cyst), \\\\\n- Lateral meniscus anterior (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Lateral meniscus body (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst),\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 7 BLOKS scores}\n\\begin{tabular}{|l|l|}\n\\hline Cartilage & 10 different scores possible ( \\(0.0,1.0,1.1,2.0,2.1,2.2\\), 3.0, 3.1, 3.2, 3.3), with the first number representing the score for the size of cartilage loss (\\% of surface area, 0 : none; \\(1:<10 \\% ; 2: 10-75 \\% ; 3:>75 \\%\\) ), and the second number representing the score for the full thickness cartilage loss (\\% full thickness, 0: none; 1: \\(<10 \\% ; 2\\) : 1075\\%; 3: >75\\%). Each score is therefore a categorical variable, and is derived for 14 different regions, matching the WORMS regions of table 5. \\\\\n\\hline Meniscal extrusion & \\begin{tabular}{l}\nScore of 0-3 applied for amount of extrusion in 2 locations: \\\\\nMedial meniscus (medial extrusion), Lateral meniscus (lateral extrusion)\n\\end{tabular} \\\\\n\\hline Meniscus tear & \\begin{tabular}{l}\nSignal change, type of tear and cyst are scored as present (score 1) or absent (score 0 ) in 6 regions and maceration is scored as absent/partial/progressive (follow-up only)/complete (38 variables in total): \\\\\n- Medial meniscus anterior (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Medial meniscus body (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Medial meniscus posterior horn (intrameniscal signal, vertical tear, horizontal tear, complex tear, root tear, maceration, meniscal cyst), \\\\\n- Lateral meniscus anterior (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Lateral meniscus body (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst),\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.25497247465918227,"confidence_rate":0.9990905767792767},{"cnt":[[258,734],[588,734],[588,2396],[258,2396]],"region":{"top_left_x":257,"top_left_y":734,"width":331,"height":1662},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc162051dfbf42189b3fa1ceb22bde7e","type":"table_column","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"","text_display":""},{"cnt":[[942,2396],[945,732],[1871,734],[1869,2397]],"region":{"top_left_x":942,"top_left_y":732,"width":930,"height":1666},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"646bd1a1a7fe4d189e7334c22f287e88","type":"table_column","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"","text_display":""},{"cnt":[[244,745],[1881,745],[1881,1154],[244,1154]],"region":{"top_left_x":244,"top_left_y":744,"width":1638,"height":411},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e338618f01d544378a14c4ed33cf6de7","type":"table_row","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"","text_display":""},{"cnt":[[244,1160],[1881,1160],[1881,1405],[244,1405]],"region":{"top_left_x":244,"top_left_y":1159,"width":1638,"height":247},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fdfc8fc14634cb2a08546e86e07b506","type":"table_row","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"","text_display":""},{"cnt":[[244,1457],[1878,1457],[1878,2387],[244,2387]],"region":{"top_left_x":244,"top_left_y":1457,"width":1635,"height":931},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b00d18805cc14b62aa02ff34623d6f00","type":"table_row","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"","text_display":""},{"cnt":[[266,756],[427,756],[427,802],[266,802]],"region":{"top_left_x":265,"top_left_y":755,"width":162,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c16fbc4dc7954acab9837ccc5c465b89","type":"simple_cell","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"Cartilage","text_display":"Cartilage","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[948,750],[1851,750],[1851,1151],[948,1151]],"region":{"top_left_x":947,"top_left_y":750,"width":904,"height":402},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f74c19f4429b469ebb9485cc88244885","type":"complex_cell","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","children_ids":["3c3e487caf7d45708ba94a2d8073dd90","cc74f8b476554f4db6880f0868c051d5","bb1871a79d214872b964b9adaf20bfe5","d485248a22034eeb8d5fc776dae06c6c","1bf1012c9cae4b8ea3c093b070cfbf49","e02e39bf373e4cc08d077ac6e808ffdd","591d8efacb114b5188b82a6f068df03a","d837081ec5614dcbbe606376d24d0981","874c9f3508b74c64941b5fe1d7a57c12"],"text":"10 different scores possible ( \\(0.0,1.0,1.1,2.0,2.1,2.2\\), 3.0, 3.1, 3.2, 3.3), with the first number representing the score for the size of cartilage loss (\\% of surface area, 0 : none; \\(1:<10 \\% ; 2: 10-75 \\% ; 3:>75 \\%\\) ), and the second number representing the score for the full thickness cartilage loss (\\% full thickness, 0: none; 1: \\(<10 \\% ; 2\\) : 1075\\%; 3: >75\\%). Each score is therefore a categorical variable, and is derived for 14 different regions, matching the WORMS regions of table 5.","text_display":"10 different scores possible ( \\(0.0,1.0,1.1,2.0,2.1,2.2\\), 3.0, 3.1, 3.2, 3.3), with the first number representing the score for the size of cartilage loss (\\% of surface area, 0 : none; \\(1:<10 \\% ; 2: 10-75 \\% ; 3:>75 \\%\\) ), and the second number representing the score for the full thickness cartilage loss (\\% full thickness, 0: none; 1: \\(<10 \\% ; 2\\) : 1075\\%; 3: >75\\%). Each score is therefore a categorical variable, and is derived for 14 different regions, matching the WORMS regions of table 5.","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.25497247465918227,"confidence_rate":0.9949550340964292},{"cnt":[[953,756],[1796,756],[1796,797],[953,797]],"region":{"top_left_x":953,"top_left_y":755,"width":844,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c3e487caf7d45708ba94a2d8073dd90","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"10 different scores possible ( \\(0.0,1.0,1.1,2.0,2.1,2.2\\),","text_display":"10 different scores possible ( \\(0.0,1.0,1.1,2.0,2.1,2.2\\),","confidence":0.25497247465918227,"confidence_rate":0.9785415222554127},{"cnt":[[953,799],[1818,799],[1818,840],[953,840]],"region":{"top_left_x":953,"top_left_y":799,"width":866,"height":42},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc74f8b476554f4db6880f0868c051d5","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"3.0, 3.1, 3.2, 3.3), with the first number representing the","text_display":" 3.0, 3.1, 3.2, 3.3), with the first number representing the","confidence":0.81640625,"confidence_rate":0.9968355924419238},{"cnt":[[953,843],[1810,843],[1810,884],[953,884]],"region":{"top_left_x":953,"top_left_y":843,"width":858,"height":42},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb1871a79d214872b964b9adaf20bfe5","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"score for the size of cartilage loss (\\% of surface area, 0 :","text_display":" score for the size of cartilage loss (\\% of surface area, 0 :","confidence":0.953125,"confidence_rate":0.9992942312428036},{"cnt":[[953,887],[1777,887],[1777,928],[953,928]],"region":{"top_left_x":953,"top_left_y":886,"width":825,"height":42},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d485248a22034eeb8d5fc776dae06c6c","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"none; \\(1:<10 \\% ; 2: 10-75 \\% ; 3:>75 \\%\\) ), and the second","text_display":" none; \\(1:<10 \\% ; 2: 10-75 \\% ; 3:>75 \\%\\) ), and the second","confidence":0.6181654085325057,"confidence_rate":0.9911321605928409},{"cnt":[[953,930],[1747,930],[1747,971],[953,971]],"region":{"top_left_x":953,"top_left_y":930,"width":795,"height":42},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bf1012c9cae4b8ea3c093b070cfbf49","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"number representing the score for the full thickness","text_display":" number representing the score for the full thickness","confidence":1,"confidence_rate":1},{"cnt":[[953,974],[1824,974],[1824,1015],[953,1015]],"region":{"top_left_x":953,"top_left_y":974,"width":871,"height":42},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e02e39bf373e4cc08d077ac6e808ffdd","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"cartilage loss (\\% full thickness, 0: none; 1: \\(<10 \\% ; 2\\) : 10-","text_display":" cartilage loss (\\% full thickness, 0: none; 1: \\(<10 \\% ; 2\\) : 10","confidence":0.5211441095774615,"confidence_rate":0.9901739176656208},{"cnt":[[953,1018],[1766,1018],[1766,1059],[953,1059]],"region":{"top_left_x":953,"top_left_y":1017,"width":814,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"591d8efacb114b5188b82a6f068df03a","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"75\\%; 3: >75\\%). Each score is therefore a categorical","text_display":"75\\%; 3: >75\\%). Each score is therefore a categorical","confidence":0.9362724493257701,"confidence_rate":0.9988454255166986},{"cnt":[[953,1061],[1846,1061],[1846,1108],[953,1108]],"region":{"top_left_x":953,"top_left_y":1061,"width":893,"height":47},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d837081ec5614dcbbe606376d24d0981","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"variable, and is derived for 14 different regions, matching","text_display":" variable, and is derived for 14 different regions, matching","confidence":1,"confidence_rate":1},{"cnt":[[953,1105],[1447,1105],[1447,1151],[953,1151]],"region":{"top_left_x":953,"top_left_y":1105,"width":495,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"874c9f3508b74c64941b5fe1d7a57c12","type":"text","conversion_output":false,"parent_id":"f74c19f4429b469ebb9485cc88244885","text":"the WORMS regions of table 5.","text_display":" the WORMS regions of table 5.","confidence":0.99951171875,"confidence_rate":0.9999852000944255},{"cnt":[[266,1165],[582,1165],[582,1201],[266,1201]],"region":{"top_left_x":265,"top_left_y":1165,"width":318,"height":36},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26175ad6efe64910b6e783922079d1a1","type":"simple_cell","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"Meniscal extrusion","text_display":"Meniscal extrusion","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[948,1162],[1799,1162],[1799,1402],[948,1402]],"region":{"top_left_x":947,"top_left_y":1162,"width":853,"height":241},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92e7478112ce44ae8c68b5a5efab6bc8","type":"complex_cell","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","children_ids":["1036d5a9a0f1474db814ac1240a19b35","70f9d2f5ee324d76a81dfb3f50b86207","ce244b0f5aca45ebb2c705f00e03c0df","6fa6cd84e8fa465ca19b658cd469f436"],"text":"\\begin{tabular}{l}\nScore of 0-3 applied for amount of extrusion in 2 locations: \\\\\nMedial meniscus (medial extrusion), Lateral meniscus (lateral extrusion)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nScore of 0-3 applied for amount of extrusion in 2 locations: \\\\\nMedial meniscus (medial extrusion), Lateral meniscus (lateral extrusion)\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999976962267192},{"cnt":[[953,1165],[1712,1165],[1712,1211],[953,1211]],"region":{"top_left_x":953,"top_left_y":1165,"width":759,"height":47},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1036d5a9a0f1474db814ac1240a19b35","type":"text","conversion_output":false,"parent_id":"92e7478112ce44ae8c68b5a5efab6bc8","text":"Score of 0-3 applied for amount of extrusion in 2","text_display":"Score of 0-3 applied for amount of extrusion in 2","confidence":0.99951171875,"confidence_rate":0.9999907849387211},{"cnt":[[953,1209],[1109,1209],[1109,1247],[953,1247]],"region":{"top_left_x":953,"top_left_y":1208,"width":156,"height":39},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70f9d2f5ee324d76a81dfb3f50b86207","type":"text","conversion_output":false,"parent_id":"92e7478112ce44ae8c68b5a5efab6bc8","text":"locations:","text_display":" locations:","confidence":1,"confidence_rate":1},{"cnt":[[953,1310],[1791,1310],[1791,1353],[953,1353]],"region":{"top_left_x":953,"top_left_y":1309,"width":838,"height":45},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce244b0f5aca45ebb2c705f00e03c0df","type":"text","conversion_output":false,"parent_id":"92e7478112ce44ae8c68b5a5efab6bc8","text":"Medial meniscus (medial extrusion), Lateral meniscus","text_display":"\nMedial meniscus (medial extrusion), Lateral meniscus","confidence":1,"confidence_rate":1},{"cnt":[[953,1356],[1234,1356],[1234,1397],[953,1397]],"region":{"top_left_x":953,"top_left_y":1356,"width":282,"height":41},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fa6cd84e8fa465ca19b658cd469f436","type":"text","conversion_output":false,"parent_id":"92e7478112ce44ae8c68b5a5efab6bc8","text":"(lateral extrusion)","text_display":" (lateral extrusion)","confidence":1,"confidence_rate":1},{"cnt":[[266,1465],[503,1465],[503,1503],[266,1503]],"region":{"top_left_x":265,"top_left_y":1465,"width":239,"height":39},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8823314217f94d668237f9d915e1bfc8","type":"simple_cell","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","text":"Meniscus tear","text_display":"Meniscus tear","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[948,1460],[1862,1460],[1862,2387],[948,2387]],"region":{"top_left_x":947,"top_left_y":1459,"width":915,"height":929},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5171e27c7c4c422cb5daa7aae4de4c32","type":"complex_cell","conversion_output":false,"parent_id":"ec3e03a6366a4a0ea4803bacf1bffe26","children_ids":["b9911823fab040e3a18510ba55ab379c","a014ad77d02a467793b0e9c356bf8a3d","fc61cbb878ba4d7c83da43b7a3da29cc","6f740eb4fe2f4b8d9366cafa3664b19b","fe5bf768475942f4be145d058d0ba376","6f4f1f9683f742488d4306d19dcb3c76","2f7f1335a4d54778ba247078303603e0","8127eb630cad47469836554b0d93e530","36a1083a01e147b0ba8903ac8c86e7c8","5624f10ddcce44678afd6844bb8ca121","e4aa50433a7445d59673cae3632bd2a7","4b7d1f61ba3640cd82c7812dfb65e13a","2893df82d25845ea9bdb4a9c106668ce","a1dcd097c9484027b2def35294230829","0c554f9032834b6581ab26bd55deb343","64e8b3dbfd53472ea210f93663f7a9a0","f01b5b3c41be4541b7fe1883d29efe93","9e76f632c9df4348b0847ddb2645cabf","affcbb9cd2f2499a87afd15f241385bb"],"text":"\\begin{tabular}{l}\nSignal change, type of tear and cyst are scored as present (score 1) or absent (score 0 ) in 6 regions and maceration is scored as absent/partial/progressive (follow-up only)/complete (38 variables in total): \\\\\n- Medial meniscus anterior (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Medial meniscus body (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Medial meniscus posterior horn (intrameniscal signal, vertical tear, horizontal tear, complex tear, root tear, maceration, meniscal cyst), \\\\\n- Lateral meniscus anterior (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst), \\\\\n- Lateral meniscus body (intrameniscal signal, vertical tear, horizontal tear, complex tear, maceration, meniscal cyst),\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nSignal change, type of tear and cyst are scored as present (score 1) or absent 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improvement (on a scale of \\(0-100\\) ) from baseline","text_display":"\n\nNumber and percent of subjects with 10 -point improvement (on a scale of \\(0-100\\) ) from baseline","confidence":0.9868490420120679,"confidence_rate":0.9998739298757363},{"cnt":[[245,1955],[1880,1955],[1880,2004],[245,2004]],"region":{"top_left_x":244,"top_left_y":1955,"width":1636,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6269c58aeeaf49f7b3f1106c54be3674","type":"text","conversion_output":true,"text":"will be summarized for WOMAC Total and WOMAC sub scores at all timepoints (including","text_display":" will be summarized for WOMAC Total and WOMAC sub scores at all timepoints (including","confidence":1,"confidence_rate":1},{"cnt":[[245,2002],[385,2002],[385,2052],[245,2052]],"region":{"top_left_x":244,"top_left_y":2002,"width":141,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"238ae0c0208f48be8e03daaa0a8eea7d","type":"text","conversion_output":true,"text":"LOCF).","text_display":" LOCF).","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[1880,2093],[1880,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2092,"width":1636,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f770b885004df3a580f4989047cd68","type":"text","conversion_output":true,"text":"Number and percent of subjects with 10 -point improvement of Total WOMAC and increase of at","text_display":"\n\nNumber and percent of subjects with 10 -point improvement of Total WOMAC and increase of at","confidence":0.92626953125,"confidence_rate":0.9992266626520623},{"cnt":[[245,2140],[1880,2140],[1880,2189],[245,2189]],"region":{"top_left_x":244,"top_left_y":2139,"width":1636,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2017f770b0c849428e9fd8dbc9445730","type":"text","conversion_output":true,"text":"least 0.01 mm in total femorotibial joint thickness will be summarized at all timepoints (including","text_display":" least 0.01 mm in total femorotibial joint thickness will be summarized at all timepoints (including","confidence":1,"confidence_rate":1},{"cnt":[[245,2187],[380,2187],[380,2237],[245,2237]],"region":{"top_left_x":244,"top_left_y":2187,"width":137,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8a07c5692134b9da95a247064f91b1b","type":"text","conversion_output":true,"text":"LOCF).","text_display":" LOCF).","confidence":1,"confidence_rate":1},{"cnt":[[245,2277],[1880,2277],[1880,2327],[245,2327]],"region":{"top_left_x":244,"top_left_y":2277,"width":1636,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f01db889c6a4769bb3387855bff2958","type":"text","conversion_output":true,"text":"Spearman's correlations and corresponding p -values between endpoints related to function and","text_display":"\n\nSpearman's correlations and corresponding p -values between endpoints related to function and","confidence":0.99658203125,"confidence_rate":0.9999670791635416},{"cnt":[[245,2325],[1878,2325],[1878,2374],[245,2374]],"region":{"top_left_x":244,"top_left_y":2324,"width":1634,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"731a58a187604542b2d39e17d500b2b9","type":"text","conversion_output":true,"text":"symptoms (WOMAC, 20 meter walk test, KOOS) and structure related endpoints (MRI total,","text_display":" symptoms (WOMAC, 20 meter walk test, KOOS) and structure related endpoints (MRI total,","confidence":1,"confidence_rate":1},{"cnt":[[245,2374],[1880,2374],[1880,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2374,"width":1636,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02e6221df878497db28952bce098a57d","type":"text","conversion_output":true,"text":"medial and lateral thickness) will be calculated for all timepoints including for change from","text_display":" medial and lateral thickness) will be calculated for all timepoints including for change from","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":38,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c001ea9733d7440bab855885a135b196","type":"page_info","conversion_output":false,"text":"53/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-54","page":54,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c68de4021c942f999c9b96587d23057","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7e15d5808554ccfbfcc56592e0d37a1","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,331],[245,331]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0d32fb3e47c4a4ba06a2be302b8d122","type":"text","conversion_output":true,"text":"baseline in the ITT analysis set. The number and proportion of non-missing and missing values","text_display":"\nbaseline in the ITT analysis set. The number and proportion of non-missing and missing values","confidence":1,"confidence_rate":1},{"cnt":[[245,329],[939,329],[939,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":695,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac69eecc99ce420e8e3aa789cef3ccf0","type":"text","conversion_output":true,"text":"will also be reported for each correlation.","text_display":" will also be reported for each correlation.","confidence":1,"confidence_rate":1},{"cnt":[[245,417],[978,417],[978,479],[245,479]],"region":{"top_left_x":244,"top_left_y":416,"width":734,"height":64},"line":5,"column":0,"font_size":40,"is_printed":true,"is_handwritten":false,"id":"15faaab1b3c04f4fa197164ba0de5ec7","type":"section_header","conversion_output":false,"children_ids":["1c05f669d4a74ebf8b49a617d9684ed1","29fac96c531e4e6bac51885b61fa4b10"],"text":"","text_display":""},{"cnt":[[243,415],[305,415],[305,468],[243,468]],"region":{"top_left_x":242,"top_left_y":414,"width":64,"height":55},"line":6,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"1c05f669d4a74ebf8b49a617d9684ed1","type":"text","conversion_output":true,"parent_id":"15faaab1b3c04f4fa197164ba0de5ec7","text":"17","text_display":"\n\n\\section*{17","confidence":1,"confidence_rate":1},{"cnt":[[593,421],[973,421],[973,475],[593,475]],"region":{"top_left_x":592,"top_left_y":421,"width":382,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29fac96c531e4e6bac51885b61fa4b10","type":"text","conversion_output":true,"parent_id":"15faaab1b3c04f4fa197164ba0de5ec7","text":"Safety Evaluation","text_display":" Safety Evaluation}","confidence":1,"confidence_rate":1},{"cnt":[[245,518],[1880,518],[1880,565],[245,565]],"region":{"top_left_x":244,"top_left_y":517,"width":1636,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d17168126193441fb032d26386b0ba22","type":"text","conversion_output":true,"text":"The subsections in this section include specifications for summarizing safety endpoints that are","text_display":"\n\nThe subsections in this section include specifications for summarizing safety endpoints that are","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,563],[1880,563],[1880,612],[245,612]],"region":{"top_left_x":244,"top_left_y":562,"width":1636,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdec1da57267453c8f66bad926ca5584","type":"text","conversion_output":true,"text":"common across clinical trials such as adverse events, laboratory tests and vital signs. Antibodies","text_display":" common across clinical trials such as adverse events, laboratory tests and vital signs. Antibodies","confidence":1,"confidence_rate":1},{"cnt":[[245,610],[1880,610],[1880,660],[245,660]],"region":{"top_left_x":244,"top_left_y":610,"width":1636,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f2799d497d9414b92c4d4f338c22279","type":"text","conversion_output":true,"text":"to sprifermin are part of the safety evaluation and analyses will be done by QPD and ECS as","text_display":" to sprifermin are part of the safety evaluation and analyses will be done by QPD and ECS as","confidence":0.99658203125,"confidence_rate":0.9999643358094245},{"cnt":[[245,660],[1880,660],[1880,709],[245,709]],"region":{"top_left_x":244,"top_left_y":659,"width":1636,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1e782261d934c43b259ead55b629c4d","type":"text","conversion_output":true,"text":"specified in Section 16.3. Safety analyses will be done on the safety analysis set and according to","text_display":" specified in Section 16.3. Safety analyses will be done on the safety analysis set and according to","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,709],[642,709],[642,758],[245,758]],"region":{"top_left_x":244,"top_left_y":708,"width":399,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dbafb6c04164cc397efb4bb1119046a","type":"text","conversion_output":true,"text":"the as-treated principle.","text_display":" the as-treated principle.","confidence":1,"confidence_rate":1},{"cnt":[[245,797],[930,797],[930,853],[245,853]],"region":{"top_left_x":244,"top_left_y":797,"width":687,"height":56},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de58ef02766c40f3aabb59546b6cde2e","type":"section_header","conversion_output":false,"children_ids":["e52250e53e664166884d19d1db205665"],"text":"","text_display":""},{"cnt":[[249,804],[926,804],[926,846],[249,846]],"region":{"top_left_x":249,"top_left_y":803,"width":677,"height":44},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e52250e53e664166884d19d1db205665","type":"text","conversion_output":true,"parent_id":"de58ef02766c40f3aabb59546b6cde2e","text":"17.1 Adverse Events","text_display":"\n\n\\subsection*{17.1 Adverse Events}","confidence":0.99951171875,"confidence_rate":0.9999796501863057},{"cnt":[[245,896],[1880,896],[1880,947],[245,947]],"region":{"top_left_x":244,"top_left_y":895,"width":1636,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7663c48441234477b17a19809057d093","type":"text","conversion_output":true,"text":"Adverse Events will be coded using latest version of MedDRA at the end of each of 2 reporting","text_display":"\n\nAdverse Events will be coded using latest version of MedDRA at the end of each of 2 reporting","confidence":0.9975600242614746,"confidence_rate":0.9999758125961802},{"cnt":[[245,941],[862,941],[862,993],[245,993]],"region":{"top_left_x":244,"top_left_y":941,"width":618,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe67391b4b46427ab2efef8ddbe7c09c","type":"text","conversion_output":true,"text":"periods (2 year and 5 year analyses).","text_display":" periods (2 year and 5 year analyses).","confidence":0.9921875,"confidence_rate":0.999825722355646},{"cnt":[[245,1033],[1880,1033],[1880,1081],[245,1081]],"region":{"top_left_x":244,"top_left_y":1033,"width":1636,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dc0addf2dd5429483a4f44f74eded17","type":"text","conversion_output":true,"text":"For 2 years analysis: Treatment-emergent adverse events (TEAEs) are defined as those adverse","text_display":"\n\nFor 2 years analysis: Treatment-emergent adverse events (TEAEs) are defined as those adverse","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,1079],[1880,1079],[1880,1130],[245,1130]],"region":{"top_left_x":244,"top_left_y":1078,"width":1636,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"504fa35ea3494987a9520e9f64e0ec5c","type":"text","conversion_output":true,"text":"events that either start or worsen in severity on or after the date of first dose of study treatment","text_display":" events that either start or worsen in severity on or after the date of first dose of study treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1128],[1880,1128],[1880,1179],[245,1179]],"region":{"top_left_x":244,"top_left_y":1127,"width":1636,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff9b103ea17e422ca490ec3fb6a78702","type":"text","conversion_output":true,"text":"(first injection) until 30 days from last dose of study treatment (last injection). Where dates are","text_display":" (first injection) until 30 days from last dose of study treatment (last injection). Where dates are","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[245,1177],[1880,1177],[1880,1227],[245,1227]],"region":{"top_left_x":244,"top_left_y":1177,"width":1636,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9797a1fb8e04c71a7a876e5a534b4f2","type":"text","conversion_output":true,"text":"missing or partially missing, adverse events will be assumed to be treatment-emergent, unless there","text_display":" missing or partially missing, adverse events will be assumed to be treatment-emergent, unless there","confidence":1,"confidence_rate":1},{"cnt":[[245,1225],[1880,1225],[1880,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1224,"width":1636,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32a82d48feec4bddaf6c6a55b6ac5fc0","type":"text","conversion_output":true,"text":"is clear evidence (through comparison of partial dates) to suggest that the adverse event started","text_display":" is clear evidence (through comparison of partial dates) to suggest that the adverse event started","confidence":1,"confidence_rate":1},{"cnt":[[245,1272],[1880,1272],[1880,1321],[245,1321]],"region":{"top_left_x":244,"top_left_y":1271,"width":1636,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ced31b96918c41f58063a9a612af7d2b","type":"text","conversion_output":true,"text":"prior to the first dose of study treatment or after the subject's last treatment ( +30 days). See","text_display":" prior to the first dose of study treatment or after the subject's last treatment ( +30 days). See","confidence":0.9970715045928955,"confidence_rate":0.9999720690392205},{"cnt":[[245,1319],[677,1319],[677,1369],[245,1369]],"region":{"top_left_x":244,"top_left_y":1319,"width":433,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b40476e2cfc34485a8534def23ec86af","type":"text","conversion_output":true,"text":"appendix 20.4 for details.","text_display":" appendix 20.4 for details.","confidence":1,"confidence_rate":1},{"cnt":[[245,1409],[1880,1409],[1880,1459],[245,1459]],"region":{"top_left_x":244,"top_left_y":1409,"width":1636,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34ced3e35bf8490299e5992020f7b48a","type":"text","conversion_output":true,"text":"For 5 years analysis: All AEs from the complete duration of the study will be summarized (but not","text_display":"\n\nFor 5 years analysis: All AEs from the complete duration of the study will be summarized (but not","confidence":1,"confidence_rate":1},{"cnt":[[245,1457],[1880,1457],[1880,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1456,"width":1636,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04fcd7823f094c78b8a99e64ed84c3f3","type":"text","conversion_output":true,"text":"TEAEs, as these are not relevant per definition above). There will be no summaries of TEAEs for","text_display":" TEAEs, as these are not relevant per definition above). There will be no summaries of TEAEs for","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,1504],[728,1504],[728,1555],[245,1555]],"region":{"top_left_x":244,"top_left_y":1503,"width":485,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"212a0c7933a1459eb9e37ee23f9cf9a1","type":"text","conversion_output":true,"text":"the 5 years analysis only AE","text_display":" the 5 years analysis only AE","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1880,1594],[1880,1644],[245,1644]],"region":{"top_left_x":244,"top_left_y":1594,"width":1636,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41a62c870bd64c7b8cced0905002c2dd","type":"text","conversion_output":true,"text":"Pre-treatment emergent adverse events, i.e. adverse events starting between date of informed","text_display":"\n\nPre-treatment emergent adverse events, i.e. adverse events starting between date of informed","confidence":0.99462890625,"confidence_rate":0.9999444802017697},{"cnt":[[245,1641],[1618,1641],[1618,1693],[245,1693]],"region":{"top_left_x":244,"top_left_y":1641,"width":1374,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d36b5a41d4034eeb8f0627cd2963b4c1","type":"text","conversion_output":true,"text":"consent and until date of first dose of study treatment will be tabulated separately.","text_display":" consent and until date of first dose of study treatment will be tabulated separately.","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1396,1732],[1396,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1731,"width":1153,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b248a873ca764b9684d47c45eddc61f0","type":"text","conversion_output":true,"text":"Adverse events of special interest (AESI) will include the following:","text_display":"\n\nAdverse events of special interest (AESI) will include the following:","confidence":1,"confidence_rate":1},{"cnt":[[245,1822],[1880,1822],[1880,1871],[245,1871]],"region":{"top_left_x":244,"top_left_y":1821,"width":1636,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4da965dacf1c4876875d67f764412d2d","type":"text","conversion_output":true,"text":"Injection site reactions will be summarized by treatment group and PT. These will be identified","text_display":"\nInjection site reactions will be summarized by treatment group and PT. These will be identified","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,1869],[1192,1869],[1192,1919],[245,1919]],"region":{"top_left_x":244,"top_left_y":1869,"width":949,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33bc611ba9af47229a02a3217ff18399","type":"text","conversion_output":true,"text":"using higher level term (HLT) \"Injection site reactions\".","text_display":" using higher level term (HLT) \"Injection site reactions\".","confidence":1,"confidence_rate":1},{"cnt":[[245,1959],[1880,1959],[1880,2009],[245,2009]],"region":{"top_left_x":244,"top_left_y":1959,"width":1636,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb69ab53a7624a16881b1aed3b63ae72","type":"text","conversion_output":true,"text":"Similarly, musculoskeletal complaints (eg. Back pain, neck pain), will be identified using pre-","text_display":"\n\nSimilarly, musculoskeletal complaints (eg. Back pain, neck pain), will be identified using pre","confidence":1,"confidence_rate":1},{"cnt":[[245,2007],[1880,2007],[1880,2056],[245,2056]],"region":{"top_left_x":244,"top_left_y":2006,"width":1636,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cc3d8b4769f4b8c9bd90337a50a5090","type":"text","conversion_output":true,"text":"specified SOC \"Musculoskeletal and connective tissue disorders\" and will be summarized by","text_display":"specified SOC \"Musculoskeletal and connective tissue disorders\" and will be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[245,2054],[711,2054],[711,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2053,"width":468,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e443a3cb5884c66b44eedfcceab546b","type":"text","conversion_output":true,"text":"treatment group and by PT.","text_display":" treatment group and by 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by","text_display":" and unspecified (including cysts and polyps)\" and will be summarized by treatment group and by","confidence":0.9990236759185791,"confidence_rate":0.999990133371946},{"cnt":[[243,2241],[312,2241],[312,2284],[243,2284]],"region":{"top_left_x":242,"top_left_y":2240,"width":70,"height":44},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3211c4b50fc749e0a139d7f96cff4f8a","type":"text","conversion_output":true,"text":"PT.","text_display":" PT.","confidence":0.99951171875,"confidence_rate":0.9999389518012535},{"cnt":[[245,2329],[1003,2329],[1003,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2328,"width":760,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cfb11f393a44ee78dc1d98c819b1b7f","type":"section_header","conversion_output":false,"children_ids":["553de3a32036403e9e0c9872ee64876b"],"text":"","text_display":""},{"cnt":[[249,2333],[999,2333],[999,2378],[249,2378]],"region":{"top_left_x":249,"top_left_y":2333,"width":751,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"553de3a32036403e9e0c9872ee64876b","type":"text","conversion_output":true,"parent_id":"8cfb11f393a44ee78dc1d98c819b1b7f","text":"17.1.1 All Adverse Events","text_display":"\n\n\\subsection*{17.1.1 All Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[245,2428],[855,2428],[855,2473],[245,2473]],"region":{"top_left_x":244,"top_left_y":2427,"width":612,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ae874d123ea4a478b53e199be0a5cb2","type":"text","conversion_output":true,"text":"AEs will be summarized as follows:","text_display":"\n\nAEs will be summarized as follows:","confidence":0.99951171875,"confidence_rate":0.9999874769887185},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4945ae90d39d48a081f6c9427631d396","type":"page_info","conversion_output":false,"text":"54/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-55","page":55,"lines":[{"cnt":[[245,129],[1167,129],[1167,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":923,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8d1e6c7637048e585f1709f6c708b22","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[640,172],[640,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":397,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0b7a09128ce495c97219906aea3a4f6","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[296,284],[698,284],[698,329],[296,329]],"region":{"top_left_x":296,"top_left_y":283,"width":403,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d74fb0b69e24705add5b65a5fcc3b4c","type":"text","conversion_output":true,"text":"- Overview of all AEs","text_display":"\n- Overview of all AEs","confidence":1,"confidence_rate":1},{"cnt":[[296,357],[746,357],[746,406],[296,406]],"region":{"top_left_x":296,"top_left_y":356,"width":450,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a8f772ba5344cf58c0a15807b80100b","type":"text","conversion_output":true,"text":"- TEAE by SOC and PT","text_display":"\n- TEAE by SOC and PT","confidence":1,"confidence_rate":1},{"cnt":[[296,430],[655,430],[655,479],[296,479]],"region":{"top_left_x":296,"top_left_y":429,"width":360,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b871d11cc6b44b69924874ec5ccb0677","type":"text","conversion_output":true,"text":"- TEAE by severity","text_display":"\n- TEAE by severity","confidence":1,"confidence_rate":1},{"cnt":[[296,501],[720,501],[720,552],[296,552]],"region":{"top_left_x":296,"top_left_y":500,"width":424,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7e23e331edf45789d87725a99cfee2e","type":"text","conversion_output":true,"text":"- TEAE by relationship","text_display":"\n- TEAE by relationship","confidence":1,"confidence_rate":1},{"cnt":[[296,571],[849,571],[849,621],[296,621]],"region":{"top_left_x":296,"top_left_y":571,"width":553,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaa506873aa54da4a123a2ae8b033d5c","type":"text","conversion_output":true,"text":"- Local TEAE by SOC and PT","text_display":"\n- Local TEAE by SOC and PT","confidence":1,"confidence_rate":1},{"cnt":[[296,642],[763,642],[763,694],[296,694]],"region":{"top_left_x":296,"top_left_y":642,"width":467,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94e6b178d90046eea551cab0453f7ebd","type":"text","conversion_output":true,"text":"- Local TEAE by severity","text_display":"\n- Local TEAE by severity","confidence":1,"confidence_rate":1},{"cnt":[[296,713],[827,713],[827,767],[296,767]],"region":{"top_left_x":296,"top_left_y":713,"width":532,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a46f016538e40e9a0f1d0e9eb588b91","type":"text","conversion_output":true,"text":"- Local TEAE by relationship","text_display":"\n- Local TEAE by 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severity","confidence":1,"confidence_rate":1},{"cnt":[[296,930],[883,930],[883,982],[296,982]],"region":{"top_left_x":296,"top_left_y":930,"width":588,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba00a2ff3a7f4eb9b47ca092e8a2bc6c","type":"text","conversion_output":true,"text":"- Systemic TEAE by relationship","text_display":"\n- Systemic TEAE by relationship","confidence":1,"confidence_rate":1},{"cnt":[[296,1001],[1519,1001],[1519,1051],[296,1051]],"region":{"top_left_x":296,"top_left_y":1001,"width":1223,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82fcb32977384d00ba221ecbd463c902","type":"text","conversion_output":true,"text":"- Any serious adverse events (SAEs) further specified in Section 17.2.2","text_display":"\n- Any serious adverse events (SAEs) further specified in Section 17.2.2","confidence":1,"confidence_rate":1},{"cnt":[[296,1074],[1596,1074],[1596,1124],[296,1124]],"region":{"top_left_x":296,"top_left_y":1074,"width":1301,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"035335bcc8c84818b98ef7b446546949","type":"text","conversion_output":true,"text":"- Any non-serious AEs (at least \\(5 \\%\\) in any treatment group) by SOC and PT","text_display":"\n- Any non-serious AEs (at least \\(5 \\%\\) in any treatment group) by SOC and PT","confidence":0.99951171875,"confidence_rate":0.9999938950124091},{"cnt":[[296,1145],[1532,1145],[1532,1197],[296,1197]],"region":{"top_left_x":296,"top_left_y":1145,"width":1236,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c313c14d19458db2b6678de2784780","type":"text","conversion_output":true,"text":"- Most frequent TEAEs (at least \\(5 \\%\\) in any treatment group) by PT only","text_display":"\n- Most frequent TEAEs (at least \\(5 \\%\\) in any treatment group) by PT only","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[296,1216],[1798,1216],[1798,1268],[296,1268]],"region":{"top_left_x":296,"top_left_y":1216,"width":1503,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa514f1b6a084738b047e89de0afa671","type":"text","conversion_output":true,"text":"- Treatment emergent Injection Site Reactions by PT only (as described in Section 17.1)","text_display":"\n- Treatment emergent Injection Site Reactions by PT only (as described in Section 17.1)","confidence":1,"confidence_rate":1},{"cnt":[[296,1289],[1334,1289],[1334,1338],[296,1338]],"region":{"top_left_x":296,"top_left_y":1289,"width":1039,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d9a7f3ec4844c0388e9f8adcae8b31f","type":"text","conversion_output":true,"text":"- Treatment emergent Musculoskeletal disorders by PT only","text_display":"\n- Treatment emergent Musculoskeletal disorders by PT only","confidence":1,"confidence_rate":1},{"cnt":[[296,1362],[1085,1362],[1085,1412],[296,1412]],"region":{"top_left_x":296,"top_left_y":1362,"width":789,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a4c390bd95d466986587e29ce9e58b1","type":"text","conversion_output":true,"text":"- Treatment emergent Neoplasms by PT only","text_display":"\n- Treatment emergent Neoplasms by PT only","confidence":1,"confidence_rate":1},{"cnt":[[245,1450],[1880,1450],[1880,1500],[245,1500]],"region":{"top_left_x":244,"top_left_y":1450,"width":1636,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e250bb05d00e42aa830cc1df8a58d323","type":"text","conversion_output":true,"text":"All AE and TEAE summaries will report the number and percentage of subjects, overall and by","text_display":"\n\nAll AE and TEAE summaries will report the number and percentage of subjects, overall and by","confidence":1,"confidence_rate":1},{"cnt":[[245,1497],[1265,1497],[1265,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1497,"width":1022,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17d47e606fd34d078571a52b8c74bca1","type":"text","conversion_output":true,"text":"SOC and PT. AESI will be summarized by subjects (and \\%).","text_display":" SOC and PT. AESI will be summarized by subjects (and \\%).","confidence":1,"confidence_rate":1},{"cnt":[[245,1586],[1880,1586],[1880,1637],[245,1637]],"region":{"top_left_x":244,"top_left_y":1585,"width":1636,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc9dbb6cd75046a9aa30abd5091eb777","type":"text","conversion_output":true,"text":"Each summary will be ordered alphabetically for SOC, and decreasing frequency for PT within","text_display":"\n\nEach summary will be ordered alphabetically for SOC, and decreasing frequency for PT within","confidence":1,"confidence_rate":1},{"cnt":[[245,1635],[471,1635],[471,1678],[245,1678]],"region":{"top_left_x":244,"top_left_y":1634,"width":227,"height":44},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e93f5d0920954f8ca826f5a252e68f93","type":"text","conversion_output":true,"text":"SOC overall.","text_display":" SOC overall.","confidence":1,"confidence_rate":1},{"cnt":[[245,1725],[1878,1725],[1878,1777],[245,1777]],"region":{"top_left_x":244,"top_left_y":1725,"width":1634,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4348191ee6e440f87726719150a370b","type":"text","conversion_output":true,"text":"Subjects can contribute to more than one relationship or severity count per SOC/PT. In this case,","text_display":"\n\nSubjects can contribute to more than one relationship or severity count per SOC/PT. In this case,","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1775],[1880,1775],[1880,1824],[245,1824]],"region":{"top_left_x":244,"top_left_y":1774,"width":1636,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d160a7d52e074d749684a99551505ae9","type":"text","conversion_output":true,"text":"the strongest relationship or worst severity will be used. If severity or relationship is missing, the","text_display":" the strongest relationship or worst severity will be used. If severity or relationship is missing, the","confidence":1,"confidence_rate":1},{"cnt":[[245,1822],[715,1822],[715,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1821,"width":472,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34c4bc4bdc474c6288fd666136052d35","type":"text","conversion_output":true,"text":"worst case will be assumed.","text_display":" worst case will be assumed.","confidence":1,"confidence_rate":1},{"cnt":[[245,1910],[1880,1910],[1880,1962],[245,1962]],"region":{"top_left_x":244,"top_left_y":1909,"width":1636,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c9b277e96564c2ba6f13d77b4b8f210","type":"text","conversion_output":true,"text":"Clinical trial.gov and EudraCT requirements: Summary table for non-serious AEs by SOC and PT","text_display":"\n\nClinical trial.gov and EudraCT requirements: Summary table for non-serious AEs by SOC and PT","confidence":0.9946362947812304,"confidence_rate":0.9999445567789893},{"cnt":[[245,1959],[1493,1959],[1493,2009],[245,2009]],"region":{"top_left_x":244,"top_left_y":1959,"width":1250,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a23f4d1ff684381a4395f80871384ab","type":"text","conversion_output":true,"text":"(excluding SAE) with at least \\(5 \\%\\) in any treatment group will be provided.","text_display":" (excluding SAE) with at least \\(5 \\%\\) in any treatment group will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,2050],[1880,2050],[1880,2099],[245,2099]],"region":{"top_left_x":244,"top_left_y":2049,"width":1636,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57cc9777fa21400da89c90f3b1b55b39","type":"text","conversion_output":true,"text":"A by-subject listing of all adverse events (including non-treatment-emergent events) will be","text_display":"\n\nA by-subject listing of all adverse events (including non-treatment-emergent events) will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2097],[1880,2097],[1880,2146],[245,2146]],"region":{"top_left_x":244,"top_left_y":2096,"width":1636,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9c2bbec02e04c95858bcbc43cb2204b","type":"text","conversion_output":true,"text":"provided. This listing will be presented by treatment group and will include: country, subject","text_display":" provided. This listing will be presented by treatment group and will include: country, subject","confidence":1,"confidence_rate":1},{"cnt":[[245,2144],[1880,2144],[1880,2194],[245,2194]],"region":{"top_left_x":244,"top_left_y":2144,"width":1636,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"675fd4a5ea804292a0f76297ecaab848","type":"text","conversion_output":true,"text":"identifier, age, sex, race, target knee (left/right), adverse event (SOC, PT, and verbatim term), date","text_display":" identifier, age, sex, race, target knee (left/right), adverse event (SOC, PT, and verbatim term), date","confidence":1,"confidence_rate":1},{"cnt":[[245,2191],[1880,2191],[1880,2241],[245,2241]],"region":{"top_left_x":244,"top_left_y":2191,"width":1636,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eeabeee83f9542958afcc742622328e6","type":"text","conversion_output":true,"text":"of onset, date of resolution, duration, severity, seriousness, action taken, outcome and causal","text_display":" of onset, date of resolution, duration, severity, seriousness, action taken, outcome and causal","confidence":1,"confidence_rate":1},{"cnt":[[245,2239],[672,2239],[672,2288],[245,2288]],"region":{"top_left_x":244,"top_left_y":2238,"width":429,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1af6370975f842cb917f35110d7074e8","type":"text","conversion_output":true,"text":"relationship to treatment.","text_display":" relationship to treatment.","confidence":1,"confidence_rate":1},{"cnt":[[243,2325],[1508,2325],[1508,2396],[243,2396]],"region":{"top_left_x":242,"top_left_y":2324,"width":1267,"height":72},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cacabd0037034f398ad323c164513b17","type":"section_header","conversion_output":false,"children_ids":["aab75d56e34244cca339af29366298a9"],"text":"","text_display":""},{"cnt":[[249,2333],[1502,2333],[1502,2391],[249,2391]],"region":{"top_left_x":249,"top_left_y":2333,"width":1253,"height":59},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aab75d56e34244cca339af29366298a9","type":"text","conversion_output":true,"parent_id":"cacabd0037034f398ad323c164513b17","text":"17.1.2 Adverse Events Leading to Discontinuation","text_display":"\n\n\\subsection*{17.1.2 Adverse Events Leading to Discontinuation}","confidence":1,"confidence_rate":1},{"cnt":[[245,2428],[978,2428],[978,2477],[245,2477]],"region":{"top_left_x":244,"top_left_y":2427,"width":734,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"968a6b1fca3f43929f56de21a919fd74","type":"text","conversion_output":true,"text":"The following summaries will be presented","text_display":"\n\nThe following summaries will be presented","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":36,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"87782082616a4126bf375127cf31f92e","type":"page_info","conversion_output":false,"text":"55/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-56","page":56,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e01fc909c129444288dc7ce05cf6a301","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[640,172],[640,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":397,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9363b5aa7e064c5c8e0dab2c965d85c7","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,284],[853,284],[853,333],[245,333]],"region":{"top_left_x":244,"top_left_y":283,"width":609,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1d3f488d80b4e86ae939568f87c7d34","type":"text","conversion_output":true,"text":"- TEAE leading to discontinuation","text_display":"\n- TEAE leading to discontinuation","confidence":1,"confidence_rate":1},{"cnt":[[245,357],[958,357],[958,406],[245,406]],"region":{"top_left_x":244,"top_left_y":356,"width":715,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"135ba783290748eb8d1d94d9e2978c06","type":"text","conversion_output":true,"text":"- Local TEAE leading to discontinuation","text_display":"\n- Local TEAE leading to discontinuation","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[1016,425],[1016,477],[245,477]],"region":{"top_left_x":244,"top_left_y":425,"width":773,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35ae740576c4423c858c8aeb70f62bd2","type":"text","conversion_output":true,"text":"- Systemic TEAE leading to discontinuation","text_display":"\n- Systemic TEAE leading to discontinuation","confidence":1,"confidence_rate":1},{"cnt":[[245,516],[1497,516],[1497,569],[245,569]],"region":{"top_left_x":244,"top_left_y":515,"width":1254,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbb3a6b3afc445f4aa3720a870bbc61a","type":"text","conversion_output":true,"text":"A by-subject listing of TEAEs leading to discontinuation will be provided.","text_display":"\n\nA by-subject listing of TEAEs leading to discontinuation will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,606],[1566,606],[1566,655],[245,655]],"region":{"top_left_x":244,"top_left_y":605,"width":1323,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"704b4a8bde764e95a86bb47d5180c633","type":"text","conversion_output":true,"text":"The time to discontinuation due to an AE in days will be calculated as follows:","text_display":"\nThe time to discontinuation due to an AE in days will be calculated as follows:","confidence":0.994140625,"confidence_rate":0.9999300428222486},{"cnt":[[432,696],[1691,696],[1691,750],[432,750]],"region":{"top_left_x":431,"top_left_y":696,"width":1260,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6b499129bbd47e2bcd76d996a683c63","type":"text","conversion_output":true,"text":"Date of discontinuation due to an AE - Date of first injection +1","text_display":"\nDate of discontinuation due to an AE - Date of first injection +1","confidence":0.5905268533502875,"confidence_rate":0.9923951488382788},{"cnt":[[245,812],[1880,812],[1880,864],[245,864]],"region":{"top_left_x":244,"top_left_y":812,"width":1636,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a9a024afdaf431fbc2c7d0d7d7ca781","type":"text","conversion_output":true,"text":"There are two types of discontinuations caused by an AE, the criteria are: action \\(=\\) drug withdrawn","text_display":"\n\nThere are two types of discontinuations caused by an AE, the criteria are: action \\(=\\) drug withdrawn","confidence":0.8824731933418661,"confidence_rate":0.9988211965951107},{"cnt":[[245,862],[1880,862],[1880,913],[245,913]],"region":{"top_left_x":244,"top_left_y":861,"width":1636,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48777756b8424eb4a0e67dc3df3ae9ca","type":"text","conversion_output":true,"text":"OR other action \\(=\\) led to study termination. These are summarized collectively as discontinuations","text_display":" OR other action \\(=\\) led to study termination. These are summarized collectively as discontinuations","confidence":0.9071327210403979,"confidence_rate":0.9990721782181078},{"cnt":[[245,911],[1884,911],[1884,960],[245,960]],"region":{"top_left_x":244,"top_left_y":910,"width":1641,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"736c0a530de2416c9e8990cc5696cb30","type":"text","conversion_output":true,"text":"due to AE. The date of discontinuation is the first date where any of the two types of","text_display":" due to AE. The date of discontinuation is the first date where any of the two types of","confidence":1,"confidence_rate":1},{"cnt":[[245,958],[655,958],[655,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":958,"width":412,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27412801b955453684a2a5e0d2f5dc5c","type":"text","conversion_output":true,"text":"discontinuations occurs.","text_display":" discontinuations occurs.","confidence":1,"confidence_rate":1},{"cnt":[[243,1044],[1886,1044],[1886,1160],[243,1160]],"region":{"top_left_x":242,"top_left_y":1044,"width":1645,"height":117},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"856a6bc287104972a0a94c0e45599e2d","type":"section_header","conversion_output":false,"children_ids":["b593ce6838484ab6ae19a8a8847e464f","77d88a66597d44848de10003d1838d9c"],"text":"","text_display":""},{"cnt":[[247,1051],[1880,1051],[1880,1106],[247,1106]],"region":{"top_left_x":247,"top_left_y":1050,"width":1633,"height":57},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b593ce6838484ab6ae19a8a8847e464f","type":"text","conversion_output":true,"parent_id":"856a6bc287104972a0a94c0e45599e2d","text":"17.2 Deaths, Other Serious Adverse Events, and Other Significant","text_display":"\n\n\\subsection*{17.2 Deaths, Other Serious Adverse Events, and Other Significant","confidence":0.69775390625,"confidence_rate":0.9947977987323473},{"cnt":[[593,1109],[926,1109],[926,1154],[593,1154]],"region":{"top_left_x":592,"top_left_y":1108,"width":334,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77d88a66597d44848de10003d1838d9c","type":"text","conversion_output":true,"parent_id":"856a6bc287104972a0a94c0e45599e2d","text":"Adverse Events","text_display":" Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[243,1199],[750,1199],[750,1257],[243,1257]],"region":{"top_left_x":242,"top_left_y":1198,"width":508,"height":59},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc513e46da2e4354acd700d633c571a9","type":"section_header","conversion_output":false,"children_ids":["d9fd753bcfc94d538640c9e08ec497c1"],"text":"","text_display":""},{"cnt":[[249,1203],[746,1203],[746,1253],[249,1253]],"region":{"top_left_x":249,"top_left_y":1203,"width":497,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9fd753bcfc94d538640c9e08ec497c1","type":"text","conversion_output":true,"parent_id":"cc513e46da2e4354acd700d633c571a9","text":"17.2.1 Deaths","text_display":"\n\n\\subsection*{17.2.1 Deaths}","confidence":1,"confidence_rate":1},{"cnt":[[245,1298],[900,1298],[900,1349],[245,1349]],"region":{"top_left_x":244,"top_left_y":1297,"width":657,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77f10aa5dfc8497b99c39d82033b2044","type":"text","conversion_output":true,"text":"All AEs leading to death will be listed.","text_display":"\n\nAll AEs leading to death will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[243,1388],[1098,1388],[1098,1446],[243,1446]],"region":{"top_left_x":242,"top_left_y":1387,"width":856,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5898dbd56854d9b80eec71d3777b735","type":"section_header","conversion_output":false,"children_ids":["25ae81555a2c4ba39681306e27990c73"],"text":"","text_display":""},{"cnt":[[249,1392],[1091,1392],[1091,1439],[249,1439]],"region":{"top_left_x":249,"top_left_y":1392,"width":843,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25ae81555a2c4ba39681306e27990c73","type":"text","conversion_output":true,"parent_id":"d5898dbd56854d9b80eec71d3777b735","text":"17.2.2 Serious Adverse Events","text_display":"\n\n\\subsection*{17.2.2 Serious Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[245,1485],[1171,1485],[1171,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1484,"width":927,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3b1f43d255f44eeb1074c079736e123","type":"text","conversion_output":true,"text":"Serious adverse events will be summarized in terms of","text_display":"\n\nSerious adverse events will be summarized in terms of","confidence":1,"confidence_rate":1},{"cnt":[[296,1560],[505,1560],[505,1601],[296,1601]],"region":{"top_left_x":296,"top_left_y":1559,"width":209,"height":42},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"771bcad314ed4024871415cdb0300031","type":"text","conversion_output":true,"text":"- All SAEs","text_display":"\n- All SAEs","confidence":1,"confidence_rate":1},{"cnt":[[296,1629],[844,1629],[844,1678],[296,1678]],"region":{"top_left_x":296,"top_left_y":1628,"width":549,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"348090195cf34784a5a44eac5df837f1","type":"text","conversion_output":true,"text":"- All treatment emergent SAEs","text_display":"\n- All treatment emergent SAEs","confidence":1,"confidence_rate":1},{"cnt":[[296,1702],[1113,1702],[1113,1751],[296,1751]],"region":{"top_left_x":296,"top_left_y":1701,"width":817,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35b2d2b403544d28afdb5fa8c4a0ae40","type":"text","conversion_output":true,"text":"- All treatment emergent SAEs leading to Death","text_display":"\n- All treatment emergent SAEs leading to Death","confidence":1,"confidence_rate":1},{"cnt":[[296,1775],[879,1775],[879,1824],[296,1824]],"region":{"top_left_x":296,"top_left_y":1774,"width":583,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c8c64cd243242a5904ade513b086c4e","type":"text","conversion_output":true,"text":"- Local treatment emergent SAEs","text_display":"\n- Local treatment emergent SAEs","confidence":1,"confidence_rate":1},{"cnt":[[296,1848],[935,1848],[935,1893],[296,1893]],"region":{"top_left_x":296,"top_left_y":1847,"width":639,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fb7c5c853e442a89947bdf074e3bb94","type":"text","conversion_output":true,"text":"- Systemic treatment emergent SAEs","text_display":"\n- Systemic treatment emergent SAEs","confidence":1,"confidence_rate":1},{"cnt":[[296,1916],[849,1916],[849,1966],[296,1966]],"region":{"top_left_x":296,"top_left_y":1916,"width":553,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"415e07aa0f924da7ad83ce421fc09333","type":"text","conversion_output":true,"text":"- Serious TEAEs by relationship","text_display":"\n- Serious TEAEs by relationship","confidence":0.962890625,"confidence_rate":0.9989501223132666},{"cnt":[[245,2004],[1609,2004],[1609,2056],[245,2056]],"region":{"top_left_x":244,"top_left_y":2004,"width":1366,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70e83866fb514c6bb6c39ce96b4f9d0b","type":"text","conversion_output":true,"text":"By-subject listings will be provided for the all SAEs (treatment-emergent or not.)","text_display":"\n\nBy-subject listings will be provided for the all SAEs (treatment-emergent or not.)","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[243,2093],[1399,2093],[1399,2159],[243,2159]],"region":{"top_left_x":242,"top_left_y":2092,"width":1157,"height":68},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc98f002d8f94380a8ee527b937eabdf","type":"section_header","conversion_output":false,"children_ids":["bdcf41bf70b94360862ae8fe67fdf312"],"text":"","text_display":""},{"cnt":[[249,2097],[1394,2097],[1394,2155],[249,2155]],"region":{"top_left_x":249,"top_left_y":2096,"width":1146,"height":59},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdcf41bf70b94360862ae8fe67fdf312","type":"text","conversion_output":true,"parent_id":"cc98f002d8f94380a8ee527b937eabdf","text":"17.2.3 Acute Inflammatory Reactions (AIRs)","text_display":"\n\n\\subsection*{17.2.3 Acute Inflammatory Reactions (AIRs)}","confidence":1,"confidence_rate":1},{"cnt":[[245,2191],[909,2191],[909,2239],[245,2239]],"region":{"top_left_x":244,"top_left_y":2191,"width":665,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"941574b4159f4cc39e4777d054ac5675","type":"text","conversion_output":true,"text":"Incidence of AIRs will be summarized.","text_display":"\n\nIncidence of AIRs will be summarized.","confidence":1,"confidence_rate":1},{"cnt":[[245,2282],[1880,2282],[1880,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2281,"width":1636,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fe783b7430a4bf49fdba84a6eeaf859","type":"text","conversion_output":true,"text":"AIR is defined as: increase of pain by 30 mm on a 100 mm VAS and a self-reported synovial fluid","text_display":"\nAIR is defined as: increase of pain by 30 mm on a 100 mm VAS and a self-reported synovial fluid","confidence":0.9956090442137793,"confidence_rate":0.9999599951243457},{"cnt":[[245,2329],[1362,2329],[1362,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2328,"width":1119,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0a408a2ff0b467d8fcdd658c0713b62","type":"text","conversion_output":true,"text":"effusion (i.e., joint swelling) within 3 days following i.a. injection.","text_display":" effusion (i.e., joint swelling) within 3 days following i.a. injection.","confidence":0.9990236759185791,"confidence_rate":0.9999876355068686},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":34,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b968f908b8904f28b7fdfa1d2d0be44b","type":"page_info","conversion_output":false,"text":"56/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-57","page":57,"lines":[{"cnt":[[245,129],[1167,129],[1167,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":923,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4db6d9b90144b66907dc0f4a6e8412e","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97486d90b36d4caabd4b683de6042337","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,279],[1880,279],[1880,331],[245,331]],"region":{"top_left_x":244,"top_left_y":279,"width":1636,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41499de744da486a8ab88860585dfa3e","type":"text","conversion_output":true,"text":"Synovial fluid effusions during the treatment period are reported in the subject diary by the subject","text_display":"\n\nSynovial fluid effusions during the treatment period are reported in the subject diary by the subject","confidence":1,"confidence_rate":1},{"cnt":[[245,329],[1880,329],[1880,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1636,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54f139ce858948b59e763e3c99e1e234","type":"text","conversion_output":true,"text":"answering 'Yes' to the question 'Swelling x Day1 before/after injection'. If this occurs within 3","text_display":" answering 'Yes' to the question 'Swelling x Day1 before/after injection'. If this occurs within 3","confidence":0.8003902435302734,"confidence_rate":0.9977979146321477},{"cnt":[[245,378],[1880,378],[1880,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52b13575f1c64e12a56e6f7d55a6c89e","type":"text","conversion_output":true,"text":"days after injection, then the subject is classified as having a self-reported synovial fluid effusion","text_display":" days after injection, then the subject is classified as having a self-reported synovial fluid effusion","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[879,425],[879,475],[245,475]],"region":{"top_left_x":244,"top_left_y":425,"width":635,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3394e10717340fca8bc7e8af4f08b12","type":"text","conversion_output":true,"text":"within 3 days following i.a. injection.","text_display":" within 3 days following i.a. injection.","confidence":0.998046875,"confidence_rate":0.9999584043792537},{"cnt":[[245,516],[1880,516],[1880,565],[245,565]],"region":{"top_left_x":244,"top_left_y":515,"width":1636,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6665bf91e62a447884373b3e8ec646e2","type":"text","conversion_output":true,"text":"Subjects are classified as experiencing an increase of pain by 30 mm on a 100 mm VAS from pre-","text_display":"\n\nSubjects are classified as experiencing an increase of pain by 30 mm on a 100 mm VAS from pre","confidence":0.9926791191101074,"confidence_rate":0.9999325911707102},{"cnt":[[245,563],[1635,563],[1635,612],[245,612]],"region":{"top_left_x":244,"top_left_y":562,"width":1391,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e50f05d893584ada9d05b82f9fa57f20","type":"text","conversion_output":true,"text":"dose to post-dose when the following occurs within 3 days following i.a. injection:","text_display":"dose to post-dose when the following occurs within 3 days following i.a. injection:","confidence":0.9853877797722816,"confidence_rate":0.9998382545081943},{"cnt":[[288,657],[1712,657],[1712,711],[288,711]],"region":{"top_left_x":287,"top_left_y":657,"width":1426,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcd0909cf5774a8fa372b8fa9f9327a7","type":"text","conversion_output":true,"text":"Pain VAS (highest value recorded within 3 days following i.a.injection)","text_display":"\n\nPain VAS (highest value recorded within 3 days following i.a.injection)","confidence":1,"confidence_rate":1},{"cnt":[[550,709],[1811,709],[1811,763],[550,763]],"region":{"top_left_x":550,"top_left_y":708,"width":1262,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1b4005057b14d2eb8a04e8009da858d","type":"text","conversion_output":true,"text":"- Pain VAS (last available value before i.a.injection) \\(\\geq 30 mm\\)","text_display":"\n- Pain VAS (last available value before i.a.injection) \\(\\geq 30 mm\\)","confidence":0.968510627746582,"confidence_rate":0.9995225644148324},{"cnt":[[245,827],[1880,827],[1880,879],[245,879]],"region":{"top_left_x":244,"top_left_y":827,"width":1636,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa2c4b2e6d944918801ab8176447fb95","type":"text","conversion_output":true,"text":"Information on pain and swelling as recorded in diary will be summarized by treatment group per","text_display":"\n\nInformation on pain and swelling as recorded in diary will be summarized by treatment group 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mm VAS from","confidence":1,"confidence_rate":1},{"cnt":[[292,1113],[1878,1113],[1878,1164],[292,1164]],"region":{"top_left_x":292,"top_left_y":1112,"width":1586,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4512167bbca54d8e8124d3817d06e6bb","type":"text","conversion_output":true,"text":"pre-dose to post-dose within 3 days following i.a. injection, for each cycle at Week 1, 2 and 3","text_display":" pre-dose to post-dose within 3 days following i.a. injection, for each cycle at Week 1, 2 and 3","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[294,1164],[479,1164],[479,1214],[294,1214]],"region":{"top_left_x":294,"top_left_y":1164,"width":186,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6369421208424658897363dc82b753d4","type":"text","conversion_output":true,"text":"(Yes, No);","text_display":" (Yes, 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In addition, Cochran-Armitage exact trend test will be used also to","text_display":" subjects experiencing AIRs. In addition, Cochran-Armitage exact trend test will be used also to","confidence":1,"confidence_rate":1},{"cnt":[[245,1826],[1878,1826],[1878,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1826,"width":1634,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ed3320587ae4c2f914e86f51c9c761b","type":"text","conversion_output":true,"text":"evaluate whether increasing occurrences of AIRs are associated with increasing dose/injections.","text_display":" evaluate whether increasing occurrences of AIRs are associated with increasing dose/injections.","confidence":1,"confidence_rate":1},{"cnt":[[245,1873],[1878,1873],[1878,1927],[245,1927]],"region":{"top_left_x":244,"top_left_y":1873,"width":1634,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84d880ca2a9f43c69bfcdbe2a234724d","type":"text","conversion_output":true,"text":"The number of subjects with non-missing and missing data for each item will also be presented.","text_display":" The number of subjects with non-missing and missing data for each item will also be presented.","confidence":1,"confidence_rate":1},{"cnt":[[245,1921],[1033,1921],[1033,1972],[245,1972]],"region":{"top_left_x":244,"top_left_y":1920,"width":790,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3ecdbc637cc4ba4b31b18a302fbdfd2","type":"text","conversion_output":true,"text":"A by-subject listing will be provided for AIRs.","text_display":" A by-subject listing will be provided for 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For the purposes of laboratory parameter summaries, 'low',","confidence":0.98193359375,"confidence_rate":0.9998101055698682},{"cnt":[[245,1852],[1833,1852],[1833,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1851,"width":1589,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aa0ebf674614b3caeb35df9a3e65a7e","type":"text","conversion_output":true,"text":"'normal' and 'high' are classified as follows: low < LLN; LLN \\(\\leq\\) normal \\(\\leq\\) ULN; high > ULN.","text_display":" 'normal' and 'high' are classified as follows: low < LLN; LLN \\(\\leq\\) normal \\(\\leq\\) ULN; high > ULN.","confidence":0.858060415166809,"confidence_rate":0.9984703634081724},{"cnt":[[245,1942],[1880,1942],[1880,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":1636,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4ecdb1783724da7bc07ead64c1ec9c3","type":"text","conversion_output":true,"text":"A shift table will be used to summarize for each laboratory parameter the number and percentage","text_display":"\n\nA shift table will be used to summarize for each laboratory parameter the number and percentage","confidence":1,"confidence_rate":1},{"cnt":[[245,1989],[1880,1989],[1880,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1989,"width":1636,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a210c31a2f546c592ee0cb939efa182","type":"text","conversion_output":true,"text":"of subjects experiencing low, normal, high or missing values at each timepoint according to their","text_display":" of subjects experiencing low, normal, high or missing values at each timepoint according to their","confidence":1,"confidence_rate":1},{"cnt":[[245,2037],[969,2037],[969,2086],[245,2086]],"region":{"top_left_x":244,"top_left_y":2036,"width":725,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d583a499fe3b4ba8b376995c11a52443","type":"text","conversion_output":true,"text":"baseline classification, by treatment group.","text_display":" baseline classification, by treatment group.","confidence":0.99951171875,"confidence_rate":0.9999900326925697},{"cnt":[[245,2127],[1880,2127],[1880,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2126,"width":1636,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc298c4c25ce4c59b3ec940c540f3a62","type":"text","conversion_output":true,"text":"Mean values of continuous parameters will be plotted per timepoint and corresponding change","text_display":"\n\nMean values of continuous parameters will be plotted per timepoint and corresponding change","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,2174],[1880,2174],[1880,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2174,"width":1636,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"608f5af3f18e40f3afeca20216f32be2","type":"text","conversion_output":true,"text":"from baseline. One symbol per treatment group will be used. Plots will also present reference range","text_display":" from baseline. One symbol per treatment group will be used. Plots will also present reference range","confidence":1,"confidence_rate":1},{"cnt":[[245,2221],[1659,2221],[1659,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2221,"width":1415,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"284534205a0e4e4dbee0817d9370a10d","type":"text","conversion_output":true,"text":"limits. Plots will be split by gender whenever reference limits are gender-dependent.","text_display":" limits. Plots will be split by gender whenever reference limits are gender-dependent.","confidence":1,"confidence_rate":1},{"cnt":[[245,2312],[1880,2312],[1880,2361],[245,2361]],"region":{"top_left_x":244,"top_left_y":2311,"width":1636,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b270829384e04056b9dda70969b554c6","type":"text","conversion_output":true,"text":"Scatter plots of the following continuous parameters will be provided for the 2 years analysis (up","text_display":"\n\nScatter plots of the following continuous parameters will be provided for the 2 years analysis (up","confidence":0.9985356330871582,"confidence_rate":0.9999861751885265},{"cnt":[[245,2359],[449,2359],[449,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2358,"width":206,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58d64c1e33d2429a94a722addd583405","type":"text","conversion_output":true,"text":"to LOCF1):","text_display":" to LOCF1):","confidence":1,"confidence_rate":1},{"cnt":[[296,2432],[990,2432],[990,2481],[296,2481]],"region":{"top_left_x":296,"top_left_y":2432,"width":695,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"826cc31157944524b7278e008101df89","type":"text","conversion_output":true,"text":"- baseline vs largest post-baseline value","text_display":"\n- baseline vs largest post-baseline value","confidence":0.9853515625,"confidence_rate":0.9996792517714577},{"cnt":[[1538,2561],[1620,2561],[1620,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":82,"height":36},"line":36,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6c698879b4b742f18f335a7b19c981fc","type":"page_info","conversion_output":false,"text":"59/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-60","page":60,"lines":[{"cnt":[[245,129],[1167,129],[1167,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":923,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16793f733fcb450fa15cd9ac9c09c358","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4186bf068f284e17a87361dea9457e5e","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[296,284],[988,284],[988,333],[296,333]],"region":{"top_left_x":296,"top_left_y":283,"width":693,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be19a3ae467b4d14af515cf5d2793413","type":"text","conversion_output":true,"text":"- baseline vs lowest post-baseline value","text_display":"\n- baseline vs lowest post-baseline value","confidence":0.9921875,"confidence_rate":0.999825722355646},{"cnt":[[245,374],[1555,374],[1555,423],[245,423]],"region":{"top_left_x":244,"top_left_y":373,"width":1312,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cc5368a824842c2868c0c1df700532d","type":"text","conversion_output":true,"text":"Plots will include 95\\% CI around the mean and present reference range limits.","text_display":"\n\nPlots will include 95\\% CI around the mean and present reference range limits.","confidence":0.8796371514908969,"confidence_rate":0.9984372493880224},{"cnt":[[245,464],[1674,464],[1674,513],[245,513]],"region":{"top_left_x":244,"top_left_y":464,"width":1430,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc60d896b3b5439290600a94467164c5","type":"text","conversion_output":true,"text":"Coagulation and pregnancy parameters collected during screening only will be listed.","text_display":"\nCoagulation and pregnancy parameters collected during screening only will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[245,554],[1880,554],[1880,604],[245,604]],"region":{"top_left_x":244,"top_left_y":554,"width":1636,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4135ca72b56040f7a4c006c79792a437","type":"text","conversion_output":true,"text":"Laboratory values that are outside the normal range will also be flagged in the data listings, along","text_display":"\nLaboratory values that are outside the normal range will also be flagged in the data listings, along","confidence":1,"confidence_rate":1},{"cnt":[[245,602],[1880,602],[1880,649],[245,649]],"region":{"top_left_x":244,"top_left_y":601,"width":1636,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fe13475fe214585ba65edaf8523f742","type":"text","conversion_output":true,"text":"with corresponding normal ranges. Baseline is the last measurement prior to the first dose of any","text_display":" with corresponding normal ranges. Baseline is the last measurement prior to the first dose of any","confidence":1,"confidence_rate":1},{"cnt":[[245,649],[1878,649],[1878,698],[245,698]],"region":{"top_left_x":244,"top_left_y":648,"width":1634,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0400af51ced422f83e79737e781f124","type":"text","conversion_output":true,"text":"trial treatment. Subjects without post baseline laboratory samples will be excluded from analyses","text_display":" trial treatment. Subjects without post baseline laboratory samples will be excluded from analyses","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[245,696],[920,696],[920,746],[245,746]],"region":{"top_left_x":244,"top_left_y":696,"width":676,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9f354f9b4dc497597a09816826dbb22","type":"text","conversion_output":true,"text":"with respect to values after the baseline.","text_display":" with respect to values after the baseline.","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[1880,786],[1880,836],[245,836]],"region":{"top_left_x":244,"top_left_y":786,"width":1636,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88d2b0297fd8429e83f88fa2404efaed","type":"text","conversion_output":true,"text":"In addition, the last available laboratory measurement (LOCF1 for 2 years analysis and LOCF2","text_display":"\n\nIn addition, the last available laboratory measurement (LOCF1 for 2 years analysis and LOCF2","confidence":1,"confidence_rate":1},{"cnt":[[245,834],[896,834],[896,883],[245,883]],"region":{"top_left_x":244,"top_left_y":833,"width":652,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d113027b641a430cbe78125f1eba25d2","type":"text","conversion_output":true,"text":"for 5 years analysis) will be presented.","text_display":" for 5 years analysis) will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[243,924],[834,924],[834,986],[243,986]],"region":{"top_left_x":242,"top_left_y":923,"width":592,"height":64},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3afbf16b50ed453087778194af0c6a0d","type":"section_header","conversion_output":false,"children_ids":["39850f94066c4c789f2e70de0c82458c"],"text":"","text_display":""},{"cnt":[[249,928],[827,928],[827,982],[249,982]],"region":{"top_left_x":249,"top_left_y":928,"width":579,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39850f94066c4c789f2e70de0c82458c","type":"text","conversion_output":true,"parent_id":"3afbf16b50ed453087778194af0c6a0d","text":"17.4 Vital Signs","text_display":"\n\n\\subsection*{17.4 Vital Signs}","confidence":0.998046875,"confidence_rate":0.9999022530357556},{"cnt":[[245,1023],[1880,1023],[1880,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1022,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bf4ce7eb1124033afc83cdba2994ab2","type":"text","conversion_output":true,"text":"The following vital signs will be summarized by treatment and timepoint together with absolute","text_display":"\n\nThe following vital signs will be summarized by treatment and timepoint together with absolute","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1880,1070],[1880,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1069,"width":1636,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32224ea2d275479bae975d031adc38b9","type":"text","conversion_output":true,"text":"change from baseline in the same manner specified for laboratory parameters. All analysis are for","text_display":" change from baseline in the same manner specified for laboratory parameters. All analysis are for","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[879,1117],[879,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":635,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f64d2f5d902f48cd920a876fbaa6233f","type":"text","conversion_output":true,"text":"timepoints defined in table 3a and 3b.","text_display":" timepoints defined in table 3a and 3b.","confidence":0.99951171875,"confidence_rate":0.9999886419133848},{"cnt":[[245,1190],[1021,1190],[1021,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1190,"width":777,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa6e6db9fa86449097bca33fbc8e585a","type":"text","conversion_output":true,"text":"- sitting systolic and diastolic blood pressure","text_display":"\n- sitting systolic and diastolic blood pressure","confidence":1,"confidence_rate":1},{"cnt":[[245,1263],[458,1263],[458,1304],[245,1304]],"region":{"top_left_x":244,"top_left_y":1263,"width":214,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"356a47b6dc96433aa3e36b5209eb6077","type":"text","conversion_output":true,"text":"- heart rate","text_display":"\n- heart rate","confidence":1,"confidence_rate":1},{"cnt":[[245,1332],[595,1332],[595,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":352,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9b0398e97a8417fbcee4bab928d6042","type":"text","conversion_output":true,"text":"- body temperature","text_display":"\n- body temperature","confidence":1,"confidence_rate":1},{"cnt":[[245,1422],[1878,1422],[1878,1472],[245,1472]],"region":{"top_left_x":244,"top_left_y":1422,"width":1634,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3ca8dfb20f843739c30365c144ed595","type":"text","conversion_output":true,"text":"All parameters will be listed by subject and visit, including all relevant criteria (as specified below)","text_display":"\n\nAll parameters will be listed by subject and visit, including all relevant criteria (as specified below)","confidence":1,"confidence_rate":1},{"cnt":[[245,1470],[415,1470],[415,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1469,"width":171,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bd7482c63f24032912babdce14f05ae","type":"text","conversion_output":true,"text":"and flags.","text_display":" and flags.","confidence":1,"confidence_rate":1},{"cnt":[[245,1560],[1880,1560],[1880,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1559,"width":1636,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a375c5a554ea4b7c882f7311ab69f454","type":"text","conversion_output":true,"text":"The maximum changes of blood pressure measurements from baseline to maximum shifts (with","text_display":"\n\nThe maximum changes of blood pressure measurements from baseline to maximum shifts (with","confidence":1,"confidence_rate":1},{"cnt":[[245,1607],[1880,1607],[1880,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1607,"width":1636,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9918a7496edb445eb73262c8870c9f47","type":"text","conversion_output":true,"text":"pre-specified categories for increase and decrease separately) after start of 1st injection will be","text_display":" pre-specified categories for increase and decrease separately) after start of 1st injection will be","confidence":0.99169921875,"confidence_rate":0.9999198548985305},{"cnt":[[245,1654],[1880,1654],[1880,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1654,"width":1636,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a045bf4d644449aa96dcfe6b18a1fb38","type":"text","conversion_output":true,"text":"summarized (number of subjects and percentages) and grouped by baseline category as follows","text_display":" summarized (number of subjects and percentages) and grouped by baseline category as follows","confidence":1,"confidence_rate":1},{"cnt":[[245,1704],[1171,1704],[1171,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1703,"width":927,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"215fffa1fe814d258a738b5191421960","type":"text","conversion_output":true,"text":"(missing values will be defined as a separate category):","text_display":" (missing values will be defined as a separate category):","confidence":1,"confidence_rate":1},{"cnt":[[243,1792],[1061,1792],[1061,1846],[243,1846]],"region":{"top_left_x":242,"top_left_y":1791,"width":820,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfbb3b479dc04af3870eff11f58efc4b","type":"figure_label","conversion_output":false,"text":"Table 8 Blood pressure categories","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,1876],[1878,1876],[1878,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":1875,"width":1634,"height":521},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8b43a55655f4a10b6baff71b6e659e4","type":"table","conversion_output":true,"children_ids":["c27100e090724475b844a8be02b3ff26","f177a825ed3a4ee284af1f0ef7655721","539a4a0df7644723885df5594f30361e","05c1c47021c847298c7dc5ae1dc08e58","53405b6b26e3460d9f0ebbc57aef42f7","645497a9fe1b40098be8c62fdc3d600a","6040fb9113bf42b4a9fa45b9e7f1df59","7ddf786284af4bfcb0bca8fea77ecacd","7c7133b124094f2fbde58e501a2aed4c","728fcbdbc3b243f99eaea54a554923ba","c903eb2ef9fa49e69a64744f355237ba","0ef1926c962948eb87de102e4e4c2122","086a2b8e5c2c4c079013060f60e0c0c7","ed82e9dc9ca74c8db6094f80fa0049e9"],"selected_labels":["dfbb3b479dc04af3870eff11f58efc4b"],"text":"\\begin{tabular}{|l|l|}\n\\hline Baseline category & Post-baseline category \\\\\n\\hline Systolic baseline: \\(<140 mmHg , \\geq 140 mmHg\\) & Increase of: \\(\\leq 20 mmHg ,>20-40 mmHg ,>40\\) mmHg \\\\\n\\hline Systolic baseline: \\(<140 mmHg\\), \\(\\geq 140 mmHg\\) & Decrease of: \\(\\leq 20 mmHg ,>20-40 mmHg ,>\\) 40 mmHg \\\\\n\\hline Diastolic baseline: \\(\\leq 90 mmHg ,>90 mmHg\\) & Increase of: \\(\\leq 10 mmHg ,>10-20 mmHg ,>20\\) mmHg \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 8 Blood pressure categories}\n\\begin{tabular}{|l|l|}\n\\hline Baseline category & Post-baseline category \\\\\n\\hline Systolic baseline: \\(<140 mmHg , \\geq 140 mmHg\\) & Increase of: \\(\\leq 20 mmHg ,>20-40 mmHg ,>40\\) mmHg \\\\\n\\hline Systolic baseline: \\(<140 mmHg\\), \\(\\geq 140 mmHg\\) & Decrease of: \\(\\leq 20 mmHg ,>20-40 mmHg ,>\\) 40 mmHg \\\\\n\\hline Diastolic baseline: \\(\\leq 90 mmHg ,>90 mmHg\\) & Increase of: \\(\\leq 10 mmHg ,>10-20 mmHg ,>20\\) mmHg \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.679189519956708,"confidence_rate":0.9983958642264446},{"cnt":[[258,1875],[1046,1875],[1046,2396],[258,2396]],"region":{"top_left_x":257,"top_left_y":1875,"width":790,"height":522},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c27100e090724475b844a8be02b3ff26","type":"table_column","conversion_output":false,"parent_id":"f8b43a55655f4a10b6baff71b6e659e4","text":"","text_display":""},{"cnt":[[1068,1875],[1870,1875],[1870,2396],[1068,2396]],"region":{"top_left_x":1067,"top_left_y":1875,"width":804,"height":522},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f177a825ed3a4ee284af1f0ef7655721","type":"table_column","conversion_output":false,"parent_id":"f8b43a55655f4a10b6baff71b6e659e4","text":"","text_display":""},{"cnt":[[244,1921],[1878,1921],[1878,1976],[244,1976]],"region":{"top_left_x":244,"top_left_y":1921,"width":1635,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"539a4a0df7644723885df5594f30361e","type":"table_row","conversion_output":false,"parent_id":"f8b43a55655f4a10b6baff71b6e659e4","text":"","text_display":""},{"cnt":[[244,2009],[1878,2009],[1878,2118],[244,2118]],"region":{"top_left_x":244,"top_left_y":2008,"width":1635,"height":110},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05c1c47021c847298c7dc5ae1dc08e58","type":"table_row","conversion_output":false,"parent_id":"f8b43a55655f4a10b6baff71b6e659e4","text":"","text_display":""},{"cnt":[[244,2148],[1878,2148],[1878,2260],[244,2260]],"region":{"top_left_x":244,"top_left_y":2147,"width":1635,"height":113},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53405b6b26e3460d9f0ebbc57aef42f7","type":"table_row","conversion_output":false,"parent_id":"f8b43a55655f4a10b6baff71b6e659e4","text":"","text_display":""},{"cnt":[[244,2284],[1878,2284],[1878,2396],[244,2396]],"region":{"top_left_x":244,"top_left_y":2284,"width":1635,"height":113},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"645497a9fe1b40098be8c62fdc3d600a","type":"table_row","conversion_output":false,"parent_id":"f8b43a55655f4a10b6baff71b6e659e4","text":"","text_display":""},{"cnt":[[260,1924],[574,1924],[574,1976],[260,1976]],"region":{"top_left_x":260,"top_left_y":1924,"width":315,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6040fb9113bf42b4a9fa45b9e7f1df59","type":"simple_cell","conversion_output":false,"parent_id":"f8b43a55655f4a10b6baff71b6e659e4","text":"Baseline 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(AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a7876161c134fa8b755d0b678799753","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,275],[1880,275],[1880,425],[245,425]],"region":{"top_left_x":244,"top_left_y":275,"width":1636,"height":151},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32e0a4ae39fd4ac29666db912156cbf3","type":"table","conversion_output":true,"text":"\\begin{tabular}{|l|l|}\n\\hline Diastolic baseline: \\(\\leq 90 mmHg ,>90 mmHg\\) & \\begin{tabular}{l} \nDecrease of: \\(\\leq 10 mmHg ,>10-20 mmHg ,>\\) \\\\\n20 mmHg\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Diastolic baseline: \\(\\leq 90 mmHg ,>90 mmHg\\) & \\begin{tabular}{l} \nDecrease of: \\(\\leq 10 mmHg ,>10-20 mmHg ,>\\) \\\\\n20 mmHg\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.9965846532722935,"confidence_rate":0.9999728480484781},{"cnt":[[245,464],[1880,464],[1880,513],[245,513]],"region":{"top_left_x":244,"top_left_y":464,"width":1636,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4c832cd39954808962172ce9e4635ca","type":"text","conversion_output":true,"text":"For each subject both the worst increase and worst decrease during the 2 year period (after first","text_display":"\n\nFor each subject both the worst increase and worst decrease during the 2 year period (after first","confidence":1,"confidence_rate":1},{"cnt":[[245,511],[1880,511],[1880,561],[245,561]],"region":{"top_left_x":244,"top_left_y":511,"width":1636,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09c18688892840f2875b311863c445e7","type":"text","conversion_output":true,"text":"injection) will be used. If subject has no change (change \\(=0\\) ), then it will not be counted in the","text_display":" injection) will be used. If subject has no change (change \\(=0\\) ), then it will not be counted in the","confidence":0.99853515625,"confidence_rate":0.9999861706835268},{"cnt":[[245,559],[1880,559],[1880,608],[245,608]],"region":{"top_left_x":244,"top_left_y":558,"width":1636,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e5df36ce1514bba9fa35b5659ea88ed","type":"text","conversion_output":true,"text":"categories of increase and decrease. The following summaries will be prepared for blood pressure","text_display":" categories of increase and decrease. The following summaries will be prepared for blood pressure","confidence":1,"confidence_rate":1},{"cnt":[[245,608],[1360,606],[1360,657],[245,660]],"region":{"top_left_x":244,"top_left_y":605,"width":1117,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"024b5e6fc61049909e0fb53896095726","type":"text","conversion_output":true,"text":"as grouped above only for subjects who have post baseline values:","text_display":" as grouped above only for subjects who have post baseline values:","confidence":1,"confidence_rate":1},{"cnt":[[245,679],[1880,679],[1880,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":1636,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1410fd2e0d04525bb86144525a227ac","type":"text","conversion_output":true,"text":"- Maximal shifts (change in categories [increase and decrease]), this will be done both relative to","text_display":"\n- Maximal shifts (change in categories [increase and decrease]), this will be done both relative to","confidence":1,"confidence_rate":1},{"cnt":[[294,726],[1523,726],[1523,776],[294,776]],"region":{"top_left_x":294,"top_left_y":726,"width":1230,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"521891573b0046e4a53987ae6ba23aef","type":"text","conversion_output":true,"text":"injections and relative to target days following either table 3a or table 3b.","text_display":" injections and relative to target days following either table 3a or table 3b.","confidence":1,"confidence_rate":1},{"cnt":[[245,816],[1734,816],[1734,866],[245,866]],"region":{"top_left_x":244,"top_left_y":816,"width":1490,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb820bcb29934d7e9b23887adbf80ead","type":"text","conversion_output":true,"text":"Mean values will be plotted per timepoint. One symbol per treatment group will be used.","text_display":"\n\nMean values will be plotted per timepoint. 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Presentation of","text_display":" summarized by treatment and timepoint as will absolute change from baseline. Presentation of","confidence":1,"confidence_rate":1},{"cnt":[[245,1384],[1609,1384],[1609,1433],[245,1433]],"region":{"top_left_x":244,"top_left_y":1383,"width":1366,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23011f44cd874ab397dc2545409728ff","type":"text","conversion_output":true,"text":"QTc intervals will also include the Bazett's and Fridericia's correction defined as","text_display":" QTc intervals will also include the Bazett's and Fridericia's correction defined as","confidence":1,"confidence_rate":1},{"cnt":[[361,1555],[1268,1555],[1268,1893],[361,1893]],"region":{"top_left_x":360,"top_left_y":1555,"width":908,"height":338},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e74456a24c14d13b5bd82285963f8dd","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& \\text { Bazett's Correction (QTcB) } \\quad Q T c_{b}=\\frac{Q T}{\\sqrt{R R}} \\\\\n& \\text { Fridericia's Correction (QTcF) } \\quad Q T c_{f}=\\frac{Q T}{\\sqrt[3]{R R}}\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& \\text { Bazett's Correction (QTcB) } \\quad Q T c_{b}=\\frac{Q T}{\\sqrt{R R}} \\\\\n& \\text { Fridericia's Correction (QTcF) } \\quad Q T c_{f}=\\frac{Q T}{\\sqrt[3]{R R}}\n\\end{aligned}\n\\]","confidence":0.75927734375,"confidence_rate":0.9979000083678023},{"cnt":[[245,1934],[1268,1934],[1268,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1933,"width":1024,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55e4856288b443b69430824e6a2f4d1c","type":"text","conversion_output":true,"text":"where: \\(RR = RR\\)-interval measured in seconds ( \\(RR =1 / HR\\) ).","text_display":"\nwhere: \\(RR = RR\\)-interval measured in seconds ( \\(RR =1 / HR\\) ).","confidence":0.5195232565774859,"confidence_rate":0.9916397111439781},{"cnt":[[245,2022],[1880,2022],[1880,2073],[245,2073]],"region":{"top_left_x":244,"top_left_y":2021,"width":1636,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88fa92921d3947eea817aedc94d7f69c","type":"text","conversion_output":true,"text":"Mean values of continuous parameters will be plotted per analysis timepoint. One symbol per","text_display":"\nMean values of continuous parameters will be plotted per analysis timepoint. One symbol per","confidence":1,"confidence_rate":1},{"cnt":[[245,2071],[1661,2071],[1661,2121],[245,2121]],"region":{"top_left_x":244,"top_left_y":2071,"width":1417,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2743e94f89e9491f81abb6cc685983af","type":"text","conversion_output":true,"text":"treatment group will be used. All ECG parameters will be listed by subject and visit.","text_display":" treatment group will be used. All ECG parameters will be listed by subject and visit.","confidence":1,"confidence_rate":1},{"cnt":[[243,2157],[836,2157],[836,2215],[243,2215]],"region":{"top_left_x":242,"top_left_y":2157,"width":594,"height":59},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b07f92f371564c96874d9e225905a89f","type":"section_header","conversion_output":false,"children_ids":["3a72f6faa15b428980a590d181d6b817"],"text":"","text_display":""},{"cnt":[[249,2161],[831,2161],[831,2211],[249,2211]],"region":{"top_left_x":249,"top_left_y":2161,"width":583,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a72f6faa15b428980a590d181d6b817","type":"text","conversion_output":true,"parent_id":"b07f92f371564c96874d9e225905a89f","text":"18 References","text_display":"\n\n\\section*{18 References}","confidence":1,"confidence_rate":1},{"cnt":[[245,2256],[834,2256],[834,2307],[245,2307]],"region":{"top_left_x":244,"top_left_y":2255,"width":590,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a5e70579b4e45deab90b7a76a3121d1","type":"text","conversion_output":true,"text":"References available upon request.","text_display":"\n\nReferences available upon request.","confidence":1,"confidence_rate":1},{"cnt":[[309,2346],[1843,2346],[1843,2396],[309,2396]],"region":{"top_left_x":309,"top_left_y":2346,"width":1535,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c531a19e5b30439d9ebca85e1baec86f","type":"text","conversion_output":true,"text":"1. Tubach F , Ravaud P , Baron G et al. Evaluation of clinically relevant changes in patient","text_display":"\n1. Tubach F , Ravaud P , Baron G et al. Evaluation of clinically relevant changes in patient","confidence":0.9088291665539145,"confidence_rate":0.9991690572673123},{"cnt":[[370,2393],[1745,2393],[1745,2447],[370,2447]],"region":{"top_left_x":369,"top_left_y":2393,"width":1376,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d134f37a4084b339d9a2bd45c851c84","type":"text","conversion_output":true,"text":"reported outcomes in knee and hip osteoarthritis: the minimal clinically important","text_display":" reported outcomes in knee and hip osteoarthritis: the minimal clinically important","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[370,2443],[1420,2443],[1420,2494],[370,2494]],"region":{"top_left_x":369,"top_left_y":2442,"width":1052,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aadebd306ace4ab59d6a69bc8adddc17","type":"text","conversion_output":true,"text":"improvement. Annals of Rheumatic Diseases. 2005; 64:29-33.","text_display":" improvement. Annals of Rheumatic Diseases. 2005; 64:29-33.","confidence":1,"confidence_rate":1},{"cnt":[[1538,2561],[1616,2561],[1616,2595],[1538,2595]],"region":{"top_left_x":1538,"top_left_y":2560,"width":78,"height":36},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d4551b25d2d248f5868f55cd09b01299","type":"page_info","conversion_output":false,"text":"61/71","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7d3f1047-18ef-437a-aee6-86ac05993601-62","page":62,"lines":[{"cnt":[[245,129],[1164,129],[1164,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":921,"height":47},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2426dacdb444fa7b6298ddb88fc9838","type":"page_info","conversion_output":false,"text":"Sprifermin (AS902330) Statistical Analysis Plan (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[638,172],[638,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":395,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44ef84ece2c0495399b19cc48830b488","type":"page_info","conversion_output":false,"text":"EMR700692_006 - v1.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,279],[1562,279],[1562,329],[305,329]],"region":{"top_left_x":305,"top_left_y":279,"width":1257,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36b5525414f74e9db4e79ae4cfa542b1","type":"text","conversion_output":true,"text":"2. Independent Data Monitoring Committee Charter version 2, July 2014.","text_display":"\n2. Independent Data Monitoring Committee Charter version 2, July 2014.","confidence":1,"confidence_rate":1},{"cnt":[[305,370],[1871,370],[1871,419],[305,419]],"region":{"top_left_x":305,"top_left_y":369,"width":1567,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a1e2e1c6cc1411b815d4080a64dac65","type":"text","conversion_output":true,"text":"3. Attur, M. et al. Radiographic severity of knee osteoarthritis is conditional on interleukin 1","text_display":"\n3. Attur, M. et al. Radiographic severity of knee osteoarthritis is conditional on interleukin 1","confidence":1,"confidence_rate":1},{"cnt":[[370,419],[1835,419],[1835,466],[370,466]],"region":{"top_left_x":369,"top_left_y":418,"width":1466,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b25c53c653a54c90ac5c5a541f5da6e1","type":"text","conversion_output":true,"text":"receptor antagonist gene variations. Annals of Rheumatic Diseases. 2010; 69, 856-861.","text_display":" receptor antagonist gene variations. Annals of Rheumatic Diseases. 2010; 69, 856-861.","confidence":1,"confidence_rate":1},{"cnt":[[305,507],[1807,507],[1807,556],[305,556]],"region":{"top_left_x":305,"top_left_y":507,"width":1502,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6567227a7aed4beba6acccbad3aed371","type":"text","conversion_output":true,"text":"4. Wu X et al. IL-1 receptor antagonist gene as a predictive biomarker of progression of","text_display":"\n4. Wu X et al. IL-1 receptor antagonist gene as a predictive biomarker of progression of","confidence":0.7541458022315055,"confidence_rate":0.9969705169040816},{"cnt":[[370,556],[1876,556],[1876,604],[370,604]],"region":{"top_left_x":369,"top_left_y":556,"width":1507,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9050d03de06d44e1845be32b0563332a","type":"text","conversion_output":true,"text":"knee osteoarthritis in a population cohort. Osteoarthritis and Cartilage 2013; 21, 930-938.","text_display":" knee osteoarthritis in a population cohort. 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Osteoarthritis and Cartilage 2014; (22) 44-50.","text_display":" inflammation derived tissue turnover. Osteoarthritis and Cartilage 2014; (22) 44-50.","confidence":1,"confidence_rate":1},{"cnt":[[305,795],[1800,795],[1800,844],[305,844]],"region":{"top_left_x":305,"top_left_y":794,"width":1496,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16b6bd50225d44dc87a4b30e0d1ee632","type":"text","conversion_output":true,"text":"6. Sharif et al., A 5-yr longitudinal study of type IIA collagen synthesis and total type II","text_display":"\n6. 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Rheumatology 2007;46: 938-943.","text_display":" progression. Rheumatology 2007;46: 938-943.","confidence":1,"confidence_rate":1},{"cnt":[[305,988],[1781,988],[1781,1036],[305,1036]],"region":{"top_left_x":305,"top_left_y":988,"width":1477,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4f807eea7cd495bb2365323575f1ad6","type":"text","conversion_output":true,"text":"7. Kraus et al., Application of biomarkers in the development of drugs intended for the","text_display":"\n7. Kraus et al., Application of biomarkers in the development of drugs intended for the","confidence":1,"confidence_rate":1},{"cnt":[[370,1036],[1635,1036],[1635,1085],[370,1085]],"region":{"top_left_x":369,"top_left_y":1035,"width":1266,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04073dbb202e443f8c331725bc90d606","type":"text","conversion_output":true,"text":"treatment of osteoarthritis: Osteoarthritis and Cartilage 2011; (19) 515-542.","text_display":" treatment of osteoarthritis: Osteoarthritis and Cartilage 2011; (19) 515-542.","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1867,1173],[1867,1222],[305,1222]],"region":{"top_left_x":305,"top_left_y":1173,"width":1562,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d8cb20d4e93470fa6fa1c3e75152016","type":"text","conversion_output":true,"text":"8. Gudmann et al., Cartilage turnover reflected by metabolic processing of type II Collagen:","text_display":"\n8. Gudmann et al., Cartilage turnover reflected by metabolic processing of type II Collagen:","confidence":1,"confidence_rate":1},{"cnt":[[370,1222],[1854,1222],[1854,1270],[370,1270]],"region":{"top_left_x":369,"top_left_y":1222,"width":1486,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76584d07a0cc4e7295de40501486f9ae","type":"text","conversion_output":true,"text":"A novel marker of anabolic function in chondrocytes. International Journal of Molecular","text_display":" A novel marker of anabolic function in chondrocytes. International Journal of Molecular","confidence":1,"confidence_rate":1},{"cnt":[[370,1268],[935,1268],[935,1315],[370,1315]],"region":{"top_left_x":369,"top_left_y":1267,"width":566,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa5abcd35f4b4fdbaf347f07934f4f65","type":"text","conversion_output":true,"text":"Sciences. 2014; 15:18789-18803.","text_display":" Sciences. 2014; 15:18789-18803.","confidence":1,"confidence_rate":1},{"cnt":[[305,1358],[1790,1358],[1790,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1357,"width":1485,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6506a7c281f74306a7eec9d0ba9df4c7","type":"text","conversion_output":true,"text":"9. Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, et al.","text_display":"\n9. 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Group & Endpoint & Treatment Phase & Follow-up (integrated) & Reference \\\\\n\\hline ![](https://cdn.mathpix.com/cropped/7d3f1047-18ef-437a-aee6-86ac05993601-63.jpg?height=183\\&width=237\\&top_left_y=571\\&top_left_x=250) & ![](https://cdn.mathpix.com/cropped/7d3f1047-18ef-437a-aee6-86ac05993601-63.jpg?height=176\\&width=376\\&top_left_y=578\\&top_left_x=497) & Baseline to LOCF1 & Baseline to LOCF2 & \\\\\n\\hline & & & & \\\\\n\\hline Trial Subjects & Disposition & Descriptive & Descriptive & 12 \\\\\n\\hline & Protocol Deviations & Descriptive & Descriptive & 12.1 \\\\\n\\hline Demographics and other baseline characteristics & Demographics & Descriptive & Descriptive & 13.1 \\\\\n\\hline & Medical History & Descriptive & Descriptive & 13.2 \\\\\n\\hline & Baseline Characteristics & Descriptive & Descriptive & 13.3 \\\\\n\\hline Concomitant Medication and procedures & Previous medication and procedures & Descriptive & Descriptive & 14 \\\\\n\\hline & Concomitant medication and procedures & Descriptive & Descriptive & 14 \\\\\n\\hline & Pain medication & Descriptive & Descriptive & 14 \\\\\n\\hline Exposure and treatment compliance & Exposure & Descriptive & Descriptive & 15 \\\\\n\\hline & Compliance & Descriptive & Descriptive & 15 \\\\\n\\hline Efficacy & Change from baseline in average cartilage thickness in the total femorotibial joint as evaluated by MRI in the target knee & \\begin{tabular}{l}\nPrimary: \\\\\nDescriptive \\\\\nAnalysis \\\\\nSensitivity analysis (PP) \\\\\nModel check\n\\end{tabular} & \\begin{tabular}{l}\nExploratory: \\\\\nDescriptive \\\\\nAnalysis \\\\\nModel check\n\\end{tabular} & 16.1 \\\\\n\\hline & WOMAC total score in the target knee at baseline and postbaseline & \\begin{tabular}{l}\nSecondary endpoint \\\\\nDescriptive \\\\\nAnalysis \\\\\nSensitivity analysis (PP) \\\\\nSubgroup analysis\n\\end{tabular} & \\begin{tabular}{l}\nExploratory: \\\\\nDescriptive \\\\\nAnalysis \\\\\nModel check\n\\end{tabular} & 16.2 \\\\\n\\hline & WOMAC sub scores in the target knee at baseline and postbaseline & \\begin{tabular}{l}\nSecondary endpoint \\\\\nDescriptive \\\\\nAnalysis \\\\\nSensitivity analysis (PP) \\\\\nSubgroup analysis\n\\end{tabular} & \\begin{tabular}{l}\nExploratory: \\\\\nDescriptive \\\\\nAnalysis \\\\\nModel check\n\\end{tabular} & 16.2 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|}\n\\hline Group & Endpoint & Treatment Phase & Follow-up (integrated) & Reference \\\\\n\\hline ![](https://cdn.mathpix.com/cropped/7d3f1047-18ef-437a-aee6-86ac05993601-63.jpg?height=183\\&width=237\\&top_left_y=571\\&top_left_x=250) & ![](https://cdn.mathpix.com/cropped/7d3f1047-18ef-437a-aee6-86ac05993601-63.jpg?height=176\\&width=376\\&top_left_y=578\\&top_left_x=497) & Baseline to LOCF1 & Baseline to LOCF2 & \\\\\n\\hline & & & & \\\\\n\\hline Trial Subjects & Disposition & Descriptive & Descriptive & 12 \\\\\n\\hline & Protocol Deviations & Descriptive & Descriptive & 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