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96","text_display":" IV infusion over 60 minutes Days 1, 3, and 5, then once every 4 weeks for up to an additional 96","confidence":0.9646471589803696,"confidence_rate":0.9996605021436942},{"cnt":[[270,599],[1926,599],[1926,651],[270,651]],"region":{"top_left_x":269,"top_left_y":598,"width":1657,"height":54},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"51297022d5ef4381a338cd2680d0df23","type":"text","conversion_output":true,"text":"weeks in an open label study extension. Dosing on Days 1, 3 and 5 will be repeated once every 24","text_display":" weeks in an open label study extension. 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Nevertheless,","text_display":" to 28 weeks in mean FVC [\\% predicted], hereafter referred to as the primary endpoint. Nevertheless,","confidence":1,"confidence_rate":1},{"cnt":[[270,1042],[1930,1042],[1930,1090],[270,1090]],"region":{"top_left_x":269,"top_left_y":1041,"width":1662,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66a8febf5d8b45509ab709d17df750df","type":"text","conversion_output":true,"text":"the sample-size has been calculated to ensure a sufficient power to demonstrate the efficacy of","text_display":" the sample-size has been calculated to ensure a sufficient power to demonstrate the efficacy of","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[270,1087],[1926,1087],[1926,1140],[270,1140]],"region":{"top_left_x":269,"top_left_y":1087,"width":1657,"height":53},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"151114e9cd204145986922c95c43c7df","type":"text","conversion_output":true,"text":"PRM-151 over placebo on the primary endpoint under a set of hypotheses on effect sizes in the two","text_display":" PRM-151 over placebo on the primary endpoint under a set of hypotheses on effect sizes in the two","confidence":0.9985356330871582,"confidence_rate":0.9999856330429514},{"cnt":[[270,1138],[1923,1138],[1923,1190],[270,1190]],"region":{"top_left_x":269,"top_left_y":1137,"width":1655,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bbf392986c1541b5aa6198a23df4c61d","type":"text","conversion_output":true,"text":"groups and on the variability of the primary endpoint. The primary endpoint will be tested in a","text_display":" groups and on the variability of the primary endpoint. 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\\multirow{2}{*}{Schedule of events} & \\multirow[b]{2}{*}{Screening \\(\\leq 28\\) days} & \\multicolumn{4}{|c|}{Treatment Period} & Open Label Extension \\\\\n\\hline & & \\multicolumn{2}{|c|}{Week 0 ( ± 1 day)} & W4, W8, W12, W16, W20, W24 ( \\(\\pm 3\\) days) & W28 ( ± 3 days) & W28-W128 ( ± 3 days) \\\\\n\\hline Informed Consent & x & & & & & \\\\\n\\hline Demographics & x & & & & & \\\\\n\\hline Past Medical History & x & & & & & \\\\\n\\hline Inclusion/Exclusion & x & x & & & & \\\\\n\\hline Vital Signs & x & x & x & x & x & x \\\\\n\\hline Physical Exam \\({ }^{1}\\) & x & x & & x & x & x \\\\\n\\hline Height (cm) & x & & & & & \\\\\n\\hline Weight (kg) & x & x & & x & & x \\\\\n\\hline Prior/Concomitant Medications & x & x & x & x & x & x \\\\\n\\hline Special list of ecluded medications & x & x & x & x & x & x \\\\\n\\hline AE/SAE Assessment & & x & x & x & x & x \\\\\n\\hline ECG \\& Cytokines (ONLY in the event of an IRR) & & x & x & x & & \\\\\n\\hline Efficacy Assessment 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Although unlikely, serious allergic reactions (e.g., anaphylaxis) may","text_display":" urticaria and somnolence. Although unlikely, serious allergic reactions (e.g., anaphylaxis) may","confidence":1,"confidence_rate":1},{"cnt":[[270,1896],[905,1896],[905,1949],[270,1949]],"region":{"top_left_x":269,"top_left_y":1896,"width":636,"height":53},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0e227180358f43269fd3dae2cd7f84a5","type":"text","conversion_output":true,"text":"occur at any time during the infusion.","text_display":" occur at any time during the infusion.","confidence":1,"confidence_rate":1},{"cnt":[[270,1994],[1898,1994],[1898,2045],[270,2045]],"region":{"top_left_x":269,"top_left_y":1994,"width":1630,"height":51},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8728cb5e56bd4bfcb5cd19db36740254","type":"text","conversion_output":true,"text":"Infusion related reactions will be classified by MedDRA Preferred Term (PT) and System Organ","text_display":"\n\nInfusion related reactions will be classified by MedDRA Preferred Term (PT) and System Organ","confidence":1,"confidence_rate":1},{"cnt":[[270,2042],[1729,2042],[1729,2092],[270,2092]],"region":{"top_left_x":269,"top_left_y":2042,"width":1461,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd4acdd78dbf4049990cd716bdda46eb","type":"text","conversion_output":true,"text":"Class (SOC). Safety will be assess based on the incidence of infusion related reactions.","text_display":" Class (SOC). Safety will be assess based on the incidence of infusion related reactions.","confidence":1,"confidence_rate":1},{"cnt":[[288,2700],[1282,2700],[1282,2746],[288,2746]],"region":{"top_left_x":287,"top_left_y":2700,"width":995,"height":46},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9c1f246d2f7f42839867ac2220c4c162","type":"page_info","conversion_output":false,"text":"PROMEDIOR-PRM-151-202-IPF-PHASE 2- SAP-v2_08JUN2017.docx","text_display":"","confidence":0.9975595474243164,"confidence_rate":0.9999599444852941},{"cnt":[[1768,2700],[1939,2700],[1939,2748],[1768,2748]],"region":{"top_left_x":1768,"top_left_y":2700,"width":172,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92c0c292ccca4ab5925680f551c71317","type":"page_info","conversion_output":false,"text":"Page 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endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[270,471],[1364,471],[1364,523],[270,523]],"region":{"top_left_x":269,"top_left_y":470,"width":1095,"height":54},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bffc0ed242ae460f8cd4bb612a1859c3","type":"text","conversion_output":true,"text":"During the study the following laboratory variables are recorded:","text_display":"\n\nDuring the study the following laboratory variables are recorded:","confidence":1,"confidence_rate":1},{"cnt":[[334,521],[1926,521],[1926,573],[334,573]],"region":{"top_left_x":333,"top_left_y":520,"width":1593,"height":54},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e925c4a8a30d422f9f94ad1b10b7f284","type":"text","conversion_output":true,"text":"- Hematology: Hemoglobin, Hematocrit, Red Blood Cell, White Blood Cell, Neutrophils,","text_display":"\n- Hematology: Hemoglobin, Hematocrit, Red Blood Cell, White Blood Cell, Neutrophils,","confidence":1,"confidence_rate":1},{"cnt":[[397,571],[1414,571],[1414,624],[397,624]],"region":{"top_left_x":397,"top_left_y":571,"width":1018,"height":53},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4ff3f6eea344f94a4819c8e57bc8758","type":"text","conversion_output":true,"text":"Eosinophils, Basophils, Lymphocytes, Monocytes, Platelets.","text_display":" Eosinophils, Basophils, Lymphocytes, Monocytes, Platelets.","confidence":1,"confidence_rate":1},{"cnt":[[334,621],[1926,621],[1926,674],[334,674]],"region":{"top_left_x":333,"top_left_y":621,"width":1593,"height":53},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b18bf110d625443aaff98a727d614fe7","type":"text","conversion_output":true,"text":"- Chemistry: Sodium, Potassium, Chloride, Glucose, Calcium, AST, ALT, Total Bilirubin,","text_display":"\n- Chemistry: Sodium, Potassium, Chloride, Glucose, Calcium, AST, ALT, Total Bilirubin,","confidence":1,"confidence_rate":1},{"cnt":[[397,669],[1926,669],[1926,720],[397,720]],"region":{"top_left_x":397,"top_left_y":669,"width":1529,"height":51},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d9e124f705542a0afd9760512a97139","type":"text","conversion_output":true,"text":"Blood Urea Nitrogen, Bicarbonate, Albumin, Creatinine, Alkaline Phosphatase, Total","text_display":" Blood Urea Nitrogen, Bicarbonate, Albumin, Creatinine, Alkaline Phosphatase, Total","confidence":1,"confidence_rate":1},{"cnt":[[397,717],[537,717],[537,763],[397,763]],"region":{"top_left_x":397,"top_left_y":717,"width":140,"height":46},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef435f10cc064704955ba48619977708","type":"text","conversion_output":true,"text":"Protein.","text_display":" Protein.","confidence":1,"confidence_rate":1},{"cnt":[[334,768],[1926,768],[1926,820],[334,820]],"region":{"top_left_x":333,"top_left_y":767,"width":1593,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"28f29f64ba924d66bc86dc80e606fd10","type":"text","conversion_output":true,"text":"- Coagulation: Prothrombin Time, Partial Thromboplastin Time, International Normalized","text_display":"\n- Coagulation: Prothrombin Time, Partial Thromboplastin Time, International Normalized","confidence":1,"confidence_rate":1},{"cnt":[[397,818],[505,818],[505,861],[397,861]],"region":{"top_left_x":397,"top_left_y":817,"width":108,"height":45},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8df592c6364047eaa84367a6e316d038","type":"text","conversion_output":true,"text":"Ratio.","text_display":" Ratio.","confidence":0.9970703125,"confidence_rate":0.9997333094378167},{"cnt":[[270,914],[1923,914],[1923,964],[270,964]],"region":{"top_left_x":269,"top_left_y":913,"width":1655,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"808c3b0b61584288b217b3ae05e43ce8","type":"text","conversion_output":true,"text":"Each laboratory result will be categorized in 3 classes of abnormalities according to (see section 8):","text_display":"\n\nEach laboratory result will be categorized in 3 classes of abnormalities according to (see section 8):","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[334,964],[532,964],[532,1012],[334,1012]],"region":{"top_left_x":333,"top_left_y":964,"width":200,"height":48},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f8174a388c7e47ddac244b9b3fa2e66e","type":"text","conversion_output":true,"text":"- Normal","text_display":"\n- Normal","confidence":1,"confidence_rate":1},{"cnt":[[334,1014],[665,1014],[665,1062],[334,1062]],"region":{"top_left_x":333,"top_left_y":1014,"width":332,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63fbba7b88194667a4762f63cc18c601","type":"text","conversion_output":true,"text":"- Abnormal NCS","text_display":"\n- Abnormal NCS","confidence":0.98876953125,"confidence_rate":0.9994057552324137},{"cnt":[[334,1065],[633,1065],[633,1110],[334,1110]],"region":{"top_left_x":333,"top_left_y":1064,"width":300,"height":47},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6a95d94aa364c01852ad80329bb5f33","type":"text","conversion_output":true,"text":"- Abnormal CS","text_display":"\n- Abnormal CS","confidence":1,"confidence_rate":1},{"cnt":[[270,1160],[1926,1160],[1926,1213],[270,1213]],"region":{"top_left_x":269,"top_left_y":1160,"width":1657,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27308794d7224761ab5ea56b7faf6148","type":"text","conversion_output":true,"text":"Biological safety will be assessed based on raw test results and change from baseline in raw and","text_display":"\n\nBiological safety will be assessed based on raw test results and change from baseline in raw and","confidence":1,"confidence_rate":1},{"cnt":[[270,1211],[781,1211],[781,1263],[270,1263]],"region":{"top_left_x":269,"top_left_y":1210,"width":513,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6a987e2314746e9b1fc034935700a6c","type":"text","conversion_output":true,"text":"categorized laboratory results.","text_display":" categorized laboratory 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A complete physical examinations will include a review of the following body","text_display":" thereafter. A complete physical examinations will include a review of the following body","confidence":1,"confidence_rate":1},{"cnt":[[270,1549],[1926,1549],[1926,1601],[270,1601]],"region":{"top_left_x":269,"top_left_y":1548,"width":1657,"height":54},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e15f58774af4b7eb3ec758ffa6ad9d1","type":"text","conversion_output":true,"text":"systems:General appearance, Head, Eyes, Ears, Nose, and Throat, Respiratory, Cardiovascular,","text_display":" systems:General appearance, Head, Eyes, Ears, Nose, and Throat, Respiratory, Cardiovascular,","confidence":1,"confidence_rate":1},{"cnt":[[270,1599],[1926,1599],[1926,1652],[270,1652]],"region":{"top_left_x":269,"top_left_y":1599,"width":1657,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"39230f9bc84f4af4b1bd013f582c7801","type":"text","conversion_output":true,"text":"Abdomen, Neurologic, Extremities and Dermatologic. Safety will be assessed based on","text_display":" Abdomen, Neurologic, Extremities and Dermatologic. 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Safety will also be assessed based on abnormalities (normal, abnormal) in vital","text_display":" signs measurements. 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All available efficacy","text_display":" on the pooled data from the individual study sites, unless otherwise stated. All available efficacy","confidence":1,"confidence_rate":1},{"cnt":[[270,1001],[1926,1001],[1926,1053],[270,1053]],"region":{"top_left_x":269,"top_left_y":1000,"width":1657,"height":54},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5cbf2776d71a487aa1c2ed695683f94e","type":"text","conversion_output":true,"text":"and safety data (according to definition provided in section 4) collected during the randomized","text_display":" and safety data (according to definition provided in section 4) collected during the randomized","confidence":1,"confidence_rate":1},{"cnt":[[270,1051],[1926,1051],[1926,1103],[270,1103]],"region":{"top_left_x":269,"top_left_y":1050,"width":1657,"height":54},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8240589b278047c28f4da52ae9291069","type":"text","conversion_output":true,"text":"phase of the study will be included in data listings and tabulations (i.e., OLE data will not be","text_display":" phase of the study will be included in data listings and tabulations (i.e., OLE data will not be","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[270,1101],[1926,1101],[1926,1154],[270,1154]],"region":{"top_left_x":269,"top_left_y":1101,"width":1657,"height":53},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2798cf289d49453aa1118fe37dd2cb99","type":"text","conversion_output":true,"text":"presented). Except for the analysis of the primary endpoint (see section 5.2.5.1 Primary efficacy","text_display":" presented). 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When relevant,","text_display":" standard deviation, median, Q1, Q3, minimum and maximum values. When relevant,","confidence":1,"confidence_rate":1},{"cnt":[[395,1688],[1926,1688],[1926,1738],[395,1738]],"region":{"top_left_x":395,"top_left_y":1688,"width":1531,"height":51},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"948c2cf0024f49f99257c1dcab94fdc0","type":"text","conversion_output":true,"text":"confidence intervals will be calculated for the mean (Student CI) or the median (Hahn \\&","text_display":" confidence intervals will be calculated for the mean (Student CI) or the median (Hahn \\&","confidence":1,"confidence_rate":1},{"cnt":[[397,1736],[651,1736],[651,1789],[397,1789]],"region":{"top_left_x":397,"top_left_y":1736,"width":255,"height":53},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5302bff1cfdc442c9d9ff32de7590936","type":"text","conversion_output":true,"text":"Meeker 1991).","text_display":" Meeker 1991).","confidence":1,"confidence_rate":1},{"cnt":[[334,1786],[1926,1786],[1926,1839],[334,1839]],"region":{"top_left_x":333,"top_left_y":1786,"width":1593,"height":53},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"68285fc34904495cb54fcf6179013971","type":"text","conversion_output":true,"text":"- For qualitative variables: number of available data, number of missing values number and","text_display":"\n- For qualitative variables: number of available data, number of missing values number and","confidence":1,"confidence_rate":1},{"cnt":[[395,1837],[1926,1837],[1926,1889],[395,1889]],"region":{"top_left_x":395,"top_left_y":1836,"width":1531,"height":54},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0fbab9eabb754cd399aaaef7b70f2b37","type":"text","conversion_output":true,"text":"percentage of observations in each category of the variable. Except if otherwise specified,","text_display":" percentage of observations in each category of the variable. Except if otherwise specified,","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[395,1882],[1926,1882],[1926,1935],[395,1935]],"region":{"top_left_x":395,"top_left_y":1882,"width":1531,"height":53},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d91fd0df7ab74a90b6e027285e23d8cd","type":"text","conversion_output":true,"text":"percentages will be calculated using the number of available data as denominator (i.e., not","text_display":" percentages will be calculated using the number of available data as denominator (i.e., not","confidence":0.9990236759185791,"confidence_rate":0.999989825041388},{"cnt":[[397,1930],[1926,1930],[1926,1981],[397,1981]],"region":{"top_left_x":397,"top_left_y":1930,"width":1529,"height":51},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"274dfe9e8c294b0e8add4b9b113f1bdc","type":"text","conversion_output":true,"text":"including missing values). When relevant, confidence intervals of proportions will be","text_display":" including missing values). 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(VP0057)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1599,251],[1939,251],[1939,295],[1599,295]],"region":{"top_left_x":1599,"top_left_y":251,"width":341,"height":44},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ff332f6462d433e89c5ba528cdbdb1e","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1592,297],[1939,297],[1939,338],[1592,338]],"region":{"top_left_x":1592,"top_left_y":296,"width":348,"height":43},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ec86f7855b245d2a708268611a43a04","type":"page_info","conversion_output":false,"text":"Version 2, 08 June 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[270,356],[1926,356],[1926,404],[270,404]],"region":{"top_left_x":269,"top_left_y":356,"width":1657,"height":49},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdb596ba73d64f8d8689a65f0a155b8f","type":"text","conversion_output":true,"text":"The numbers of patient within each dataset (ATS, PP and SAF), globally and by treatment group,","text_display":"\n\nThe numbers of patient within each dataset (ATS, PP and SAF), globally and by treatment group,","confidence":1,"confidence_rate":1},{"cnt":[[270,404],[1926,404],[1926,455],[270,455]],"region":{"top_left_x":269,"top_left_y":404,"width":1657,"height":51},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22208034c2df413aa8afdc7e7728fb67","type":"text","conversion_output":true,"text":"will be provided (Statistical table 14.1.20, Listing 16.2.3.1) along with reasons for exclusion from","text_display":" will be provided (Statistical table 14.1.20, Listing 16.2.3.1) along with reasons for exclusion from","confidence":0.9970703125,"confidence_rate":0.9999720576529205},{"cnt":[[270,452],[1926,452],[1926,503],[270,503]],"region":{"top_left_x":269,"top_left_y":452,"width":1657,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d208b41445a40db90f03baa3cf57e4b","type":"text","conversion_output":true,"text":"the ATS and PP populations (Statistical table 14.1.21 and 14.1.22 respectively). Reasons for","text_display":" the ATS and PP populations (Statistical table 14.1.21 and 14.1.22 respectively). Reasons for","confidence":0.80322265625,"confidence_rate":0.9977435462983036},{"cnt":[[270,498],[1926,498],[1926,551],[270,551]],"region":{"top_left_x":269,"top_left_y":497,"width":1657,"height":54},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2ca28c236e340c0aa83561a6d5a3311","type":"text","conversion_output":true,"text":"exclusions from the ATS and PP populations will also be provided in Listing 16.2.3.2, according to","text_display":" exclusions from the ATS and PP populations will also be provided in Listing 16.2.3.2, according to","confidence":1,"confidence_rate":1},{"cnt":[[270,548],[409,548],[409,592],[270,592]],"region":{"top_left_x":269,"top_left_y":548,"width":140,"height":44},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e77552874eb4a809813d10e53249553","type":"text","conversion_output":true,"text":"ICHE3.","text_display":" ICHE3.","confidence":1,"confidence_rate":1},{"cnt":[[270,642],[1926,642],[1926,692],[270,692]],"region":{"top_left_x":269,"top_left_y":641,"width":1657,"height":52},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"220485a7e53f49ab9e56b991b1995540","type":"text","conversion_output":true,"text":"A breakdown of the reasons for study discontinuations (Statistical Table 14.1.23 will be tabulated","text_display":"\n\nA breakdown of the reasons for study discontinuations (Statistical Table 14.1.23 will be tabulated","confidence":0.985358476638794,"confidence_rate":0.9998568086184504},{"cnt":[[270,690],[1830,690],[1830,742],[270,742]],"region":{"top_left_x":269,"top_left_y":689,"width":1561,"height":54},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9821f8f3aa6f443aa9c402f43402294b","type":"text","conversion_output":true,"text":"by treatment group. All reasons for study discontinuations will be provided in Listing 16.2.1.","text_display":" by treatment group. All reasons for study discontinuations will be provided in Listing 16.2.1.","confidence":1,"confidence_rate":1},{"cnt":[[270,786],[1926,786],[1926,838],[270,838]],"region":{"top_left_x":269,"top_left_y":785,"width":1657,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30723632177d4c01aa3cbcb3ebcb7f82","type":"text","conversion_output":true,"text":"All protocol deviations classified during the blinded review meeting according to definitions","text_display":"\n\nAll protocol deviations classified during the blinded review meeting according to definitions","confidence":1,"confidence_rate":1},{"cnt":[[270,834],[1926,834],[1926,884],[270,884]],"region":{"top_left_x":269,"top_left_y":833,"width":1657,"height":52},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2ac2cae2497f45d382f3b59b027a015d","type":"text","conversion_output":true,"text":"provided in section 3.1.1 (Major deviations) and 3.1.2 (Minor deviations) will be tabulated by","text_display":" provided in section 3.1.1 (Major deviations) and 3.1.2 (Minor deviations) will be tabulated by","confidence":1,"confidence_rate":1},{"cnt":[[270,882],[1926,882],[1926,934],[270,934]],"region":{"top_left_x":269,"top_left_y":881,"width":1657,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87e5086cb02141039cfd5b6091f6d0b9","type":"text","conversion_output":true,"text":"treatment group for the ATS (Statistical table 14.1.24 and 14.1.25 respectively). All major and","text_display":" treatment group for the ATS (Statistical table 14.1.24 and 14.1.25 respectively). All major and","confidence":1,"confidence_rate":1},{"cnt":[[270,927],[1725,927],[1725,982],[270,982]],"region":{"top_left_x":269,"top_left_y":927,"width":1456,"height":56},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5f660a55e34d4aa9a0f7e813cce7d184","type":"text","conversion_output":true,"text":"minor protocol deviations will also be provided in Listing 16.2.2, according to ICHE3.","text_display":" minor protocol deviations will also be provided in Listing 16.2.2, according to ICHE3.","confidence":0.99609375,"confidence_rate":0.9999569910422619},{"cnt":[[489,1062],[1684,1062],[1684,1124],[489,1124]],"region":{"top_left_x":488,"top_left_y":1062,"width":1196,"height":62},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"50e5d7b8209b40e484948e2869416d41","type":"section_header","conversion_output":false,"children_ids":["320494d098374ee69da44608a5619d42"],"text":"","text_display":""},{"cnt":[[493,1065],[1679,1065],[1679,1117],[493,1117]],"region":{"top_left_x":493,"top_left_y":1064,"width":1187,"height":54},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"320494d098374ee69da44608a5619d42","type":"text","conversion_output":true,"parent_id":"50e5d7b8209b40e484948e2869416d41","text":"5.2.3 Medical history - Previous and concomitant therapy","text_display":"\n\n\\subsection*{5.2.3 Medical history - Previous and concomitant therapy}","confidence":1,"confidence_rate":1},{"cnt":[[270,1138],[1926,1138],[1926,1190],[270,1190]],"region":{"top_left_x":269,"top_left_y":1137,"width":1657,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95c9b759aef54dec8af539da11e2d55c","type":"text","conversion_output":true,"text":"All medication will be coded according to the latest available version of the WHO-Drug dictionary","text_display":"\n\nAll medication will be coded according to the latest available version of the WHO-Drug dictionary","confidence":1,"confidence_rate":1},{"cnt":[[270,1183],[1926,1183],[1926,1236],[270,1236]],"region":{"top_left_x":269,"top_left_y":1183,"width":1657,"height":53},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55af6d37b81942ae9d455ecbeb98ad40","type":"text","conversion_output":true,"text":"at the start of the coding activities. For the study of medical histories/therapy for IPF we will","text_display":" at the start of the coding activities. For the study of medical histories/therapy for IPF we will","confidence":1,"confidence_rate":1},{"cnt":[[270,1234],[1926,1234],[1926,1286],[270,1286]],"region":{"top_left_x":269,"top_left_y":1233,"width":1657,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5924d08c312d4037bca2e5e19b345512","type":"text","conversion_output":true,"text":"distinguish the one ended before baseline from the ones still present at baseline. More specifically,","text_display":" distinguish the one ended before baseline from the ones still present at baseline. More specifically,","confidence":1,"confidence_rate":1},{"cnt":[[270,1282],[1738,1282],[1738,1332],[270,1332]],"region":{"top_left_x":269,"top_left_y":1281,"width":1470,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c687474b8f6a4469b852340d08b26d5d","type":"text","conversion_output":true,"text":"the following variables will be summarised for the ATS and the SAF analysis data sets:","text_display":" the following variables will be summarised for the ATS and the SAF analysis data sets:","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[331,1330],[1743,1330],[1743,1382],[331,1382]],"region":{"top_left_x":331,"top_left_y":1329,"width":1412,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0d7dccb304149e190440df218bce33f","type":"text","conversion_output":true,"text":"- Past medical history by treatment group (Statistical table 14.1.26.1 to 14.1.26.2)","text_display":"\n- Past medical history by treatment group (Statistical table 14.1.26.1 to 14.1.26.2)","confidence":1,"confidence_rate":1},{"cnt":[[334,1380],[1800,1380],[1800,1432],[334,1432]],"region":{"top_left_x":333,"top_left_y":1379,"width":1468,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"987717c5bf324e09845ca1627c1713a6","type":"text","conversion_output":true,"text":"- Current medical history by treatment group (Statistical table 14.1.27.1 to 14.1.27.2)","text_display":"\n- Current medical history by treatment group (Statistical table 14.1.27.1 to 14.1.27.2)","confidence":1,"confidence_rate":1},{"cnt":[[334,1432],[1816,1432],[1816,1487],[334,1487]],"region":{"top_left_x":333,"top_left_y":1432,"width":1484,"height":56},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"10dcffafdf2a406bb47b040e44a94fcb","type":"text","conversion_output":true,"text":"- Previous therapy for IPF by treatment group (Statistical table 14.1.28.1 to 14.1.28.2)","text_display":"\n- Previous therapy for IPF by treatment group (Statistical table 14.1.28.1 to 14.1.28.2)","confidence":1,"confidence_rate":1},{"cnt":[[334,1485],[1930,1485],[1930,1537],[334,1537]],"region":{"top_left_x":333,"top_left_y":1484,"width":1598,"height":54},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"476f54e8de1a45d88b405c806f7bf512","type":"text","conversion_output":true,"text":"- Current therapy for IPF by treatment group, with information on dose of","text_display":"\n- Current therapy for IPF by treatment group, with information on dose of","confidence":1,"confidence_rate":1},{"cnt":[[393,1531],[1455,1531],[1455,1583],[393,1583]],"region":{"top_left_x":392,"top_left_y":1530,"width":1064,"height":54},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69bc3ae2f2204144b6a575641de0d872","type":"text","conversion_output":true,"text":"pirfenidone/nintedanib (Statistical table 14.1.29.1 to 14.1.29.2)","text_display":" pirfenidone/nintedanib (Statistical table 14.1.29.1 to 14.1.29.2)","confidence":0.9951171875,"confidence_rate":0.9999300771250507},{"cnt":[[334,1581],[1780,1581],[1780,1633],[334,1633]],"region":{"top_left_x":333,"top_left_y":1580,"width":1447,"height":54},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5bf0e8b5de942f6a705f53f659a18b6","type":"text","conversion_output":true,"text":"- Previous other therapy by treatment group (Statistical table 14.1.30.1 to 14.1.30.2)","text_display":"\n- Previous other therapy by treatment group (Statistical table 14.1.30.1 to 14.1.30.2)","confidence":1,"confidence_rate":1},{"cnt":[[334,1631],[1446,1631],[1446,1686],[334,1686]],"region":{"top_left_x":333,"top_left_y":1631,"width":1114,"height":55},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2941c01155a4ed6bae7002e4042c85a","type":"text","conversion_output":true,"text":"- Current other therapy (Statistical table 14.1.31.1 to 14.1.31.2)","text_display":"\n- Current other therapy (Statistical table 14.1.31.1 to 14.1.31.2)","confidence":1,"confidence_rate":1},{"cnt":[[270,1729],[1926,1729],[1926,1782],[270,1782]],"region":{"top_left_x":269,"top_left_y":1729,"width":1657,"height":53},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"20182b3b9a97400393216e5241fb8939","type":"text","conversion_output":true,"text":"Medical history as well as previous and concomitant therapy for each patient will be respectively","text_display":"\n\nMedical history as well as previous and concomitant therapy for each patient will be respectively","confidence":1,"confidence_rate":1},{"cnt":[[270,1777],[989,1777],[989,1830],[270,1830]],"region":{"top_left_x":269,"top_left_y":1777,"width":721,"height":53},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fc9b1d3f3ad94ee19e6bf270d4fff471","type":"text","conversion_output":true,"text":"reported in Listings 16.2.4.3. and 16.2.4.4.","text_display":" reported in Listings 16.2.4.3. and 16.2.4.4.","confidence":1,"confidence_rate":1},{"cnt":[[489,1910],[1350,1910],[1350,1969],[489,1969]],"region":{"top_left_x":488,"top_left_y":1909,"width":863,"height":61},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6d3d609392004750811182d23afb23d1","type":"section_header","conversion_output":false,"children_ids":["fdc0b820ae9248698c441ada50c1c1c7"],"text":"","text_display":""},{"cnt":[[493,1914],[1345,1914],[1345,1967],[493,1967]],"region":{"top_left_x":493,"top_left_y":1914,"width":853,"height":53},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fdc0b820ae9248698c441ada50c1c1c7","type":"text","conversion_output":true,"parent_id":"6d3d609392004750811182d23afb23d1","text":"5.2.4 Extent of exposure and compliance","text_display":"\n\n\\subsection*{5.2.4 Extent of exposure and compliance}","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[270,2031],[1926,2031],[1926,2086],[270,2086]],"region":{"top_left_x":269,"top_left_y":2030,"width":1657,"height":56},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e90c3a31533469a891a47cf88f18a1a","type":"text","conversion_output":true,"text":"Compliance with study treatment will be computed for each subject of the ATS and the PP","text_display":"\n\nCompliance with study treatment will be computed for each subject of the ATS and the PP","confidence":1,"confidence_rate":1},{"cnt":[[270,2079],[1926,2079],[1926,2131],[270,2131]],"region":{"top_left_x":269,"top_left_y":2078,"width":1657,"height":54},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e0c3b3e12c5d4360a96b40f08a3c6695","type":"text","conversion_output":true,"text":"populations as the proportion of the prescribed IMP that has been actually administered (see section","text_display":" populations as the proportion of the prescribed IMP that has been actually administered (see section","confidence":1,"confidence_rate":1},{"cnt":[[270,2129],[1926,2129],[1926,2177],[270,2177]],"region":{"top_left_x":269,"top_left_y":2129,"width":1657,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccfa8888ebf740cda8471b8cbc4c06bc","type":"text","conversion_output":true,"text":"8). Treatment compliance will then be analyzed globally and by treatment group, as a numerical","text_display":" 8). Treatment compliance will then be analyzed globally and by treatment group, as a numerical","confidence":0.7431640625,"confidence_rate":0.9970061224575459},{"cnt":[[270,2175],[1866,2175],[1866,2227],[270,2227]],"region":{"top_left_x":269,"top_left_y":2174,"width":1598,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7461eea9c444a189f4eb105e358ac11","type":"text","conversion_output":true,"text":"variable as well as a categorical variable (see section 8, Statistical table 14.1.32.1 to 14.1.32.2).","text_display":" variable as well as a categorical variable (see section 8, Statistical table 14.1.32.1 to 14.1.32.2).","confidence":0.99609375,"confidence_rate":0.9999630771031657},{"cnt":[[270,2271],[1926,2271],[1926,2323],[270,2323]],"region":{"top_left_x":269,"top_left_y":2270,"width":1657,"height":54},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48127839f81c41a1a6903598bd4dde04","type":"text","conversion_output":true,"text":"To analyse the extent of exposure the following variables will be summarised by treatment group","text_display":"\n\nTo analyse the extent of exposure the following variables will be summarised by treatment group","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[270,2316],[1085,2316],[1085,2369],[270,2369]],"region":{"top_left_x":269,"top_left_y":2316,"width":817,"height":53},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d77c38730504bb4b8c1ff532c265564","type":"text","conversion_output":true,"text":"for the SAF population (Statistical table 14.3.1):","text_display":" 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The mean difference between the two groups","text_display":"\ngroups (Statistical table 14.2.5.1.1 and 14.2.5.2.2). The mean difference between the two groups","confidence":0.996584415435791,"confidence_rate":0.9999661250194176},{"cnt":[[270,402],[1476,402],[1476,455],[270,455]],"region":{"top_left_x":269,"top_left_y":402,"width":1207,"height":53},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a3ded88e4ca4fe0aaebbb8764771eab","type":"text","conversion_output":true,"text":"will also be presented with its 2 -sided 90 and \\(95 \\%\\) confidence intervals.","text_display":" will also be presented with its 2 -sided 90 and \\(95 \\%\\) confidence intervals.","confidence":0.9868583679199219,"confidence_rate":0.9998479569919672},{"cnt":[[265,532],[1007,532],[1007,596],[265,596]],"region":{"top_left_x":264,"top_left_y":532,"width":744,"height":65},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ae4deada5f214a53a2121ee2626907b9","type":"section_header","conversion_output":false,"children_ids":["32d8bd06167d43d4924add1f32bf0ca7"],"text":"","text_display":""},{"cnt":[[270,535],[1001,535],[1001,589],[270,589]],"region":{"top_left_x":269,"top_left_y":534,"width":732,"height":56},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"32d8bd06167d43d4924add1f32bf0ca7","type":"text","conversion_output":true,"parent_id":"ae4deada5f214a53a2121ee2626907b9","text":"5.2.5.2 Secondary efficacy analyses","text_display":"\n\n\\subsection*{5.2.5.2 Secondary efficacy analyses}","confidence":0.9990236759185791,"confidence_rate":0.9999755802732609},{"cnt":[[270,649],[1926,649],[1926,701],[270,701]],"region":{"top_left_x":269,"top_left_y":648,"width":1657,"height":54},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ba16051bf66749f5925f48320159e5e3","type":"text","conversion_output":true,"text":"For all secondary efficacy endpoints, the analyses will be based on observed data only i.e., no data","text_display":"\n\nFor all secondary efficacy endpoints, the analyses will be based on observed data only i.e., no data","confidence":1,"confidence_rate":1},{"cnt":[[270,697],[1926,697],[1926,752],[270,752]],"region":{"top_left_x":269,"top_left_y":696,"width":1657,"height":56},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1745715f121b454e8bfde446e37f2d78","type":"text","conversion_output":true,"text":"will be imputed. All the following analyses will be performed on both the ATS and the PP analysis","text_display":" will be imputed. All the following analyses will be performed on both the ATS and the PP analysis","confidence":1,"confidence_rate":1},{"cnt":[[270,745],[416,745],[416,793],[270,793]],"region":{"top_left_x":269,"top_left_y":744,"width":147,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a8559847e8c54f169104252cb99eba05","type":"text","conversion_output":true,"text":"data set.","text_display":" data set.","confidence":1,"confidence_rate":1},{"cnt":[[270,886],[1928,886],[1928,939],[270,939]],"region":{"top_left_x":269,"top_left_y":886,"width":1660,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d9d97c8357442ae826d34a17dc6d677","type":"text","conversion_output":true,"text":"SO1: To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week","text_display":"\n\nSO1: To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week","confidence":1,"confidence_rate":1},{"cnt":[[270,937],[1926,937],[1926,989],[270,989]],"region":{"top_left_x":269,"top_left_y":936,"width":1657,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5346a9071f3a4cd282514573ae8a097d","type":"text","conversion_output":true,"text":"28 in normal lung parenchyma (normal + mild LAA) and interstitial lung abnormalities (ILA) as","text_display":" 28 in normal lung parenchyma (normal + mild LAA) and interstitial lung abnormalities (ILA) as","confidence":0.9956088066101074,"confidence_rate":0.9999546313075678},{"cnt":[[270,982],[1935,982],[1935,1037],[270,1037]],"region":{"top_left_x":269,"top_left_y":982,"width":1666,"height":56},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9b9eb6aade2c4d53a4570a0f5a0b3f92","type":"text","conversion_output":true,"text":"quantified on high-resolution CT (HRCT) imaging analysis, pooling subjects on a stable dose of","text_display":" quantified on high-resolution CT (HRCT) imaging analysis, pooling subjects on a stable dose of","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[267,1033],[1469,1033],[1469,1085],[267,1085]],"region":{"top_left_x":267,"top_left_y":1032,"width":1202,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2e504c541c9c4a848f88e4aed7e3ac2b","type":"text","conversion_output":true,"text":"pirfenidone or nintedanib with subjects not on other treatment for IPF.","text_display":" pirfenidone or nintedanib with subjects not on other treatment for IPF.","confidence":1,"confidence_rate":1},{"cnt":[[270,1128],[1926,1128],[1926,1181],[270,1181]],"region":{"top_left_x":269,"top_left_y":1128,"width":1657,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"902a7b74462a40879ee33d2bec10597b","type":"text","conversion_output":true,"text":"HRCT is performed at baseline and W28. Descriptive statistics will be computed by treatment group","text_display":"\n\nHRCT is performed at baseline and W28. Descriptive statistics will be computed by treatment group","confidence":1,"confidence_rate":1},{"cnt":[[270,1176],[1926,1176],[1926,1227],[270,1227]],"region":{"top_left_x":269,"top_left_y":1176,"width":1657,"height":51},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"68aec9242a774cb1b485a16854e7d3f8","type":"text","conversion_output":true,"text":"for baseline, week 28 and change from baseline to Week 28 in total lung volume and volume (in ml","text_display":" for baseline, week 28 and change from baseline to Week 28 in total lung volume and volume (in ml","confidence":0.9091796875,"confidence_rate":0.9991268719641557},{"cnt":[[270,1224],[1926,1224],[1926,1275],[270,1275]],"region":{"top_left_x":269,"top_left_y":1224,"width":1657,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2494884939d4d2f8064d3a7d5575073","type":"text","conversion_output":true,"text":"and \\% of total lung volume) of parenchyma features representative of normal lung (normal + mild","text_display":" and \\% of total lung volume) of parenchyma features representative of normal lung (normal + mild","confidence":1,"confidence_rate":1},{"cnt":[[270,1272],[1926,1272],[1926,1325],[270,1325]],"region":{"top_left_x":269,"top_left_y":1272,"width":1657,"height":53},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebd5140b53364b7688d941ca7c0b3df2","type":"text","conversion_output":true,"text":"LAA) and representative of interstitial lung abnormalities (ILA) as quantified by HRCT imaging (","text_display":" LAA) and representative of interstitial lung abnormalities (ILA) as quantified by HRCT imaging (","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[270,1320],[1926,1320],[1926,1373],[270,1373]],"region":{"top_left_x":269,"top_left_y":1320,"width":1657,"height":53},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7af7356bdd724eee872d8d308988c010","type":"text","conversion_output":true,"text":"see section 8, Statistical table 14.2.6.1.1 and 14.2.6.2.2). A model similar to that of the primary","text_display":" see section 8, Statistical table 14.2.6.1.1 and 14.2.6.2.2). A model similar to that of the primary","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[270,1366],[1921,1366],[1921,1419],[270,1419]],"region":{"top_left_x":269,"top_left_y":1366,"width":1653,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"340c67f8bfd2482585eafc5f05d85c89","type":"text","conversion_output":true,"text":"analysis (see section 5.2.5.1) will be used to compare the two groups (Statistical tables 14.2.6.3.1","text_display":" analysis (see section 5.2.5.1) will be used to compare the two groups (Statistical tables 14.2.6.3.1","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[270,1416],[1926,1416],[1926,1467],[270,1467]],"region":{"top_left_x":269,"top_left_y":1416,"width":1657,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44dfe9d952314ebea50adbdf13e39c2c","type":"text","conversion_output":true,"text":"to 14.2.6.3.2, Figure 14.2.4.1 to 14.2.4.2). Individual's measurement of total lung volume and","text_display":" to 14.2.6.3.2, Figure 14.2.4.1 to 14.2.4.2). Individual's measurement of total lung volume and","confidence":0.97119140625,"confidence_rate":0.9997047738170667},{"cnt":[[270,1462],[1921,1462],[1921,1519],[270,1519]],"region":{"top_left_x":269,"top_left_y":1462,"width":1653,"height":58},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72be905c62f5492282c0ebbeadc101e7","type":"text","conversion_output":true,"text":"volume of parenchymal features quantified by HRCT imaging will be reported in Listing 16.2.6.3.","text_display":" volume of parenchymal features quantified by HRCT imaging will be reported in Listing 16.2.6.3.","confidence":1,"confidence_rate":1},{"cnt":[[270,1604],[1928,1604],[1928,1658],[270,1658]],"region":{"top_left_x":269,"top_left_y":1603,"width":1660,"height":56},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"141d1b782ee74a2f80beae62081fe9f6","type":"text","conversion_output":true,"text":"SO2: To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week","text_display":"\n\nSO2: To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week","confidence":1,"confidence_rate":1},{"cnt":[[270,1654],[1926,1654],[1926,1709],[270,1709]],"region":{"top_left_x":269,"top_left_y":1653,"width":1657,"height":56},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c65695eb138a491eb49a7ed25bd13010","type":"text","conversion_output":true,"text":"28 in mean FVC\\% predicted, separately in subjects on a stable dose of pirfenidone or nintedanib","text_display":" 28 in mean FVC\\% predicted, separately in subjects on a stable dose of pirfenidone or nintedanib","confidence":0.9990236759185791,"confidence_rate":0.999990133371946},{"cnt":[[270,1704],[1081,1704],[1081,1757],[270,1757]],"region":{"top_left_x":269,"top_left_y":1704,"width":812,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4e2aa427aa34281b44700ddeeef1436","type":"text","conversion_output":true,"text":"and in subjects not on other treatments for IPF.","text_display":" and in subjects not on other treatments for IPF.","confidence":1,"confidence_rate":1},{"cnt":[[270,1800],[1926,1800],[1926,1853],[270,1853]],"region":{"top_left_x":269,"top_left_y":1800,"width":1657,"height":53},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e7a3a96e6b54f49beb188da6d98f20d","type":"text","conversion_output":true,"text":"The same model as the one for the primary analysis (see section 5.2.5.1) will be used for each","text_display":"\n\nThe same model as the one for the primary analysis (see section 5.2.5.1) will be used for each","confidence":1,"confidence_rate":1},{"cnt":[[270,1848],[1926,1848],[1926,1898],[270,1898]],"region":{"top_left_x":269,"top_left_y":1848,"width":1657,"height":51},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d965ee609d2b4768a2eeecc5fccf9d13","type":"text","conversion_output":true,"text":"subgroup (Statistical table 14.2.7.1.1 to 14.2.7.2.2, Figure 14.2.5.1.1 to 14.2.5.2.2). All","text_display":" subgroup (Statistical table 14.2.7.1.1 to 14.2.7.2.2, Figure 14.2.5.1.1 to 14.2.5.2.2). All","confidence":1,"confidence_rate":1},{"cnt":[[270,1896],[1492,1896],[1492,1949],[270,1949]],"region":{"top_left_x":269,"top_left_y":1896,"width":1223,"height":53},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccf10f9a1374408e92bc9728bf669a44","type":"text","conversion_output":true,"text":"measurements of FVC [\\% predicted] will be reported in Listing 16.2.6.1.1.","text_display":" measurements of FVC [\\% predicted] will be reported in Listing 16.2.6.1.1.","confidence":1,"confidence_rate":1},{"cnt":[[270,1987],[1926,1987],[1926,2042],[270,2042]],"region":{"top_left_x":269,"top_left_y":1987,"width":1657,"height":56},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bee9ce625334450eb41365094664f6a4","type":"text","conversion_output":true,"text":"SO3: To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week","text_display":"\n\nSO3: To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week","confidence":1,"confidence_rate":1},{"cnt":[[270,2040],[1926,2040],[1926,2090],[270,2090]],"region":{"top_left_x":269,"top_left_y":2039,"width":1657,"height":52},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e74d46f2c344169a57fe2acebdd7957","type":"text","conversion_output":true,"text":"28 in normal lung (defined as normal + mild LAA) parenchyma and interstitial lung abnormalities","text_display":" 28 in normal lung (defined as normal + mild LAA) parenchyma and interstitial lung abnormalities","confidence":0.9746558498591185,"confidence_rate":0.9997407321531134},{"cnt":[[270,2088],[1935,2088],[1935,2140],[270,2140]],"region":{"top_left_x":269,"top_left_y":2087,"width":1666,"height":54},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b2acd6b24eab43b1851a66f6f3fbf3b0","type":"text","conversion_output":true,"text":"(ILA) as quantified on HRCT imaging analysis, separately in subjects on a stable dose of","text_display":" (ILA) as quantified on HRCT imaging analysis, separately in subjects on a stable dose of","confidence":1,"confidence_rate":1},{"cnt":[[267,2134],[1515,2134],[1515,2186],[267,2186]],"region":{"top_left_x":267,"top_left_y":2133,"width":1248,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01d5bb85e378453daaa1629948b12347","type":"text","conversion_output":true,"text":"pirfenidone or nintedanib and in subjects not on other treatments for IPF.","text_display":" pirfenidone or nintedanib and in subjects not on other treatments for IPF.","confidence":0.9970703125,"confidence_rate":0.9999628616081941},{"cnt":[[270,2230],[1926,2230],[1926,2282],[270,2282]],"region":{"top_left_x":269,"top_left_y":2229,"width":1657,"height":54},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f392ade8670343449e476e32b6059b7a","type":"text","conversion_output":true,"text":"Descriptive statistics will be computed by treatment group and stratification level for week 0 , week","text_display":"\n\nDescriptive statistics will be computed by treatment group and stratification level for week 0 , week","confidence":1,"confidence_rate":1},{"cnt":[[270,2280],[1926,2280],[1926,2330],[270,2330]],"region":{"top_left_x":269,"top_left_y":2279,"width":1657,"height":52},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"861a22d883f54c89a0db219076375056","type":"text","conversion_output":true,"text":"28 and change from baseline to Week 28 in total lung volume and volume (in ml and \\% of total","text_display":" 28 and change from baseline to Week 28 in total lung volume and volume (in ml and \\% of total","confidence":0.9970703125,"confidence_rate":0.9999720576529205},{"cnt":[[270,2325],[1926,2325],[1926,2378],[270,2378]],"region":{"top_left_x":269,"top_left_y":2325,"width":1657,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d065d18e674143fb8fb95b7760a1d76b","type":"text","conversion_output":true,"text":"lung volume) of parenchyma features representative of normal (normal + mild LAA) lung and","text_display":" lung volume) of parenchyma features representative of normal (normal + mild LAA) lung and","confidence":1,"confidence_rate":1},{"cnt":[[270,2376],[1926,2376],[1926,2426],[270,2426]],"region":{"top_left_x":269,"top_left_y":2375,"width":1657,"height":52},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9daf0b12fb434ba3a40aa5797895a96c","type":"text","conversion_output":true,"text":"representative of interstitial lung abnormalities (ILA) as quantified by HRCT imaging (see section","text_display":" representative of interstitial lung abnormalities (ILA) as quantified by HRCT imaging (see section","confidence":1,"confidence_rate":1},{"cnt":[[270,2424],[1926,2424],[1926,2474],[270,2474]],"region":{"top_left_x":269,"top_left_y":2423,"width":1657,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12f9b517066741638e0093e9dd896f22","type":"text","conversion_output":true,"text":"8). 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and the PP data sets the efficacy and estimate,","text_display":" slopes will be used to evaluate on both the ATS and the PP data sets the efficacy and estimate,","confidence":1,"confidence_rate":1},{"cnt":[[270,1658],[1923,1658],[1923,1711],[270,1711]],"region":{"top_left_x":269,"top_left_y":1658,"width":1655,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de056033963f4dbcb24c0f1be2f01a26","type":"text","conversion_output":true,"text":"pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment","text_display":" pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other 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The individual slopes","text_display":" (Statistical tables 14.2.17.1 to 14.18.2.2, Figures 14.2.14.1 to 14.2.15.2.2). The individual slopes","confidence":1,"confidence_rate":1},{"cnt":[[270,1949],[1926,1949],[1926,1999],[270,1999]],"region":{"top_left_x":269,"top_left_y":1948,"width":1657,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b164dd09ed224d4186c6ffc5c93f0a87","type":"text","conversion_output":true,"text":"and intercepts will be listed (Listings 16.2.6.10 to 16.2.6.12). Statistical inference ( \\(90 \\% CI\\) and p-","text_display":" and intercepts will be listed (Listings 16.2.6.10 to 16.2.6.12). Statistical inference ( \\(90 \\% CI\\) and p","confidence":0.9834413128101005,"confidence_rate":0.9998509279453107},{"cnt":[[270,1997],[1684,1997],[1684,2049],[270,2049]],"region":{"top_left_x":269,"top_left_y":1996,"width":1415,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c91b930eb9474bba882f6a26530a8558","type":"text","conversion_output":true,"text":"values) on the slope difference between treated and placebo groups will be reported.","text_display":"values) on the slope difference between treated and placebo groups will be reported.","confidence":1,"confidence_rate":1},{"cnt":[[270,2138],[1871,2138],[1871,2191],[270,2191]],"region":{"top_left_x":269,"top_left_y":2138,"width":1602,"height":53},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1566e9ec86154221b028919862c0b8d2","type":"text","conversion_output":true,"text":"EO2: To assess the impact of PRM-151 on disease related symptoms and 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Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1590,297],[1939,297],[1939,340],[1590,340]],"region":{"top_left_x":1589,"top_left_y":296,"width":351,"height":45},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5067e0709924a15b243d0faae886e65","type":"page_info","conversion_output":false,"text":"Version 2, 08 June 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[270,354],[1926,354],[1926,404],[270,404]],"region":{"top_left_x":269,"top_left_y":354,"width":1657,"height":51},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c388495688804cbc9ac33faa34b9b124","type":"text","conversion_output":true,"text":"for the primary analysis (statistical tables 14.2.19.1.1.1 to 14.2.19.2.3.2, Figure 14.2.16.1.1 to","text_display":"\nfor the primary analysis (statistical tables 14.2.19.1.1.1 to 14.2.19.2.3.2, Figure 14.2.16.1.1 to","confidence":1,"confidence_rate":1},{"cnt":[[274,402],[491,402],[491,455],[274,455]],"region":{"top_left_x":274,"top_left_y":402,"width":218,"height":53},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83d241c38d234c7e80b54021a6d8443a","type":"text","conversion_output":true,"text":"14.2.16.2.2).","text_display":" 14.2.16.2.2).","confidence":0.99951171875,"confidence_rate":0.9999728670071003},{"cnt":[[270,498],[1923,498],[1923,551],[270,551]],"region":{"top_left_x":269,"top_left_y":497,"width":1655,"height":54},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"80fbd5881c7a421fbe154b125df261d8","type":"text","conversion_output":true,"text":"For all categories of lung features (including PVV), the change from baseline to week 28 in volume","text_display":"\n\nFor all categories of lung features (including PVV), the change from baseline to week 28 in volume","confidence":1,"confidence_rate":1},{"cnt":[[270,548],[1923,548],[1923,599],[270,599]],"region":{"top_left_x":269,"top_left_y":548,"width":1655,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abb481eb34184df8a090a40812992c69","type":"text","conversion_output":true,"text":"of a given lung feature (both in ml as well as in \\% of total lung volume) wil be computed in subjects","text_display":" of a given lung feature (both in ml as well as in \\% of total lung volume) wil be computed in subjects","confidence":0.9795448570512235,"confidence_rate":0.9998154880353226},{"cnt":[[270,594],[1926,594],[1926,646],[270,646]],"region":{"top_left_x":269,"top_left_y":593,"width":1657,"height":54},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0c7b5f0ce21447ba60824a9876ca2da","type":"text","conversion_output":true,"text":"treated with PRM-151 and placebo, depending on the completeness and usability of the obtained","text_display":" treated with PRM-151 and placebo, depending on the completeness and usability of the obtained","confidence":1,"confidence_rate":1},{"cnt":[[270,644],[359,644],[359,688],[270,688]],"region":{"top_left_x":269,"top_left_y":644,"width":90,"height":44},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b31e900949ca40d5b4bd076140008880","type":"text","conversion_output":true,"text":"data.","text_display":" data.","confidence":1,"confidence_rate":1},{"cnt":[[270,786],[1926,786],[1926,838],[270,838]],"region":{"top_left_x":269,"top_left_y":785,"width":1657,"height":54},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4a65fd7b6c4d4926a422ac2251dd49ec","type":"text","conversion_output":true,"text":"Change in Patient Reported Outcomes will be assessed based on the King's Brief Interstitial Lung","text_display":"\n\nChange in Patient Reported Outcomes will be assessed based on the King's Brief Interstitial Lung","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[270,836],[1926,836],[1926,884],[270,884]],"region":{"top_left_x":269,"top_left_y":836,"width":1657,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"873d2d28a88b4390bb521637ac5da991","type":"text","conversion_output":true,"text":"Disease Questionnaire (K-BILD) and Leicester Cough Questionnaire (LCQ). Descriptive statistics","text_display":" Disease Questionnaire (K-BILD) and Leicester Cough Questionnaire (LCQ). Descriptive statistics","confidence":1,"confidence_rate":1},{"cnt":[[270,882],[1926,882],[1926,934],[270,934]],"region":{"top_left_x":269,"top_left_y":881,"width":1657,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6d1477020af4962b4c3d970b7f1062e","type":"text","conversion_output":true,"text":"for raw values and change from Baseline to each visit in total score of both questionnaire will be","text_display":" for raw values and change from Baseline to each visit in total score of both questionnaire will be","confidence":1,"confidence_rate":1},{"cnt":[[270,927],[1926,927],[1926,982],[270,982]],"region":{"top_left_x":269,"top_left_y":927,"width":1657,"height":56},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f921aa31709b4900888e0d7790f30c3f","type":"text","conversion_output":true,"text":"computed by treatment group. Differences between treatment groups in change from baseline to","text_display":" computed by treatment group. Differences between treatment groups in change from baseline to","confidence":1,"confidence_rate":1},{"cnt":[[270,978],[1926,978],[1926,1030],[270,1030]],"region":{"top_left_x":269,"top_left_y":977,"width":1657,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"25238d0a29dd49f5b5bbadf130ebb079","type":"text","conversion_output":true,"text":"week 28 for total score of each questionnaire will be tested using a similar approach to the one used","text_display":" week 28 for total score of each questionnaire will be tested using a similar approach to the one used","confidence":1,"confidence_rate":1},{"cnt":[[270,1028],[1923,1028],[1923,1081],[270,1081]],"region":{"top_left_x":269,"top_left_y":1027,"width":1655,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3a22af7ee7f14a0e9ea84c57d1f29329","type":"text","conversion_output":true,"text":"for the primary ananlysis (see section 5.2.5.1). These analysis will be performed on both the ATS","text_display":" for the primary ananlysis (see section 5.2.5.1). These analysis will be performed on both the ATS","confidence":1,"confidence_rate":1},{"cnt":[[270,1074],[1926,1074],[1926,1126],[270,1126]],"region":{"top_left_x":269,"top_left_y":1073,"width":1657,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0d4b608357e4aaa895b1c8530b7567a","type":"text","conversion_output":true,"text":"and the PP data sets (Statistical tables 14.2.20.1.1 to 14.2.20.3.2 and 14.2.21.1.1 to 14.2.21.3.2,","text_display":" and the PP data sets (Statistical tables 14.2.20.1.1 to 14.2.20.3.2 and 14.2.21.1.1 to 14.2.21.3.2,","confidence":1,"confidence_rate":1},{"cnt":[[270,1119],[1926,1119],[1926,1172],[270,1172]],"region":{"top_left_x":269,"top_left_y":1119,"width":1657,"height":53},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6292a5a1996c4539b0e5d1d0751d8e31","type":"text","conversion_output":true,"text":"Figures 14.2.17.1 to 14.2.17.2 and 14.2.18.1 to 14.2.18.2). All results of K-BILD and LCQ will be","text_display":" Figures 14.2.17.1 to 14.2.17.2 and 14.2.18.1 to 14.2.18.2). All results of K-BILD and LCQ will be","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[270,1170],[1542,1170],[1542,1222],[270,1222]],"region":{"top_left_x":269,"top_left_y":1169,"width":1273,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0e35518b3c64811a56cf0e6ad20454b","type":"text","conversion_output":true,"text":"reported in Listings 16.2.6.4.1 to 14.2.6.4.2.2 and 16.2.6.5.1 to 16.2.6.5.2.2.","text_display":" reported in Listings 16.2.6.4.1 to 14.2.6.4.2.2 and 16.2.6.5.1 to 16.2.6.5.2.2.","confidence":0.964505672454834,"confidence_rate":0.999569859615307},{"cnt":[[270,1266],[1921,1266],[1921,1318],[270,1318]],"region":{"top_left_x":269,"top_left_y":1265,"width":1653,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6b3fcbaec85440d9fdec15c2e9e9753","type":"text","conversion_output":true,"text":"For the LCQ, in addition to the above approach, frequency of patients with changes below or above","text_display":"\n\nFor the LCQ, in addition to the above approach, frequency of patients with changes below or above","confidence":0.7373046875,"confidence_rate":0.9970166741210856},{"cnt":[[270,1311],[1926,1311],[1926,1364],[270,1364]],"region":{"top_left_x":269,"top_left_y":1311,"width":1657,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"787fd711731e465b8b56255ca9b4c4b0","type":"text","conversion_output":true,"text":"1.3 (identified as the minimal important difference) will be tabulated by treatment groups at week","text_display":" 1.3 (identified as the minimal important difference) will be tabulated by treatment groups at week","confidence":1,"confidence_rate":1},{"cnt":[[270,1361],[1485,1361],[1485,1412],[270,1412]],"region":{"top_left_x":269,"top_left_y":1361,"width":1216,"height":51},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f42ded1e346746b7bb4d7c5409a59ae8","type":"text","conversion_output":true,"text":"4, 8, 12, 16, 20, 24 and 28 (Statistical table 14.2.21.4.1 and 14.2.21.4.2).","text_display":" 4, 8, 12, 16, 20, 24 and 28 (Statistical table 14.2.21.4.1 and 14.2.21.4.2).","confidence":0.9970715045928955,"confidence_rate":0.999966290317151},{"cnt":[[270,1457],[1926,1457],[1926,1510],[270,1510]],"region":{"top_left_x":269,"top_left_y":1457,"width":1657,"height":53},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2b32e411c594e518a9e6d7c3ff78923","type":"text","conversion_output":true,"text":"Descriptive statistics for raw values at each visit and change from baseline to each visit in anti-","text_display":"\n\nDescriptive statistics for raw values at each visit and change from baseline to each visit in anti-","confidence":1,"confidence_rate":1},{"cnt":[[270,1508],[1923,1508],[1923,1556],[270,1556]],"region":{"top_left_x":269,"top_left_y":1507,"width":1655,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fd31b69193394eebb036decee037f277","type":"text","conversion_output":true,"text":"Pentraxin-2 antibodies measurements will be computed by treatment group. This analysis will be","text_display":"Pentraxin-2 antibodies measurements will be computed by treatment group. This analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[270,1553],[1926,1553],[1926,1604],[270,1604]],"region":{"top_left_x":269,"top_left_y":1553,"width":1657,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2e1aeaae3e148c8985449e13a7ab9cf","type":"text","conversion_output":true,"text":"performed on both the ATS and the PP dataset (Statistical 14.2.22.1.1 to 14.2.22.2.2). Individual","text_display":" performed on both the ATS and the PP dataset (Statistical 14.2.22.1.1 to 14.2.22.2.2). Individual","confidence":1,"confidence_rate":1},{"cnt":[[270,1599],[1624,1599],[1624,1652],[270,1652]],"region":{"top_left_x":269,"top_left_y":1599,"width":1356,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eea0d3891a65420dbf3e42a9b27a30c0","type":"text","conversion_output":true,"text":"measurements of anti-pentraxin-2 antibodies will be reported in Listing 16.2.6.8.","text_display":" measurements of anti-pentraxin-2 antibodies will be reported in Listing 16.2.6.8.","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[263,1786],[1195,1786],[1195,1850],[263,1850]],"region":{"top_left_x":262,"top_left_y":1786,"width":933,"height":65},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a85cfe3f118947faaadc4ce76a4ed8b2","type":"section_header","conversion_output":false,"children_ids":["9498ba47cd6543658cf5ad006cf78783"],"text":"","text_display":""},{"cnt":[[270,1793],[1190,1793],[1190,1843],[270,1843]],"region":{"top_left_x":269,"top_left_y":1793,"width":922,"height":51},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9498ba47cd6543658cf5ad006cf78783","type":"text","conversion_output":true,"parent_id":"a85cfe3f118947faaadc4ce76a4ed8b2","text":"EO3: To assess the use of quantitative imaging in IPF","text_display":"\n\n\\section*{EO3: To assess the use of quantitative imaging in IPF}","confidence":0.9980475902557373,"confidence_rate":0.99996630542663},{"cnt":[[270,1887],[1923,1887],[1923,1939],[270,1939]],"region":{"top_left_x":269,"top_left_y":1886,"width":1655,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a4a5b8fd9d57469c9a3efb78d4de5906","type":"text","conversion_output":true,"text":"The correlation between baseline FVC [\\% predicted], DLCO (corrected for Hb , [\\% predicted]),","text_display":"\n\nThe correlation between baseline FVC [\\% predicted], DLCO (corrected for Hb , [\\% predicted]),","confidence":0.9668283462524414,"confidence_rate":0.999672536046307},{"cnt":[[270,1937],[1926,1937],[1926,1987],[270,1987]],"region":{"top_left_x":269,"top_left_y":1937,"width":1657,"height":51},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc61b1654ade4c9bbf90feae339ea925","type":"text","conversion_output":true,"text":"TLC by nitrogen washout, PROs and 6MWD and total lung volume and volume of parenchymal","text_display":" TLC by nitrogen washout, PROs and 6MWD and total lung volume and volume of parenchymal","confidence":1,"confidence_rate":1},{"cnt":[[270,1985],[1923,1985],[1923,2035],[270,2035]],"region":{"top_left_x":269,"top_left_y":1985,"width":1655,"height":51},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"40d7943fc7e14cef8c7ccc62fe1c7dd0","type":"text","conversion_output":true,"text":"features on HRCT (in ml and \\% of total lung volume) representative of ILA by quantitative imaging,","text_display":" features on HRCT (in ml and \\% of total lung volume) representative of ILA by quantitative imaging,","confidence":0.9892780780792236,"confidence_rate":0.9999011074964174},{"cnt":[[270,2033],[1926,2033],[1926,2086],[270,2086]],"region":{"top_left_x":269,"top_left_y":2033,"width":1657,"height":53},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18b9d0b4b95842a6bf0d71f720c03424","type":"text","conversion_output":true,"text":"as well as change from Baseline to Week 28 in FVC [\\% predicted], DLCO (corrected for Hb, [\\%","text_display":" as well as change from Baseline to Week 28 in FVC [\\% predicted], DLCO (corrected for Hb, [\\%","confidence":0.90283203125,"confidence_rate":0.9989680201833341},{"cnt":[[270,2079],[1926,2079],[1926,2131],[270,2131]],"region":{"top_left_x":269,"top_left_y":2078,"width":1657,"height":54},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bd5f32c2fd99446d9533ae4883a3514a","type":"text","conversion_output":true,"text":"predicted]), TLC by nitrogen washout, PROs and 6MWD and change from Baseline to Week 28 in","text_display":" predicted]), TLC by nitrogen washout, PROs and 6MWD and change from Baseline to Week 28 in","confidence":1,"confidence_rate":1},{"cnt":[[270,2129],[1921,2129],[1921,2179],[270,2179]],"region":{"top_left_x":269,"top_left_y":2129,"width":1653,"height":51},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7ec864d31e60497da9694e01dee02a82","type":"text","conversion_output":true,"text":"total lung volume and volume of parenchymal features on HRCT (in ml and \\% of total lung volume)","text_display":" total lung volume and volume of parenchymal features on HRCT (in ml and \\% of total lung 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This analysis will be performed on both the ATS and the","text_display":" representative of ILA will be computed. 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between baseline characteristics (e.g., FVC/DLCO/6MWD) and change in FVC.","confidence":0.97705078125,"confidence_rate":0.9997023949140066},{"cnt":[[265,2220],[1035,2220],[1035,2280],[265,2280]],"region":{"top_left_x":264,"top_left_y":2220,"width":771,"height":60},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00e8ac4149b74125ae0ecda2a82e1beb","type":"section_header","conversion_output":false,"children_ids":["0d558f7982074edc938afb61a20097db"],"text":"","text_display":""},{"cnt":[[270,2225],[1030,2225],[1030,2278],[270,2278]],"region":{"top_left_x":269,"top_left_y":2224,"width":762,"height":54},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d558f7982074edc938afb61a20097db","type":"text","conversion_output":true,"parent_id":"00e8ac4149b74125ae0ecda2a82e1beb","text":"Exploratory analysis of PK/PD relationship","text_display":"\n\n\\section*{Exploratory analysis of PK/PD relationship}","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[270,2367],[1885,2367],[1885,2419],[270,2419]],"region":{"top_left_x":269,"top_left_y":2366,"width":1616,"height":54},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0eb44aa470b94dbfaa50f15b94770a24","type":"text","conversion_output":true,"text":"Descriptive statistics and correlation will be computed to explore the relationship of Pentraxin- 2","text_display":"\n\nDescriptive statistics and correlation will be computed to explore the relationship of Pentraxin- 2","confidence":0.60009765625,"confidence_rate":0.9950543780545564},{"cnt":[[270,2417],[1898,2417],[1898,2469],[270,2469]],"region":{"top_left_x":269,"top_left_y":2416,"width":1630,"height":54},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ae6188a252944ecabd3455e413440f2","type":"text","conversion_output":true,"text":"levels vs FVC [\\% predicted]/FVC [ml]/slope of FVC ml at week 24 and 28, and the relationship of","text_display":" levels vs FVC [\\% predicted]/FVC [ml]/slope of FVC ml at week 24 and 28, and the relationship of","confidence":0.8800737547744575,"confidence_rate":0.9987604818207854},{"cnt":[[288,2705],[1282,2705],[1282,2748],[288,2748]],"region":{"top_left_x":287,"top_left_y":2704,"width":995,"height":45},"line":42,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"c7f2ad36e805440c9491525f90dddff2","type":"page_info","conversion_output":false,"text":"PROMEDIOR-PRM-151-202-IPF-PHASE 2- SAP-v2_08JUN2017.docx","text_display":"","confidence":0.9824302196502686,"confidence_rate":0.999709452692166},{"cnt":[[1768,2705],[1939,2705],[1939,2748],[1768,2748]],"region":{"top_left_x":1768,"top_left_y":2704,"width":172,"height":45},"line":43,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"fe2df306972f4294ae089b48c9778747","type":"page_info","conversion_output":false,"text":"Page 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(VP0057)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1599,251],[1939,251],[1939,295],[1599,295]],"region":{"top_left_x":1599,"top_left_y":251,"width":341,"height":44},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aeab58dd502046eeb73d0f82f5198a51","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1592,297],[1939,297],[1939,340],[1592,340]],"region":{"top_left_x":1592,"top_left_y":296,"width":348,"height":45},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c459090925b7499b95d66487605ac451","type":"page_info","conversion_output":false,"text":"Version 2, 08 June 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[270,354],[1914,354],[1914,404],[270,404]],"region":{"top_left_x":269,"top_left_y":354,"width":1646,"height":51},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"24ea33cc6b3e46e6861f7ca11cec6ced","type":"text","conversion_output":true,"text":"Pentraxin-2 vs other PFTs/PROs/6MWT (Statistical table 14.2.26.1 and 14.2.26.2). If relevant the","text_display":"\n\nPentraxin-2 vs other PFTs/PROs/6MWT (Statistical table 14.2.26.1 and 14.2.26.2). If relevant the","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[270,404],[1012,404],[1012,455],[270,455]],"region":{"top_left_x":269,"top_left_y":404,"width":743,"height":51},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19f72faa3b714f3885bfb631a4b78e35","type":"text","conversion_output":true,"text":"corresponding scatter plot will be produced.","text_display":" corresponding scatter plot will be produced.","confidence":1,"confidence_rate":1},{"cnt":[[265,496],[1547,496],[1547,553],[265,553]],"region":{"top_left_x":264,"top_left_y":495,"width":1283,"height":58},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b3fe869145442c791dca8f795af8344","type":"section_header","conversion_output":false,"children_ids":["64093413de3c48aea18052683483ce55"],"text":"","text_display":""},{"cnt":[[270,498],[1542,498],[1542,546],[270,546]],"region":{"top_left_x":269,"top_left_y":497,"width":1273,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"64093413de3c48aea18052683483ce55","type":"text","conversion_output":true,"parent_id":"0b3fe869145442c791dca8f795af8344","text":"Exploratory analysis of relationship between Pentraxin-2 levels and ADA","text_display":"\n\n\\section*{Exploratory analysis of relationship between Pentraxin-2 levels and ADA}","confidence":0.9518909454345703,"confidence_rate":0.9993514629717994},{"cnt":[[270,544],[1862,544],[1862,596],[270,596]],"region":{"top_left_x":269,"top_left_y":543,"width":1593,"height":54},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dee3183caf324394a67ad36be712a029","type":"text","conversion_output":true,"text":"Correlation coefficient between Pentraxin-2 levels and ADA titer at week 28 will be computed","text_display":"\n\nCorrelation coefficient between Pentraxin-2 levels and ADA titer at week 28 will be computed","confidence":0.98681640625,"confidence_rate":0.9998672961183814},{"cnt":[[270,594],[1741,594],[1741,646],[270,646]],"region":{"top_left_x":269,"top_left_y":593,"width":1472,"height":54},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"585aa75d2475435bb443d49d3490d866","type":"text","conversion_output":true,"text":"(Statistical tables 14.2.27.1 and 14.2.27.2) and a scatterplot prepared (using logarithmic","text_display":" (Statistical tables 14.2.27.1 and 14.2.27.2) and a scatterplot prepared (using logarithmic","confidence":1,"confidence_rate":1},{"cnt":[[270,644],[646,644],[646,692],[270,692]],"region":{"top_left_x":269,"top_left_y":644,"width":378,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee004b62ed1a40b3acb8910d3a982e9d","type":"text","conversion_output":true,"text":"coordinates for titers).","text_display":" coordinates for titers).","confidence":1,"confidence_rate":1},{"cnt":[[265,736],[1039,736],[1039,793],[265,793]],"region":{"top_left_x":264,"top_left_y":735,"width":776,"height":58},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ec646014fd948818b30c8646b26353d","type":"section_header","conversion_output":false,"children_ids":["e7333c9494634c4c95b6c07288b4e5a3"],"text":"","text_display":""},{"cnt":[[270,740],[1035,740],[1035,788],[270,788]],"region":{"top_left_x":269,"top_left_y":740,"width":766,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e7333c9494634c4c95b6c07288b4e5a3","type":"text","conversion_output":true,"parent_id":"6ec646014fd948818b30c8646b26353d","text":"Exploratory analysis of acute exacerbations","text_display":"\n\n\\section*{Exploratory analysis of acute exacerbations}","confidence":1,"confidence_rate":1},{"cnt":[[270,786],[1898,786],[1898,836],[270,836]],"region":{"top_left_x":269,"top_left_y":785,"width":1630,"height":52},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1897ee2d05f84cd3856e1951dc0e8fee","type":"text","conversion_output":true,"text":"Tabulation of each type of acute exacerbations will be produced (Statistical table 14.2.28.1.1 and","text_display":"\n\nTabulation of each type of acute exacerbations will be produced (Statistical table 14.2.28.1.1 and","confidence":0.9482421875,"confidence_rate":0.9994841589431468},{"cnt":[[274,834],[1873,834],[1873,884],[274,884]],"region":{"top_left_x":274,"top_left_y":833,"width":1600,"height":52},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff1d7163fc08412587065239f161eb7a","type":"text","conversion_output":true,"text":"14.2.28.1.2). Descriptive statistic and Kaplan-meier curve will be computed by treatment group","text_display":" 14.2.28.1.2). Descriptive statistic and Kaplan-meier curve will be computed by treatment group","confidence":1,"confidence_rate":1},{"cnt":[[270,882],[1793,882],[1793,934],[270,934]],"region":{"top_left_x":269,"top_left_y":881,"width":1525,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e4e02f116eb40588b85efe36e2d59f4","type":"text","conversion_output":true,"text":"for time to first reported acute exacerbation (Statistical tables 14.2.28.2.1 and 14.2.28.2.2).","text_display":" for time to first reported acute exacerbation (Statistical tables 14.2.28.2.1 and 14.2.28.2.2).","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[270,978],[1898,978],[1898,1030],[270,1030]],"region":{"top_left_x":269,"top_left_y":977,"width":1630,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2c21d514bc204e19b77201a032e0d2cd","type":"text","conversion_output":true,"text":"Additional exploratory analysis: FVC [\\% predicted] separately on pirfenidone and nintedanib","text_display":"\n\nAdditional exploratory analysis: FVC [\\% predicted] separately on pirfenidone and nintedanib","confidence":0.9912221396807581,"confidence_rate":0.9999081645017522},{"cnt":[[270,1028],[1878,1028],[1878,1081],[270,1081]],"region":{"top_left_x":269,"top_left_y":1027,"width":1609,"height":54},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c26e8c7d9504a8aaf9b75d1d4931621","type":"text","conversion_output":true,"text":"The same model as the one for the primary analysis (see section 5.2.5.1) will be used separately","text_display":" The same model as the one for the primary analysis (see section 5.2.5.1) will be used separately","confidence":1,"confidence_rate":1},{"cnt":[[270,1074],[1748,1074],[1748,1126],[270,1126]],"region":{"top_left_x":269,"top_left_y":1073,"width":1479,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8121714505714bdd865416dfcd8b88e6","type":"text","conversion_output":true,"text":"on (i) patient on a stable dose pirfenidone and (ii) patient on a stable dose of nintedanib","text_display":" on (i) patient on a stable dose pirfenidone and (ii) patient on a stable dose of nintedanib","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[270,1124],[1012,1124],[1012,1172],[270,1172]],"region":{"top_left_x":269,"top_left_y":1123,"width":743,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"12c474ff82994eb59646db2d1c9ce950","type":"text","conversion_output":true,"text":"(Statistical table 14.2.20.1.1 to 14.2.20.2.2).","text_display":" (Statistical table 14.2.20.1.1 to 14.2.20.2.2).","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[270,1220],[1926,1220],[1926,1268],[270,1268]],"region":{"top_left_x":269,"top_left_y":1219,"width":1657,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ac3d49c7f2f4271b9eab7bfb7385fd5","type":"text","conversion_output":true,"text":"Additional exploratory analysis: time variation in historic FVC [\\% predicted; ml] measurements:","text_display":"\n\nAdditional exploratory analysis: time variation in historic FVC [\\% predicted; ml] measurements:","confidence":0.9761482818694206,"confidence_rate":0.999758621376868},{"cnt":[[270,1266],[1926,1266],[1926,1318],[270,1318]],"region":{"top_left_x":269,"top_left_y":1265,"width":1657,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87064e89caf74f418182714ee4234a43","type":"text","conversion_output":true,"text":"The time variations in historic FVC [\\% predicted] data (see section 8) will be modelled using a","text_display":" The time variations in historic FVC [\\% predicted] data (see section 8) will be modelled using a","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[270,1316],[1926,1316],[1926,1364],[270,1364]],"region":{"top_left_x":269,"top_left_y":1315,"width":1657,"height":49},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13159d6c0d8246208f53e0213d6e2709","type":"text","conversion_output":true,"text":"linear mixed effect model with random intercept and slope, with available historic FVC","text_display":" linear mixed effect model with random intercept and slope, with available historic FVC","confidence":1,"confidence_rate":1},{"cnt":[[270,1361],[1923,1361],[1923,1414],[270,1414]],"region":{"top_left_x":269,"top_left_y":1361,"width":1655,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4141f9e7ed454887af5577c8bd692a48","type":"text","conversion_output":true,"text":"measurements for each patient (until baseline, baseline included) as dependent variable (outcome)","text_display":" measurements for each patient (until baseline, baseline included) as dependent variable (outcome)","confidence":1,"confidence_rate":1},{"cnt":[[270,1412],[1923,1412],[1923,1460],[270,1460]],"region":{"top_left_x":269,"top_left_y":1411,"width":1655,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6c35e061aac4002804acab6a5ce5bfc","type":"text","conversion_output":true,"text":"and time (continuous variable calculated as the actual number of days before baseline) as","text_display":" and time (continuous variable calculated as the actual number of days before baseline) as","confidence":1,"confidence_rate":1},{"cnt":[[270,1457],[1923,1457],[1923,1510],[270,1510]],"region":{"top_left_x":269,"top_left_y":1457,"width":1655,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60babe02bdb949ff98cbb0a754e0f52a","type":"text","conversion_output":true,"text":"explanatory variables (Statistical table 14.2.30.1.1 to 14.2.30.1.2, Figure 14.2.21.1.1 to 14.2.21.1.2).","text_display":" explanatory variables (Statistical table 14.2.30.1.1 to 14.2.30.1.2, Figure 14.2.21.1.1 to 14.2.21.1.2).","confidence":1,"confidence_rate":1},{"cnt":[[270,1508],[1923,1508],[1923,1556],[270,1556]],"region":{"top_left_x":269,"top_left_y":1507,"width":1655,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f4e258053e484e4aa45501eb7de3273d","type":"text","conversion_output":true,"text":"This analysis will be repeated using historic FVC [ ml ] measurement as dependent variable.","text_display":" This analysis will be repeated using historic FVC [ ml ] measurement as dependent variable.","confidence":0.812723327663889,"confidence_rate":0.9979690794516525},{"cnt":[[270,1553],[1926,1553],[1926,1604],[270,1604]],"region":{"top_left_x":269,"top_left_y":1553,"width":1657,"height":51},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"943eb6e2b53040d5b55fe6c55732cec8","type":"text","conversion_output":true,"text":"(Statistical table 14.2.30.2.1 to 14.2.30.2.2, Figure 14.2.21.2.1 to 14.2.21.2.2). All available","text_display":" (Statistical table 14.2.30.2.1 to 14.2.30.2.2, Figure 14.2.21.2.1 to 14.2.21.2.2). All available","confidence":1,"confidence_rate":1},{"cnt":[[270,1599],[1330,1599],[1330,1652],[270,1652]],"region":{"top_left_x":269,"top_left_y":1599,"width":1061,"height":53},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6a12be39e3734268bd28bc631bc8fea6","type":"text","conversion_output":true,"text":"individual measurements will be provided in Listing 16.2.6.13.","text_display":" individual measurements will be provided in Listing 16.2.6.13.","confidence":1,"confidence_rate":1},{"cnt":[[489,1732],[962,1732],[962,1793],[489,1793]],"region":{"top_left_x":488,"top_left_y":1731,"width":474,"height":63},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"22530bbe0d9d4ec6824900857c3fb5cb","type":"section_header","conversion_output":false,"children_ids":["694e59c46adb4c74bf8b6f869b324de4"],"text":"","text_display":""},{"cnt":[[493,1736],[957,1736],[957,1789],[493,1789]],"region":{"top_left_x":493,"top_left_y":1736,"width":465,"height":53},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"694e59c46adb4c74bf8b6f869b324de4","type":"text","conversion_output":true,"parent_id":"22530bbe0d9d4ec6824900857c3fb5cb","text":"5.2.6 Safety analyses","text_display":"\n\n\\subsection*{5.2.6 Safety analyses}","confidence":1,"confidence_rate":1},{"cnt":[[270,1855],[1930,1855],[1930,1907],[270,1907]],"region":{"top_left_x":269,"top_left_y":1854,"width":1662,"height":54},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78f4d89b6ce54026b3d6409a0c4dcd35","type":"text","conversion_output":true,"text":"Safety analysis will be based on the incidence, intensity, and type of adverse events, incidence of","text_display":"\n\nSafety analysis will be based on the incidence, intensity, and type of adverse events, incidence of","confidence":1,"confidence_rate":1},{"cnt":[[270,1905],[1926,1905],[1926,1953],[270,1953]],"region":{"top_left_x":269,"top_left_y":1905,"width":1657,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96d169b00cf44b87ac4b8d93c2de39b0","type":"text","conversion_output":true,"text":"respiratory decline, Infusion related reactions, and clinically significant changes in the subject's","text_display":" respiratory decline, Infusion related reactions, and clinically significant changes in the subject's","confidence":1,"confidence_rate":1},{"cnt":[[270,1951],[1926,1951],[1926,2003],[270,2003]],"region":{"top_left_x":269,"top_left_y":1950,"width":1657,"height":54},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d9021f7b8f174e91bd3c99e48468e4a8","type":"text","conversion_output":true,"text":"physical examination, vital signs and clinical laboratory results. 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Safety variables will be tabulated","confidence":1,"confidence_rate":1},{"cnt":[[270,2001],[1647,2001],[1647,2051],[270,2051]],"region":{"top_left_x":269,"top_left_y":2001,"width":1379,"height":51},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11006da05f504d5380b3b8356c17ca06","type":"text","conversion_output":true,"text":"and presented for all subjects who have received any amount of study medication.","text_display":" and presented for all subjects who have received any amount of study 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2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[265,347],[982,347],[982,409],[265,409]],"region":{"top_left_x":264,"top_left_y":347,"width":719,"height":62},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"882d1ef9e1f6478ab59fab9766bef070","type":"section_header","conversion_output":false,"children_ids":["8c3c3010c4894a509de82cd9d3373b99"],"text":"","text_display":""},{"cnt":[[270,352],[975,352],[975,404],[270,404]],"region":{"top_left_x":269,"top_left_y":351,"width":707,"height":54},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8c3c3010c4894a509de82cd9d3373b99","type":"text","conversion_output":true,"parent_id":"882d1ef9e1f6478ab59fab9766bef070","text":"5.2.6.4 Laboratory safety variables","text_display":"\n\n\\subsection*{5.2.6.4 Laboratory safety variables}","confidence":1,"confidence_rate":1},{"cnt":[[265,461],[902,461],[902,525],[265,525]],"region":{"top_left_x":264,"top_left_y":461,"width":639,"height":65},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55feafe378c246d7b526ecb054911a79","type":"section_header","conversion_output":false,"children_ids":["afaa07336d6e420c86836c69416df673"],"text":"","text_display":""},{"cnt":[[270,466],[898,466],[898,519],[270,519]],"region":{"top_left_x":269,"top_left_y":466,"width":629,"height":53},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"afaa07336d6e420c86836c69416df673","type":"text","conversion_output":true,"parent_id":"55feafe378c246d7b526ecb054911a79","text":"Table of laboratory safety variables:","text_display":"\n\n\\section*{Table of laboratory safety variables:}","confidence":1,"confidence_rate":1},{"cnt":[[270,562],[1926,562],[1926,614],[270,614]],"region":{"top_left_x":269,"top_left_y":561,"width":1657,"height":54},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41caa3994dab4f8bbe514240036b17b3","type":"text","conversion_output":true,"text":"Laboratory evaluations will be summarized by visit and by treatment group on the SAF population.","text_display":"\n\nLaboratory evaluations will be summarized by visit and by treatment group on the SAF population.","confidence":0.9970703125,"confidence_rate":0.9999709510413867},{"cnt":[[270,612],[1556,612],[1556,665],[270,665]],"region":{"top_left_x":269,"top_left_y":612,"width":1287,"height":53},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b60289d60d454916b5142eec1e4da955","type":"text","conversion_output":true,"text":"For each hematology, chemistry and coagulation variables we will compute:","text_display":" For each hematology, chemistry and coagulation variables we will compute:","confidence":1,"confidence_rate":1},{"cnt":[[331,662],[1928,662],[1928,715],[331,715]],"region":{"top_left_x":331,"top_left_y":662,"width":1598,"height":54},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de7a4bc6fa4140be83305c10aceff9ca","type":"text","conversion_output":true,"text":"- Quantitative descriptive statistics on both raw values and change from baseline (Statistical","text_display":"\n- Quantitative descriptive statistics on both raw values and change from baseline (Statistical","confidence":1,"confidence_rate":1},{"cnt":[[395,708],[1160,708],[1160,761],[395,761]],"region":{"top_left_x":395,"top_left_y":708,"width":766,"height":53},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b0f6a6553a084aa78e6c717c790ff0a4","type":"text","conversion_output":true,"text":"tables 14.3.8.1-2, 14.3.9.1-2 and 14.3.10.1-2)","text_display":" tables 14.3.8.1-2, 14.3.9.1-2 and 14.3.10.1-2)","confidence":1,"confidence_rate":1},{"cnt":[[334,761],[1428,761],[1428,813],[334,813]],"region":{"top_left_x":333,"top_left_y":760,"width":1095,"height":54},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0f411da4fab4b3491d168e1e7e4d827","type":"text","conversion_output":true,"text":"- Qualitative descriptive statistics (individual patient changes):","text_display":"\n- Qualitative descriptive statistics (individual patient changes):","confidence":1,"confidence_rate":1},{"cnt":[[459,809],[1926,809],[1926,861],[459,861]],"region":{"top_left_x":459,"top_left_y":808,"width":1467,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6f95f71361114ee6910c3b4f6105888f","type":"text","conversion_output":true,"text":"- Number of patients with values: normal, abnormal NCS, abnormal CS (Statistical","text_display":"\n- Number of patients with values: normal, abnormal NCS, abnormal CS (Statistical","confidence":1,"confidence_rate":1},{"cnt":[[519,854],[1167,854],[1167,907],[519,907]],"region":{"top_left_x":518,"top_left_y":854,"width":650,"height":53},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0768cb5fdf9e48a1a1a9cee86a2c69f0","type":"text","conversion_output":true,"text":"table 14.3.8.2, 14.3.9.2 and 14.3.10.3)","text_display":" table 14.3.8.2, 14.3.9.2 and 14.3.10.3)","confidence":1,"confidence_rate":1},{"cnt":[[459,905],[1926,905],[1926,957],[459,957]],"region":{"top_left_x":459,"top_left_y":904,"width":1467,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fb3783cd7cda42a596aa4fcc4ba3126d","type":"text","conversion_output":true,"text":"- Shift Tables from baseline to each visit (Statistical table 14.3.8.3, 14.3.9.3 and","text_display":"\n- Shift Tables from baseline to each visit (Statistical table 14.3.8.3, 14.3.9.3 and","confidence":1,"confidence_rate":1},{"cnt":[[523,955],[701,955],[701,1003],[523,1003]],"region":{"top_left_x":523,"top_left_y":954,"width":179,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2caa12a976c4b1fb3baf2e7ae6009f4","type":"text","conversion_output":true,"text":"14.3.10.3)","text_display":" 14.3.10.3)","confidence":1,"confidence_rate":1},{"cnt":[[270,1046],[1926,1046],[1926,1099],[270,1099]],"region":{"top_left_x":269,"top_left_y":1046,"width":1657,"height":53},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de5dd9720c4a41179ceac471b5f4b4f4","type":"text","conversion_output":true,"text":"Depending of their number the clinically significant laboratory abnormalities will not be tabulated","text_display":"\n\nDepending of their number the clinically significant laboratory abnormalities will not be tabulated","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[270,1096],[1560,1096],[1560,1149],[270,1149]],"region":{"top_left_x":269,"top_left_y":1096,"width":1292,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff71c785cd23445e929800a800f64d2c","type":"text","conversion_output":true,"text":"but rather presented in individual data listings (Listings 16.2.8.1 to 16.2.8.4).","text_display":" but rather presented in individual data listings (Listings 16.2.8.1 to 16.2.8.4).","confidence":0.9960954189300537,"confidence_rate":0.9999545100597259},{"cnt":[[265,1231],[943,1231],[943,1291],[265,1291]],"region":{"top_left_x":264,"top_left_y":1231,"width":680,"height":60},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab5de245c0044cacaece6e0135c20142","type":"section_header","conversion_output":false,"children_ids":["22a13989b73346fe87f510007c65cbff"],"text":"","text_display":""},{"cnt":[[270,1238],[939,1238],[939,1286],[270,1286]],"region":{"top_left_x":269,"top_left_y":1238,"width":670,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"22a13989b73346fe87f510007c65cbff","type":"text","conversion_output":true,"parent_id":"ab5de245c0044cacaece6e0135c20142","text":"Figures on laboratory safety variables:","text_display":"\n\n\\section*{Figures on laboratory safety variables:}","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[270,1330],[1926,1330],[1926,1382],[270,1382]],"region":{"top_left_x":269,"top_left_y":1329,"width":1657,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"826296c195774185b4fc20c4f7d0c98e","type":"text","conversion_output":true,"text":"All individual values of a given laboratory measurement for each patient will be produced. When","text_display":"\n\nAll individual values of a given laboratory measurement for each patient will be produced. When","confidence":1,"confidence_rate":1},{"cnt":[[270,1380],[1926,1380],[1926,1432],[270,1432]],"region":{"top_left_x":269,"top_left_y":1379,"width":1657,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b5e72a7f2bd48e4a4374ea742fe5399","type":"text","conversion_output":true,"text":"available, the LLN and ULN will be displayed on the graph. Figures will be produced for all","text_display":" available, the LLN and ULN will be displayed on the graph. Figures will be produced for all","confidence":1,"confidence_rate":1},{"cnt":[[270,1430],[1396,1430],[1396,1483],[270,1483]],"region":{"top_left_x":269,"top_left_y":1430,"width":1127,"height":53},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f744d748099f4f018c3e6459a39b1a08","type":"text","conversion_output":true,"text":"hematologic, chemistry and coagulation variables (Figures 14.3.2).","text_display":" hematologic, chemistry and coagulation variables (Figures 14.3.2).","confidence":1,"confidence_rate":1},{"cnt":[[270,1505],[1930,1505],[1930,1560],[270,1560]],"region":{"top_left_x":269,"top_left_y":1505,"width":1662,"height":56},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d65072b117f429d99a6043eeca801f0","type":"text","conversion_output":true,"text":"To facilitate the exploration of potential Drug-Induced Liver Injury (DILI), eDISH (Evaluation of","text_display":"\n\nTo facilitate the exploration of potential Drug-Induced Liver Injury (DILI), eDISH (Evaluation of","confidence":1,"confidence_rate":1},{"cnt":[[270,1556],[1926,1556],[1926,1610],[270,1610]],"region":{"top_left_x":269,"top_left_y":1555,"width":1657,"height":56},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2841efa9f2ad4425bdcdcb0510f3afc2","type":"text","conversion_output":true,"text":"Drug-Induced Serious Hepatotoxicity) plots, plotting peak total bilirubin level versus peak ALT","text_display":" Drug-Induced Serious Hepatotoxicity) plots, plotting peak total bilirubin level versus peak ALT","confidence":1,"confidence_rate":1},{"cnt":[[270,1604],[1926,1604],[1926,1656],[270,1656]],"region":{"top_left_x":269,"top_left_y":1603,"width":1657,"height":54},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7b42e781fef44764a5af995924705d4e","type":"text","conversion_output":true,"text":"level, both expressed as multiples of the upper limit of normal on a base 10 logarithmic scale,","text_display":" level, both expressed as multiples of the upper limit of normal on a base 10 logarithmic scale,","confidence":1,"confidence_rate":1},{"cnt":[[270,1654],[1926,1654],[1926,1702],[270,1702]],"region":{"top_left_x":269,"top_left_y":1653,"width":1657,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"44db39bb639b4f8899f562341b6ff1af","type":"text","conversion_output":true,"text":"together with mlines identifying the normal range and 2 times the upper lipit of the normal range","text_display":" together with mlines identifying the normal range and 2 times the upper lipit of the normal range","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[270,1700],[1926,1700],[1926,1752],[270,1752]],"region":{"top_left_x":269,"top_left_y":1699,"width":1657,"height":54},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87fcf0c856644cf99896e7df195d4657","type":"text","conversion_output":true,"text":"for total bilirubin and three times the upper limit of the normal range for ALT, will be presented","text_display":" for total bilirubin and three times the upper limit of the normal range for ALT, will be presented","confidence":1,"confidence_rate":1},{"cnt":[[270,1745],[541,1745],[541,1798],[270,1798]],"region":{"top_left_x":269,"top_left_y":1745,"width":273,"height":53},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f6cbc9894344f04a9f08d46dd87f3b5","type":"text","conversion_output":true,"text":"(Figure 14.3.3).","text_display":" (Figure 14.3.3).","confidence":1,"confidence_rate":1},{"cnt":[[265,1901],[921,1901],[921,1962],[265,1962]],"region":{"top_left_x":264,"top_left_y":1900,"width":657,"height":63},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0ed3c62f600346bc817805d18c0efe9b","type":"section_header","conversion_output":false,"children_ids":["de73a62d96f44032b9961425582222f8"],"text":"","text_display":""},{"cnt":[[270,1905],[916,1905],[916,1958],[270,1958]],"region":{"top_left_x":269,"top_left_y":1905,"width":648,"height":53},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"de73a62d96f44032b9961425582222f8","type":"text","conversion_output":true,"parent_id":"0ed3c62f600346bc817805d18c0efe9b","text":"Listing of laboratory safety variables:","text_display":"\n\n\\section*{Listing of laboratory safety 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weight,","text_display":" will be prepared, presenting patient id, identification of time point, age, sex, race-ethnicity, weight,","confidence":1,"confidence_rate":1},{"cnt":[[270,2129],[1926,2129],[1926,2182],[270,2182]],"region":{"top_left_x":269,"top_left_y":2129,"width":1657,"height":53},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a71109e2c10f4afa9f0b26b963d215e2","type":"text","conversion_output":true,"text":"identification of laboratory test, raw result, evaluation (normal, abnormal...), investigator judgment","text_display":" identification of laboratory test, raw result, evaluation (normal, abnormal...), investigator 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analyses}","confidence":1,"confidence_rate":1},{"cnt":[[270,937],[1620,937],[1620,989],[270,989]],"region":{"top_left_x":269,"top_left_y":936,"width":1351,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9fcf37df05b42a09dc08f2522273a54","type":"text","conversion_output":true,"text":"All exploratory efficacy analysis will be performed on both the ATS and the PP.","text_display":"\n\nAll exploratory efficacy analysis will be performed on both the ATS and the PP.","confidence":1,"confidence_rate":1},{"cnt":[[270,1033],[1921,1033],[1921,1085],[270,1085]],"region":{"top_left_x":269,"top_left_y":1032,"width":1653,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d06c9fd308f4b53a04e2e24a124380d","type":"text","conversion_output":true,"text":"It was initially planned (EO1) to evaluate the efficacy and estimate the size of effect of PRM-151","text_display":"\nIt was initially planned (EO1) to evaluate the efficacy and estimate the size of effect of PRM-151","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[270,1083],[1921,1083],[1921,1135],[270,1135]],"region":{"top_left_x":269,"top_left_y":1082,"width":1653,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"568461da08334609b00c8da08f6cf9e5","type":"text","conversion_output":true,"text":"relative to placebo in change from baseline to weeks \\(4,8,12,16,20\\), and 24 in FVC \\% predicted,","text_display":" relative to placebo in change from baseline to weeks \\(4,8,12,16,20\\), and 24 in FVC \\% predicted,","confidence":0.9050129516981542,"confidence_rate":0.9990499180509156},{"cnt":[[270,1133],[1926,1133],[1926,1181],[270,1181]],"region":{"top_left_x":269,"top_left_y":1133,"width":1657,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ac300977d5a4a6e831d1f55d8d49242","type":"text","conversion_output":true,"text":"FVC in ml and 6 minute walking distance using mixed models with random intercepts. To obtain a","text_display":" FVC in ml and 6 minute walking distance using mixed models with random intercepts. To obtain a","confidence":1,"confidence_rate":1},{"cnt":[[270,1179],[1912,1179],[1912,1229],[270,1229]],"region":{"top_left_x":269,"top_left_y":1178,"width":1644,"height":51},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6217db005b14b019a759117c1b8865e","type":"text","conversion_output":true,"text":"better decription of individual variability, both random intercepts and random slopes will be used.","text_display":" better decription of individual variability, both random intercepts and random slopes will be used.","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[270,1275],[1926,1275],[1926,1327],[270,1327]],"region":{"top_left_x":269,"top_left_y":1274,"width":1657,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7388400a9d474fff85fd0ef9b28b5bd3","type":"text","conversion_output":true,"text":"The following not initialy planned exploratory analysis were added (see section 5.2.5.3 for details):","text_display":"\n\nThe following not initialy planned exploratory analysis were added (see section 5.2.5.3 for details):","confidence":1,"confidence_rate":1},{"cnt":[[334,1325],[1309,1325],[1309,1377],[334,1377]],"region":{"top_left_x":333,"top_left_y":1324,"width":976,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0985dfc8099440b181b85014b480ada0","type":"text","conversion_output":true,"text":"- To assess the use of quantitative imaging in IPF (E03)","text_display":"\n- To assess the use of quantitative imaging in IPF (E03)","confidence":1,"confidence_rate":1},{"cnt":[[334,1375],[1926,1375],[1926,1428],[334,1428]],"region":{"top_left_x":333,"top_left_y":1375,"width":1593,"height":53},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ebf3244c53084e7d8879a00b68ce590c","type":"text","conversion_output":true,"text":"- To explore the relationship between Anti-Pentraxin 2 antibodies (ADA) presence and level","text_display":"\n- To explore the relationship between Anti-Pentraxin 2 antibodies (ADA) presence and level","confidence":1,"confidence_rate":1},{"cnt":[[397,1425],[898,1425],[898,1473],[397,1473]],"region":{"top_left_x":397,"top_left_y":1425,"width":501,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"89dbd87a1beb445aa6c5f551a9c9165d","type":"text","conversion_output":true,"text":"of FVC [\\% predicted] in time","text_display":" of FVC [\\% predicted] in time","confidence":1,"confidence_rate":1},{"cnt":[[334,1476],[930,1476],[930,1528],[334,1528]],"region":{"top_left_x":333,"top_left_y":1475,"width":597,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f44e7f18f05f4bb0bfb6f751aa398827","type":"text","conversion_output":true,"text":"- To explore PK/PD relationship.","text_display":"\n- To explore PK/PD relationship.","confidence":1,"confidence_rate":1},{"cnt":[[334,1526],[1428,1526],[1428,1579],[334,1579]],"region":{"top_left_x":333,"top_left_y":1525,"width":1095,"height":54},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6fa9781dc7141059fc71b4cc62b5217","type":"text","conversion_output":true,"text":"- To explore relationship between Pentraxin-2 levels and ADA","text_display":"\n- To explore relationship between Pentraxin-2 levels and ADA","confidence":0.99951171875,"confidence_rate":0.9999924861744118},{"cnt":[[334,1576],[925,1576],[925,1629],[334,1629]],"region":{"top_left_x":333,"top_left_y":1576,"width":593,"height":53},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"70c87383dd0f45978760b5ffa7dd8b66","type":"text","conversion_output":true,"text":"- To explore acute exacerbations","text_display":"\n- To explore acute 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stable dose of pirfenidone.","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[265,1896],[927,1896],[927,1958],[265,1958]],"region":{"top_left_x":264,"top_left_y":1896,"width":664,"height":62},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a3844a0517ce4d5da9c49117dbe79daf","type":"section_header","conversion_output":false,"children_ids":["835f5e1f65374e79b7627303a49fbec3"],"text":"","text_display":""},{"cnt":[[270,1903],[921,1903],[921,1953],[270,1953]],"region":{"top_left_x":269,"top_left_y":1902,"width":652,"height":52},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"835f5e1f65374e79b7627303a49fbec3","type":"text","conversion_output":true,"parent_id":"a3844a0517ce4d5da9c49117dbe79daf","text":"7 Software documentation","text_display":"\n\n\\section*{7 Software 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Percent change from baseline to visit V (continuous) & \\begin{tabular}{l}\nPercent change from baseline of variable \\(X =100 *\\left[ X _{(\\text {Visit V) }}- X _{\\text {(Baseline })}\\right] / X _{\\text {(Baseline) }}\\) \\\\\n- Negative values indicate a decrease in X \\\\\n- Positive values indicate an increase in X\n\\end{tabular} \\\\\n\\hline Treatment compliance & \\begin{tabular}{l}\nContinuous variable: The compliance \\(C_{i}\\) for patient \\(i\\) will be computed according to:\n\\[\nC_{i}=\\frac{D_{i}^{t} * 100}{D_{i}^{p}}\n\\] \\\\\nwhere \\(D_{i}^{p} mg\\) is the total amount (mg) of IP prescribed to patient \\(i\\) and \\(D_{i}^{t}\\) is the total amount ( mg ) of IP actually taken by the patient during the study i.e., before the end of study for patient \\(i\\).\n\\end{tabular} \\\\\n\\hline Treatment compliance (categorical) & \\begin{tabular}{l}\nCategorial variable with three modalities: \\\\\n- \\(C_{i}<80 \\%\\) \\\\\n- \\(80 \\% \\leq C_{i}<120 \\%\\) \\\\\n- \\(C_{i} \\geq 120 \\%\\)\n\\end{tabular} \\\\\n\\hline Vital Sign abnormalities & \\begin{tabular}{l}\n- Heart rate: <50 or >90 \\\\\n- Respiratory rate: <12 or >20 \\\\\n- Body temperature: \\(<36.5^{\\circ} C\\) or \\(>37.5^{\\circ} C\\) \\\\\n- Diastolic Blood Pressure: <60 or >90 \\\\\n- Systolic Blood Pressure: <90 or >140 \\\\\n- Oxygen Saturation: <90\n\\end{tabular} \\\\\n\\hline Event Duration & (End Date) - (Start Date) + 1 \\\\\n\\hline Total Lung Volume in ml (TLV) & Total lung volume (excluding vessel volume) in ml \\\\\n\\hline Normal Lung Volume in ml (NLV) & NLV=Areas of Normal lung in ml + Mild Low Attenuation Area (LAA) in ml \\\\\n\\hline \\% of Normal Lung Volume & 100 * (NLV in ml) / (TLV in ml) \\\\\n\\hline \\% of mild Low Attenuation Areas (LAA) & 100 * (mild LAA in ml) / (TLV in ml) \\\\\n\\hline \\% of moderate Low Attenuation Areas (LAA) & 100 * (moderate LAA in ml) / (TLV in ml) \\\\\n\\hline \\% of severe Low Attenuation Areas (LAA) & 100 * (severe LAA in ml) / (TLV in ml) \\\\\n\\hline \\% Ground Glass (GG) & 100 * (GG in ml) / (TLV in ml) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Percent change from baseline to visit V (continuous) & \\begin{tabular}{l}\nPercent change from baseline of variable \\(X =100 *\\left[ X _{(\\text {Visit V) }}- X _{\\text {(Baseline })}\\right] / X _{\\text {(Baseline) }}\\) \\\\\n- Negative values indicate a decrease in X \\\\\n- Positive values indicate an increase in X\n\\end{tabular} \\\\\n\\hline Treatment compliance & \\begin{tabular}{l}\nContinuous variable: The compliance \\(C_{i}\\) for patient \\(i\\) will be computed according to:\n\\[\nC_{i}=\\frac{D_{i}^{t} * 100}{D_{i}^{p}}\n\\] \\\\\nwhere \\(D_{i}^{p} mg\\) is the total amount (mg) of IP prescribed to patient \\(i\\) and \\(D_{i}^{t}\\) is the total amount ( mg ) of IP actually taken by the patient during the study i.e., before the end of study for patient \\(i\\).\n\\end{tabular} \\\\\n\\hline Treatment compliance (categorical) & \\begin{tabular}{l}\nCategorial variable with three modalities: \\\\\n- \\(C_{i}<80 \\%\\) \\\\\n- \\(80 \\% \\leq C_{i}<120 \\%\\) \\\\\n- \\(C_{i} \\geq 120 \\%\\)\n\\end{tabular} \\\\\n\\hline Vital Sign abnormalities & \\begin{tabular}{l}\n- Heart rate: <50 or >90 \\\\\n- Respiratory rate: <12 or >20 \\\\\n- Body temperature: \\(<36.5^{\\circ} C\\) or \\(>37.5^{\\circ} C\\) \\\\\n- Diastolic Blood Pressure: <60 or >90 \\\\\n- Systolic Blood Pressure: <90 or >140 \\\\\n- Oxygen Saturation: <90\n\\end{tabular} \\\\\n\\hline Event Duration & (End Date) - (Start Date) + 1 \\\\\n\\hline Total Lung Volume in ml (TLV) & Total lung volume (excluding vessel volume) in ml \\\\\n\\hline Normal Lung Volume in ml (NLV) & NLV=Areas of Normal lung in ml + Mild Low Attenuation Area (LAA) in ml \\\\\n\\hline \\% of Normal Lung Volume & 100 * (NLV in ml) / (TLV in ml) \\\\\n\\hline \\% of mild Low Attenuation Areas (LAA) & 100 * (mild LAA in ml) / (TLV in ml) \\\\\n\\hline \\% of moderate Low Attenuation Areas (LAA) & 100 * (moderate LAA in ml) / (TLV in ml) \\\\\n\\hline \\% of severe Low Attenuation Areas (LAA) & 100 * (severe LAA in ml) / (TLV in ml) \\\\\n\\hline \\% Ground Glass (GG) & 100 * (GG in ml) / (TLV in ml) 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14.1.28.1 to 14.1.28.2 & Previous therapy for IPF \\\\\n\\hline 14.1.29.1 to 14.1.29.2 & Current therapy for IPF \\\\\n\\hline 14.1.30.1 to 14.1.30.2 & Previous other therapy \\\\\n\\hline 14.1.31.1 to 14.1.31.2 & Current other therapy \\\\\n\\hline 14.1.32.1 to 14.1.32.2 & Treatment compliance (11.3) \\\\\n\\hline \\(n ^{\\circ}\\) & Efficacy Results \\\\\n\\hline 14.2.1.1.1 to 14.2.1.1.3 & (PO1) Forced Vital Capacity (\\% predicted FVC) - raw values at each visit \\\\\n\\hline 14.2.1.2.1 to 14.2.1.2.3 & (PO1) Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit \\\\\n\\hline 14.2.1.3.1.a to 14.2.1.3.3.a & (PO1) Forced Vital Capacity (\\% predicted FVC): Anova table \\\\\n\\hline 14.2.1.3.1.b to 14.2.1.3.3.b & (PO1) Forced Vital Capacity (\\% predicted FVC): Model parameter estimates \\\\\n\\hline 14.2.1.3.1.c to 14.2.1.3.3.c & (PO1) Forced Vital Capacity (\\% predicted FVC): Least Square Means by stratum at each visit \\\\\n\\hline 14.2.1.3.1.d to 14.2.1.3.3.d & (PO1) Forced Vital Capacity (\\% predicted FVC): Least Square Means for Change from baseline at each visit \\\\\n\\hline 14.2.2.1.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - raw values by visit and stratum - No Background Therapy \\\\\n\\hline 14.2.2.1.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - raw values by visit and stratum - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.2.2.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit by stratum - No Background Therapy \\\\\n\\hline 14.2.2.2.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit by stratum - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.2.3.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction - Anova table \\\\\n\\hline 14.2.2.3.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction- Model parameter estimates \\\\\n\\hline 14.2.2.3.c & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction- Least Square Means by stratum at each visit \\\\\n\\hline 14.2.2.3.d & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction- Least Square Means by stratum for change from baseline at each visit \\\\\n\\hline 14.2.3.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Anova table \\\\\n\\hline 14.2.3.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Model parameter estimates \\\\\n\\hline 14.2.3.c & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Least Square Means at each visit \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.1.28.1 to 14.1.28.2 & Previous therapy for IPF \\\\\n\\hline 14.1.29.1 to 14.1.29.2 & Current therapy for IPF \\\\\n\\hline 14.1.30.1 to 14.1.30.2 & Previous other therapy \\\\\n\\hline 14.1.31.1 to 14.1.31.2 & Current other therapy \\\\\n\\hline 14.1.32.1 to 14.1.32.2 & Treatment compliance (11.3) \\\\\n\\hline \\(n ^{\\circ}\\) & Efficacy Results \\\\\n\\hline 14.2.1.1.1 to 14.2.1.1.3 & (PO1) Forced Vital Capacity (\\% predicted FVC) - raw values at each visit \\\\\n\\hline 14.2.1.2.1 to 14.2.1.2.3 & (PO1) Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit \\\\\n\\hline 14.2.1.3.1.a to 14.2.1.3.3.a & (PO1) Forced Vital Capacity (\\% predicted FVC): Anova table \\\\\n\\hline 14.2.1.3.1.b to 14.2.1.3.3.b & (PO1) Forced Vital Capacity (\\% predicted FVC): Model parameter estimates \\\\\n\\hline 14.2.1.3.1.c to 14.2.1.3.3.c & (PO1) Forced Vital Capacity (\\% predicted FVC): Least Square Means by stratum at each visit \\\\\n\\hline 14.2.1.3.1.d to 14.2.1.3.3.d & (PO1) Forced Vital Capacity (\\% predicted FVC): Least Square Means for Change from baseline at each visit \\\\\n\\hline 14.2.2.1.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - raw values by visit and stratum - No Background Therapy \\\\\n\\hline 14.2.2.1.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - raw values by visit and stratum - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.2.2.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit by stratum - No Background Therapy \\\\\n\\hline 14.2.2.2.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit by stratum - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.2.3.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction - Anova table \\\\\n\\hline 14.2.2.3.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction- Model parameter estimates \\\\\n\\hline 14.2.2.3.c & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction- Least Square Means by stratum at each visit \\\\\n\\hline 14.2.2.3.d & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction- Least Square Means by stratum for change from baseline at each visit \\\\\n\\hline 14.2.3.a & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Anova table \\\\\n\\hline 14.2.3.b & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Model parameter estimates \\\\\n\\hline 14.2.3.c & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Least Square Means at each visit 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14.2.3.d & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Least Square Means for Change from baseline at each visit \\\\\n\\hline 14.2.4.1.1 to 14.2.4.1.18 & (PO1) Sensitivity analysis: Forced Vital Capacity (\\% predicted FVC) - raw values at each visit by site \\\\\n\\hline 14.2.4.2.1 to 14.2.4.2.18 & (PO1) Sensitivity analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit by site \\\\\n\\hline 14.2.5.1.1 to 14.2.5.1.2 & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Initially planned analysis - Model parameter estimates \\\\\n\\hline 14.2.5.2.1 to 14.2.5.2.2 & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Initially planned analysis - Least Square Means by stratum for change from baseline at each visit \\\\\n\\hline 14.2.6.1.1 to 14.2.6.1.2 & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - raw value at each visit \\\\\n\\hline 14.2.6.2.1 to 14.2.6.2.2 & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - change from baseline \\\\\n\\hline 14.2.6.3.1.a to 14.2.6.3.2.a & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - Anova table \\\\\n\\hline 14.2.6.3.1.b to 14.2.6.3.2.b & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - Model parameter estimates \\\\\n\\hline 14.2.6.3.1.c to 14.2.6.3.2.c & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - Least Square Means by stratum for change from baseline \\\\\n\\hline 14.2.7.1.1.a to 14.2.7.1.2.a & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Anova table - No Background Therapy \\\\\n\\hline 14.2.7.1.1.b to 14.2.7.1.2.b & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Model parameter estimates - No Background Therapy \\\\\n\\hline 14.2.7.1.1.c to 14.2.7.1.2.c & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Least Square Means at each visit - No Background Therapy \\\\\n\\hline 14.2.7.1.1.d to 14.2.7.1.2.d & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Least Square Means for chage from baseline at each visit - No Background Therapy \\\\\n\\hline 14.2.7.2.1.a to 14.2.7.2.2.a & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Anova table - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.7.2.1.b to 14.2.7.2.2.b & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Model parameter estimates - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.7.2.1.c to 14.2.7.2.2.c & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Least Square Means at each visit - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.7.2.1.d to 14.2.7.2.2.d & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Least Square Means for chage from baseline at each visit - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.8.1.1.1 to 14.2.8.1.1.2 & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - raw values at each stratum- No Background Therapy \\\\\n\\hline 14.2.8.1.2.1 to 14.2.8.1.2.2 & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Change from baseline- No Background Therapy \\\\\n\\hline 14.2.8.1.3.1.a to 14.2.8.1.3.2.a & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Anova table - No Background Therapy \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.3.d & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Without adjusting on stratum - Least Square Means for Change from baseline at each visit \\\\\n\\hline 14.2.4.1.1 to 14.2.4.1.18 & (PO1) Sensitivity analysis: Forced Vital Capacity (\\% predicted FVC) - raw values at each visit by site \\\\\n\\hline 14.2.4.2.1 to 14.2.4.2.18 & (PO1) Sensitivity analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline to each visit by site \\\\\n\\hline 14.2.5.1.1 to 14.2.5.1.2 & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Initially planned analysis - Model parameter estimates \\\\\n\\hline 14.2.5.2.1 to 14.2.5.2.2 & (PO1) Sensitivity Analysis: Forced Vital Capacity (\\% predicted FVC) - Initially planned analysis - Least Square Means by stratum for change from baseline at each visit \\\\\n\\hline 14.2.6.1.1 to 14.2.6.1.2 & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - raw value at each visit \\\\\n\\hline 14.2.6.2.1 to 14.2.6.2.2 & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - change from baseline \\\\\n\\hline 14.2.6.3.1.a to 14.2.6.3.2.a & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - Anova table \\\\\n\\hline 14.2.6.3.1.b to 14.2.6.3.2.b & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - Model parameter estimates \\\\\n\\hline 14.2.6.3.1.c to 14.2.6.3.2.c & (SO1) Secondary Efficacy Analysis: HRCT imaging analysis - Least Square Means by stratum for change from baseline \\\\\n\\hline 14.2.7.1.1.a to 14.2.7.1.2.a & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Anova table - No Background Therapy \\\\\n\\hline 14.2.7.1.1.b to 14.2.7.1.2.b & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Model parameter estimates - No Background Therapy \\\\\n\\hline 14.2.7.1.1.c to 14.2.7.1.2.c & (SO2) Secondary Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) Separately for each stratum - Least Square Means at each visit - No Background Therapy \\\\\n\\hline 14.2.7.1.1.d to 14.2.7.1.2.d & (SO2) Secondary 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Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Model parameter estimates - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.8.2.3.1.c to 14.2.8.2.3.2.c & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Least Square Means for change from baseline - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.9.1.a to 14.2.9.2.a & (SO6) Secondary analyses: Effect size in PRM-151 - Treatment Effect \\\\\n\\hline 14.2.9.1.b to 14.2.9.2.b & (SO6) Secondary analyses: Effect size in PRM-151 - Common Odds Ratio \\\\\n\\hline 14.2.10.1.1 to 14.2.10.1.2 & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - raw values at each visit \\\\\n\\hline 14.2.10.2.1 to 14.2.10.2.2 & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - change from baseline to each visit \\\\\n\\hline 14.2.10.3.1a to 14.2.10.3.2a & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Anova table \\\\\n\\hline 14.2.10.3.1b to 14.2.10.3.2b & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Model parameter estimates \\\\\n\\hline 14.2.10.3.1c to 14.2.10.3.2c & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Least Square Means by stratum at each visit \\\\\n\\hline 14.2.10.3.1d to 14.2.10.3.2d & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Least Square Means for Change from baseline at each visit \\\\\n\\hline 14.2.11.1.1 to 14.2.11.1.2 & (SO8) Secondary Efficacy Analysis: DLCO - raw values at each visit \\\\\n\\hline 14.2.11.2.1 to 14.2.11.2.2 & (SO8) Secondary Efficacy Analysis: DLCO - change from baseline \\\\\n\\hline 14.2.11.3.1a to 14.2.11.3.2a & (SO8) Secondary Efficacy Analysis: DLCO - Anova table \\\\\n\\hline 14.2.11.3.1b to 14.2.11.3.2b & (SO8) Secondary Efficacy Analysis: DLCO - Model parameter estimates \\\\\n\\hline 14.2.11.3.1c to 14.2.11.3.2c & (SO8) Secondary Efficacy Analysis: DLCO - Least Square Means by stratum for change from baseline \\\\\n\\hline 14.2.12.1.1 to 14.2.12.1.2 & (SO9) Secondary Efficacy Analysis: Correlation between Forced Vital Capacity (\\% predicted FVC) and total lung volume \\\\\n\\hline 14.2.12.2.1 to 14.2.12.2.2 & (SO9) Secondary Efficacy Analysis: Correlation between Forced Vital Capacity (\\% predicted FVC) and volume of ILA on HRCT \\\\\n\\hline 14.2.13.1.a to 14.2.13.2.a & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis - Anova table \\\\\n\\hline 14.2.13.1.b to 14.2.13.2.b & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis- Model parameter estimates \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.8.1.3.1.b to 14.2.8.1.3.2.b & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Model parameter estimates - No Background Therapy \\\\\n\\hline 14.2.8.1.3.1.c to 14.2.8.1.3.2.c & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Least Square Means for change from baseline- No Background Therapy \\\\\n\\hline 14.2.8.2.1.1 to 14.2.8.2.1.2 & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - raw values at each stratum - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.8.2.2.1 to 14.2.8.2.2.2 & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Change from baseline - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.8.2.3.1.a to 14.2.8.2.3.2.a & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Anova table - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.8.2.3.1.b to 14.2.8.2.3.2.b & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Model parameter estimates - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.8.2.3.1.c to 14.2.8.2.3.2.c & (SO3) Secondary Efficacy Analysis: HRCT imaging analysis - Separately for each stratum - Least Square Means for change from baseline - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.9.1.a to 14.2.9.2.a & (SO6) Secondary analyses: Effect size in PRM-151 - Treatment Effect \\\\\n\\hline 14.2.9.1.b to 14.2.9.2.b & (SO6) Secondary analyses: Effect size in PRM-151 - Common Odds Ratio \\\\\n\\hline 14.2.10.1.1 to 14.2.10.1.2 & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - raw values at each visit \\\\\n\\hline 14.2.10.2.1 to 14.2.10.2.2 & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - change from baseline to each visit \\\\\n\\hline 14.2.10.3.1a to 14.2.10.3.2a & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Anova table \\\\\n\\hline 14.2.10.3.1b to 14.2.10.3.2b & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Model parameter estimates \\\\\n\\hline 14.2.10.3.1c to 14.2.10.3.2c & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Least Square Means by stratum at each visit \\\\\n\\hline 14.2.10.3.1d to 14.2.10.3.2d & (SO7) Secondary Efficacy Analysis: 6 Minute Walk Distance - Least Square Means for Change from baseline at each 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Random Slope Analysis Separately for each stratum - Least Square Means for change from baseline at each visit - No Background Therapy \\\\\n\\hline 14.2.14.2.1.a to 14.2.14.2.2.a & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Anova table - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.14.2.1.b to 14.2.14.2.2.b & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Model parameter estimates - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.14.2.1.c to 14.2.14.2.2.c & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Least Square Means at each visit- Pirfenidone or Nintedanib \\\\\n\\hline 14.2.14.2.1.d to 14.2.14.2.2.d & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Least Square Means for change from baseline at each visit Pirfenidone or Nintedanib \\\\\n\\hline 14.2.15.1.1 to 14.2.15.1.2 & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis - Raw Values at Each Visit \\\\\n\\hline 14.2.15.1.2 to 14.2.15.2.2 & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis - Change from baseline at each visit \\\\\n\\hline 14.2.15.3.1.a to 14.2.15.3.2.a & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis - Anova table \\\\\n\\hline 14.2.15.3.1.b to 14.2.15.3.2.b & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis- Model parameter estimates \\\\\n\\hline 14.2.15.3.1.c to 14.2.15.3.2.c & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis- Least Square Means by stratum at each visit \\\\\n\\hline 14.2.15.3.1.d to 14.2.15.3.2.d & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis- Least Square Means for change from baseline at each visit \\\\\n\\hline 14.2.16.1.1.1 to 14.2.16.1.1.2 & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis Separately for each stratum - Raw values at each visit - No Background Therapy \\\\\n\\hline 14.2.16.1.2.1 to 14.2.16.1.2.2 & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis Separately for each stratum - Change from baseline to eah visit - No Background Therapy \\\\\n\\hline 14.2.16.1.3.1.a to 14.2.16.1.3.2.a & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis Separately for each stratum - Anova table - No Background Therapy \\\\\n\\hline 14.2.16.1.3.1.b to 14.2.16.1.3.2.b & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis Separately for each stratum - Model parameter estimates - No Background Therapy \\\\\n\\hline 14.2.16.1.3.1.c to 14.2.16.1.3.2.c & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis Separately for each stratum - Least Square Means at each visit - No Background Therapy \\\\\n\\hline 14.2.16.1.3.1.d to 14.2.16.1.3.2.d & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis Separately for each stratum - Least Square Means for change from baseline at each visit - No Background Therapy \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.13.1.c to 14.2.13.2.c & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis- Least Square Means by stratum at each visit \\\\\n\\hline 14.2.13.1.d to 14.2.13.2.d & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis- Least Square Means for change from baseline at each visit \\\\\n\\hline 14.2.14.1.1.a to 14.2.14.1.2.a & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Anova table - No Background Therapy \\\\\n\\hline 14.2.14.1.1.b to 14.2.14.1.2.b & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Model parameter estimates - No Background Therapy \\\\\n\\hline 14.2.14.1.1.c to 14.2.14.1.2.c & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Least Square Means at each visit - No Background Therapy \\\\\n\\hline 14.2.14.1.1.d to 14.2.14.1.2.d & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Least Square Means for change from baseline at each visit - No Background Therapy \\\\\n\\hline 14.2.14.2.1.a to 14.2.14.2.2.a & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Anova table - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.14.2.1.b to 14.2.14.2.2.b & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Model parameter estimates - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.14.2.1.c to 14.2.14.2.2.c & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Least Square Means at each visit- Pirfenidone or Nintedanib \\\\\n\\hline 14.2.14.2.1.d to 14.2.14.2.2.d & (EO1) Exploratory analyses: FV [\\%predicted] - Random Slope Analysis Separately for each stratum - Least Square Means for change from baseline at each visit Pirfenidone or Nintedanib \\\\\n\\hline 14.2.15.1.1 to 14.2.15.1.2 & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis - Raw Values at Each Visit \\\\\n\\hline 14.2.15.1.2 to 14.2.15.2.2 & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis - Change from baseline at each visit \\\\\n\\hline 14.2.15.3.1.a to 14.2.15.3.2.a & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis - Anova table \\\\\n\\hline 14.2.15.3.1.b to 14.2.15.3.2.b & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis- Model parameter estimates \\\\\n\\hline 14.2.15.3.1.c to 14.2.15.3.2.c & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis- Least Square Means by stratum at each visit \\\\\n\\hline 14.2.15.3.1.d to 14.2.15.3.2.d & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis- Least Square Means for change from baseline at each visit \\\\\n\\hline 14.2.16.1.1.1 to 14.2.16.1.1.2 & (EO1) Exploratory analyses: FV [ml] - Random Slope Analysis Separately 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14.2.18.2.3.1.d to 14.2.18.2.3.2.d & (EO1) Exploratory analyses:6-Minute Walk distance - Random Slope Analysis Separately for each stratum - Least Square Means for change from baseline at each visit - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.19.1.1.1 to 14.2.19.1.1.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - raw value at each visit \\\\\n\\hline 14.2.19.1.2.1.b to 14.2.19.1.2.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - change from baseline \\\\\n\\hline 14.2.19.1.3.1.a to 14.2.19.1.3.2.a & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - Anova table \\\\\n\\hline 14.2.19.1.3.1.b to 14.2.19.1.3.2.b & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - Model parameter estimates \\\\\n\\hline 14.2.19.1.3.1.c to 14.2.19.1.3.2.c & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - Least Square Means for change In baseline \\\\\n\\hline 14.2.19.2.1.1 to 14.2.19.2.1.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - raw value at each visit \\\\\n\\hline 14.2.19.2.2.1.b to 14.2.19.2.2.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - change from baseline \\\\\n\\hline 14.2.19.2.3.1.a to 14.2.19.2.3.2.a & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - Anova table \\\\\n\\hline 14.2.19.2.3.1.b to 14.2.19.2.3.2.b & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - Model parameter estimates \\\\\n\\hline 14.2.19.2.3.1.c to 14.2.19.2.3.2.c & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - Least Square Means for change I nbaseline \\\\\n\\hline 14.2.20.1.1 to 14.2.20.1.2 & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - raw values at each visit \\\\\n\\hline 14.2.20.2.1 to 14.2.20.2.2 & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - change from baseline to each visit \\\\\n\\hline 14.2.20.3.1.a to 14.2.20.3.2.a & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Anova table \\\\\n\\hline 14.2.20.3.1.b to 14.2.20.3.2.b & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Model parameter estimates \\\\\n\\hline 14.2.20.3.1.c to 14.2.20.3.2.c & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Least Square Means by stratum at each visit \\\\\n\\hline 14.2.20.3.1.d to 14.2.20.3.2.d & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Least Square Means for change from baseline at each visit \\\\\n\\hline 14.2.21.1.1 to 14.2.21.1.2 & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) - raw values at each visit \\\\\n\\hline 14.2.21.2.1 to 14.2.21.2.2 & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) change from baseline to each visit \\\\\n\\hline 14.2.21.3.1.a to 14.2.21.3.2.a & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) - Least Square Means \\\\\n\\hline 14.2.21.3.1.b to 14.2.21.3.2.b & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) Anova table \\\\\n\\hline 14.2.21.3.1.c to 14.2.21.3.2.c & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) Model parameter estimates \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.18.2.3.1.d to 14.2.18.2.3.2.d & (EO1) Exploratory analyses:6-Minute Walk distance - Random Slope Analysis Separately for each stratum - Least Square Means for change from baseline at each visit - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.19.1.1.1 to 14.2.19.1.1.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - raw value at each visit \\\\\n\\hline 14.2.19.1.2.1.b to 14.2.19.1.2.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - change from baseline \\\\\n\\hline 14.2.19.1.3.1.a to 14.2.19.1.3.2.a & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - Anova table \\\\\n\\hline 14.2.19.1.3.1.b to 14.2.19.1.3.2.b & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - Model parameter estimates \\\\\n\\hline 14.2.19.1.3.1.c to 14.2.19.1.3.2.c & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning \\(\\geq 90 \\%\\) of SVC supine - Least Square Means for change In baseline \\\\\n\\hline 14.2.19.2.1.1 to 14.2.19.2.1.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - raw value at each visit \\\\\n\\hline 14.2.19.2.2.1.b to 14.2.19.2.2.2 & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - change from baseline \\\\\n\\hline 14.2.19.2.3.1.a to 14.2.19.2.3.2.a & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - Anova table \\\\\n\\hline 14.2.19.2.3.1.b to 14.2.19.2.3.2.b & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - Model parameter estimates \\\\\n\\hline 14.2.19.2.3.1.c to 14.2.19.2.3.2.c & (EO2) Exploratory analyses: HRCT image analysis (total lung volume) - SVC breathhold at CT scanning <90\\% of SVC supine - Least Square Means for change I nbaseline \\\\\n\\hline 14.2.20.1.1 to 14.2.20.1.2 & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - raw values at each visit \\\\\n\\hline 14.2.20.2.1 to 14.2.20.2.2 & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - change from baseline to each visit \\\\\n\\hline 14.2.20.3.1.a to 14.2.20.3.2.a & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Anova table \\\\\n\\hline 14.2.20.3.1.b to 14.2.20.3.2.b & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Model parameter estimates \\\\\n\\hline 14.2.20.3.1.c to 14.2.20.3.2.c & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Least Square Means by stratum at each visit \\\\\n\\hline 14.2.20.3.1.d to 14.2.20.3.2.d & (EO2) Exploratory Efficacy Analysis: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) - Least Square Means for change from baseline at each visit \\\\\n\\hline 14.2.21.1.1 to 14.2.21.1.2 & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) - raw values at each visit \\\\\n\\hline 14.2.21.2.1 to 14.2.21.2.2 & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) change from baseline to each visit \\\\\n\\hline 14.2.21.3.1.a to 14.2.21.3.2.a & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) - Least Square Means \\\\\n\\hline 14.2.21.3.1.b to 14.2.21.3.2.b & (EO2) Exploratory 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14.2.21.4.1 to 14.2.21.4.2 & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) frequency of patients with changes below or above 1.3 at each visit \\\\\n\\hline 14.2.22.1.1 to 14.2.22.1.2 & (EO2) Exploratory Efficacy Analysis: anti-Pentraxin-2 antibodies - raw values at each visit \\\\\n\\hline 14.2.22.2.1 to 14.2.22.2.2 & (EO2) Exploratory Efficacy Analysis: anti-Pentraxin-2 antibodies - change from baseline to each visit \\\\\n\\hline 14.2.23.1.1 to 14.2.23.1.2 & (EO3) Exploratory Efficacy Analysis: Use of quantitative imaging in IPF - Baseline correlations \\\\\n\\hline 14.2.23.2.1 to 14.2.23.2.2 & (EO3) Exploratory Efficacy Analysis: Use of quantitative imaging in IPF Correlations with change from baseline to week 28 in FVC [\\%predicted] \\\\\n\\hline 14.2.23.3.1 to 14.2.23.3.2 & (EO3) Exploratory Efficacy Analysis: Use of quantitative imaging in IPF Correlations with change from baseline to week 28 in DLCO \\\\\n\\hline 14.2.23.4.1 to 14.2.23.4.2 & (EO3) Exploratory Efficacy Analysis: Impact of respiratory effort on HRCT quantitative imaging \\\\\n\\hline 14.2.24.1.to 14.2.24.2 & (EO4) Exploratory analyses: Biomarkers \\\\\n\\hline 14.2.25.1.1 to 14.2.25.1.2 & (EOA) Additional Exploratory analyses: Influence of ADA on FVC[\\%predicted] model selection \\\\\n\\hline 14.2.25.2.1 to 14.2.25.2.2 & (EOA) Additional Exploratory analyses: Influence of ADA on FVC[\\%predicted] model parameter estimates \\\\\n\\hline 14.2.26.1 to 14.2.26.2 & (EOA) Additional Exploratory analyses: PK/PD relationship \\\\\n\\hline 14.2.27.1 to 14.2.27.2 & (EOA) Additional Exploratory analyses: Relationship between Pentraxin-2 levels and ADA \\\\\n\\hline 14.2.28.1.1 to 14.2.28.1.2 & (EOA) Additional Exploratory analyses: Acute exacerbations \\\\\n\\hline 14.2.28.2.1 to 14.2.28.2.2 & (EOA) Additional Exploratory analyses: Acute exacerbations - Descriptive statistics \\\\\n\\hline 14.2.29.1.1.1 to 14.2.29.1.1.2 & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - raw value at each visit - Nintedanib \\\\\n\\hline 14.2.29.1.2.1 to 14.2.29.1.2.2 & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline - Nintedanib \\\\\n\\hline 14.2.29.1.3.1.a to 14.2.29.1.3.2.a & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Anova table - Nintedanib \\\\\n\\hline 14.2.29.1.3.1.b to 14.2.29.1.3.2.b & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Model parameter estimates Nintedanib \\\\\n\\hline 14.2.29.1.3.1.c to 14.2.29.1.3.2.c & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Least Square Means at each visit Nintedanib \\\\\n\\hline 14.2.29.1.3.1.d to 14.2.29.1.3.2.d & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Least Square Means for chage from baseline at each visit - Nintedanib \\\\\n\\hline 14.2.29.2.1.1 to 14.2.29.2.1.2 & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - raw value at each visit - Pirfenidone \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.21.4.1 to 14.2.21.4.2 & (EO2) Exploratory Efficacy Analysis: Leicester Cough Questionnaire (LCQ) frequency of patients with changes below or above 1.3 at each visit \\\\\n\\hline 14.2.22.1.1 to 14.2.22.1.2 & (EO2) Exploratory Efficacy Analysis: anti-Pentraxin-2 antibodies - raw values at each visit \\\\\n\\hline 14.2.22.2.1 to 14.2.22.2.2 & (EO2) Exploratory Efficacy Analysis: anti-Pentraxin-2 antibodies - change from baseline to each visit \\\\\n\\hline 14.2.23.1.1 to 14.2.23.1.2 & (EO3) Exploratory Efficacy Analysis: Use of quantitative imaging in IPF - Baseline correlations \\\\\n\\hline 14.2.23.2.1 to 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14.2.29.2.2.1 to 14.2.29.2.2.2 & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline - Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.a to 14.2.29.2.3.2.a & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Anova table - Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.b to 14.2.29.2.3.2.b & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Model parameter estimates Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.c to 14.2.29.2.3.2.c & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Least Square Means at each visit Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.d to 14.2.29.2.3.2.d & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Least Square Means for chage from baseline at each visit - Pirfenidone \\\\\n\\hline 14.2.30.1.1 to 14.2.30.1.2 & (EOA) Additional Exploratory Efficacy Analysis: Historic Forced Vital Capacity (\\% predicted FVC) - Model parameter estimates \\\\\n\\hline 14.2.30.2.1 to 14.2.30.2.2 & (EOA) Additional Exploratory Efficacy Analysis: Historic Forced Vital Capacity (ml) Model parameter estimates \\\\\n\\hline \\(n ^{ \\circ }\\) & SAFETY RESULTS \\\\\n\\hline 14.3.1 & Extent of exposure \\\\\n\\hline 14.3.2.1 to 14.3.2.3 & Pentraxin-2 levels over time \\\\\n\\hline 14.3.3 & Summary of Adverse Events \\\\\n\\hline 14.3.4.1 & Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.4.2 & Frequent Treatment Emergent Adverse Events (TEAEs) (>5\\% Overall) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.4.3 & Possibly of Probably Related Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.4.4 & Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Intensity \\\\\n\\hline 14.3.4.5 & Treatment Emergent Adverse Events (TEAEs) Leading to Permanent Study Drug Discontinuation by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.4.6 & All TEAEs leading to permanent study discontinuation by SOC and PT \\\\\n\\hline 14.3.5.1 & Serious Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.5.2 & Possibly or Probably Related Serious Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.5.3 & Serious Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Intensity \\\\\n\\hline 14.3.5.4 & Serious Treatment Emergent Adverse Events (TEAEs) Leading to Permanent Study Drug Discontinuation by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.5.5 & All TESAEs leading to permanent study discontinuation by SOC and PT \\\\\n\\hline 14.3.5.6 & Deaths \\\\\n\\hline 14.3.6.1 & Respiratory Decline Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.2.29.2.2.1 to 14.2.29.2.2.2 & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - change from baseline - Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.a to 14.2.29.2.3.2.a & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Anova table - Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.b to 14.2.29.2.3.2.b & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Model parameter estimates Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.c to 14.2.29.2.3.2.c & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Least Square Means at each visit Pirfenidone \\\\\n\\hline 14.2.29.2.3.1.d to 14.2.29.2.3.2.d & (EOA) Additional Exploratory Efficacy Analysis: Forced Vital Capacity (\\% predicted FVC) - Separately for each stratum - Least Square Means for chage from baseline at each visit - Pirfenidone \\\\\n\\hline 14.2.30.1.1 to 14.2.30.1.2 & (EOA) Additional Exploratory Efficacy Analysis: Historic Forced Vital Capacity (\\% predicted FVC) - Model parameter estimates \\\\\n\\hline 14.2.30.2.1 to 14.2.30.2.2 & (EOA) Additional Exploratory Efficacy Analysis: Historic Forced Vital Capacity (ml) Model parameter estimates \\\\\n\\hline \\(n ^{ \\circ }\\) & SAFETY RESULTS \\\\\n\\hline 14.3.1 & Extent of exposure \\\\\n\\hline 14.3.2.1 to 14.3.2.3 & Pentraxin-2 levels over time \\\\\n\\hline 14.3.3 & Summary of Adverse Events \\\\\n\\hline 14.3.4.1 & Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) 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14.3.6.2 & Respiratory Decline Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Intensity \\\\\n\\hline 14.3.6.3 & Respiratory Decline Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Seriousness \\\\\n\\hline 14.3.7.1.1 & Infusion Related Reaction Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.7.1.2 & Infusion Related Reaction Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Intensity \\\\\n\\hline 14.3.7.1.3 & Infusion Related Reaction Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Seriousness \\\\\n\\hline 14.3.7.2.1 & Infusion Related Reactions by Preferred Term (PT) and presence/absence of ADA \\\\\n\\hline 14.3.7.2.2 & Infusion Related Reactions by Preferred Term (PT), intensity and presence/absence of ADA \\\\\n\\hline 14.3.7.2.3 & Infusion Related Reactions by Preferred Term (PT), seriousness and presence/absence of ADA \\\\\n\\hline 14.3.8.1.1 & Laboratory Tests - Hematology - Descriptive statistics for raw values \\\\\n\\hline 14.3.8.1.2 & Laboratory Tests - Hematology - Descriptive statistics for change from baseline \\\\\n\\hline 14.3.8.2 & Laboratory Tests - Hematology - Qualitative \\\\\n\\hline 14.3.8.3 & Laboratory Tests - Hematology - Shift tables \\\\\n\\hline 14.3.9.1.1 & Laboratory Tests - Chemistry - Descriptive statistics for raw values \\\\\n\\hline 14.3.9.1.2 & Laboratory Tests - Chemistry - Descriptive statistics for change from baseline \\\\\n\\hline 14.3.9.2 & Laboratory Tests - Chemistry - Qualitative \\\\\n\\hline 14.3.9.3 & Laboratory Tests - Chemistry - Shift tables \\\\\n\\hline 14.3.10.1.1 & Laboratory Tests - Coagulation - Descriptive statistics for raw values \\\\\n\\hline 14.3.10.1.2 & Laboratory Tests - Coagulation - Descriptive statistics for change from baseline \\\\\n\\hline 14.3.10.2 & Laboratory Tests - Coagulation - Qualitative \\\\\n\\hline 14.3.10.3 & Laboratory Tests - Coagulation - Shift tables \\\\\n\\hline 14.3.11 & Physical Examination \\\\\n\\hline 14.3.12.1 & Vital signs - Descriptive statistics for raw values \\\\\n\\hline 14.3.12.2 & Vital signs - Descriptive statistics for change from baseline \\\\\n\\hline 14.3.12.3 & Vital signs - Descriptive statistics for normal/abnormal values \\\\\n\\hline 14.3.12.4 & Vital signs - Shift tables \\\\\n\\hline 14.3.13.1 & Concomitant medication at baseline \\\\\n\\hline 14.3.13.2 & Concomitant medication started after baseline \\\\\n\\hline 14.3.13.3 & Concomitant medications - Use of nintedanib and pirfenidone at baseline \\\\\n\\hline 14.3.13.4 & Concomitant medications - Use of nintedanib and pirfenidone started after baseline \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.3.6.2 & Respiratory Decline Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Intensity \\\\\n\\hline 14.3.6.3 & Respiratory Decline Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Seriousness \\\\\n\\hline 14.3.7.1.1 & Infusion Related Reaction Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT) \\\\\n\\hline 14.3.7.1.2 & Infusion Related Reaction Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Intensity \\\\\n\\hline 14.3.7.1.3 & Infusion Related Reaction Treatment Emergent Adverse Events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Seriousness \\\\\n\\hline 14.3.7.2.1 & Infusion Related Reactions by Preferred Term (PT) and presence/absence of ADA \\\\\n\\hline 14.3.7.2.2 & Infusion Related Reactions by Preferred Term (PT), intensity and presence/absence of ADA \\\\\n\\hline 14.3.7.2.3 & Infusion Related Reactions by Preferred Term (PT), seriousness and presence/absence of 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\\(n ^{\\circ}\\) & Demographics and Baseline \\\\\n\\hline Body & Disposition of patients (10.1) \\\\\n\\hline \\(n ^{ \\circ }\\) & Efficacy Results \\\\\n\\hline 14.2.1.1 to 14.2.1.3 & (PO1) Forced Vital Capacity (\\% predicted FVC) - Least Square Means at Each Visit \\\\\n\\hline 14.2.2 & (PO1) Forced Vital Capacity (\\% predicted FVC) - Stratum Interaction - Least Square Means at Each Visit \\\\\n\\hline 14.2.3 & (PO1) Forced Vital Capacity (\\% predicted FVC) Without Adjusting on Stratum - Least Square Means at Each Visit \\\\\n\\hline 14.2.4.1 to 14.2.4.2 & (SO1) HRCT imaging analysis - Least square means at each visit \\\\\n\\hline 14.2.5.1.1 to 14.2.5.1.2 & (SO2) Forced Vital Capacity (\\% predicted FVC) - Separately on Each Stratum - Least Square Means at Each Visit - No Background Therapy \\\\\n\\hline 14.2.5.2.1 to 14.2.5.2.2 & (SO2) Forced Vital Capacity (\\% predicted FVC) - Separately on Each Stratum - Least Square Means at Each Visit - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.6.1.1 to 14.2.6.1.2 & (SO3) HRCT imaging analysis - Separately on Each Stratum - No Background Therapy \\\\\n\\hline 14.2.6.2.1 to 14.2.6.2.2 & (SO3) HRCT imaging analysis - Separately on Each Stratum - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.7.1 to 14.2.7.2 & (SO7) 6-Minute Walk Distance - Least Square Means at Each Visit \\\\\n\\hline 14.2.8.1 to 14.2.8.2 & (SO8) DLCO (\\% predicted HGB Corrected DLCO) - Least Square Means at Each Visit \\\\\n\\hline 14.2.9.1.1 to 14.2.9.1.2 & (SO9) Correlation between FVC [\\% predicted] and total lung volume \\\\\n\\hline 14.2.9.2.1 to 14.2.9.2.2 & (SO9) Correlation between FVC [\\% predicted] and volume of ILA on HRCT \\\\\n\\hline 14.2.10.1 to 14.2.10.2 & (EO1) Forced Vital Capacity (\\% predicted FVC) - Random Slope Anaysis - Least Square Means at Each Visit \\\\\n\\hline 14.2.11.1.1 to 14.2.11.1.2 & (EO1) Forced Vital Capacity (\\% predicted FVC) - Random Slope Analysis Separately on Each Stratum - Least Square Means at Each Visit - No Background Therapy \\\\\n\\hline 14.2.11.2.1 to 14.2.11.2.2 & (EO1) Forced Vital Capacity (\\% predicted FVC) - Random Slope Analysis Separately on Each Stratum - Least Square Means at Each Visit - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.12.1 to 14.2.12.2 & (EO1) Forced Vital Capacity (mL) - Random Slope Analysis - Least Square Means at Each Visit \\\\\n\\hline 14.2.13.1.1 to 14.2.13.1.2 & (EO1) Forced Vital Capacity (mL) - Random Slope Analysis Separately on Each Stratum - Least Square Means at Each Visit - No Background Therapy \\\\\n\\hline 14.2.13.2.1 to 14.2.13.2.2 & (EO1) Forced Vital Capacity (mL) - Random Slope Analysis Separately on Each Stratum - Least Square Means at Each Visit - Pirfenidone or Nintedanib \\\\\n\\hline 14.2.14.1 to 14.2.14.2 & (EO1) 6-Minute Walk Distance - Random Slope Analysis - Least Square Means at Each Visit \\\\\n\\hline 14.2.15.1.1 to 14.2.15.1.2 & (EO1) 6-Minute Walk Distance - Random Slope Analysis Separately on Each Stratum - 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