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Trial Periods & & Screening \\({ }^{1}\\) & Randomisation & \\multicolumn{8}{|c|}{Treatment} & End-oftreatment \\({ }^{2}\\) & Followup \\({ }^{2}\\) & End-of-trial premature discontinuation \\({ }^{3}\\) \\\\\n\\hline \\multicolumn{2}{|c|}{Visit number} & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 11X \\\\\n\\hline Timing of visit & Weeks & -2 & 0 & 2 & 4 & 6 & 8 & 12 & 16 & 20 & 24 & 26 & 31 & 26 \\\\\n\\hline Visit window & Days & & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & +5 & \\(\\pm 3\\) \\\\\n\\hline \\multicolumn{2}{|c|}{SUBJECT RELATED INFO/ASSESSMENTS} & & & & & & & & & & & & & \\\\\n\\hline Informed consent & & x & & & & & & & & & & & & \\\\\n\\hline In- and exclusion criteria & & x & x & & & & & & & & & & & \\\\\n\\hline Concomitant medication & & x & x & x & x & x & x & x & x & x & x & x & & x \\\\\n\\hline Concomitant illness & & x & & & & & & & & & & & & \\\\\n\\hline 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& x & x & & x \\\\\n\\hline \\(HbA _{1 c }\\) & & x & x & & x & & x & & x & & & x & & x \\\\\n\\hline Glucose metabolism & & & x & & X & & x & & x & & & x & & \\\\\n\\hline Lipids & & & x & & & & & & x & & & x & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline Trial Periods & & Screening \\({ }^{1}\\) & Randomisation & \\multicolumn{8}{|c|}{Treatment} & End-oftreatment \\({ }^{2}\\) & Followup \\({ }^{2}\\) & End-of-trial premature discontinuation \\({ }^{3}\\) \\\\\n\\hline \\multicolumn{2}{|c|}{Visit number} & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 11X \\\\\n\\hline Timing of visit & Weeks & -2 & 0 & 2 & 4 & 6 & 8 & 12 & 16 & 20 & 24 & 26 & 31 & 26 \\\\\n\\hline Visit window & Days & & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & +5 & \\(\\pm 3\\) \\\\\n\\hline \\multicolumn{2}{|c|}{SUBJECT RELATED INFO/ASSESSMENTS} & & & & & & & & & & & & & \\\\\n\\hline Informed consent & & x & & & & & & & & & & & & \\\\\n\\hline In- and exclusion criteria & & x & x & & & & & & & & & & & \\\\\n\\hline Concomitant medication & & x & x & x & x & x & x & x & x & x & x & x & & x \\\\\n\\hline Concomitant illness & & x & & & & & & & & & & & & \\\\\n\\hline Demography & & x & & & & & & & & & & & & \\\\\n\\hline Diagnosis of diabetes & & x & & & & & & & & & & & & \\\\\n\\hline Diabetes treatment history & & x & & & & & & & & & & & & \\\\\n\\hline Medical history & & x & & & & & & & & & & & & \\\\\n\\hline Smoking habits & & x & & & & & & & & & & & & \\\\\n\\hline History of gallbladder disease & & x & & & & & & & & & & & & \\\\\n\\hline History of cardiovascular disease & & x & & & & & & & & & & & & \\\\\n\\hline Renal impairment history & & x & & & & & & & & & & & & \\\\\n\\hline Randomisation & & & x & & & & & & & & & & & \\\\\n\\hline Withdrawal criteria & & & x & x & x & x & x & x & x & x & x & x & & \\\\\n\\hline 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Nordisk\n\\end{tabular}","confidence":0.4720017309862737,"confidence_rate":0.9967691415866393},{"cnt":[[497,401],[1858,401],[1858,2455],[497,2455]],"region":{"top_left_x":497,"top_left_y":400,"width":1362,"height":2055},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"008da98a823f49afaaa8ae69dfe8f1fc","type":"table","conversion_output":true,"parent_id":"f282d8453e7c401b8dfff995cd5aeeda","children_ids":["ff23ef29f2a9492ca103c109c682626e","9b3a3c3bdb564a11b91789a991f24d12","f725e16a5873424fbd14682a3111808b","7a51243768c947c7b4a638674db86692","71023bb8599a42efa6bf85baf987c45a","06a39bc6491541439c05652917d9762d","abcf99d8c32044ecbfee87d829569615","569edd769fbe4f40bfb4705f7b98c49f","879de85689de4f25bc97bcfdb0f463eb","329df7ac7ce348b18a783470cc1755c5","1c896ff24f5c423098e1ff10f1251d34","f5fa2a89d0934d2fbc03248f13a828b2","d05c545ea13948eca4100d6de7a8a05d","ba15b256ba7c4dbaa3048e8830dde1de","dd2afcc9b77c4214bac12889fa99b446","c89c678c4f684949ac3e272db353b424","98ac18a88bb14532983f9c4d8103a58d","a56ab1ca6b8a48e7bc1dbdfb60790d71","e8cf91ff7fb84c95918d0317170621d6","8a9f74fa6f3d4d6a9c88721b646d8e24","50fd878b1bd94a90a80ddb4d45b27dff","7fa2a63d083f4d20aa35f243da626923","c2b4e4537c924693b3541eef7af1d5b6","88583f1866154412a653e75cd9c6d0e2","d90a5022f76f4a2ea4b7375575f90034","856572fba1ea4b3faceaec03031ca960","682e3e9e06bc4282afc3738273d7952d","13b6b15722d9496eadf51a519c0b6eff","087cb6b23e47448487d1415a47994683","4532ceb0989f4ab8923068bc8fd8f530","8e87e2d0d59e4b298887c4e6f647d02a","f22bb5d821c84ddd9c4cf49f9a171d5c","a0b459ef4d814393a5322d222d3e4efb","1a13a2c4c7fc4718a596733eadc3a5d1","d61684ddc6cc4ce4b68da4c093a9c6e2","4a1cbcea667842fdb9e5c03222b9c307","ba4f4740acc0469c84d1811a12fe9209","571b3f3fa59c422eada6c1d8bf81df69","bddd6ba24284409ea5e94ef2d4603271","7fb78d2674a0439489aaffb2313535fd","7deea2213fb54cdf899c0ae7486a3211","46944dc4c58a434386c2e08cde5e1c92","09439040acce4eaca29b132ae941d494","09a3c5bffba6484096f3a944f192007c","90c6d19ce3684ea0b0fee6c937c73c90","d604d5c96a1849f58f33c4fadb360cfe","52ac8d171cb649958604bdef6cb03938","e230838a3ec14611b10385935857bbfa","5ba2470ee2184499a976f43f02d012ef","09dec5780c234e0a8a30f006bb3ca97b","a3d166caf40c4b0d9942d0a3f5b38e96","77f6e716f7274fa995bfafe36f82ed48","a37f3ff161a14b1cb39ef991ea04a26d","2ac9b12e67a34851b89d8ece0d6c0003","0bcc68bca8a8446fa5d8daf56d715600","0cdc08c5067c4badb5826cea655b4ddb","af9a8f29c550491c9b56c912b1edf26b","3ac94d68528b40ad912caeba77d7f707","582772421ff54c22a736578da1cd364b","7137aa420c514eeba9fc1be4518c6d2b","5496eb29957547448b4e95e9760705f1","9d5a5b7656304b96a72377b0af917b0e","a7ffd3708d8b4cfdae3eecaba9b58a02","8338a165115d4aceb24d70a1cab43f1d","c3f00b4c367544c59020645e2d4f0a85","d72579bd271041cf81f0707032994042","1c8f298a44d846e0bacb75c6ff505c02","41a2bf57fb3b403d8e1a86c1bb4b4ec1","4354e1b27f904190ac604e2e9b137c49","cff10d659e364a16b3c2d22e83f2a526","5960f88acbba47f9a49810928805b78d","67c20098ea5e4864b0002570b0763039","cca4346313d54754bbd3a5d78fcf79c7","88049920e7714a4aa8b9db58b7b2611b","6cd7dccbb30d43f997154eb75fe15e8b","9406cd7eb7eb4b79ac057e8680ae1206","5054352669284afab9a8534b803b25a6","21e66f0819d04438b5dbfc306f8d9ae5","e009cd0707c8442c9ee4395c069206a2","bb74efb386804b49822818f8da4f0531","2f55477a31014264909845ae12f3d49c","7a697757e1984778ab8b0c0346c13174","934715f3c0ba435592e0d4644e42df6f","79637659624044d89674993200d18a59","017f6ec7ee7c43318c4351a88d0903a6","a26d520006a34a26a8215b2b4f2fc829","ef9d9de5eb5947d0b1d828040222eebe","ef05387de73a48e690eab99ba05a9331","79c27472b0444424981dda9969fe984a","9aea700635ce49768a37f4c268a87808","f1575818c44d4c5b8b657484a3fc1313","ed1ec2ea927f40a6a813525a74aedfa0","ce3dddf07b374f96a6befb8b2625e02a","5a1c8528906f4458b391981cadd9b9e5","f6011c01cd8a402280691191e6e59e38","49e62ca7d90c4f6f8dcbe54cc812e247","af793da2c902457995cf9cc04f8b445a","3341c43959b448ed984ad5cdb6443d52","c466d0a1cc5e44c5b8de9be08759c6c5","45e52908f5064593b1c8c610d6822ef8","e15a6c56ef564bc09494d38fe3da6b5a","fbe06a190bf8453a9593953ba8cc8f37","33646f1410224e8bbecce94f7af0b9a1","f92f10f27c7040b5b4f1691e71b4bd48","c0c0568ec7674ea284d911165a0fcac8","aefa0f8f2cfa4eb49fbfa2d6fe091946","4585ba60159f495d950c9bcf3e42e6d9","75ef1e4ab9864f9f8cdf6a3c08663d8c","595d1fecc9764e8593559e8acc34cf6b","e2f8ff1baed34814aab761c5e29eac62","5ea6ec8438c048d292543af7b8ef6e25","2f521cdb52b14ff1a66b0346978b6c04","249cb1ae258f40bdaffa7c305535771b","462060c04160442fa6fa0d0c3f662e84","1821641001f745c9bf6af672a6a5fd26","454474f7fa2849788b467f4d68ee9d39","ebc473384c23421f8a3b548819ce5baa","350c170dce8448bc8666eb5234a651fe","0ed8acf04e814a47b71adec3f59ab53e","bfa6a748f84b41e59552f90a317ba140","3eb4146705d24d758b046214965c6b0d","3ebbec8964e64835b9e1a54f2f4d8da1","868d42ed10c3452ab9998e861f8dd24e","c8558650088b4853a03914a9d27d8ebe","38593c19f0c247918e4c9bda560967b4","7829cfa3b4da4bcc8c81f4cb6e64255f","2d95b4bf76ad4b70b6740e61f74b7af1","fb7975a832f8406a91bbc45e5c8e6a12","742d617d72c4473484968c4ee8189768","65e786290302435e8c871bd686c35a09","207a528bd8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\\multicolumn{2}{|c|}{Trial Periods} & Screening \\({ }^{1}\\) & Randomisation & \\multicolumn{8}{|c|}{Treatment} & End-oftreatment \\({ }^{2}\\) & Followup \\({ }^{2}\\) & End-of-trial premature discontinuation \\({ }^{3}\\) \\\\\n\\hline \\multicolumn{2}{|c|}{Visit number} & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 11X \\\\\n\\hline Timing of visit & Weeks & -2 & 0 & 2 & 4 & 6 & 8 & 12 & 16 & 20 & 24 & 26 & 31 & 26 \\\\\n\\hline Visit window & Days & & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & +5 & \\(\\pm 3\\) \\\\\n\\hline \\multicolumn{2}{|c|}{SUBJECT RELATED INFO/ASSESSMENTS} & & & & & & & & & & & & & \\\\\n\\hline PRO questionnaire & & & x & & & & & & & & & x & & \\\\\n\\hline \\multicolumn{2}{|c|}{SAFETY} & & & & & & & & & & & & & \\\\\n\\hline Adverse events & & & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Hypoglycaemic episodes & & & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline ECG, overall interpretation \\({ }^{4}\\) & & & x & & & & & & & & & x & & \\\\\n\\hline Fundoscopy/fundus photography & & & x & & & & & & & & & & & \\\\\n\\hline Physical examination & & x & & & & & & & & & & x & & \\\\\n\\hline Vital signs & & x & x & x & x & x & x & x & x & x & x & x & & \\\\\n\\hline Antibodies \\({ }^{5}\\) & & & x & & & & & & x & & & x & x & \\\\\n\\hline Biochemistry & & & x & & & & & & x & & & x & & \\\\\n\\hline Creatinine & & x & & & & & & & x & & & x & & \\\\\n\\hline Calcitonin & & x & & & & & & & x & & & x & & \\\\\n\\hline Haematology & & & x & & & & & & x & & & x & & \\\\\n\\hline PK sampling & & & & x & x & x & x & x & x & x & x & x & & \\\\\n\\hline PK sampling (trough + peak) \\({ }^{6}\\) & & & & & x & & & & x & & & x & & \\\\\n\\hline Blood pregnancy test \\({ }^{7}\\) & & x & x & & x & & x & x & x & x & x & x & x & x \\\\\n\\hline Urinalysis & & & x & & & & & & x & & & x & & \\\\\n\\hline \\multicolumn{2}{|c|}{TRIAL MATERIAL} & & & & & & & & & & & & & \\\\\n\\hline IV/IWRS call & & x & x & x & x & x & x & x & x & x & x & x & & \\\\\n\\hline Dispensing visit & & & x & x & x & x & x & x & x & x & x & & & \\\\\n\\hline Hand out directions for use of s.c. trial product & & & x & x & x & x & x & x & x & x & x & & & \\\\\n\\hline Drug accountability & & & & x & x & x & x & x & x & x & x & x & & \\\\\n\\hline \\multicolumn{2}{|r|}{REMINDERS} & & & & & & & & & & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multicolumn{2}{|c|}{Trial Periods} & Screening \\({ }^{1}\\) & Randomisation & \\multicolumn{8}{|c|}{Treatment} & End-oftreatment \\({ }^{2}\\) & Followup \\({ }^{2}\\) & End-of-trial premature discontinuation \\({ }^{3}\\) \\\\\n\\hline \\multicolumn{2}{|c|}{Visit number} & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 11X \\\\\n\\hline Timing of visit & Weeks & -2 & 0 & 2 & 4 & 6 & 8 & 12 & 16 & 20 & 24 & 26 & 31 & 26 \\\\\n\\hline Visit window & Days & & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 5\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & +5 & \\(\\pm 3\\) \\\\\n\\hline \\multicolumn{2}{|c|}{SUBJECT RELATED INFO/ASSESSMENTS} & & & & & & & & & & & & & \\\\\n\\hline PRO questionnaire & & & x & & & & & & & & & x & & \\\\\n\\hline \\multicolumn{2}{|c|}{SAFETY} & & & & & & & & & & & & & \\\\\n\\hline Adverse events & & & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Hypoglycaemic episodes & & & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline ECG, overall interpretation \\({ }^{4}\\) & & & x & & & & & & & & & x & & \\\\\n\\hline Fundoscopy/fundus photography & & & x & & & & & & & & & & & \\\\\n\\hline Physical examination & & x & & & & & & & & & & x & & \\\\\n\\hline Vital signs & & x & x & x & x & x & x & x & x & x & x & x & & \\\\\n\\hline Antibodies \\({ }^{5}\\) & & & x & & & & & & x & & & x & x & 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Due to the beneficial effects of GLP-1 on both glycaemic and weight control, treatment of","confidence":0.99609375,"confidence_rate":0.9999620016994184},{"cnt":[[327,1719],[1274,1719],[1274,1762],[327,1762]],"region":{"top_left_x":326,"top_left_y":1718,"width":949,"height":44},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36007f5107a849648c7d931421d1c928","type":"text","conversion_output":true,"text":"T2D patients with GLP-1 analogues is considered favourable.","text_display":" T2D patients with GLP-1 analogues is considered favourable.","confidence":1,"confidence_rate":1},{"cnt":[[322,1805],[849,1805],[849,1850],[322,1850]],"region":{"top_left_x":322,"top_left_y":1804,"width":527,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac91a86656424d8e92119cad9ee0a373","type":"section_header","conversion_output":false,"children_ids":["c8768ff3052e438381a899d72de9548b"],"text":"","text_display":""},{"cnt":[[327,1809],[844,1809],[844,1850],[327,1850]],"region":{"top_left_x":326,"top_left_y":1808,"width":519,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8768ff3052e438381a899d72de9548b","type":"text","conversion_output":true,"parent_id":"ac91a86656424d8e92119cad9ee0a373","text":"3.2 Semaglutide and SNAC","text_display":"\n\n\\subsection*{3.2 Semaglutide and SNAC}","confidence":0.99853515625,"confidence_rate":0.9999494523919701},{"cnt":[[327,1876],[1781,1876],[1781,1916],[327,1916]],"region":{"top_left_x":326,"top_left_y":1875,"width":1456,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0586d311ff48470ca43b4531a8e37c98","type":"text","conversion_output":true,"text":"Semaglutide is a long-acting GLP-1 analogue that has achieved clinical proof of concept when","text_display":"\n\nSemaglutide is a long-acting GLP-1 analogue that has achieved clinical proof of concept when","confidence":1,"confidence_rate":1},{"cnt":[[327,1921],[1846,1921],[1846,1966],[327,1966]],"region":{"top_left_x":326,"top_left_y":1920,"width":1520,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c974c6a1f20e4b94b71c1a56b0c040de","type":"text","conversion_output":true,"text":"administered subcutaneously (s.c.). Currently, semaglutide is in clinical development (NN9535) as","text_display":" administered subcutaneously (s.c.). Currently, semaglutide is in clinical development (NN9535) as","confidence":1,"confidence_rate":1},{"cnt":[[327,1972],[1678,1972],[1678,2013],[327,2013]],"region":{"top_left_x":326,"top_left_y":1972,"width":1352,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e28410e28bcf434baceb59e583ad1e6a","type":"text","conversion_output":true,"text":"a once-weekly s.c. injection for the treatment of T2D. The NN9535 project is in phase 3","text_display":" a once-weekly s.c. injection for the treatment of T2D. The NN9535 project is in phase 3","confidence":1,"confidence_rate":1},{"cnt":[[327,2020],[1865,2020],[1865,2060],[327,2060]],"region":{"top_left_x":326,"top_left_y":2019,"width":1539,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d3c5c3a7cf845648bf099a193f57228","type":"text","conversion_output":true,"text":"development, encompassing six major safety and efficacy trials (see Section 3.2.3.2 for clinical data","text_display":" development, encompassing six major safety and efficacy trials (see Section 3.2.3.2 for clinical data","confidence":1,"confidence_rate":1},{"cnt":[[327,2069],[642,2069],[642,2110],[327,2110]],"region":{"top_left_x":326,"top_left_y":2068,"width":317,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"030095fd3beb42bb8872edc25f75790b","type":"text","conversion_output":true,"text":"on s.c. semaglutide).","text_display":" on s.c. semaglutide).","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[327,2155],[1837,2155],[1837,2196],[327,2196]],"region":{"top_left_x":326,"top_left_y":2154,"width":1511,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f321c7135f694612a830c3f7a2d20e8a","type":"text","conversion_output":true,"text":"Oral administration inherently represents a different absorption route to reach systemic circulation","text_display":"\n\nOral administration inherently represents a different absorption route to reach systemic circulation","confidence":1,"confidence_rate":1},{"cnt":[[327,2204],[821,2204],[821,2245],[327,2245]],"region":{"top_left_x":326,"top_left_y":2204,"width":495,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2fb6c0e50bb94b8cba730ab6b0528e18","type":"text","conversion_output":true,"text":"compared to s.c. administration.","text_display":" compared to s.c. administration.","confidence":1,"confidence_rate":1},{"cnt":[[327,2290],[1669,2290],[1669,2331],[327,2331]],"region":{"top_left_x":326,"top_left_y":2290,"width":1344,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6be5463e4ff648e58c2d53a692de304c","type":"text","conversion_output":true,"text":"Native GLP-1 and GLP-1 analogues have in general very low oral bioavailability when","text_display":"\n\nNative GLP-1 and GLP-1 analogues have in general very low oral bioavailability when","confidence":1,"confidence_rate":1},{"cnt":[[327,2342],[1798,2342],[1798,2383],[327,2383]],"region":{"top_left_x":326,"top_left_y":2341,"width":1473,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06a0f81b520f4ce5aaa22f42a6bd5b68","type":"text","conversion_output":true,"text":"administered in a formulation without absorption enhancement. Formulation with an absorption","text_display":" administered in a formulation without absorption enhancement. Formulation with an absorption","confidence":1,"confidence_rate":1},{"cnt":[[327,2389],[1790,2389],[1790,2430],[327,2430]],"region":{"top_left_x":326,"top_left_y":2389,"width":1464,"height":41},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"76e6457cb6914ef3b7d23000752d20ce","type":"text","conversion_output":true,"text":"enhancing excipient is therefore needed to increase the oral bioavailability. However, exposure","text_display":" enhancing excipient is therefore needed to increase the oral bioavailability. However, exposure","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-020","page":20,"lines":[{"cnt":[[322,262],[428,262],[428,294],[322,294]],"region":{"top_left_x":322,"top_left_y":262,"width":106,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d5234b1d9b594acfbee3357d0670e3e0","type":"page_info","conversion_output":false,"text":"Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[922,258],[1751,258],[1751,397],[922,397]],"region":{"top_left_x":921,"top_left_y":257,"width":830,"height":141},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1905896313644ed98cceb0ded5ada7d9","type":"table","conversion_output":true,"text":"\\begin{tabular}{l|lr|} \n& Date: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 18 of 98\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{l|lr|} \n& Date: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 18 of 98\n\\end{tabular}","confidence":0.5080517991370015,"confidence_rate":0.994419169285051},{"cnt":[[1766,262],[1940,262],[1940,290],[1766,290]],"region":{"top_left_x":1766,"top_left_y":262,"width":175,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ca5b9553912f4100a7dc0b52f0d45316","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,296],[608,296],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":296,"width":287,"height":33},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4114c913a36b418f87d680e0ab6302cb","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,329],[621,329],[621,363],[322,363]],"region":{"top_left_x":322,"top_left_y":328,"width":299,"height":36},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7a6de1fb39344a2d9c8e5a7ddf8891d8","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[694,361],[694,393],[322,393]],"region":{"top_left_x":322,"top_left_y":360,"width":372,"height":34},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8c562168b0064e1dbdf5cf628c209d39","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,481],[1869,481],[1869,526],[322,526]],"region":{"top_left_x":322,"top_left_y":481,"width":1548,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5faa0877ff8b4696a32ed1851bf429de","type":"text","conversion_output":true,"text":"exhibits a substantially greater dose-to-dose variation following oral administration compared to s.c.","text_display":"\nexhibits a substantially greater dose-to-dose variation following oral administration compared to s.c.","confidence":1,"confidence_rate":1},{"cnt":[[322,529],[1867,529],[1867,574],[322,574]],"region":{"top_left_x":322,"top_left_y":528,"width":1545,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fc87e4be3b045b5bc42d694f8371683","type":"text","conversion_output":true,"text":"administration. 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The initial side effects like","text_display":"daily administration, limit the variation in steady state plasma exposure. The initial side effects like","confidence":1,"confidence_rate":1},{"cnt":[[322,672],[1755,672],[1755,720],[322,720]],"region":{"top_left_x":322,"top_left_y":672,"width":1434,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52850a2c3de2402cba954951b139395d","type":"text","conversion_output":true,"text":"nausea may therefore be low or absent following gradual dose escalation. Food interaction is","text_display":" nausea may therefore be low or absent following gradual dose escalation. Food interaction is","confidence":1,"confidence_rate":1},{"cnt":[[322,722],[1803,722],[1803,769],[322,769]],"region":{"top_left_x":322,"top_left_y":721,"width":1481,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e79a314aa713487689b72098b3480f10","type":"text","conversion_output":true,"text":"expected to limit absorption, but a long-acting GLP-1 analogue product will allow dosing in the","text_display":" expected to limit absorption, but a long-acting GLP-1 analogue product will allow dosing in the","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[322,769],[1751,769],[1751,819],[322,819]],"region":{"top_left_x":322,"top_left_y":769,"width":1429,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a13b66634784e58be862ccc61e976d5","type":"text","conversion_output":true,"text":"fasting state, without compromising the effective plasma profile. In addition, GLP-1 therapy","text_display":" fasting state, without compromising the effective plasma profile. In addition, GLP-1 therapy","confidence":1,"confidence_rate":1},{"cnt":[[322,819],[1687,819],[1687,866],[322,866]],"region":{"top_left_x":322,"top_left_y":818,"width":1365,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c697cd5876994c94bf286bb81f2fdd52","type":"text","conversion_output":true,"text":"generally does not induce hypoglycaemia on its own, which potentially could have been","text_display":" generally does not induce hypoglycaemia on its own, which potentially could have been","confidence":1,"confidence_rate":1},{"cnt":[[322,868],[1371,868],[1371,917],[322,917]],"region":{"top_left_x":322,"top_left_y":867,"width":1049,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0be3414dee4c44f2bb45e13fe7198555","type":"text","conversion_output":true,"text":"problematic given the large intra-patient plasma exposure variation.","text_display":" problematic given the large intra-patient plasma exposure variation.","confidence":0.9990234375,"confidence_rate":0.999986615984802},{"cnt":[[322,954],[1865,954],[1865,1003],[322,1003]],"region":{"top_left_x":322,"top_left_y":953,"width":1543,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44ee8a578eb44116b7471d95dc13f044","type":"text","conversion_output":true,"text":"Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate / salcaprozate sodium (SNAC) has been studied","text_display":"\n\nSodium N-[8-(2-hydroxybenzoyl) amino] caprylate / salcaprozate sodium (SNAC) has been studied","confidence":1,"confidence_rate":1},{"cnt":[[322,1003],[1869,1003],[1869,1051],[322,1051]],"region":{"top_left_x":322,"top_left_y":1003,"width":1548,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df1e6be774e2426cb57119d4e9769ccb","type":"text","conversion_output":true,"text":"in combination with acyclovir, peptide tyrosine tyrosine (PYY), cromolyn, ibandronate and heparin.","text_display":" in combination with acyclovir, peptide tyrosine tyrosine (PYY), cromolyn, ibandronate and heparin.","confidence":1,"confidence_rate":1},{"cnt":[[322,1053],[1790,1053],[1790,1102],[322,1102]],"region":{"top_left_x":322,"top_left_y":1052,"width":1468,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67f086241d4341dd9fcb2fb82659c7fd","type":"text","conversion_output":true,"text":"Impact on metformin when co-administering SNAC and metformin was investigated as part of","text_display":" Impact on metformin when co-administering SNAC and metformin was investigated as part of","confidence":1,"confidence_rate":1},{"cnt":[[322,1100],[1738,1100],[1738,1147],[322,1147]],"region":{"top_left_x":322,"top_left_y":1100,"width":1417,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65472b97d40140c4a6b2a9f486637c43","type":"text","conversion_output":true,"text":"another trial involving healthy volunteers. The trial did not show any increase in metformin","text_display":" another trial involving healthy volunteers. The trial did not show any increase in metformin","confidence":1,"confidence_rate":1},{"cnt":[[322,1143],[1760,1143],[1760,1197],[322,1197]],"region":{"top_left_x":322,"top_left_y":1142,"width":1438,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1abe807bb5a40b6bbd63458b8eae501","type":"text","conversion_output":true,"text":"exposure when adding SNAC \\({ }^{\\underline{3}}\\). When co-formulated with SNAC, exposure of ibandronate (a","text_display":" exposure when adding SNAC \\({ }^{\\underline{3}}\\). When co-formulated with SNAC, exposure of ibandronate (a","confidence":0.7243764400482178,"confidence_rate":0.9969043775341908},{"cnt":[[322,1197],[1865,1197],[1865,1246],[322,1246]],"region":{"top_left_x":322,"top_left_y":1196,"width":1543,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94efe9c1f7cb448bafe51dcd17d8b40c","type":"text","conversion_output":true,"text":"nitrogen-containing bisphosphonate), is increased by 11 - and 17 -fold (AUC and \\(C _{\\text {max }}\\), respectively).","text_display":" nitrogen-containing bisphosphonate), is increased by 11 - and 17 -fold (AUC and \\(C _{\\text {max }}\\), respectively).","confidence":0.6171843940876443,"confidence_rate":0.9962946706311466},{"cnt":[[322,1246],[1841,1246],[1841,1296],[322,1296]],"region":{"top_left_x":322,"top_left_y":1246,"width":1520,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b08679b978964a2281b031bb9fa25817","type":"text","conversion_output":true,"text":"On the other hand, when co-administered with SNAC (in separate formulations) exposure was not","text_display":" On the other hand, when co-administered with SNAC (in separate formulations) exposure was not","confidence":1,"confidence_rate":1},{"cnt":[[322,1293],[1841,1293],[1841,1343],[322,1343]],"region":{"top_left_x":322,"top_left_y":1293,"width":1520,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d7f080754794026887b5ac08d1e7db6","type":"text","conversion_output":true,"text":"affected compared to dosing ibandronate without SNAC, suggesting that the drug-drug interaction","text_display":" affected compared to dosing ibandronate without SNAC, suggesting that the drug-drug interaction","confidence":1,"confidence_rate":1},{"cnt":[[322,1343],[1813,1343],[1813,1390],[322,1390]],"region":{"top_left_x":322,"top_left_y":1342,"width":1492,"height":49},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2832401d4ee4803913f74429c12c10d","type":"text","conversion_output":true,"text":"potential between SNAC and co-administered drugs with comparable physiochemical properties","text_display":" potential between SNAC and co-administered drugs with comparable physiochemical properties","confidence":1,"confidence_rate":1},{"cnt":[[322,1386],[1231,1386],[1231,1439],[322,1439]],"region":{"top_left_x":322,"top_left_y":1385,"width":910,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ee606f923534fa0b9939ed5057c24eb","type":"text","conversion_output":true,"text":"(compounds with permeability limited absorption) is low \\({ }^{4}\\).","text_display":" (compounds with permeability limited absorption) is low \\({ }^{4}\\).","confidence":0.99951171875,"confidence_rate":0.9999934000150488},{"cnt":[[322,1478],[1766,1478],[1766,1525],[322,1525]],"region":{"top_left_x":322,"top_left_y":1478,"width":1445,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e28ada22d64d44ceb62757e1ef760ed5","type":"text","conversion_output":true,"text":"The most extensive safety and PK data are available from the heparin formulated with SNAC","text_display":"\n\nThe most extensive safety and PK data are available from the heparin formulated with SNAC","confidence":1,"confidence_rate":1},{"cnt":[[322,1525],[1777,1525],[1777,1575],[322,1575]],"region":{"top_left_x":322,"top_left_y":1525,"width":1455,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e72b3c6564f14df78a6ad3fde81c9122","type":"text","conversion_output":true,"text":"programme including 32 phase 1 studies (daily SNAC doses ranged from \\(0.172 g-10.5 g\\) ) of","text_display":" programme including 32 phase 1 studies (daily SNAC doses ranged from \\(0.172 g-10.5 g\\) ) of","confidence":1,"confidence_rate":1},{"cnt":[[322,1575],[1833,1575],[1833,1622],[322,1622]],"region":{"top_left_x":322,"top_left_y":1574,"width":1511,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1225c415707d41a89836f38e59397c92","type":"text","conversion_output":true,"text":"which three investigated SNAC alone. 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However this was not the case","confidence":1,"confidence_rate":1},{"cnt":[[322,688],[1867,688],[1867,737],[322,737]],"region":{"top_left_x":322,"top_left_y":687,"width":1545,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3dd0f98dd6f4b51805c8442ed4b4869","type":"text","conversion_output":true,"text":"in other species including a 52-week repeat dose study in non-human primates at exposure levels up","text_display":" in other species including a 52-week repeat dose study in non-human primates at exposure levels up","confidence":0.59228515625,"confidence_rate":0.9949277900665464},{"cnt":[[322,735],[1811,735],[1811,784],[322,784]],"region":{"top_left_x":322,"top_left_y":734,"width":1490,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a51fcdd9896f4480ad319d8ac668b0a0","type":"text","conversion_output":true,"text":"to 36 -fold above the expected clinical exposure. 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The effect on rat embryo","confidence":1,"confidence_rate":1},{"cnt":[[322,1323],[1846,1323],[1846,1371],[322,1371]],"region":{"top_left_x":322,"top_left_y":1323,"width":1524,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0af3348d997c4eeabf8804aff45a3d72","type":"text","conversion_output":true,"text":"foetal development is therefore not likely to be relevant to humans. Preliminary and main embryo-","text_display":"foetal development is therefore not likely to be relevant to humans. Preliminary and main embryo","confidence":1,"confidence_rate":1},{"cnt":[[322,1371],[1717,1371],[1717,1420],[322,1420]],"region":{"top_left_x":322,"top_left_y":1370,"width":1395,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82018332136d412f9247b252efd4c5b6","type":"text","conversion_output":true,"text":"foetal development (EFD) and pre- and postnatal development (PPND) studies with doses","text_display":"foetal development (EFD) and pre- and postnatal development (PPND) studies with doses","confidence":1,"confidence_rate":1},{"cnt":[[322,1420],[1854,1420],[1854,1467],[322,1467]],"region":{"top_left_x":322,"top_left_y":1420,"width":1533,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e57ebf1b08342c9a985fd3d2fd45f2f","type":"text","conversion_output":true,"text":"corresponding to 7-fold expected clinical exposure in cynomolgus monkeys have been finalised. In","text_display":" corresponding to 7-fold expected clinical exposure in cynomolgus monkeys have been finalised. In","confidence":0.994140625,"confidence_rate":0.9999418174502049},{"cnt":[[322,1470],[1837,1470],[1837,1517],[322,1517]],"region":{"top_left_x":322,"top_left_y":1469,"width":1515,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e5f226ea6b44d87b50f12d0ebd4d073","type":"text","conversion_output":true,"text":"the main EFD study sporadic abnormalities were reported across all dose groups and in the PPND","text_display":" the main EFD study sporadic abnormalities were reported across all dose groups and in the PPND","confidence":1,"confidence_rate":1},{"cnt":[[322,1517],[1815,1517],[1815,1566],[322,1566]],"region":{"top_left_x":322,"top_left_y":1516,"width":1494,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6879bd3a67a04d5f83c35991aea67fbb","type":"text","conversion_output":true,"text":"study a dose dependent increase in early pregnancy losses were observed. The findings observed","text_display":" study a dose dependent increase in early pregnancy losses were observed. The findings observed","confidence":1,"confidence_rate":1},{"cnt":[[322,1566],[1760,1566],[1760,1613],[322,1613]],"region":{"top_left_x":322,"top_left_y":1566,"width":1438,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53177ba7db7c4f0cb075e7519220c4d5","type":"text","conversion_output":true,"text":"across the three studies in cynomolgus monkeys are not indicative of teratogenic potential of","text_display":" across the three studies in cynomolgus monkeys are not indicative of teratogenic potential of","confidence":1,"confidence_rate":1},{"cnt":[[322,1611],[1858,1611],[1858,1663],[322,1663]],"region":{"top_left_x":322,"top_left_y":1611,"width":1537,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ca9bdd8f88e46b892a76f834bfb8b2d","type":"text","conversion_output":true,"text":"semaglutide in this species. The increase in early pregnancy losses is indicative of embryo-toxicity,","text_display":" semaglutide in this species. The increase in early pregnancy losses is indicative of embryo-toxicity,","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[322,1663],[1704,1663],[1704,1712],[322,1712]],"region":{"top_left_x":322,"top_left_y":1662,"width":1382,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7452e1cbae6b4daf96e0e90943c042d6","type":"text","conversion_output":true,"text":"which may be related to the maternal effect of semaglutide (marked body weight loss). A","text_display":" which may be related to the maternal effect of semaglutide (marked body weight loss). A","confidence":1,"confidence_rate":1},{"cnt":[[322,1710],[1766,1710],[1766,1760],[322,1760]],"region":{"top_left_x":322,"top_left_y":1710,"width":1445,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"994dd2d6a2ba431089e212554437a6b6","type":"text","conversion_output":true,"text":"developmental toxicity NOAEL was determined at an exposure 0.8 -fold the expected clinical","text_display":" developmental toxicity NOAEL was determined at an exposure 0.8 -fold the expected clinical","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[322,1757],[1871,1757],[1871,1809],[322,1809]],"region":{"top_left_x":322,"top_left_y":1757,"width":1550,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"667a85bf2d604067a43930ed87ab9465","type":"text","conversion_output":true,"text":"exposure ( \\(1 mg /\\) week ). A risk for the developing human embryo or foetus cannot be definitely ruled","text_display":" exposure ( \\(1 mg /\\) week ). A risk for the developing human embryo or foetus cannot be definitely ruled","confidence":0.7405439379019391,"confidence_rate":0.9973686408162228},{"cnt":[[322,1809],[1745,1809],[1745,1858],[322,1858]],"region":{"top_left_x":322,"top_left_y":1808,"width":1423,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"536ae4eddaeb47668464a177c6ab47ec","type":"text","conversion_output":true,"text":"out, but the absence of findings indicative of teratogenicity in the EFD and PPND studies in","text_display":" out, but the absence of findings indicative of teratogenicity in the EFD and PPND studies in","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[322,1856],[1119,1856],[1119,1906],[322,1906]],"region":{"top_left_x":322,"top_left_y":1856,"width":798,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4835c6b1f536405ab2faffb1f9040637","type":"text","conversion_output":true,"text":"cynomolgus monkey decrease the level of concern.","text_display":" cynomolgus monkey decrease the level of concern.","confidence":0.998046875,"confidence_rate":0.9999631132306015},{"cnt":[[322,1944],[1725,1944],[1725,1992],[322,1992]],"region":{"top_left_x":322,"top_left_y":1944,"width":1404,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b37092b9606e47f2a51bf8a8b3e1184d","type":"text","conversion_output":true,"text":"A comprehensive review of results from the non-clinical studies can be found in the IB for","text_display":"\n\nA comprehensive review of results from the non-clinical studies can be found in the IB for","confidence":1,"confidence_rate":1},{"cnt":[[322,1987],[1751,1987],[1751,2039],[322,2039]],"region":{"top_left_x":322,"top_left_y":1987,"width":1429,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27a53f2af4344cb49fe29e88e1abccb9","type":"text","conversion_output":true,"text":"Semaglutide (subcutaneous administration), Edition \\(8^{\\frac{5}{}}\\) and the IB for Oral administration of","text_display":" Semaglutide (subcutaneous administration), Edition \\(8^{\\frac{5}{}}\\) and the IB for Oral administration of","confidence":0.8108527189772303,"confidence_rate":0.9981128743462316},{"cnt":[[322,2037],[1412,2037],[1412,2090],[322,2090]],"region":{"top_left_x":322,"top_left_y":2036,"width":1090,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1669cc3eb184631bc97f0f0b906bf64","type":"text","conversion_output":true,"text":"semaglutide (NN9924), Edition \\(5^{\\underline{6}}\\), or any updates of these documents","text_display":" semaglutide (NN9924), Edition \\(5^{\\underline{6}}\\), or any updates of these documents","confidence":0.5364492610096931,"confidence_rate":0.992784491458794},{"cnt":[[318,2125],[834,2125],[834,2181],[318,2181]],"region":{"top_left_x":317,"top_left_y":2124,"width":517,"height":57},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e449ff5125bf4e6086327aa3d78ea78b","type":"section_header","conversion_output":false,"children_ids":["95aad510521946d29a0f9c3f4b7f556e"],"text":"","text_display":""},{"cnt":[[322,2131],[831,2131],[831,2176],[322,2176]],"region":{"top_left_x":322,"top_left_y":2131,"width":510,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95aad510521946d29a0f9c3f4b7f556e","type":"text","conversion_output":true,"parent_id":"e449ff5125bf4e6086327aa3d78ea78b","text":"3.2.1.3 SNAC toxicology","text_display":"\n\n\\subsection*{3.2.1.3 SNAC toxicology}","confidence":1,"confidence_rate":1},{"cnt":[[322,2191],[1818,2191],[1818,2239],[322,2239]],"region":{"top_left_x":322,"top_left_y":2191,"width":1496,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1320bd5bc0c44b0c9281b6baec724325","type":"text","conversion_output":true,"text":"The nonclinical safety programme for SNAC includes safety pharmacology, metabolism and PK","text_display":"\n\nThe nonclinical safety programme for SNAC includes safety pharmacology, metabolism and PK","confidence":1,"confidence_rate":1},{"cnt":[[322,2234],[1824,2234],[1824,2288],[322,2288]],"region":{"top_left_x":322,"top_left_y":2234,"width":1503,"height":55},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"553ad16835c44efeb942c1c08ba00816","type":"text","conversion_output":true,"text":"and toxicology and is in line with the ICH M3 guideline \\({ }^{7}\\). SNAC was developed as an absorption","text_display":" and toxicology and is in line with the ICH M3 guideline \\({ }^{7}\\). SNAC was developed as an absorption","confidence":1,"confidence_rate":1},{"cnt":[[322,2288],[1192,2288],[1192,2335],[322,2335]],"region":{"top_left_x":322,"top_left_y":2288,"width":871,"height":48},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3d86a98e68d4455b1d1dc0a0ebb464f","type":"text","conversion_output":true,"text":"enhancing excipient for the oral route of administration.","text_display":" enhancing excipient for the oral route of 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2012-004994-16","confidence":1,"confidence_rate":1},{"cnt":[[920,299],[1154,299],[1154,342],[920,342]],"region":{"top_left_x":919,"top_left_y":298,"width":235,"height":44},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1e102714d89342ddb466027613d19f86","type":"text","conversion_output":true,"text":"GONFIDENTIAL","text_display":"\n\nGONFIDENTIAL","confidence":0.9033203125,"confidence_rate":0.9940367881206835},{"cnt":[[1242,254],[1751,254],[1751,402],[1242,402]],"region":{"top_left_x":1241,"top_left_y":253,"width":510,"height":149},"line":7,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a95f7dec8deb495db54f40fc9d7d1cba","type":"table","conversion_output":true,"text":"\\begin{tabular}{|lr|} \nDate: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 20 of 98\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|lr|} \nDate: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 20 of 98\n\\end{tabular}","confidence":0.8778769257478416,"confidence_rate":0.9988873812073188},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":8,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a1608b849b0d4c158dc84410175c2405","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,477],[1871,477],[1871,529],[322,529]],"region":{"top_left_x":322,"top_left_y":476,"width":1550,"height":53},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53a49c97e0a14a4f8a7705b4b4aa8ecd","type":"text","conversion_output":true,"text":"SNAC is rapidly absorbed (time to maximal concentration ( \\(t _{\\max }\\) ) within 1 hour) and eliminated ( \\(t _{1 / 2}=\\)","text_display":"\n\nSNAC is rapidly absorbed (time to maximal concentration ( \\(t _{\\max }\\) ) within 1 hour) and eliminated ( \\(t _{1 / 2}=\\)","confidence":0.8366052675474319,"confidence_rate":0.9986793696628432},{"cnt":[[322,526],[1803,526],[1803,578],[322,578]],"region":{"top_left_x":322,"top_left_y":526,"width":1481,"height":52},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71b9eae2db1845a68e33dd392db5c56d","type":"text","conversion_output":true,"text":"1 and 3 hours across species). SNAC is metabolised mainly via stepwise beta-oxidation and de-","text_display":" 1 and 3 hours across species). SNAC is metabolised mainly via stepwise beta-oxidation and de","confidence":1,"confidence_rate":1},{"cnt":[[322,576],[1858,576],[1858,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":1537,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb7230f58eb24ff4a466f2b03482780d","type":"text","conversion_output":true,"text":"acetylation of the side chain and the parent compound and its metabolites also undergo conjugation","text_display":"acetylation of the side chain and the parent compound and its metabolites also undergo conjugation","confidence":1,"confidence_rate":1},{"cnt":[[322,623],[1813,623],[1813,672],[322,672]],"region":{"top_left_x":322,"top_left_y":623,"width":1492,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e95c3ac8b7ab400f9461527a15c0a13b","type":"text","conversion_output":true,"text":"with glucuronic acid. The main elimination route for SNAC metabolites is via urinary excretion.","text_display":" with glucuronic acid. The main elimination route for SNAC metabolites is via urinary excretion.","confidence":1,"confidence_rate":1},{"cnt":[[322,709],[1863,709],[1863,761],[322,761]],"region":{"top_left_x":322,"top_left_y":708,"width":1541,"height":53},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"971d1ff38b484e1b92794870ecda37e9","type":"text","conversion_output":true,"text":"SNAC was generally well tolerated in animals at and below oral doses of \\(500 mg / kg /\\) day (NOAEL)","text_display":"\n\nSNAC was generally well tolerated in animals at and below oral doses of \\(500 mg / kg /\\) day (NOAEL)","confidence":0.9678957462310791,"confidence_rate":0.9996950848355185},{"cnt":[[322,758],[1852,758],[1852,810],[322,810]],"region":{"top_left_x":322,"top_left_y":758,"width":1530,"height":52},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ef68174b8aca4d0f9eaaac222f81a69a","type":"text","conversion_output":true,"text":"for up to nine (Rhesus monkey) and twelve (rat) months. Although no overt specific organ toxicity","text_display":" for up to nine (Rhesus monkey) and twelve (rat) months. Although no overt specific organ toxicity","confidence":1,"confidence_rate":1},{"cnt":[[322,808],[625,808],[625,857],[322,857]],"region":{"top_left_x":322,"top_left_y":807,"width":304,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d229c58adaef48fcb5f247cf5aeedce0","type":"text","conversion_output":true,"text":"has been observed,","text_display":" has been observed,","confidence":1,"confidence_rate":1},{"cnt":[[327,849],[1162,849],[1162,913],[327,913]],"region":{"top_left_x":326,"top_left_y":848,"width":837,"height":66},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dccdb0b542514270853fe6eee3f4f0d1","type":"form_field","conversion_output":true,"text":"","text_display":"\n□","subtype":"box"},{"cnt":[[1147,855],[1807,855],[1807,907],[1147,907]],"region":{"top_left_x":1147,"top_left_y":855,"width":660,"height":52},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8c3c82fd46343918e69d6c66e63f9fa","type":"text","conversion_output":true,"text":". A series of nonclinical studies to explore","text_display":" . A series of nonclinical studies to explore","confidence":0.5869140625,"confidence_rate":0.989183881265599},{"cnt":[[322,907],[1777,907],[1777,956],[322,956]],"region":{"top_left_x":322,"top_left_y":906,"width":1455,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27a146bb035e445184d16899ddee3b3e","type":"text","conversion_output":true,"text":"possible cause of death have been initiated. These studies include investigations to expand the","text_display":" possible cause of death have been initiated. These studies include investigations to expand the","confidence":1,"confidence_rate":1},{"cnt":[[322,954],[1674,954],[1674,1003],[322,1003]],"region":{"top_left_x":322,"top_left_y":953,"width":1352,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e44922ebfb6f45fab6cdef1e4a4db4c4","type":"text","conversion_output":true,"text":"standard package of nonclinical studies on CV and respiratory function, and systematic","text_display":" standard package of nonclinical studies on CV and respiratory function, and systematic","confidence":1,"confidence_rate":1},{"cnt":[[322,1003],[1592,1003],[1592,1051],[322,1051]],"region":{"top_left_x":322,"top_left_y":1003,"width":1270,"height":48},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2460361cf84463fa07f85544a0d6331","type":"text","conversion_output":true,"text":"investigations of histological changes in the GI tract and liver after dosing of high","text_display":" investigations of histological changes in the GI tract and liver after dosing of high","confidence":1,"confidence_rate":1},{"cnt":[[322,1051],[1863,1051],[1863,1102],[322,1102]],"region":{"top_left_x":322,"top_left_y":1050,"width":1541,"height":53},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d9ad77373f040ce970a495c8f186182","type":"text","conversion_output":true,"text":"concentration/high volumes of SNAC. To support the assessment of exposure margins between rats","text_display":" concentration/high volumes of SNAC. To support the assessment of exposure margins between rats","confidence":1,"confidence_rate":1},{"cnt":[[322,1100],[1794,1100],[1794,1149],[322,1149]],"region":{"top_left_x":322,"top_left_y":1100,"width":1472,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30f62122e2e84495b259489002db9565","type":"text","conversion_output":true,"text":"and humans, extensive PK and metabolism studies in rats are carried out. The quantification of","text_display":" and humans, extensive PK and metabolism studies in rats are carried out. The quantification of","confidence":1,"confidence_rate":1},{"cnt":[[322,1147],[1867,1147],[1867,1197],[322,1197]],"region":{"top_left_x":322,"top_left_y":1147,"width":1545,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a20d7ced3a64687bf9ecf2b97c93d9c","type":"text","conversion_output":true,"text":"SNAC metabolites will also be assessed in the on-going multiple dose (MD) clinical trial (NN9924-","text_display":" SNAC metabolites will also be assessed in the on-going multiple dose (MD) clinical trial (NN9924","confidence":1,"confidence_rate":1},{"cnt":[[322,1197],[432,1197],[432,1244],[322,1244]],"region":{"top_left_x":322,"top_left_y":1196,"width":110,"height":48},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb5496d46b1e4ad5889eeb73eb9ac056","type":"text","conversion_output":true,"text":"3991).","text_display":"3991).","confidence":1,"confidence_rate":1},{"cnt":[[322,1283],[1841,1283],[1841,1332],[322,1332]],"region":{"top_left_x":322,"top_left_y":1282,"width":1520,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab35fd77971a40cb9cabbb05637e21f8","type":"text","conversion_output":true,"text":"In an on-going two-year carcinogenicity study with rats, one unexplained death occurred at a dose","text_display":"\n\nIn an on-going two-year carcinogenicity study with rats, one unexplained death occurred at a dose","confidence":1,"confidence_rate":1},{"cnt":[[322,1332],[1815,1332],[1815,1381],[322,1381]],"region":{"top_left_x":322,"top_left_y":1332,"width":1494,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"742050897d4e4e6799292ba1890ce662","type":"text","conversion_output":true,"text":"of \\(200 mg / kg /\\) day . Several cases of unexplained death were observed at \\(900 mg / kg /\\) day in repeat","text_display":" of \\(200 mg / kg /\\) day . Several cases of unexplained death were observed at \\(900 mg / kg /\\) day in repeat","confidence":0.6491408348083496,"confidence_rate":0.996435248346364},{"cnt":[[322,1379],[1697,1379],[1697,1429],[322,1429]],"region":{"top_left_x":322,"top_left_y":1379,"width":1376,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b48fb2f5fcf44342bb546fa0f4e16cc2","type":"text","conversion_output":true,"text":"dose toxicity studies of 26 weeks and 52-weeks duration. A NOAEL for SNAC has been","text_display":" dose toxicity studies of 26 weeks and 52-weeks duration. A NOAEL for SNAC has been","confidence":0.5356407165527344,"confidence_rate":0.9930874286357623},{"cnt":[[322,1429],[1837,1429],[1837,1480],[322,1480]],"region":{"top_left_x":322,"top_left_y":1428,"width":1515,"height":53},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91d90b5a22fd4ef9a6e3fef5728d6bb7","type":"text","conversion_output":true,"text":"determined to be \\(90 mg / kg /\\) day (corresponding to \\(\\sim 4\\) to 6 times a human dose of 300 mg based on","text_display":" determined to be \\(90 mg / kg /\\) day (corresponding to \\(\\sim 4\\) to 6 times a human dose of 300 mg based on","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[322,1478],[1833,1478],[1833,1528],[322,1528]],"region":{"top_left_x":322,"top_left_y":1478,"width":1511,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc3d8e74e6104e51a476884ebb88a4f5","type":"text","conversion_output":true,"text":"exposure (area under curve)). Histological changes (perivascular lymphoid aggregates) have been","text_display":" exposure (area under curve)). Histological changes (perivascular lymphoid aggregates) have been","confidence":1,"confidence_rate":1},{"cnt":[[322,1525],[1725,1525],[1725,1575],[322,1575]],"region":{"top_left_x":322,"top_left_y":1525,"width":1404,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d98761eda914712a4c7dfecfb6512a5","type":"text","conversion_output":true,"text":"observed in the lungs at all SNAC dose levels in the 6-month rat study. SNAC appeared to","text_display":" observed in the lungs at all SNAC dose levels in the 6-month rat study. SNAC appeared to","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[322,1575],[1596,1575],[1596,1624],[322,1624]],"region":{"top_left_x":322,"top_left_y":1574,"width":1275,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b5c8f92f1a94ca2a9ba8cb8cb9091a8","type":"text","conversion_output":true,"text":"exacerbate these lesions which may be indicative of an immunosuppressant effect.","text_display":" exacerbate these lesions which may be indicative of an immunosuppressant effect.","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[314,1654],[1326,1654],[1326,1721],[314,1721]],"region":{"top_left_x":313,"top_left_y":1654,"width":1013,"height":67},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c884714e6bb4475897844a439bfe5a31","type":"section_header","conversion_output":false,"children_ids":["1cb0ee4ebe9a4cf5b96bd008d6895fc5"],"text":"","text_display":""},{"cnt":[[322,1663],[1317,1663],[1317,1712],[322,1712]],"region":{"top_left_x":322,"top_left_y":1662,"width":995,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cb0ee4ebe9a4cf5b96bd008d6895fc5","type":"text","conversion_output":true,"parent_id":"c884714e6bb4475897844a439bfe5a31","text":"3.2.2 Nonclinical pharmacology and pharmacokinetics","text_display":"\n\n\\subsection*{3.2.2 Nonclinical pharmacology and pharmacokinetics}","confidence":1,"confidence_rate":1},{"cnt":[[322,1727],[1848,1727],[1848,1777],[322,1777]],"region":{"top_left_x":322,"top_left_y":1727,"width":1526,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eeb64e7a69004399b53921b9e0532aaf","type":"text","conversion_output":true,"text":"The focus of the studies done in relation to oral administration of semaglutide in combination with","text_display":"\n\nThe focus of the studies done in relation to oral administration of semaglutide in combination with","confidence":1,"confidence_rate":1},{"cnt":[[322,1777],[954,1777],[954,1828],[322,1828]],"region":{"top_left_x":322,"top_left_y":1776,"width":632,"height":53},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11bd1c06d54d4b2c8c1e6d11f6364eb6","type":"text","conversion_output":true,"text":"SNAC has been on the following issues:","text_display":" SNAC has been on the following issues:","confidence":1,"confidence_rate":1},{"cnt":[[318,1861],[655,1861],[655,1914],[318,1914]],"region":{"top_left_x":317,"top_left_y":1860,"width":339,"height":55},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e78c6bc7e4c4c97bb977276be0884c5","type":"section_header","conversion_output":false,"children_ids":["2eb56cfbba154239b0faa64c067a7e13"],"text":"","text_display":""},{"cnt":[[322,1865],[647,1865],[647,1910],[322,1910]],"region":{"top_left_x":322,"top_left_y":1864,"width":325,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2eb56cfbba154239b0faa64c067a7e13","type":"text","conversion_output":true,"parent_id":"6e78c6bc7e4c4c97bb977276be0884c5","text":"Mechanism in vitro","text_display":"\n\n\\section*{Mechanism in vitro}","confidence":1,"confidence_rate":1},{"cnt":[[322,1980],[322,1929],[1841,1931],[1841,1983]],"region":{"top_left_x":322,"top_left_y":1929,"width":1520,"height":54},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0fc70373b5c84a18ac813d9b47c0e883","type":"text","conversion_output":true,"text":"SNAC increases absorption of drug compounds through the GI epithelium, which has been shown","text_display":"\n\nSNAC increases absorption of drug compounds through the GI epithelium, which has been shown","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[322,1981],[1695,1981],[1695,2030],[322,2030]],"region":{"top_left_x":322,"top_left_y":1980,"width":1374,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1608ee78b2d140648b800410559cba2b","type":"text","conversion_output":true,"text":"in humans (e.g., for endogenous GLP-1). In vitro studies have indicated that transport of","text_display":" in humans (e.g., for endogenous GLP-1). In vitro studies have indicated that transport of","confidence":1,"confidence_rate":1},{"cnt":[[322,2028],[1755,2028],[1755,2078],[322,2078]],"region":{"top_left_x":322,"top_left_y":2028,"width":1434,"height":50},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"469f5fe430f949958e238509c6f87158","type":"text","conversion_output":true,"text":"compounds occurs mainly via the trans-cellular route and the effect is dependent on both the","text_display":" compounds occurs mainly via the trans-cellular route and the effect is dependent on both the","confidence":1,"confidence_rate":1},{"cnt":[[322,2075],[1177,2075],[1177,2125],[322,2125]],"region":{"top_left_x":322,"top_left_y":2075,"width":856,"height":50},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3ca4f8ca89946d09210afd6fb955610","type":"text","conversion_output":true,"text":"concentration of SNAC and the duration of incubation.","text_display":" concentration of SNAC and the duration of incubation.","confidence":1,"confidence_rate":1},{"cnt":[[318,2159],[913,2159],[913,2219],[318,2219]],"region":{"top_left_x":317,"top_left_y":2159,"width":597,"height":61},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f8b50dbb74e4089b6d87117c1187f56","type":"section_header","conversion_output":false,"children_ids":["cfddc16e67054a1b8371ee619e9b0e38"],"text":"","text_display":""},{"cnt":[[322,2166],[904,2166],[904,2215],[322,2215]],"region":{"top_left_x":322,"top_left_y":2165,"width":583,"height":51},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfddc16e67054a1b8371ee619e9b0e38","type":"text","conversion_output":true,"parent_id":"2f8b50dbb74e4089b6d87117c1187f56","text":"Enhancement of absorption in vivo","text_display":"\n\n\\section*{Enhancement of absorption in vivo}","confidence":1,"confidence_rate":1},{"cnt":[[322,2230],[1818,2230],[1818,2279],[322,2279]],"region":{"top_left_x":322,"top_left_y":2230,"width":1496,"height":50},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db38ad3325324a359f69a0ef4c8ca9bb","type":"text","conversion_output":true,"text":"SNAC enhances absorption of semaglutide from the stomach and small intestine in rats. 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bioavailability of semaglutide, indicating that close interaction between","confidence":1,"confidence_rate":1},{"cnt":[[322,529],[1729,529],[1729,574],[322,574]],"region":{"top_left_x":322,"top_left_y":528,"width":1408,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12e22fa5453745d4ac6f0d6c765db356","type":"text","conversion_output":true,"text":"the two molecules is necessary for enhancing the absorption. There is a strong reduction of","text_display":" the two molecules is necessary for enhancing the absorption. There is a strong reduction of","confidence":0.93603515625,"confidence_rate":0.9993116719740658},{"cnt":[[322,580],[1729,580],[1729,623],[322,623]],"region":{"top_left_x":322,"top_left_y":580,"width":1408,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a0eef868d33492499ef0601b487dffe","type":"text","conversion_output":true,"text":"bioavailability to practically zero when given concomitantly with food in dogs, and also an","text_display":" bioavailability to practically zero when given concomitantly with food in dogs, and also an","confidence":1,"confidence_rate":1},{"cnt":[[322,627],[1869,627],[1869,672],[322,672]],"region":{"top_left_x":322,"top_left_y":627,"width":1548,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b92427c44594997bdc854fdd9ddcb06","type":"text","conversion_output":true,"text":"increasing amount of water dosed with the tablet seems to reduce oral bioavailability of semaglutide","text_display":" increasing amount of water dosed with the tablet seems to reduce oral bioavailability of semaglutide","confidence":1,"confidence_rate":1},{"cnt":[[322,675],[1826,675],[1826,720],[322,720]],"region":{"top_left_x":322,"top_left_y":674,"width":1505,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ac23185c5a747deb462be26f30312c4","type":"text","conversion_output":true,"text":"in this model, mimicking recent results in a human trial. Doses of SNAC of 150, 300 and 600 mg","text_display":" in this model, mimicking recent results in a human trial. 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from 2 phase 1 trials (NN9535-3616 and 3819) show that s.c. semaglutide has","text_display":"\n\nResults from 2 phase 1 trials (NN9535-3616 and 3819) show that s.c. semaglutide has","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[322,593],[1863,593],[1863,642],[322,642]],"region":{"top_left_x":322,"top_left_y":592,"width":1541,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"776f4c481a774890bc372dfac8ff1ef9","type":"text","conversion_output":true,"text":"pharmacokinetics (PK) properties compatible with once-weekly administration, with a median time","text_display":" pharmacokinetics (PK) properties compatible with once-weekly administration, with a median time","confidence":1,"confidence_rate":1},{"cnt":[[322,645],[1828,645],[1828,692],[322,692]],"region":{"top_left_x":322,"top_left_y":644,"width":1507,"height":48},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6db1c2da7a6e40fb9cdfffaf16160385","type":"text","conversion_output":true,"text":"to maximum concentration (tmax) of 36 hours post dosing and an elimination half-life ( \\(t \\frac{1}{2}\\) ) in the","text_display":" to maximum concentration (tmax) of 36 hours post dosing and an elimination half-life ( \\(t \\frac{1}{2}\\) ) in the","confidence":0.8540261356233714,"confidence_rate":0.998663660800155},{"cnt":[[322,692],[1824,692],[1824,741],[322,741]],"region":{"top_left_x":322,"top_left_y":691,"width":1503,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f2eaded88dc4892913158ac61e4eb98","type":"text","conversion_output":true,"text":"range of 165-184 hours ( \\(\\sim 7\\) days, harmonic mean). Overall, the PK properties of s.c. semaglutide","text_display":" range of 165-184 hours ( \\(\\sim 7\\) days, harmonic mean). Overall, the PK properties of s.c. semaglutide","confidence":0.9941477742982556,"confidence_rate":0.9999435648898355},{"cnt":[[322,741],[1824,741],[1824,788],[322,788]],"region":{"top_left_x":322,"top_left_y":741,"width":1503,"height":48},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15fc09ec65c94551b9911a0f8bcb0f19","type":"text","conversion_output":true,"text":"appear similar in Caucasian and Japanese subjects, and also in healthy subjects and subjects with","text_display":" appear similar in Caucasian and Japanese subjects, and also in healthy subjects and subjects with","confidence":1,"confidence_rate":1},{"cnt":[[322,786],[1764,786],[1764,836],[322,836]],"region":{"top_left_x":322,"top_left_y":786,"width":1442,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7604cfe775c4d93a46d5df8d5f0086f","type":"text","conversion_output":true,"text":"T2D. In a trial with subjects with different degrees of renal impairment (NN9535-3616), data","text_display":" T2D. In a trial with subjects with different degrees of renal impairment (NN9535-3616), data","confidence":1,"confidence_rate":1},{"cnt":[[322,838],[1807,838],[1807,887],[322,887]],"region":{"top_left_x":322,"top_left_y":837,"width":1485,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"002ece66f83f4da9ab497c41669b1221","type":"text","conversion_output":true,"text":"suggested that severe renal impairment result in a slightly higher exposure compared to subjects","text_display":" suggested that severe renal impairment result in a slightly higher exposure compared to subjects","confidence":1,"confidence_rate":1},{"cnt":[[322,885],[1800,885],[1800,935],[322,935]],"region":{"top_left_x":322,"top_left_y":885,"width":1479,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"118e88db9d834de8a23bf4c8ce325056","type":"text","conversion_output":true,"text":"with normal renal function (AUC0- \\(\\infty\\) increased by approximately \\(22 \\%\\) ), whereas subjects with","text_display":" with normal renal function (AUC0- \\(\\infty\\) increased by approximately \\(22 \\%\\) ), whereas subjects with","confidence":0.9492433071136475,"confidence_rate":0.9994894428237436},{"cnt":[[322,935],[1848,935],[1848,984],[322,984]],"region":{"top_left_x":322,"top_left_y":934,"width":1526,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c007721ff334ed5baf6d0773dccf259","type":"text","conversion_output":true,"text":"mild or moderate renal impairment and subjects on haemodialysis had exposure similar to subjects","text_display":" mild or moderate renal impairment and subjects on haemodialysis had exposure similar to subjects","confidence":1,"confidence_rate":1},{"cnt":[[322,984],[1777,984],[1777,1033],[322,1033]],"region":{"top_left_x":322,"top_left_y":983,"width":1455,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15bf83074b8b4687a38c9bb6b9735088","type":"text","conversion_output":true,"text":"with normal renal function. No safety signals were identified in either of the renal groups, and","text_display":" with normal renal function. No safety signals were identified in either of the renal groups, and","confidence":1,"confidence_rate":1},{"cnt":[[322,1031],[1807,1031],[1807,1081],[322,1081]],"region":{"top_left_x":322,"top_left_y":1031,"width":1485,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25dd4dd3ee714085840ad06deaca175b","type":"text","conversion_output":true,"text":"tolerability profiles appeared similar across renal groups; thus, a dose-reduction in subjects with","text_display":" tolerability profiles appeared similar across renal groups; thus, a dose-reduction in subjects with","confidence":1,"confidence_rate":1},{"cnt":[[322,1079],[1212,1079],[1212,1128],[322,1128]],"region":{"top_left_x":322,"top_left_y":1078,"width":890,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee7074a6c11a4f31a611fe26ccec7a04","type":"text","conversion_output":true,"text":"severe renal impairment does not appear to be warranted.","text_display":" severe renal impairment does not appear to be warranted.","confidence":1,"confidence_rate":1},{"cnt":[[322,1164],[1828,1164],[1828,1216],[322,1216]],"region":{"top_left_x":322,"top_left_y":1164,"width":1507,"height":53},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2463518c21c248a5b2fe3e4042579c0b","type":"text","conversion_output":true,"text":"Interaction with oral contraceptives was assessed at semaglutide 1.0 mg steady-state exposures in","text_display":"\n\nInteraction with oral contraceptives was assessed at semaglutide 1.0 mg steady-state exposures in","confidence":1,"confidence_rate":1},{"cnt":[[322,1216],[1740,1216],[1740,1265],[322,1265]],"region":{"top_left_x":322,"top_left_y":1216,"width":1419,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99f0f487e43746f59e4a53271a4f5ae0","type":"text","conversion_output":true,"text":"postmenopausal women with T2D (NN9535-3819). Steady-state exposures (AUC0-24h) of","text_display":" postmenopausal women with T2D (NN9535-3819). Steady-state exposures (AUC0-24h) of","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[322,1263],[1691,1263],[1691,1313],[322,1313]],"region":{"top_left_x":322,"top_left_y":1263,"width":1369,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9158bd63c924c7aa37f86581faa8866","type":"text","conversion_output":true,"text":"ethinylestradiol (EE) and levonorgestrel (LN) were slightly increased (by \\(10 \\%\\) and \\(21 \\%\\),","text_display":" ethinylestradiol (EE) and levonorgestrel (LN) were slightly increased (by \\(10 \\%\\) and \\(21 \\%\\),","confidence":0.9296487480968381,"confidence_rate":0.9992559049924616},{"cnt":[[322,1313],[1824,1313],[1824,1362],[322,1362]],"region":{"top_left_x":322,"top_left_y":1312,"width":1503,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bfe02054d9574249b3a98d5523a05c5d","type":"text","conversion_output":true,"text":"respectively), with bioequivalence established for EE but not for LN; the increase was seen when","text_display":" respectively), with bioequivalence established for EE but not for LN; the increase was seen when","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[322,1362],[1841,1362],[1841,1412],[322,1412]],"region":{"top_left_x":322,"top_left_y":1362,"width":1520,"height":50},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29ead2ce26924d449ba988320a72613b","type":"text","conversion_output":true,"text":"oral contraceptives were co-administered with semaglutide compared to oral contraceptives alone.","text_display":" oral contraceptives were co-administered with semaglutide compared to oral contraceptives alone.","confidence":1,"confidence_rate":1},{"cnt":[[322,1448],[1869,1448],[1869,1497],[322,1497]],"region":{"top_left_x":322,"top_left_y":1448,"width":1548,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3768f43c6d245c6a6ca7bc334417c9c","type":"text","conversion_output":true,"text":"Bioequivalence was demonstrated for \\(C _{\\text {max }}\\) of both EE and LN. These data indicate that semaglutide","text_display":"\n\nBioequivalence was demonstrated for \\(C _{\\text {max }}\\) of both EE and LN. These data indicate that semaglutide","confidence":0.8976173400878906,"confidence_rate":0.9990927527548391},{"cnt":[[322,1497],[1768,1497],[1768,1545],[322,1545]],"region":{"top_left_x":322,"top_left_y":1497,"width":1447,"height":48},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bccda970d12a49109b811e033c02425f","type":"text","conversion_output":true,"text":"does not decrease the exposure of oral contraceptives, and suggest that no adjustments of oral","text_display":" does not decrease the exposure of oral contraceptives, and suggest that no adjustments of oral","confidence":1,"confidence_rate":1},{"cnt":[[322,1543],[1742,1543],[1742,1592],[322,1592]],"region":{"top_left_x":322,"top_left_y":1542,"width":1421,"height":50},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b18e15b6f166418597f46bcc5ef8ae9a","type":"text","conversion_output":true,"text":"contraceptive dose are warranted for women of childbearing potential using a low-dose oral","text_display":" contraceptive dose are warranted for women of childbearing potential using a low-dose oral","confidence":1,"confidence_rate":1},{"cnt":[[322,1594],[548,1594],[548,1644],[322,1644]],"region":{"top_left_x":322,"top_left_y":1594,"width":226,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1f6b0c8f9864de28c2adfef5256d013","type":"text","conversion_output":true,"text":"contraceptive.","text_display":" contraceptive.","confidence":1,"confidence_rate":1},{"cnt":[[316,1676],[473,1676],[473,1738],[316,1738]],"region":{"top_left_x":315,"top_left_y":1675,"width":158,"height":64},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0824c49b9ca47d39d04a477fcac3391","type":"section_header","conversion_output":false,"children_ids":["4fb48aaa0d61434cba8ac4a7b609e549"],"text":"","text_display":""},{"cnt":[[322,1680],[466,1680],[466,1732],[322,1732]],"region":{"top_left_x":322,"top_left_y":1680,"width":145,"height":52},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fb48aaa0d61434cba8ac4a7b609e549","type":"text","conversion_output":true,"parent_id":"b0824c49b9ca47d39d04a477fcac3391","text":"Efficacy","text_display":"\n\n\\section*{Efficacy}","confidence":1,"confidence_rate":1},{"cnt":[[322,1749],[1837,1749],[1837,1798],[322,1798]],"region":{"top_left_x":322,"top_left_y":1748,"width":1515,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7fdde00e5bb4a0fa7af56b41add3bf3","type":"text","conversion_output":true,"text":"As of 1 February 2013, efficacy of s.c. semaglutide in the target population - subjects with T2D -","text_display":"\n\nAs of 1 February 2013, efficacy of s.c. semaglutide in the target population - subjects with T2D ","confidence":0.9985356330871582,"confidence_rate":0.9999861751885265},{"cnt":[[322,1796],[1824,1796],[1824,1846],[322,1846]],"region":{"top_left_x":322,"top_left_y":1796,"width":1503,"height":50},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99fc1d8b66fb4c03b7bfebb09aac1810","type":"text","conversion_output":true,"text":"has been investigated in one phase 2 dose range finding trial (NN9535-1821). The trial was a 12-","text_display":"has been investigated in one phase 2 dose range finding trial (NN9535-1821). The trial was a 12","confidence":0.85400390625,"confidence_rate":0.9984836555143694},{"cnt":[[322,1843],[1854,1843],[1854,1893],[322,1893]],"region":{"top_left_x":322,"top_left_y":1843,"width":1533,"height":50},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35baff68199948368b360f3535e0796f","type":"text","conversion_output":true,"text":"week, randomised, double-blind, placebo- and active-controlled trial in which 411 adults with T2D","text_display":"week, randomised, double-blind, placebo- and active-controlled trial in which 411 adults with T2D","confidence":1,"confidence_rate":1},{"cnt":[[322,1895],[1867,1895],[1867,1944],[322,1944]],"region":{"top_left_x":322,"top_left_y":1894,"width":1545,"height":51},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d741a79473f4decbfb2023b2b490fbf","type":"text","conversion_output":true,"text":"received once-weekly s.c. injection of 1 of 5 semaglutide dose levels ( \\(0.1-1.6 mg\\) ) once-daily, open-","text_display":" received once-weekly s.c. injection of 1 of 5 semaglutide dose levels ( \\(0.1-1.6 mg\\) ) once-daily, open","confidence":0.8349508130515915,"confidence_rate":0.9984725028775816},{"cnt":[[322,1942],[1869,1942],[1869,1992],[322,1992]],"region":{"top_left_x":322,"top_left_y":1942,"width":1548,"height":50},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dbbd12f51745437e92e23027612d7668","type":"text","conversion_output":true,"text":"label liraglutide ( 1.2 mg or 1.8 mg ) or once-weekly placebo. 12 weeks of treatment, equivalent to 5-","text_display":"label liraglutide ( 1.2 mg or 1.8 mg ) or once-weekly placebo. 12 weeks of treatment, equivalent to 5","confidence":0.8794804257013311,"confidence_rate":0.9989303726993718},{"cnt":[[322,1989],[1747,1989],[1747,2039],[322,2039]],"region":{"top_left_x":322,"top_left_y":1989,"width":1425,"height":50},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf46076586564dc5b6f3a2a85b348308","type":"text","conversion_output":true,"text":"7 weeks in steady state on maintenance dose, provided statistically significant and clinically","text_display":"7 weeks in steady state on maintenance dose, provided statistically significant and clinically","confidence":1,"confidence_rate":1},{"cnt":[[322,2039],[1854,2039],[1854,2088],[322,2088]],"region":{"top_left_x":322,"top_left_y":2038,"width":1533,"height":51},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33b894ce70a14b518343cab5fa962418","type":"text","conversion_output":true,"text":"relevant improvement in glycaemic control for dose levels of 0.2 mg and above. Changes in \\(HbA _{1 c}\\)","text_display":" relevant improvement in glycaemic control for dose levels of 0.2 mg and above. Changes in \\(HbA _{1 c}\\)","confidence":0.9000468254089355,"confidence_rate":0.9990766678601944},{"cnt":[[322,2088],[1867,2088],[1867,2138],[322,2138]],"region":{"top_left_x":322,"top_left_y":2088,"width":1545,"height":50},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4656cf0622984dd395fc67fb1b4fe8d2","type":"text","conversion_output":true,"text":"from baseline was up to \\(-1.19 \\%\\) (placebo adjusted estimated treatment difference). Dose-dependent","text_display":" from baseline was up to \\(-1.19 \\%\\) (placebo adjusted estimated treatment difference). Dose-dependent","confidence":1,"confidence_rate":1},{"cnt":[[322,2138],[1721,2138],[1721,2185],[322,2185]],"region":{"top_left_x":322,"top_left_y":2137,"width":1399,"height":48},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cdfafc1d3714b9d9fd898be5272ca5b","type":"text","conversion_output":true,"text":"improvements in fasting plasma glucose (FPG) and postprandial plasma glucose were also","text_display":" improvements in fasting plasma glucose (FPG) and postprandial plasma glucose were also","confidence":1,"confidence_rate":1},{"cnt":[[322,2185],[1852,2185],[1852,2237],[322,2237]],"region":{"top_left_x":322,"top_left_y":2184,"width":1530,"height":53},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3db2fc32708a47c9b7e4ed37534bd598","type":"text","conversion_output":true,"text":"observed. The improvement in glycaemic control was accompanied by weight loss for semaglutide","text_display":" observed. The improvement in glycaemic control was accompanied by weight loss for semaglutide","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[322,2234],[1742,2234],[1742,2284],[322,2284]],"region":{"top_left_x":322,"top_left_y":2234,"width":1421,"height":50},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac02ddaab5d340c3a3a9ace2b245fbe6","type":"text","conversion_output":true,"text":"doses of 0.8 mg and above (placebo adjusted estimated treatment difference up to -3.64 kg ).","text_display":" doses of 0.8 mg and above (placebo adjusted estimated treatment difference up to -3.64 kg 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the clinical trials conducted so far the following safety observations have been made.","text_display":"\n\nFrom the clinical trials conducted so far the following safety observations have been 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2012-004994-16","confidence":1,"confidence_rate":1},{"cnt":[[1239,251],[1765,251],[1765,405],[1239,405]],"region":{"top_left_x":1239,"top_left_y":251,"width":526,"height":154},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a685292b80e046e988a55983d0577d8c","type":"column","conversion_output":false,"children_ids":["59dd83b51df74510b264653fc8ac41a2"],"text":"","text_display":""},{"cnt":[[1242,254],[1762,254],[1762,402],[1242,402]],"region":{"top_left_x":1241,"top_left_y":253,"width":521,"height":149},"line":7,"column":2,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"59dd83b51df74510b264653fc8ac41a2","type":"table","conversion_output":true,"parent_id":"a685292b80e046e988a55983d0577d8c","text":"\\begin{tabular}{|lr|} \nDate: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 23 of 98\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|lr|} \nDate: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: 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(AEs)","confidence":1,"confidence_rate":1},{"cnt":[[322,526],[1815,526],[1815,576],[322,576]],"region":{"top_left_x":322,"top_left_y":526,"width":1494,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c3c991b47ba4c7bb9c62538fb145bed","type":"text","conversion_output":true,"text":"included nausea and vomiting; most of them were mild to moderate in intensity. Hypoglycaemia","text_display":" included nausea and vomiting; most of them were mild to moderate in intensity. Hypoglycaemia","confidence":1,"confidence_rate":1},{"cnt":[[322,576],[1699,576],[1699,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":1378,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ff6beb7c7e446b0b65893a1f9889986","type":"text","conversion_output":true,"text":"has occurred in subjects receiving semaglutide and these events have mainly been minor.","text_display":" has occurred in subjects receiving semaglutide and these events have mainly been minor.","confidence":1,"confidence_rate":1},{"cnt":[[322,662],[1783,662],[1783,711],[322,711]],"region":{"top_left_x":322,"top_left_y":661,"width":1462,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02dc5a13ec9f4ab08deb671c996954d2","type":"text","conversion_output":true,"text":"An increase in heart rate has been observed in subjects exposed to semaglutide in line with the","text_display":"\n\nAn increase in heart rate has been observed in subjects exposed to semaglutide in line with the","confidence":1,"confidence_rate":1},{"cnt":[[322,711],[1721,711],[1721,758],[322,758]],"region":{"top_left_x":322,"top_left_y":711,"width":1399,"height":48},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0801526bbe1f476cba3385237e481dc9","type":"text","conversion_output":true,"text":"increase seen with other GLP-1 analogous. The implications of this increase are unknown.","text_display":" increase seen with other GLP-1 analogous. The implications of this increase are unknown.","confidence":1,"confidence_rate":1},{"cnt":[[322,799],[1811,799],[1811,846],[322,846]],"region":{"top_left_x":322,"top_left_y":799,"width":1490,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aef4d55e6ba14f519c94b6ca7acf01bf","type":"text","conversion_output":true,"text":"As is the case with all protein-based pharmaceuticals, subjects treated with s.c. semaglutide may","text_display":"\n\nAs is the case with all protein-based pharmaceuticals, subjects treated with s.c. semaglutide may","confidence":0.99853515625,"confidence_rate":0.9999856283612877},{"cnt":[[322,846],[1712,846],[1712,896],[322,896]],"region":{"top_left_x":322,"top_left_y":846,"width":1391,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5eae0d81c0db41629c6f5cebb825b992","type":"text","conversion_output":true,"text":"develop immunogenic and allergic reactions. Few allergic reactions have been reported in","text_display":" develop immunogenic and allergic reactions. Few allergic reactions have been reported in","confidence":1,"confidence_rate":1},{"cnt":[[322,896],[1710,896],[1710,943],[322,943]],"region":{"top_left_x":322,"top_left_y":895,"width":1389,"height":49},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ac37daa9ba74920bc514a3d12d37e25","type":"text","conversion_output":true,"text":"connection with semaglutide. These have mainly been mild and transient. However, more","text_display":" connection with semaglutide. These have mainly been mild and transient. However, more","confidence":1,"confidence_rate":1},{"cnt":[[322,945],[836,945],[836,993],[322,993]],"region":{"top_left_x":322,"top_left_y":945,"width":514,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3fff2047a704e909dc383783c711e37","type":"text","conversion_output":true,"text":"generalised reactions may occur.","text_display":" generalised reactions may occur.","confidence":1,"confidence_rate":1},{"cnt":[[322,1031],[1858,1031],[1858,1081],[322,1081]],"region":{"top_left_x":322,"top_left_y":1031,"width":1537,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81b2ea4096634e6e97adab7a2a87bf90","type":"text","conversion_output":true,"text":"Injection site reactions have been infrequently reported. These have mainly been mild and transient","text_display":"\n\nInjection site reactions have been infrequently reported. These have mainly been mild and transient","confidence":1,"confidence_rate":1},{"cnt":[[322,1079],[475,1079],[475,1124],[322,1124]],"region":{"top_left_x":322,"top_left_y":1078,"width":153,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39bceacaf1824a3b9897b0ac900a2021","type":"text","conversion_output":true,"text":"in nature.","text_display":" in nature.","confidence":1,"confidence_rate":1},{"cnt":[[322,1160],[1023,1160],[1023,1214],[322,1214]],"region":{"top_left_x":322,"top_left_y":1160,"width":701,"height":54},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"556d0223bd4e46aeb514f9852539665e","type":"text","conversion_output":true,"text":"Please see appropriate IB \\({ }^{5}\\) for further details.","text_display":"\n\nPlease see appropriate IB \\({ }^{5}\\) for further details.","confidence":0.5621166229248047,"confidence_rate":0.990898089173457},{"cnt":[[318,1250],[999,1250],[999,1300],[318,1300]],"region":{"top_left_x":317,"top_left_y":1250,"width":683,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ef9a1497cca4d77a5690542a691dae6","type":"section_header","conversion_output":false,"children_ids":["f10e6a81bba8479cbd8562bcd8c23021"],"text":"","text_display":""},{"cnt":[[322,1255],[995,1255],[995,1296],[322,1296]],"region":{"top_left_x":322,"top_left_y":1254,"width":673,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f10e6a81bba8479cbd8562bcd8c23021","type":"text","conversion_output":true,"parent_id":"7ef9a1497cca4d77a5690542a691dae6","text":"3.2.3.3 Clinical data of oral GLP-1","text_display":"\n\n\\subsection*{3.2.3.3 Clinical data of oral GLP-1}","confidence":0.99853515625,"confidence_rate":0.9999633527294652},{"cnt":[[322,1315],[1833,1315],[1833,1364],[322,1364]],"region":{"top_left_x":322,"top_left_y":1314,"width":1511,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a280ffd801e44e9980e00e01ae9e0156","type":"text","conversion_output":true,"text":"Clinical trials with increasing doses of oral semaglutide up to two tablets with 10 mg semaglutide","text_display":"\n\nClinical trials with increasing doses of oral semaglutide up to two tablets with 10 mg semaglutide","confidence":1,"confidence_rate":1},{"cnt":[[322,1366],[1738,1366],[1738,1412],[322,1412]],"region":{"top_left_x":322,"top_left_y":1366,"width":1417,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a3fa47bfe49427d963a6d0807561e77","type":"text","conversion_output":true,"text":"and 300 mg SNAC have shown this to be safe and well tolerated. 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The oral semaglutide had","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[322,1414],[1871,1414],[1871,1463],[322,1463]],"region":{"top_left_x":322,"top_left_y":1413,"width":1550,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bace1e1a5a71421ca96043bb7f2adaf1","type":"text","conversion_output":true,"text":"acceptable bioavailability and a PK profile of two tablets with 10 mg semaglutide was similar to 0.5","text_display":" acceptable bioavailability and a PK profile of two tablets with 10 mg semaglutide was similar to 0.5","confidence":0.99462890625,"confidence_rate":0.9999505923221353},{"cnt":[[322,1463],[1876,1463],[1876,1510],[322,1510]],"region":{"top_left_x":322,"top_left_y":1463,"width":1554,"height":48},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4ca0b66cad040c3966b0d6c7d8a342a","type":"text","conversion_output":true,"text":"mg s.c. semaglutide. Variability of the day-to-day PK profile was \\(3-4\\) times higher than compared to","text_display":" mg s.c. semaglutide. Variability of the day-to-day PK profile was \\(3-4\\) times higher than compared to","confidence":0.9308868912976499,"confidence_rate":0.9993431745134429},{"cnt":[[322,1512],[1519,1512],[1519,1560],[322,1560]],"region":{"top_left_x":322,"top_left_y":1512,"width":1197,"height":48},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50abb94a4d2f4c81b5a3877cea06aa38","type":"text","conversion_output":true,"text":"0.5 mg s.c. once-weekly semaglutide but acceptable for further development.","text_display":" 0.5 mg s.c. once-weekly semaglutide but acceptable for further development.","confidence":0.9990236759185791,"confidence_rate":0.9999879408011545},{"cnt":[[322,1598],[1781,1598],[1781,1644],[322,1644]],"region":{"top_left_x":322,"top_left_y":1598,"width":1460,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65dd3553d9804f2bbbbe55fdf2871e29","type":"text","conversion_output":true,"text":"The oral bioavailability of human GLP-1 has been demonstrated to increase several fold when","text_display":"\n\nThe oral bioavailability of human GLP-1 has been demonstrated to increase several fold when","confidence":1,"confidence_rate":1},{"cnt":[[322,1646],[1745,1646],[1745,1695],[322,1695]],"region":{"top_left_x":322,"top_left_y":1645,"width":1423,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c72a4ceaf0e432c87eacb28217b596d","type":"text","conversion_output":true,"text":"formulated with SNAC with a \\(t _{\\text {max }}\\) of approximately \\(15-30 min\\). 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U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[694,361],[694,393],[322,393]],"region":{"top_left_x":322,"top_left_y":360,"width":372,"height":34},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5e0298dc0d1c434ab5a115de636b7082","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,481],[1867,481],[1867,526],[322,526]],"region":{"top_left_x":322,"top_left_y":481,"width":1545,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28f1e354a7e74db785a9112d5c4fa065","type":"text","conversion_output":true,"text":"(doses 1.5 g and 2.25 g of SNAC three times daily for 5 days) and two phase 3 trials (doses: 1.5 and","text_display":"\n(doses 1.5 g and 2.25 g of SNAC three times daily for 5 days) and two phase 3 trials (doses: 1.5 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Enrolled subjects were randomised in three treatments arms:","text_display":" following total hip replacement. Enrolled subjects were randomised in three treatments arms:","confidence":1,"confidence_rate":1},{"cnt":[[322,801],[1626,801],[1626,849],[322,849]],"region":{"top_left_x":322,"top_left_y":801,"width":1305,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a23266802ae4a758fc86e479988559b","type":"text","conversion_output":true,"text":"- Low dose SNAC ( 1.5 g ) and heparin (60,000 USP units) thrice-daily for 30 days","text_display":"\n- Low dose SNAC ( 1.5 g ) and heparin (60,000 USP units) thrice-daily for 30 days","confidence":0.8859078346285969,"confidence_rate":0.9987120815913115},{"cnt":[[322,853],[1652,853],[1652,900],[322,900]],"region":{"top_left_x":322,"top_left_y":852,"width":1331,"height":49},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4921d4095ac7480680b43c0fa351b644","type":"text","conversion_output":true,"text":"- High dose SNAC ( 2.25 g ) and heparin ( 90,000 USP units) thrice-daily for 30 days","text_display":"\n- High dose SNAC ( 2.25 g ) and heparin ( 90,000 USP units) thrice-daily for 30 days","confidence":0.9922091709552205,"confidence_rate":0.9999217896975163},{"cnt":[[322,907],[1222,907],[1222,952],[322,952]],"region":{"top_left_x":322,"top_left_y":906,"width":901,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a92998ba307d4493b8673632711306cf","type":"text","conversion_output":true,"text":"- Enoxaparin sodium 30 mg s.c. twice-daily for 10 days","text_display":"\n- Enoxaparin sodium 30 mg s.c. twice-daily for 10 days","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[322,990],[1863,990],[1863,1038],[322,1038]],"region":{"top_left_x":322,"top_left_y":990,"width":1541,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7761f5f73874464194a6a699b9fe8d63","type":"text","conversion_output":true,"text":"Total daily dose of oral SNAC was 4.5 g (low dose), 6.75 g (high dose) or 0 g (heparin s.c.). 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The SAEs were evenly","text_display":" which also reflected the most common AEs reported for discontinuation. The SAEs were evenly","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[322,1225],[1818,1225],[1818,1270],[322,1270]],"region":{"top_left_x":322,"top_left_y":1224,"width":1496,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"689b815959b54489ab493b0eafa81648","type":"text","conversion_output":true,"text":"distributed between the groups for all system organ classes other than GI disorders. Likewise, all","text_display":" distributed between the groups for all system organ classes other than GI disorders. 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At randomisation,","confidence":1,"confidence_rate":1},{"cnt":[[322,1051],[1775,1051],[1775,1102],[322,1102]],"region":{"top_left_x":322,"top_left_y":1050,"width":1453,"height":53},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1388f9605ed4a968989100b416357ac","type":"text","conversion_output":true,"text":"subjects will be stratified according to one stratification value with two strata: Treatment with","text_display":" subjects will be stratified according to one stratification value with two strata: Treatment with","confidence":0.998046875,"confidence_rate":0.9999808331754918},{"cnt":[[322,1100],[834,1100],[834,1149],[322,1149]],"region":{"top_left_x":322,"top_left_y":1100,"width":512,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dfc74813e004a5c9215c17eb74692d3","type":"text","conversion_output":true,"text":"metformin at screening (yes/no).","text_display":" metformin at screening (yes/no).","confidence":1,"confidence_rate":1},{"cnt":[[318,1182],[879,1182],[879,1242],[318,1242]],"region":{"top_left_x":317,"top_left_y":1181,"width":562,"height":61},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ef7c8427b14c4cdf91abf84995d9107a","type":"section_header","conversion_output":false,"children_ids":["514ddc9517ae47d7a15ab1d8da052d87"],"text":"","text_display":""},{"cnt":[[322,1186],[870,1186],[870,1235],[322,1235]],"region":{"top_left_x":322,"top_left_y":1185,"width":549,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"514ddc9517ae47d7a15ab1d8da052d87","type":"text","conversion_output":true,"parent_id":"ef7c8427b14c4cdf91abf84995d9107a","text":"5.2 Rationale for trial design","text_display":"\n\n\\subsection*{5.2 Rationale for trial design}","confidence":0.9965834617614746,"confidence_rate":0.9999022222681856},{"cnt":[[322,1255],[1869,1255],[1869,1304],[322,1304]],"region":{"top_left_x":322,"top_left_y":1254,"width":1548,"height":51},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6251944e826c46bb9bf041a0b8171938","type":"text","conversion_output":true,"text":"Parallel treatment groups and a randomised partially-blinded, controlled design have been chosen in","text_display":"\n\nParallel treatment groups and a randomised partially-blinded, controlled design have been chosen in","confidence":1,"confidence_rate":1},{"cnt":[[322,1302],[1828,1302],[1828,1351],[322,1351]],"region":{"top_left_x":322,"top_left_y":1301,"width":1507,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7055f5a9e3554175bbcac279172d09f3","type":"text","conversion_output":true,"text":"accordance with the trial objectives. 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The dose range of the oral treatment ( \\(2.5 mg , 5 mg , 10 mg , 20 mg\\) and 40 mg ) has","text_display":" tablet format. 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The standard escalation scheme (i.e., dose","text_display":" the same exposure as observed with s.c. semaglutide. The standard escalation scheme (i.e., dose","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[322,1079],[1841,1079],[1841,1128],[322,1128]],"region":{"top_left_x":322,"top_left_y":1078,"width":1520,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"378f1b45b26d4a61bb3793d07b381ae3","type":"text","conversion_output":true,"text":"escalation every four weeks to desired dose) has been chosen based on phase 1 data. The slow and","text_display":" escalation every four weeks to desired dose) has been chosen based on phase 1 data. The slow and","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[322,1126],[1858,1126],[1858,1175],[322,1175]],"region":{"top_left_x":322,"top_left_y":1125,"width":1537,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"846c2ae5b5fd4ddd9b7eb04b987abbde","type":"text","conversion_output":true,"text":"fast dose escalation arms will investigate if AEs decrease or increase, respectively, compared to the","text_display":" fast dose escalation arms will investigate if AEs decrease or increase, respectively, compared to the","confidence":1,"confidence_rate":1},{"cnt":[[322,1175],[1835,1175],[1835,1225],[322,1225]],"region":{"top_left_x":322,"top_left_y":1175,"width":1513,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8058edbc92ee42219e5082ad588a91f7","type":"text","conversion_output":true,"text":"standard dose escalation. The 26-week treatment period will provide additional data on safety and","text_display":" standard dose escalation. 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The subject may be withdrawn from the trial at the","text_display":"\n\nThe subject may withdraw at will at any time. The subject may be withdrawn from the trial at the","confidence":1,"confidence_rate":1},{"cnt":[[322,922],[1846,922],[1846,973],[322,973]],"region":{"top_left_x":322,"top_left_y":921,"width":1524,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"842ddfa7cc274bf98711808964671170","type":"text","conversion_output":true,"text":"discretion of the investigator due to a safety concern. Please see Section 8.1 .10 for procedure to be","text_display":" discretion of the investigator due to a safety concern. 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or","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[322,1435],[1811,1435],[1811,1485],[322,1485]],"region":{"top_left_x":322,"top_left_y":1435,"width":1490,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20babfe0810e47cba9b272f1a1626046","type":"text","conversion_output":true,"text":"clinical outcomes, hence this should not be considered as a valid reason for withdrawal from the","text_display":" clinical outcomes, hence this should not be considered as a valid reason for withdrawal from the","confidence":1,"confidence_rate":1},{"cnt":[[322,1485],[402,1485],[402,1528],[322,1528]],"region":{"top_left_x":322,"top_left_y":1484,"width":80,"height":44},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ec84b44bf9a4671b4a4690a87ee171d","type":"text","conversion_output":true,"text":"trial.","text_display":" 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according to the End-of-treatment visit and the Follow-up visit, please see Section 8.1.8.","confidence":1,"confidence_rate":1},{"cnt":[[322,1706],[1089,1706],[1089,1755],[322,1755]],"region":{"top_left_x":322,"top_left_y":1705,"width":768,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a6ff76f5df0410c8edd10e624309f0b","type":"text","conversion_output":true,"text":"Subjects who are withdrawn will not be replaced.","text_display":"\n\nSubjects who are withdrawn will not be 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The investigator suspects acute pancreatitis. All drugs suspected to relate to this condition","text_display":"\n1. The investigator suspects acute pancreatitis. All drugs suspected to relate to this condition","confidence":1,"confidence_rate":1},{"cnt":[[378,1998],[1850,1998],[1850,2047],[378,2047]],"region":{"top_left_x":378,"top_left_y":1998,"width":1472,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9d770c0a6f14f4192ea6c20685edeef","type":"text","conversion_output":true,"text":"should be discontinued until confirmatory tests have been conducted and appropriate treatment","text_display":" should be discontinued until confirmatory tests have been conducted and appropriate treatment","confidence":1,"confidence_rate":1},{"cnt":[[378,2045],[1813,2045],[1813,2095],[378,2095]],"region":{"top_left_x":378,"top_left_y":2045,"width":1436,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5518b57b6a52421cbfa50128fa8536a8","type":"text","conversion_output":true,"text":"should be initiated. Subjects who are diagnosed with acute pancreatitis must be discontinued","text_display":" should be initiated. Subjects who are diagnosed with acute pancreatitis must be discontinued","confidence":1,"confidence_rate":1},{"cnt":[[378,2093],[1605,2093],[1605,2142],[378,2142]],"region":{"top_left_x":378,"top_left_y":2092,"width":1227,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44f785b1b8124fddb84515683489ea0f","type":"text","conversion_output":true,"text":"from trial treatment. Diagnosis is based on at least 2 of the following 3 criteria:","text_display":" from trial treatment. 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Calcitonin level \\(\\geq 50 ng / L\\). The subject should be referred to a specialist in thyroid disease. All","text_display":"\n2. Calcitonin level \\(\\geq 50 ng / L\\). The subject should be referred to a specialist in thyroid disease. All","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[378,2385],[1394,2385],[1394,2434],[378,2434]],"region":{"top_left_x":378,"top_left_y":2384,"width":1017,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"998e916be4e64af8ad78b3551a3b154f","type":"text","conversion_output":true,"text":"drugs suspected to relate to this condition should be discontinued","text_display":" drugs suspected to relate to this condition should be discontinued","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-037","page":37,"lines":[{"cnt":[[322,258],[1781,258],[1781,406],[322,406]],"region":{"top_left_x":322,"top_left_y":257,"width":1460,"height":150},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"afdb6b40be6a4da69ab0edf2d8c638ff","type":"table","conversion_output":true,"text":"\\begin{tabular}{l|l|lr|r} \nProtocol & & Date: & 25 June 2013 & N \\\\\nTrial ID: NN9924-3790 & CONFIDENTIAL & Version: & 1.0 & \\\\\nUTN: U1111-1136-4716 & & Status: & Final & \\\\\nEudraCT No.: 2012-004994-16 & & Page: & 35 of 98 &\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{l|l|lr|r} \nProtocol & & Date: & 25 June 2013 & N \\\\\nTrial ID: NN9924-3790 & CONFIDENTIAL & Version: & 1.0 & \\\\\nUTN: U1111-1136-4716 & & Status: & Final & \\\\\nEudraCT No.: 2012-004994-16 & & Page: & 35 of 98 &\n\\end{tabular}","confidence":0.6431974054312845,"confidence_rate":0.9984023515325343},{"cnt":[[1770,262],[1940,262],[1940,290],[1770,290]],"region":{"top_left_x":1770,"top_left_y":262,"width":171,"height":29},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5772bf35928744acaf857603bff0169e","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,481],[1218,481],[1218,526],[322,526]],"region":{"top_left_x":322,"top_left_y":481,"width":897,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24cabc7abd464783945daa86affaa328","type":"text","conversion_output":true,"text":"3. Other safety concerns as evaluated by the investigator","text_display":"\n3. Other safety concerns as evaluated by the investigator","confidence":1,"confidence_rate":1},{"cnt":[[322,569],[1760,569],[1760,612],[322,612]],"region":{"top_left_x":322,"top_left_y":569,"width":1438,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4344ab8a446144909f9e7490c2a97eb4","type":"text","conversion_output":true,"text":"A treatment discontinuation session must be performed in the interactive voice/web response","text_display":"\n\nA treatment discontinuation session must be performed in the interactive voice/web response","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[324,614],[1779,614],[1779,660],[324,660]],"region":{"top_left_x":324,"top_left_y":614,"width":1455,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79361bf54a9b427586d372ea7ab0fad9","type":"text","conversion_output":true,"text":"system (IV/WRS). The primary reason for discontinuation of the IMP must be specified in the","text_display":" system (IV/WRS). The primary reason for discontinuation of the IMP must be specified in the","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[322,666],[879,666],[879,711],[322,711]],"region":{"top_left_x":322,"top_left_y":666,"width":557,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b5d5519ec35453ea672f734c05f845f","type":"text","conversion_output":true,"text":"electronic case report form (eCRF).","text_display":" electronic case report form (eCRF).","confidence":0.990234375,"confidence_rate":0.9997546895573202},{"cnt":[[324,752],[1738,752],[1738,797],[324,797]],"region":{"top_left_x":324,"top_left_y":751,"width":1415,"height":47},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dfea534d59043b3852cd1056ba0f5fe","type":"text","conversion_output":true,"text":"Subjects discontinuing the IMP should be called in for the End-of-treatment visit as soon as","text_display":"\n\nSubjects discontinuing the IMP should be called in for the End-of-treatment visit as soon as","confidence":1,"confidence_rate":1},{"cnt":[[322,799],[1852,799],[1852,846],[322,846]],"region":{"top_left_x":322,"top_left_y":799,"width":1530,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9671acc2071c4e899caf745d81b2a15a","type":"text","conversion_output":true,"text":"possible after discontinuation of the IMP and for the Follow-up visit five weeks later. Furthermore,","text_display":" possible after discontinuation of the IMP and for the Follow-up visit five weeks later. Furthermore,","confidence":1,"confidence_rate":1},{"cnt":[[322,846],[1794,846],[1794,896],[322,896]],"region":{"top_left_x":322,"top_left_y":846,"width":1472,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2b6d4ba873c438da9fd1dca0f95047a","type":"text","conversion_output":true,"text":"the subjects should attend the End-of-trial - premature discontinuation visit (see Section 8.1.9).","text_display":" the subjects should attend the End-of-trial - premature discontinuation visit (see Section 8.1.9).","confidence":0.9409747123718262,"confidence_rate":0.9994095043830297},{"cnt":[[322,937],[1807,937],[1807,982],[322,982]],"region":{"top_left_x":322,"top_left_y":936,"width":1485,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96fa9c16ce6c4677aa504b9a054e5195","type":"text","conversion_output":true,"text":"If the IMP is discontinued, the subject can be prescribed alternative therapy at the investigator's","text_display":"\n\nIf the IMP is discontinued, the subject can be prescribed alternative therapy at the investigator's","confidence":1,"confidence_rate":1},{"cnt":[[322,984],[492,984],[492,1025],[322,1025]],"region":{"top_left_x":322,"top_left_y":983,"width":170,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99d26c6c358943d6b75b90c0915ad462","type":"text","conversion_output":true,"text":"discretion.","text_display":" discretion.","confidence":1,"confidence_rate":1},{"cnt":[[320,1068],[947,1068],[947,1119],[320,1119]],"region":{"top_left_x":320,"top_left_y":1067,"width":628,"height":53},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5353b5b66cd44addacf331ff644da639","type":"section_header","conversion_output":false,"children_ids":["73a3ed39ccd24b6392d4f6a8d064ebf4"],"text":"","text_display":""},{"cnt":[[322,1072],[943,1072],[943,1117],[322,1117]],"region":{"top_left_x":322,"top_left_y":1072,"width":622,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73a3ed39ccd24b6392d4f6a8d064ebf4","type":"text","conversion_output":true,"parent_id":"5353b5b66cd44addacf331ff644da639","text":"6.6 Rationale for trial population","text_display":"\n\n\\subsection*{6.6 Rationale for trial population}","confidence":1,"confidence_rate":1},{"cnt":[[322,1139],[1738,1139],[1738,1184],[322,1184]],"region":{"top_left_x":322,"top_left_y":1138,"width":1417,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01f88a0ae9484b3cb60b763989a6d336","type":"text","conversion_output":true,"text":"This trial will include adult subjects with T2D and insufficient glycaemic control following","text_display":"\n\nThis trial will include adult subjects with T2D and insufficient glycaemic control following","confidence":1,"confidence_rate":1},{"cnt":[[322,1186],[1852,1186],[1852,1231],[322,1231]],"region":{"top_left_x":322,"top_left_y":1185,"width":1530,"height":47},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20d1608d11ab4c00b0d82eb898705d70","type":"text","conversion_output":true,"text":"treatment with diet/exercise or metformin. The T2D subjects will have an \\(HbA _{1 c }\\) of \\(7.0-9.5 \\%\\) and a","text_display":" treatment with diet/exercise or metformin. The T2D subjects will have an \\(HbA _{1 c }\\) of \\(7.0-9.5 \\%\\) and a","confidence":0.9970703125,"confidence_rate":0.9999755504036063},{"cnt":[[322,1229],[1854,1229],[1854,1283],[322,1283]],"region":{"top_left_x":322,"top_left_y":1228,"width":1533,"height":55},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3216a194b6694db5915b0a4efe0bf65c","type":"text","conversion_output":true,"text":"BMI of \\(25-40 kg / m ^{2}\\). The trial will be carried out in Europe, North America and single countries in","text_display":" BMI of \\(25-40 kg / m ^{2}\\). 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For information on informed consent procedure please see Section","confidence":1,"confidence_rate":1},{"cnt":[[322,1225],[406,1225],[406,1265],[322,1265]],"region":{"top_left_x":322,"top_left_y":1224,"width":85,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb10981a343a447d8e0db127c89ec665","type":"text","conversion_output":true,"text":"18.1.","text_display":" 18.1.","confidence":0.99853515625,"confidence_rate":0.9998534189757986},{"cnt":[[322,1311],[1798,1311],[1798,1356],[322,1356]],"region":{"top_left_x":322,"top_left_y":1310,"width":1477,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c7b79c1462e4687b2ef432cbdac92cd","type":"text","conversion_output":true,"text":"All subjects will be provided with a copy of their own signed and dated informed consent form.","text_display":"\n\nAll subjects will be provided with a copy of their own signed and dated informed consent form.","confidence":1,"confidence_rate":1},{"cnt":[[322,1396],[1854,1396],[1854,1442],[322,1442]],"region":{"top_left_x":322,"top_left_y":1396,"width":1533,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"205c7e2369c647689a13a1448cc3fad8","type":"text","conversion_output":true,"text":"The IV/WRS must be contacted to register the subject as screened (see Section \\(\\underline{10}\\) ) at the screening","text_display":"\nThe IV/WRS must be contacted to register the subject as screened (see Section \\(\\underline{10}\\) ) at the screening","confidence":0.9305813880637288,"confidence_rate":0.9993461616663828},{"cnt":[[322,1444],[1854,1444],[1854,1489],[322,1489]],"region":{"top_left_x":322,"top_left_y":1443,"width":1533,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"697f722c67054f3081d5e8dfd3482149","type":"text","conversion_output":true,"text":"visit. Subject will be assigned a unique number (lowest available number allocated to site) which is","text_display":" visit. Subject will be assigned a unique number (lowest available number allocated to site) which is","confidence":1,"confidence_rate":1},{"cnt":[[322,1491],[816,1491],[816,1536],[322,1536]],"region":{"top_left_x":322,"top_left_y":1491,"width":495,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df4b65b5616a4017bfda0b2adc58735f","type":"text","conversion_output":true,"text":"maintained throughout the trial.","text_display":" maintained throughout the trial.","confidence":1,"confidence_rate":1},{"cnt":[[322,1579],[1828,1579],[1828,1624],[322,1624]],"region":{"top_left_x":322,"top_left_y":1579,"width":1507,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cec72cec4ecc4f79bd480e5ab0db61bb","type":"text","conversion_output":true,"text":"The investigator must keep a subject screening log, a subject identification code list and a subject","text_display":"\n\nThe investigator must keep a subject screening log, a subject identification code list and a subject","confidence":0.99853515625,"confidence_rate":0.9999860389766703},{"cnt":[[322,1629],[1811,1629],[1811,1674],[322,1674]],"region":{"top_left_x":322,"top_left_y":1628,"width":1490,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ef4f6f023bb41788539f88db3d31030","type":"text","conversion_output":true,"text":"enrolment log. The subject screening log and subject enrolment log may be combined in one list","text_display":" enrolment log. The subject screening log and subject enrolment log may be combined in one list","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[322,1676],[904,1676],[904,1721],[322,1721]],"region":{"top_left_x":322,"top_left_y":1675,"width":583,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40bbe44e83a342918cdc5da3bd20e83a","type":"text","conversion_output":true,"text":"and may be generated from IV/WRS.","text_display":" and may be generated from IV/WRS.","confidence":1,"confidence_rate":1},{"cnt":[[322,1764],[1828,1764],[1828,1809],[322,1809]],"region":{"top_left_x":322,"top_left_y":1763,"width":1507,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"536a1aa05c5849649c73c7090fe12231","type":"text","conversion_output":true,"text":"At screening, subjects will be provided with a card stating that they are participating in a trial and","text_display":"\n\nAt screening, subjects will be provided with a card stating that they are participating in a trial and","confidence":1,"confidence_rate":1},{"cnt":[[322,1813],[1818,1813],[1818,1858],[322,1858]],"region":{"top_left_x":322,"top_left_y":1813,"width":1496,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eec3885210874f41ad4051b67e2a73ef","type":"text","conversion_output":true,"text":"giving contact address(es) and telephone number(s) of relevant trial site staff. Subjects should be","text_display":" giving contact address(es) and telephone number(s) of relevant trial site staff. Subjects should be","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[322,1861],[1818,1861],[1818,1906],[322,1906]],"region":{"top_left_x":322,"top_left_y":1860,"width":1496,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"113ed15b826f4cefb7bce7333c54092d","type":"text","conversion_output":true,"text":"instructed to return the card to the investigator at the last trial visit or to destroy the card after the","text_display":" instructed to return the card to the investigator at the last trial visit or to destroy the card after the","confidence":1,"confidence_rate":1},{"cnt":[[322,1908],[471,1908],[471,1949],[322,1949]],"region":{"top_left_x":322,"top_left_y":1907,"width":149,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90fbe0bf727d4e0dba31fbe1390f96f9","type":"text","conversion_output":true,"text":"last visit.","text_display":" last visit.","confidence":1,"confidence_rate":1},{"cnt":[[322,2041],[322,1994],[1732,1996],[1732,2043]],"region":{"top_left_x":322,"top_left_y":1993,"width":1410,"height":51},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f47842a87bf4258995e88a4b4d2ab77","type":"text","conversion_output":true,"text":"For screening failures the screening failure form must be completed with the reason for not","text_display":"\n\nFor screening failures the screening failure form must be completed with the reason for not","confidence":1,"confidence_rate":1},{"cnt":[[322,2045],[1781,2045],[1781,2090],[322,2090]],"region":{"top_left_x":322,"top_left_y":2045,"width":1460,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c850414524041b3bffaedfaf2934e81","type":"text","conversion_output":true,"text":"continuing in the trial. Serious and non-serious adverse events from screening failures must be","text_display":" continuing in the trial. Serious and non-serious adverse events from screening failures must be","confidence":1,"confidence_rate":1},{"cnt":[[322,2093],[1807,2093],[1807,2138],[322,2138]],"region":{"top_left_x":322,"top_left_y":2092,"width":1485,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"691ab6048aa340afbac76870d7312af7","type":"text","conversion_output":true,"text":"transcribed by the investigator into the electronic case report form (eCRF). Follow-up of serious","text_display":" transcribed by the investigator into the electronic case report form (eCRF). Follow-up of serious","confidence":0.99267578125,"confidence_rate":0.9999279322780712},{"cnt":[[322,2140],[1820,2140],[1820,2187],[322,2187]],"region":{"top_left_x":322,"top_left_y":2139,"width":1498,"height":49},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15977d0fa70a4f16acc9fcc6adc67967","type":"text","conversion_output":true,"text":"adverse events (SAEs) must be carried out according to Section 12.3. A screening failure session","text_display":" adverse events (SAEs) must be carried out according to Section 12.3. A screening failure session","confidence":0.9951171875,"confidence_rate":0.9999515380814779},{"cnt":[[322,2191],[1274,2191],[1274,2237],[322,2237]],"region":{"top_left_x":322,"top_left_y":2191,"width":953,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f8eba289fa54ac09d605277b51bc6dd","type":"text","conversion_output":true,"text":"must be made in the IV/WRS. The case book must be signed.","text_display":" must be made in the IV/WRS. The case book must be signed.","confidence":1,"confidence_rate":1},{"cnt":[[322,2277],[1497,2277],[1497,2322],[322,2322]],"region":{"top_left_x":322,"top_left_y":2277,"width":1176,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2911bd5f67a47c6a7c74cee7312e04e","type":"text","conversion_output":true,"text":"Re-screening of subjects having signed the informed consent is not allowed.","text_display":"\n\nRe-screening of subjects having signed the informed consent is not 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Final } \\\\ \\text { Page: } & 38 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 38 \\text { of } 98\\end{array}\\right|\\)","confidence":0.6392191801719049,"confidence_rate":0.9966659592650897},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"28a7dd96da7d45cbbe3e92ad7d20e3b0","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,294],[608,294],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":294,"width":287,"height":35},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dc08062b9a474b79954c95aec6d9ec1c","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,327],[621,327],[621,363],[322,363]],"region":{"top_left_x":322,"top_left_y":326,"width":299,"height":38},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0f7552528bc54731825f20d26033f300","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[698,361],[698,397],[322,397]],"region":{"top_left_x":322,"top_left_y":360,"width":377,"height":38},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c5d579d0398a44c087316b4c38709d13","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,477],[1833,477],[1833,529],[322,529]],"region":{"top_left_x":322,"top_left_y":476,"width":1511,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c44b7de67f34aa881f7af42c3c009e2","type":"text","conversion_output":true,"text":"Once all data relating to Visit 1 have been obtained, these must be reviewed by the investigator to","text_display":"\n\nOnce all data relating to Visit 1 have been obtained, these must be reviewed by the investigator to","confidence":1,"confidence_rate":1},{"cnt":[[322,524],[1154,524],[1154,576],[322,576]],"region":{"top_left_x":322,"top_left_y":524,"width":832,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ed1a6396349432aba78590e97c28661","type":"text","conversion_output":true,"text":"ensure that the subject is eligible to continue the trial.","text_display":" ensure that the subject is eligible to continue the trial.","confidence":1,"confidence_rate":1},{"cnt":[[318,610],[733,610],[733,668],[318,668]],"region":{"top_left_x":317,"top_left_y":610,"width":416,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01398a01d70146d284f35048f6aa97a8","type":"section_header","conversion_output":false,"children_ids":["eeb2f8eeb97242ffa3e0776fadf30cd1"],"text":"","text_display":""},{"cnt":[[322,614],[728,614],[728,664],[322,664]],"region":{"top_left_x":322,"top_left_y":614,"width":407,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eeb2f8eeb97242ffa3e0776fadf30cd1","type":"text","conversion_output":true,"parent_id":"01398a01d70146d284f35048f6aa97a8","text":"8.1.3 Fasting visits","text_display":"\n\n\\subsection*{8.1.3 Fasting visits}","confidence":0.9990234375,"confidence_rate":0.9999609191777622},{"cnt":[[322,683],[1781,683],[1781,730],[322,730]],"region":{"top_left_x":322,"top_left_y":683,"width":1460,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9e501031a9549418e633dc7d98b4c20","type":"text","conversion_output":true,"text":"The subjects should attend several visits in a fasting state (see Section 2). Fasting is defined as","text_display":"\n\nThe subjects should attend several visits in a fasting state (see Section 2). Fasting is defined as","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[322,730],[1826,730],[1826,780],[322,780]],"region":{"top_left_x":322,"top_left_y":730,"width":1505,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4625496da414050b9a9471bba0aad29","type":"text","conversion_output":true,"text":"having consumed only water since midnight. An exception from this is the Follow-up visit where","text_display":" having consumed only water since midnight. An exception from this is the Follow-up visit where","confidence":1,"confidence_rate":1},{"cnt":[[322,778],[1433,778],[1433,827],[322,827]],"region":{"top_left_x":322,"top_left_y":777,"width":1112,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a281a6586c734a3b8135ac48efbdbde9","type":"text","conversion_output":true,"text":"fasting is defined as having consumed only water for the last two hours.","text_display":" fasting is defined as having consumed only water for the last two hours.","confidence":1,"confidence_rate":1},{"cnt":[[322,866],[1828,866],[1828,915],[322,915]],"region":{"top_left_x":322,"top_left_y":865,"width":1507,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2726b088870842c4b07eafe25efafede","type":"text","conversion_output":true,"text":"Subjects are allowed to take the IMP and oral concomitant medication during fasting if following","text_display":"\n\nSubjects are allowed to take the IMP and oral concomitant medication during fasting if following","confidence":1,"confidence_rate":1},{"cnt":[[322,915],[1785,915],[1785,965],[322,965]],"region":{"top_left_x":322,"top_left_y":915,"width":1464,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c19c438f6c8d4654b8937064db5fe907","type":"text","conversion_output":true,"text":"the conditions outlined in Section 5.3. An exception is at three visits in the oral treatment arms","text_display":" the conditions outlined in Section 5.3. An exception is at three visits in the oral treatment arms","confidence":1,"confidence_rate":1},{"cnt":[[322,962],[1833,962],[1833,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":962,"width":1511,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56abc59081654409bfc11ee2d8ee2e0d","type":"text","conversion_output":true,"text":"where peak and trough PK will be measured and the oral IMP will be administered at the site (see","text_display":" where peak and trough PK will be measured and the oral IMP will be administered at the site (see","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[322,1010],[574,1010],[574,1059],[322,1059]],"region":{"top_left_x":322,"top_left_y":1009,"width":252,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"166a65ff762640b38970930ef5d18163","type":"text","conversion_output":true,"text":"Section 8.4.10).","text_display":" Section 8.4.10).","confidence":0.99951171875,"confidence_rate":0.9999767431038692},{"cnt":[[322,1096],[1876,1096],[1876,1149],[322,1149]],"region":{"top_left_x":322,"top_left_y":1095,"width":1554,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db162cb8f9c5444caae16ea78080e17d","type":"text","conversion_output":true,"text":"If a subject attends a fasting visit in a non-fasting condition or a peak and trough PK meeting having","text_display":"\n\nIf a subject attends a fasting visit in a non-fasting condition or a peak and trough PK meeting having","confidence":1,"confidence_rate":1},{"cnt":[[322,1147],[1876,1147],[1876,1197],[322,1197]],"region":{"top_left_x":322,"top_left_y":1147,"width":1554,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3223532b9e7e48c6b738591e49c86253","type":"text","conversion_output":true,"text":"taken the oral dose the same day, then blood sampling and body weight must be re-scheduled within","text_display":" taken the oral dose the same day, then blood sampling and body weight must be re-scheduled within","confidence":1,"confidence_rate":1},{"cnt":[[322,1195],[1835,1195],[1835,1244],[322,1244]],"region":{"top_left_x":322,"top_left_y":1194,"width":1513,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee07c855f8f746aeb6f57b698ec35672","type":"text","conversion_output":true,"text":"the visit window. The date for each fasting assessment or PK assessment at the specific visit must","text_display":" the visit window. The date for each fasting assessment or PK assessment at the specific visit must","confidence":1,"confidence_rate":1},{"cnt":[[322,1242],[1803,1242],[1803,1293],[322,1293]],"region":{"top_left_x":322,"top_left_y":1241,"width":1481,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ccf390f4a624c71a5c739748512c65f","type":"text","conversion_output":true,"text":"be updated accordingly in the eCRF. All other assessments can be performed. Re-scheduling of","text_display":" be updated accordingly in the eCRF. All other assessments can be performed. Re-scheduling of","confidence":0.9912109375,"confidence_rate":0.9999089947172777},{"cnt":[[322,1291],[1566,1291],[1566,1343],[322,1343]],"region":{"top_left_x":322,"top_left_y":1291,"width":1245,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc8f513107f94dc09a80b5967992469f","type":"text","conversion_output":true,"text":"fasting visits or peak and trough PK visits are not considered unscheduled visits.","text_display":" fasting visits or peak and trough PK visits are not considered unscheduled visits.","confidence":1,"confidence_rate":1},{"cnt":[[318,1375],[823,1375],[823,1429],[318,1429]],"region":{"top_left_x":317,"top_left_y":1375,"width":506,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bccfd3270acf4c1fad9d9b4a8bb2bd05","type":"section_header","conversion_output":false,"children_ids":["561c590c84d94fa59e750967b53a0edb"],"text":"","text_display":""},{"cnt":[[322,1379],[819,1379],[819,1424],[322,1424]],"region":{"top_left_x":322,"top_left_y":1379,"width":497,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"561c590c84d94fa59e750967b53a0edb","type":"text","conversion_output":true,"parent_id":"bccfd3270acf4c1fad9d9b4a8bb2bd05","text":"8.1.4 Unscheduled visits","text_display":"\n\n\\subsection*{8.1.4 Unscheduled visits}","confidence":1,"confidence_rate":1},{"cnt":[[322,1448],[1721,1448],[1721,1497],[322,1497]],"region":{"top_left_x":322,"top_left_y":1448,"width":1399,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fe52b3d409d4c96bdf1469e9158ac8a","type":"text","conversion_output":true,"text":"An unscheduled visit can be scheduled at any time at the discretion of the investigator. An","text_display":"\n\nAn unscheduled visit can be scheduled at any time at the discretion of the investigator. An","confidence":1,"confidence_rate":1},{"cnt":[[322,1495],[1841,1495],[1841,1545],[322,1545]],"region":{"top_left_x":322,"top_left_y":1495,"width":1520,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6edc7a260e424b00a13ef81d4f9d52d9","type":"text","conversion_output":true,"text":"unscheduled visit form must be completed in the eCRF indicating the reason for the visit. Coming","text_display":" unscheduled visit form must be completed in the eCRF indicating the reason for the visit. Coming","confidence":0.98828125,"confidence_rate":0.9998832943774425},{"cnt":[[322,1543],[1721,1543],[1721,1592],[322,1592]],"region":{"top_left_x":322,"top_left_y":1542,"width":1399,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"633a86519b91466686f73dcee541dc11","type":"text","conversion_output":true,"text":"to the site for any of the following reasons should not be considered as unscheduled visits:","text_display":" to the site for any of the following reasons should not be considered as unscheduled visits:","confidence":1,"confidence_rate":1},{"cnt":[[322,1635],[900,1635],[900,1682],[322,1682]],"region":{"top_left_x":322,"top_left_y":1634,"width":579,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff0c47363d1643349b7967903f581a25","type":"text","conversion_output":true,"text":"- dispense additional trial products","text_display":"\n- dispense additional trial products","confidence":1,"confidence_rate":1},{"cnt":[[322,1684],[967,1684],[967,1734],[322,1734]],"region":{"top_left_x":322,"top_left_y":1684,"width":645,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12a4668e17ef4998b7a23d65405d698f","type":"text","conversion_output":true,"text":"- dispense additional auxiliary supplies","text_display":"\n- dispense additional auxiliary supplies","confidence":1,"confidence_rate":1},{"cnt":[[322,1736],[1480,1736],[1480,1785],[322,1785]],"region":{"top_left_x":322,"top_left_y":1735,"width":1159,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14ee87e73bc648da8586fa7d2194efa4","type":"text","conversion_output":true,"text":"- re-test of blood- or urine sampling (not allowed if results are available)","text_display":"\n- re-test of blood- or urine sampling (not allowed if results are available)","confidence":1,"confidence_rate":1},{"cnt":[[322,1822],[1792,1822],[1792,1871],[322,1871]],"region":{"top_left_x":322,"top_left_y":1821,"width":1470,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52215734c0ac481e8147510872224474","type":"text","conversion_output":true,"text":"In case of additional trial products being dispensed, a dispensing session should be made in the","text_display":"\n\nIn case of additional trial products being dispensed, a dispensing session should be made in the","confidence":1,"confidence_rate":1},{"cnt":[[322,1869],[965,1869],[965,1919],[322,1919]],"region":{"top_left_x":322,"top_left_y":1869,"width":643,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c302f0ac8964f81af8e0077336806b1","type":"text","conversion_output":true,"text":"IV/WRS selecting additional medication.","text_display":" IV/WRS selecting additional medication.","confidence":1,"confidence_rate":1},{"cnt":[[318,1953],[909,1953],[909,2013],[318,2013]],"region":{"top_left_x":317,"top_left_y":1952,"width":592,"height":62},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b33a3cadbb754da4b414990605234f41","type":"section_header","conversion_output":false,"children_ids":["c227cdd671e2477c8b0e4343ca7f29c3"],"text":"","text_display":""},{"cnt":[[322,1959],[904,1959],[904,2009],[322,2009]],"region":{"top_left_x":322,"top_left_y":1959,"width":583,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c227cdd671e2477c8b0e4343ca7f29c3","type":"text","conversion_output":true,"parent_id":"b33a3cadbb754da4b414990605234f41","text":"8.1.5 Visit 2 (Randomisation)","text_display":"\n\n\\subsection*{8.1.5 Visit 2 (Randomisation)}","confidence":1,"confidence_rate":1},{"cnt":[[322,2024],[1489,2024],[1489,2075],[322,2075]],"region":{"top_left_x":322,"top_left_y":2023,"width":1167,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b7b2a7b62d1496382bfb880108ae766","type":"text","conversion_output":true,"text":"For procedures and assessments performed at randomisation, see Section 2.","text_display":"\n\nFor procedures and assessments performed at randomisation, see Section 2.","confidence":0.96533203125,"confidence_rate":0.9995418820721195},{"cnt":[[322,2110],[1154,2110],[1154,2161],[322,2161]],"region":{"top_left_x":322,"top_left_y":2109,"width":832,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2df34e1accc045458d9ebe41f53191df","type":"text","conversion_output":true,"text":"Visit 2 will take place within two weeks after Visit 1.","text_display":"\nVisit 2 will take place within two weeks after Visit 1.","confidence":1,"confidence_rate":1},{"cnt":[[322,2200],[1824,2200],[1824,2249],[322,2249]],"region":{"top_left_x":322,"top_left_y":2200,"width":1503,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bf73b3b7cf0439499324964db5c43e7","type":"text","conversion_output":true,"text":"The randomisation session must be performed in the IV/WRS which will allocate the Dispensing","text_display":"\nThe randomisation session must be performed in the IV/WRS which will allocate the Dispensing","confidence":1,"confidence_rate":1},{"cnt":[[322,2247],[1871,2247],[1871,2299],[322,2299]],"region":{"top_left_x":322,"top_left_y":2247,"width":1550,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2b9441208964f5685a4d742079a51f1","type":"text","conversion_output":true,"text":"Unit Number (DUN) of the IMP to be dispensed to the subject. Eligible subjects will be randomised","text_display":" Unit Number (DUN) of the IMP to be dispensed to the subject. Eligible subjects will be randomised","confidence":1,"confidence_rate":1},{"cnt":[[322,2297],[823,2297],[823,2344],[322,2344]],"region":{"top_left_x":322,"top_left_y":2296,"width":501,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81c07963a390499e8781ff6cbbfca6fc","type":"text","conversion_output":true,"text":"into one of nine treatment arms.","text_display":" into one of nine treatment arms.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-041","page":41,"lines":[{"cnt":[[322,262],[432,262],[432,294],[322,294]],"region":{"top_left_x":322,"top_left_y":262,"width":110,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"da68d15cafa74d149d1f0a85301719d8","type":"page_info","conversion_output":false,"text":"Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1766,260],[1940,260],[1940,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":259,"width":175,"height":36},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"64b099636f104e4387a929767e526f4a","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,296],[608,296],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":296,"width":287,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0fb24d905a894cb0946f2ca092b39406","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,329],[621,329],[621,363],[322,363]],"region":{"top_left_x":322,"top_left_y":328,"width":299,"height":36},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5e9a5f27c5a54fb2b7010ab54e770983","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[694,361],[694,393],[322,393]],"region":{"top_left_x":322,"top_left_y":360,"width":372,"height":34},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"882bad1d45134b048d2a0af942b6ced9","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[889,260],[1764,260],[1764,406],[889,406]],"region":{"top_left_x":889,"top_left_y":259,"width":875,"height":148},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"06836c45649144059654e83a0464759f","type":"table","conversion_output":true,"text":"CONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 39 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 39 \\text { of } 98\\end{array}\\right|\\)","confidence":0.4848595689344757,"confidence_rate":0.9946123568939366},{"cnt":[[322,481],[1867,481],[1867,526],[322,526]],"region":{"top_left_x":322,"top_left_y":481,"width":1545,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bed40a4fda94306a00717d5364cb611","type":"text","conversion_output":true,"text":"The IMP will be dispensed to the subject by the trial site staff, hospital pharmacy staff or equivalent","text_display":"\n\nThe IMP will be dispensed to the subject by the trial site staff, hospital pharmacy staff or equivalent","confidence":1,"confidence_rate":1},{"cnt":[[322,529],[1830,529],[1830,574],[322,574]],"region":{"top_left_x":322,"top_left_y":528,"width":1509,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ea8d34155d54d199e4a3c0b02d96bcc","type":"text","conversion_output":true,"text":"at each visit during the trial from randomisation to last visit before the End-of-treatment visit (see","text_display":" at each visit during the trial from randomisation to last visit before the End-of-treatment visit (see","confidence":1,"confidence_rate":1},{"cnt":[[322,576],[1841,576],[1841,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":1520,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42ec96199e30454abbe66054be834b00","type":"text","conversion_output":true,"text":"Section 2). The investigator must document that subjects are instructed in oral IMP administration","text_display":" Section 2). The investigator must document that subjects are instructed in oral IMP administration","confidence":1,"confidence_rate":1},{"cnt":[[322,625],[711,625],[711,672],[322,672]],"region":{"top_left_x":322,"top_left_y":625,"width":390,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80d133c9beff4b4ebeceaf42b6ad41e2","type":"text","conversion_output":true,"text":"at every dispensing visit.","text_display":" at every dispensing visit.","confidence":1,"confidence_rate":1},{"cnt":[[322,713],[1863,713],[1863,758],[322,758]],"region":{"top_left_x":322,"top_left_y":713,"width":1541,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f56fc831b44481db0766c01f0795a22","type":"text","conversion_output":true,"text":"For subjects randomised to the s.c. injection, the investigator must document that a direction for use","text_display":"\n\nFor subjects randomised to the s.c. injection, the investigator must document that a direction for use","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[322,761],[1850,761],[1850,810],[322,810]],"region":{"top_left_x":322,"top_left_y":760,"width":1528,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ee3be6871c342c488829083b64135c3","type":"text","conversion_output":true,"text":"(DFU) is handed out at each dispensing visit. Ability and willingness to self-inject can be tested by","text_display":" (DFU) is handed out at each dispensing visit. Ability and willingness to self-inject can be tested by","confidence":1,"confidence_rate":1},{"cnt":[[322,808],[1852,808],[1852,857],[322,857]],"region":{"top_left_x":322,"top_left_y":807,"width":1530,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd81ba2e3d6f4c729d492aa9ca23a1e0","type":"text","conversion_output":true,"text":"administration of injections with a test pen for subjects who do not have prior experience with self-","text_display":" administration of injections with a test pen for subjects who do not have prior experience with self","confidence":0.9990234375,"confidence_rate":0.9999907826873115},{"cnt":[[322,855],[1106,855],[1106,904],[322,904]],"region":{"top_left_x":322,"top_left_y":855,"width":785,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98a39c2b8cfb4eb288c6d5fd431a011c","type":"text","conversion_output":true,"text":"injection. Novo Nordisk will provide the test pens.","text_display":"injection. Novo Nordisk will provide the test pens.","confidence":0.98583984375,"confidence_rate":0.9997453651419856},{"cnt":[[322,945],[1253,945],[1253,990],[322,990]],"region":{"top_left_x":322,"top_left_y":945,"width":931,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a54a4f1b7c0e419398daead9ec9aa38c","type":"text","conversion_output":true,"text":"Please see Section 9 for further information about the IMPs.","text_display":"\n\nPlease see Section 9 for further information about the IMPs.","confidence":0.759765625,"confidence_rate":0.9959677795346623},{"cnt":[[318,1027],[750,1027],[750,1076],[318,1076]],"region":{"top_left_x":317,"top_left_y":1026,"width":433,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8943c07835994dabadf961663415c8ea","type":"section_header","conversion_output":false,"children_ids":["3b3d3b0733814c28b36e839dcdaaddd9"],"text":"","text_display":""},{"cnt":[[322,1031],[746,1031],[746,1072],[322,1072]],"region":{"top_left_x":322,"top_left_y":1031,"width":424,"height":42},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b3d3b0733814c28b36e839dcdaaddd9","type":"text","conversion_output":true,"parent_id":"8943c07835994dabadf961663415c8ea","text":"8.1.6 Visit numbers","text_display":"\n\n\\subsection*{8.1.6 Visit numbers}","confidence":1,"confidence_rate":1},{"cnt":[[322,1100],[1846,1100],[1846,1147],[322,1147]],"region":{"top_left_x":322,"top_left_y":1100,"width":1524,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"794a582f4b224cd4b8a755b6e6bad7f6","type":"text","conversion_output":true,"text":"For visit numbers, timing of site visits and visit windows during the trial period, please refer to the","text_display":"\n\nFor visit numbers, timing of site visits and visit windows during the trial period, please refer to the","confidence":1,"confidence_rate":1},{"cnt":[[322,1147],[1712,1147],[1712,1195],[322,1195]],"region":{"top_left_x":322,"top_left_y":1147,"width":1391,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85c52f00ad044397b0c64869bce02f89","type":"text","conversion_output":true,"text":"flow chart, Section 2. Planned visits can be re-scheduled within the allowed visit window.","text_display":" flow chart, Section 2. Planned visits can be re-scheduled within the allowed visit window.","confidence":0.9892628192901611,"confidence_rate":0.9998863723486843},{"cnt":[[322,1233],[1803,1233],[1803,1283],[322,1283]],"region":{"top_left_x":322,"top_left_y":1233,"width":1481,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf0553b198f04dc2beb7fe988a8f5ac5","type":"text","conversion_output":true,"text":"It is the responsibility of the investigator to ensure that all site visits occur according to the flow","text_display":"\n\nIt is the responsibility of the investigator to ensure that all site visits occur according to the flow","confidence":1,"confidence_rate":1},{"cnt":[[322,1283],[655,1283],[655,1330],[322,1330]],"region":{"top_left_x":322,"top_left_y":1282,"width":334,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a80a82d1c004450aceaad7b101f36fb","type":"text","conversion_output":true,"text":"chart (see Section 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(Treatment)}","confidence":0.99951171875,"confidence_rate":0.9999856353826395},{"cnt":[[322,1439],[1835,1439],[1835,1485],[322,1485]],"region":{"top_left_x":322,"top_left_y":1439,"width":1513,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6af62517008d41c9b5a15e9bc15ff5a6","type":"text","conversion_output":true,"text":"For procedures and assessments performed at visits \\(3,4,5,6,7,8,9\\), and 10 , see the flow chart in","text_display":"\n\nFor procedures and assessments performed at visits \\(3,4,5,6,7,8,9\\), and 10 , see the flow chart in","confidence":0.99853515625,"confidence_rate":0.999986426780242},{"cnt":[[322,1487],[488,1487],[488,1532],[322,1532]],"region":{"top_left_x":322,"top_left_y":1486,"width":166,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d592c259da74414aa62262ceedfbe5b8","type":"text","conversion_output":true,"text":"Section 2.","text_display":" Section 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Follow-up)}","confidence":1,"confidence_rate":1},{"cnt":[[322,1641],[1841,1641],[1841,1687],[322,1687]],"region":{"top_left_x":322,"top_left_y":1641,"width":1520,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa908708de27493fb0ba22042ad58723","type":"text","conversion_output":true,"text":"All subjects must attend the End-of-treatment visit (Visit 11) which should be scheduled when the","text_display":"\n\nAll subjects must attend the End-of-treatment visit (Visit 11) which should be scheduled when the","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[322,1689],[1747,1689],[1747,1738],[322,1738]],"region":{"top_left_x":322,"top_left_y":1688,"width":1425,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fb999958ecc416b871fccdd95534b95","type":"text","conversion_output":true,"text":"subject has completed the treatment with the IMP and a Follow-up visit (Visit 12) should be","text_display":" subject has completed the treatment with the IMP and a Follow-up visit (Visit 12) should be","confidence":1,"confidence_rate":1},{"cnt":[[322,1738],[1841,1738],[1841,1785],[322,1785]],"region":{"top_left_x":322,"top_left_y":1738,"width":1520,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c2aa21a1ccf4ada88fe4324ad9b3997","type":"text","conversion_output":true,"text":"performed at least 5 weeks after ( +5 days visit window). A completion session must be performed","text_display":" performed at least 5 weeks after ( +5 days visit window). A completion session must be performed","confidence":0.998046875,"confidence_rate":0.9999817288133145},{"cnt":[[322,1788],[1313,1788],[1313,1833],[322,1833]],"region":{"top_left_x":322,"top_left_y":1787,"width":991,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f478bc0acd3405fa62920c2c02d0094","type":"text","conversion_output":true,"text":"in the IV/WRS. Please see the flow chart for details (Section 2).","text_display":" in the IV/WRS. Please see the flow chart for details (Section 2).","confidence":0.99462890625,"confidence_rate":0.9999230662462303},{"cnt":[[322,1873],[1876,1873],[1876,1923],[322,1923]],"region":{"top_left_x":322,"top_left_y":1873,"width":1554,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c378b9817c074bbcbf1286ef54c10c82","type":"text","conversion_output":true,"text":"The Follow-up visit serves to collect AEs, technical complaints, hyperglycaemic episodes and blood","text_display":"\n\nThe Follow-up visit serves to collect AEs, technical complaints, hyperglycaemic episodes and blood","confidence":1,"confidence_rate":1},{"cnt":[[322,1921],[952,1921],[952,1970],[322,1970]],"region":{"top_left_x":322,"top_left_y":1920,"width":630,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"721102f604924bd297817a06f63ffa8f","type":"text","conversion_output":true,"text":"samples for anti-semaglutide antibodies.","text_display":" samples for anti-semaglutide antibodies.","confidence":1,"confidence_rate":1},{"cnt":[[318,2002],[1394,2002],[1394,2065],[318,2065]],"region":{"top_left_x":317,"top_left_y":2002,"width":1078,"height":63},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a87ea17e4bb48ff8db539aeb51ba152","type":"section_header","conversion_output":false,"children_ids":["d55021fad46648d7add72ff7df7a7313"],"text":"","text_display":""},{"cnt":[[322,2011],[1388,2011],[1388,2060],[322,2060]],"region":{"top_left_x":322,"top_left_y":2010,"width":1066,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d55021fad46648d7add72ff7df7a7313","type":"text","conversion_output":true,"parent_id":"2a87ea17e4bb48ff8db539aeb51ba152","text":"8.1.9 Visit 11X (End-of-Trial - premature discontinuation)","text_display":"\n\n\\subsection*{8.1.9 Visit 11X (End-of-Trial - premature discontinuation)}","confidence":0.9590234756469727,"confidence_rate":0.9993360978599795},{"cnt":[[322,2075],[1833,2075],[1833,2125],[322,2125]],"region":{"top_left_x":322,"top_left_y":2075,"width":1511,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78e0074effd042268b1e8bc0b44a6cb4","type":"text","conversion_output":true,"text":"For subjects who discontinue the IMP prematurely the End-of-treatment visit (Visit 11) should be","text_display":"\n\nFor subjects who discontinue the IMP prematurely the End-of-treatment visit (Visit 11) should be","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[322,2125],[1863,2125],[1863,2172],[322,2172]],"region":{"top_left_x":322,"top_left_y":2124,"width":1541,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f7dbc8195b844809d3c290d441e3d26","type":"text","conversion_output":true,"text":"scheduled shortly after the subject has discontinued the IMP. The Follow-Up visit (Visit 12) should","text_display":" scheduled shortly after the subject has discontinued the IMP. The Follow-Up visit (Visit 12) should","confidence":1,"confidence_rate":1},{"cnt":[[322,2174],[1807,2174],[1807,2221],[322,2221]],"region":{"top_left_x":322,"top_left_y":2174,"width":1485,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"538397cf65334fcc9bfccee43137ba8a","type":"text","conversion_output":true,"text":"be scheduled at least 5 weeks ( +5 days visit window) after treatment discontinuation. Treatment","text_display":" be scheduled at least 5 weeks ( +5 days visit window) after treatment discontinuation. Treatment","confidence":0.994631290435791,"confidence_rate":0.9999496912386605},{"cnt":[[322,2221],[1841,2221],[1841,2271],[322,2271]],"region":{"top_left_x":322,"top_left_y":2221,"width":1520,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc923c6116304174b7e7c4fa8e73ad16","type":"text","conversion_output":true,"text":"discontinuation and drug accountability sessions must be done in the IV/WRS. Please see the flow","text_display":" discontinuation and drug accountability sessions must be done in the IV/WRS. Please see the flow","confidence":0.9150390625,"confidence_rate":0.9991212919994792},{"cnt":[[322,2271],[763,2271],[763,2318],[322,2318]],"region":{"top_left_x":322,"top_left_y":2270,"width":441,"height":49},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7180821f3dbc48fd8f696e3a980977f7","type":"text","conversion_output":true,"text":"chart for details (Section 2).","text_display":" chart for details (Section 2).","confidence":0.9990234375,"confidence_rate":0.9999720849711223}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-042","page":42,"lines":[{"cnt":[[322,262],[432,262],[432,294],[322,294]],"region":{"top_left_x":322,"top_left_y":262,"width":110,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"34b1df9ce1a74c8f91d01c42e2d75b9e","type":"page_info","conversion_output":false,"text":"Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[920,254],[1762,254],[1762,402],[920,402]],"region":{"top_left_x":919,"top_left_y":253,"width":843,"height":149},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"80f38b480a1e4ee19d2a9c9afcd68cd7","type":"table","conversion_output":true,"text":"CONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 40 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 40 \\text { of } 98\\end{array}\\right|\\)","confidence":0.4135537130315289,"confidence_rate":0.9934323494185318},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"09fb978cd1b144a594992fbf7bcaf7b0","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,292],[608,292],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":292,"width":287,"height":37},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4fcd47d7091d4600bb98090af6625858","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,327],[621,327],[621,363],[322,363]],"region":{"top_left_x":322,"top_left_y":326,"width":299,"height":38},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a570d19fc2a84be1a115901775bfcac7","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[698,361],[698,397],[322,397]],"region":{"top_left_x":322,"top_left_y":360,"width":377,"height":38},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d19a014851a644aebb43c6d04de0f106","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,477],[1841,477],[1841,526],[322,526]],"region":{"top_left_x":322,"top_left_y":476,"width":1520,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"946e54369c6d48f787e5e56bc9e03500","type":"text","conversion_output":true,"text":"Subjects who discontinue their IMP prematurely must also be requested to attend the visit End-of-","text_display":"\n\nSubjects who discontinue their IMP prematurely must also be requested to attend the visit End-of","confidence":1,"confidence_rate":1},{"cnt":[[322,524],[1841,524],[1841,578],[322,578]],"region":{"top_left_x":322,"top_left_y":524,"width":1520,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c57d05b2c7f47dc890cbee9e8c093db","type":"text","conversion_output":true,"text":"trial - premature discontinuation (Visit 11X) at the time of the scheduled end of treatment (i.e., 26","text_display":"trial - premature discontinuation (Visit 11X) at the time of the scheduled end of treatment (i.e., 26","confidence":0.9897553898626938,"confidence_rate":0.9999019338818457},{"cnt":[[322,576],[1725,576],[1725,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":1404,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f216df8c712a43b0b87d419addcd8028","type":"text","conversion_output":true,"text":"weeks after randomisation). Data on AEs and the primary endpoint from this final visit are","text_display":" weeks after randomisation). Data on AEs and the primary endpoint from this final visit are","confidence":1,"confidence_rate":1},{"cnt":[[322,623],[960,623],[960,672],[322,672]],"region":{"top_left_x":322,"top_left_y":623,"width":639,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"658aa47e2fd441b7b6c6ee5ac7f8313a","type":"text","conversion_output":true,"text":"important for the data quality of the trial.","text_display":" important for the data quality of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[318,709],[733,709],[733,761],[318,761]],"region":{"top_left_x":317,"top_left_y":708,"width":416,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"724b7741343b4f9e9270510730f50c9a","type":"section_header","conversion_output":false,"children_ids":["41ef5beae73b4541a0c915b1a637e66f"],"text":"","text_display":""},{"cnt":[[322,713],[728,713],[728,758],[322,758]],"region":{"top_left_x":322,"top_left_y":713,"width":407,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41ef5beae73b4541a0c915b1a637e66f","type":"text","conversion_output":true,"parent_id":"724b7741343b4f9e9270510730f50c9a","text":"8.1.10 Withdrawals","text_display":"\n\n\\subsection*{8.1.10 Withdrawals}","confidence":1,"confidence_rate":1},{"cnt":[[322,778],[1867,778],[1867,827],[322,827]],"region":{"top_left_x":322,"top_left_y":777,"width":1545,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38bb920a567446968741fb93554a42bb","type":"text","conversion_output":true,"text":"If a subject is withdrawn from the trial, the investigator must aim to undertake procedures similar to","text_display":"\n\nIf a subject is withdrawn from the trial, the investigator must aim to undertake procedures similar to","confidence":1,"confidence_rate":1},{"cnt":[[322,827],[1820,827],[1820,879],[322,879]],"region":{"top_left_x":322,"top_left_y":827,"width":1498,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fac0af7d250645b99b701b96c9d8b8c6","type":"text","conversion_output":true,"text":"those for visit 11 (End-of-treatment) as soon as possible, and the Follow-up visit at least 5 weeks","text_display":" those for visit 11 (End-of-treatment) as soon as possible, and the Follow-up visit at least 5 weeks","confidence":1,"confidence_rate":1},{"cnt":[[322,872],[1863,872],[1863,926],[322,926]],"region":{"top_left_x":322,"top_left_y":872,"width":1541,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cfecd33c398409f9fa9f7353aa6fec4","type":"text","conversion_output":true,"text":"after. The end-of-trial form must be completed and the subject should return all trial products to the","text_display":" after. The end-of-trial form must be completed and the subject should return all trial products to the","confidence":1,"confidence_rate":1},{"cnt":[[322,924],[1861,924],[1861,973],[322,973]],"region":{"top_left_x":322,"top_left_y":923,"width":1539,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea498695db8d4bfeb5e3834d354d85a9","type":"text","conversion_output":true,"text":"site to have final drug accountability performed. Drug accountability must be performed even if the","text_display":" site to have final drug accountability performed. Drug accountability must be performed even if the","confidence":1,"confidence_rate":1},{"cnt":[[322,971],[1841,971],[1841,1023],[322,1023]],"region":{"top_left_x":322,"top_left_y":971,"width":1520,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4bab70757dc4170959ffef4eb70d1e1","type":"text","conversion_output":true,"text":"subject is not able to come to the trial site. A treatment discontinuation session must be performed","text_display":" subject is not able to come to the trial site. A treatment discontinuation session must be performed","confidence":0.9970703125,"confidence_rate":0.9999720576529205},{"cnt":[[322,1021],[1308,1021],[1308,1072],[322,1072]],"region":{"top_left_x":322,"top_left_y":1020,"width":987,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ec0a539bdc44f04b4e356004da6dfdb","type":"text","conversion_output":true,"text":"in the IV/WRS (see Section 10). The case book must be signed.","text_display":" in the IV/WRS (see Section 10). 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Where the reasons are obtained, the primary reason for discontinuation must be","text_display":" subject's rights. 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The documents should be signed prior to the following visit and","text_display":" or in the subject's medical record. The documents should be signed prior to the following visit and","confidence":1,"confidence_rate":1},{"cnt":[[322,1603],[1330,1603],[1330,1652],[322,1652]],"region":{"top_left_x":322,"top_left_y":1602,"width":1008,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b37f0a2826b54fc9abe55f503b45bdbf","type":"text","conversion_output":true,"text":"must be retained at the investigator site as source documentation.","text_display":" must be retained at the investigator site as source documentation.","confidence":1,"confidence_rate":1},{"cnt":[[322,1689],[1631,1689],[1631,1738],[322,1738]],"region":{"top_left_x":322,"top_left_y":1688,"width":1309,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9176485269d64ceabd4e6327e966eeb2","type":"text","conversion_output":true,"text":"For ECGs and eye examinations the evaluations must be in the following categories:","text_display":"\n\nFor ECGs and eye examinations the evaluations must be in the following categories:","confidence":0.9985356330871582,"confidence_rate":0.9999831560022533},{"cnt":[[322,1740],[507,1740],[507,1785],[322,1785]],"region":{"top_left_x":322,"top_left_y":1740,"width":186,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89f4e944f59940aea44bdadf2bbd8f2a","type":"text","conversion_output":true,"text":"- Normal","text_display":"\n- Normal","confidence":1,"confidence_rate":1},{"cnt":[[322,1792],[546,1792],[546,1837],[322,1837]],"region":{"top_left_x":322,"top_left_y":1791,"width":224,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01c5a97b5f824438a59ab2c3f1580309","type":"text","conversion_output":true,"text":"- Abnormal","text_display":"\n- Abnormal","confidence":1,"confidence_rate":1},{"cnt":[[387,1843],[1179,1843],[1179,1893],[387,1893]],"region":{"top_left_x":386,"top_left_y":1843,"width":794,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2994d1c15f74160bfae21eee8af1b4a","type":"text","conversion_output":true,"text":"- Was the finding clinically significant? (yes/no)","text_display":"\n- Was the finding clinically significant? (yes/no)","confidence":1,"confidence_rate":1},{"cnt":[[322,1931],[1837,1931],[1837,1979],[322,1979]],"region":{"top_left_x":322,"top_left_y":1931,"width":1515,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"218705b63a864b64bd42f55f27408cf0","type":"text","conversion_output":true,"text":"For laboratory report values outside the reference range, the investigator must specify whether the","text_display":"\n\nFor laboratory report values outside the reference range, the investigator must specify whether the","confidence":1,"confidence_rate":1},{"cnt":[[322,1979],[1867,1979],[1867,2030],[322,2030]],"region":{"top_left_x":322,"top_left_y":1978,"width":1545,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4393416b10404063bf5557421705effe","type":"text","conversion_output":true,"text":"value is non-clinically or clinically significant. All laboratory printouts must be signed and dated by","text_display":" value is non-clinically or clinically significant. All laboratory printouts must be signed and dated by","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[322,2028],[960,2028],[960,2078],[322,2078]],"region":{"top_left_x":322,"top_left_y":2028,"width":639,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48e5017025bb4f098fba62aea69777b2","type":"text","conversion_output":true,"text":"the investigator on the day of evaluation.","text_display":" the investigator on the day of evaluation.","confidence":0.98583984375,"confidence_rate":0.9996966126728081},{"cnt":[[322,2114],[1689,2114],[1689,2163],[322,2163]],"region":{"top_left_x":322,"top_left_y":2114,"width":1367,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75dddae5f7f54b39988e824451c39921","type":"text","conversion_output":true,"text":"In case of abnormal clinically significant findings (e.g., in laboratory reports, ECGs, eye","text_display":"\n\nIn case of abnormal clinically significant findings (e.g., in laboratory reports, ECGs, eye","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[322,2161],[1755,2161],[1755,2211],[322,2211]],"region":{"top_left_x":322,"top_left_y":2161,"width":1434,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bea327e9c9d040fe82c349f991ce12b4","type":"text","conversion_output":true,"text":"examination or physical examination), the investigator must state a comment in the subject's","text_display":" examination or physical examination), the investigator must state a comment in the subject's","confidence":1,"confidence_rate":1},{"cnt":[[322,2211],[1783,2211],[1783,2260],[322,2260]],"region":{"top_left_x":322,"top_left_y":2210,"width":1462,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63af3be3e3cc47ac95f1e58e08b7d181","type":"text","conversion_output":true,"text":"medical record and record this on the concomitant illness form in the eCRF at the screening or","text_display":" medical record and record this on the concomitant illness form in the eCRF at the screening or","confidence":1,"confidence_rate":1},{"cnt":[[322,2260],[1762,2260],[1762,2310],[322,2310]],"region":{"top_left_x":322,"top_left_y":2260,"width":1440,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c093ca62c5b46d9b6362c73eb4a6f0a","type":"text","conversion_output":true,"text":"randomisation visits. At subsequent visits any clinically significant changes or new clinically","text_display":" randomisation visits. At subsequent visits any clinically significant changes or new clinically","confidence":1,"confidence_rate":1},{"cnt":[[322,2307],[1454,2307],[1454,2357],[322,2357]],"region":{"top_left_x":322,"top_left_y":2307,"width":1133,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cd5d45a12fd4be488e980d5bb173979","type":"text","conversion_output":true,"text":"significant findings must be reported as an AE according to Section 12.2.","text_display":" significant findings must be reported as an AE according to Section 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98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 41 \\text { of } 98\\end{array}\\right|\\)","confidence":0.5262333787020959,"confidence_rate":0.9952203361448443},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":8,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6b0f72ad483d4115b1adb4732362d0da","type":"text","conversion_output":true,"text":"Novo Nordisk","text_display":"\n\nNovo Nordisk","confidence":1,"confidence_rate":1},{"cnt":[[322,477],[1760,477],[1760,526],[322,526]],"region":{"top_left_x":322,"top_left_y":476,"width":1438,"height":51},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c72f2fdfce774a3baaaa62853a5b4113","type":"text","conversion_output":true,"text":"If clarification of entries or discrepancies in the diary or PROs is needed, the subject must be","text_display":"\n\nIf clarification of entries or discrepancies in the diary or PROs is needed, the subject must be","confidence":1,"confidence_rate":1},{"cnt":[[322,526],[1824,526],[1824,576],[322,576]],"region":{"top_left_x":322,"top_left_y":526,"width":1503,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7897c31d176249daa90f79e000d2c88b","type":"text","conversion_output":true,"text":"questioned and a conclusion made in the subject's medical record. Care must be taken not to bias","text_display":" questioned and a conclusion made in the subject's medical record. Care must be taken not to bias","confidence":1,"confidence_rate":1},{"cnt":[[322,576],[507,576],[507,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":186,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3629aefa55164f5786594d23583503d1","type":"text","conversion_output":true,"text":"the subject.","text_display":" the subject.","confidence":1,"confidence_rate":1},{"cnt":[[318,657],[920,657],[920,718],[318,718]],"region":{"top_left_x":317,"top_left_y":657,"width":603,"height":61},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b506dbed2c7048549d625eaf04628bd7","type":"section_header","conversion_output":false,"children_ids":["cd97f288bfdc4fc688f0a54c86ea4c1d"],"text":"","text_display":""},{"cnt":[[322,662],[915,662],[915,711],[322,711]],"region":{"top_left_x":322,"top_left_y":661,"width":594,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd97f288bfdc4fc688f0a54c86ea4c1d","type":"text","conversion_output":true,"parent_id":"b506dbed2c7048549d625eaf04628bd7","text":"8.2 Subject related information","text_display":"\n\n\\subsection*{8.2 Subject related information}","confidence":1,"confidence_rate":1},{"cnt":[[318,746],[1175,746],[1175,804],[318,804]],"region":{"top_left_x":317,"top_left_y":745,"width":859,"height":59},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b950ab8c714a4dc89261eeba9b72b177","type":"section_header","conversion_output":false,"children_ids":["e75769487b874817aeef4ff861f186ee"],"text":"","text_display":""},{"cnt":[[322,752],[1171,752],[1171,799],[322,799]],"region":{"top_left_x":322,"top_left_y":751,"width":849,"height":49},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e75769487b874817aeef4ff861f186ee","type":"text","conversion_output":true,"parent_id":"b950ab8c714a4dc89261eeba9b72b177","text":"8.2.1 Concomitant illness and medical history","text_display":"\n\n\\subsection*{8.2.1 Concomitant illness and medical history}","confidence":0.9931640625,"confidence_rate":0.9998628212188517},{"cnt":[[322,816],[1858,816],[1858,866],[322,866]],"region":{"top_left_x":322,"top_left_y":816,"width":1537,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"906c89994e704fc1a968e4a8aaf8d5d1","type":"text","conversion_output":true,"text":"A concomitant illness is any illness that is present at the start of the trial (i.e., at the screening visit","text_display":"\n\nA concomitant illness is any illness that is present at the start of the trial (i.e., at the screening visit","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[322,866],[1783,866],[1783,913],[322,913]],"region":{"top_left_x":322,"top_left_y":865,"width":1462,"height":49},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f990f7e7407746618a74171ba182cfcc","type":"text","conversion_output":true,"text":"or found as a result of screening procedure). The concomitant illness should be recorded in the","text_display":" or found as a result of screening procedure). The concomitant illness should be recorded in the","confidence":1,"confidence_rate":1},{"cnt":[[322,915],[432,915],[432,956],[322,956]],"region":{"top_left_x":322,"top_left_y":915,"width":110,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05555403555e4177af82b8453680b2d0","type":"text","conversion_output":true,"text":"eCRF.","text_display":" eCRF.","confidence":0.99951171875,"confidence_rate":0.9999511611428449},{"cnt":[[322,962],[1768,962],[1768,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":962,"width":1447,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee7e894910854d6db8ef9cf6a4e8839c","type":"text","conversion_output":true,"text":"Medical history is a medical event that the subject has experienced in the past. Only medical","text_display":"\nMedical history is a medical event that the subject has experienced in the past. 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The waist circumferences will be measured using a non-stretchable measuring tape. It should","text_display":" eCRF. The waist circumferences will be measured using a non-stretchable measuring tape. It should","confidence":0.98193359375,"confidence_rate":0.9998212748321995},{"cnt":[[322,778],[1772,778],[1772,827],[322,827]],"region":{"top_left_x":322,"top_left_y":777,"width":1451,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52986a94133846388c0799fb3a153466","type":"text","conversion_output":true,"text":"be recorded to the nearest \\(\\frac{1}{2} cm\\) or \\(\\frac{1}{4}\\) inch using the same measuring tape throughout the trial.","text_display":" be recorded to the nearest \\(\\frac{1}{2} cm\\) or \\(\\frac{1}{4}\\) inch using the same measuring tape throughout the trial.","confidence":0.9278154261410236,"confidence_rate":0.9993652654256914},{"cnt":[[322,866],[1798,866],[1798,915],[322,915]],"region":{"top_left_x":322,"top_left_y":865,"width":1477,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bc4310026b04a83bd7de1d30f39b779","type":"text","conversion_output":true,"text":"The subject should be measured in a standing position with an empty bladder and wearing light","text_display":"\n\nThe subject should be measured in a standing position with an empty bladder and wearing light","confidence":1,"confidence_rate":1},{"cnt":[[322,913],[1828,913],[1828,965],[322,965]],"region":{"top_left_x":322,"top_left_y":913,"width":1507,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6f3937e9533428ba98a73a399a508d9","type":"text","conversion_output":true,"text":"clothing with accessible waist. The subject should be standing with arms down their side and feet","text_display":" clothing with accessible waist. The subject should be standing with arms down their side and feet","confidence":1,"confidence_rate":1},{"cnt":[[322,962],[1830,962],[1830,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":962,"width":1509,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"657027368dd84c4f9413be258372ef53","type":"text","conversion_output":true,"text":"together. The tape should touch the skin but not compress soft tissue and twists in the tape should","text_display":" together. 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The subject should be asked to breathe normally and the measurement should be taken","confidence":1,"confidence_rate":1},{"cnt":[[322,1059],[952,1059],[952,1111],[322,1111]],"region":{"top_left_x":322,"top_left_y":1059,"width":630,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d3c75798ef94bdaa80c1559ddc613af","type":"text","conversion_output":true,"text":"when the subject is breathing out gently.","text_display":" when the subject is breathing out gently.","confidence":1,"confidence_rate":1},{"cnt":[[318,1143],[415,1143],[415,1197],[318,1197]],"region":{"top_left_x":317,"top_left_y":1142,"width":98,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c498c6adb8e14c898ec29f665c15b788","type":"section_header","conversion_output":false,"children_ids":["ad7b066815214a38bcc96fd3f0cbccc3"],"text":"","text_display":""},{"cnt":[[322,1147],[410,1147],[410,1192],[322,1192]],"region":{"top_left_x":322,"top_left_y":1147,"width":89,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad7b066815214a38bcc96fd3f0cbccc3","type":"text","conversion_output":true,"parent_id":"c498c6adb8e14c898ec29f665c15b788","text":"BMI","text_display":"\n\n\\section*{BMI}","confidence":1,"confidence_rate":1},{"cnt":[[322,1216],[1158,1216],[1158,1265],[322,1265]],"region":{"top_left_x":322,"top_left_y":1216,"width":837,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4a9d57112a24a93bdc4e9cb38705f1f","type":"text","conversion_output":true,"text":"BMI will be captured in the eCRF using the equation:","text_display":"\n\nBMI will be captured in the eCRF using the equation:","confidence":1,"confidence_rate":1},{"cnt":[[322,1293],[1476,1293],[1476,1351],[322,1351]],"region":{"top_left_x":322,"top_left_y":1293,"width":1154,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f9519e1a9a24f9bab969b86afea2b3c","type":"text","conversion_output":true,"text":"BMI \\(=\\) Body weight \\(( kg ) /(\\) Height \\(( m ) \\times\\) Height \\(( m ))\\left[ kg / m ^{2}= lb / in ^{2} \\times 703\\right]\\)","text_display":"\nBMI \\(=\\) Body weight \\(( kg ) /(\\) Height \\(( m ) \\times\\) Height \\(( m ))\\left[ kg / m ^{2}= lb / in ^{2} \\times 703\\right]\\)","confidence":0.9820406450703282,"confidence_rate":0.9998410426228502},{"cnt":[[318,1384],[952,1384],[952,1442],[318,1442]],"region":{"top_left_x":317,"top_left_y":1383,"width":635,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ab75104807e423c9bcb0c17b8a645bc","type":"section_header","conversion_output":false,"children_ids":["b15af28c23a2476cbe6cd4cd7f0da328"],"text":"","text_display":""},{"cnt":[[322,1388],[947,1388],[947,1437],[322,1437]],"region":{"top_left_x":322,"top_left_y":1387,"width":626,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b15af28c23a2476cbe6cd4cd7f0da328","type":"text","conversion_output":true,"parent_id":"3ab75104807e423c9bcb0c17b8a645bc","text":"8.3.3 Patient reported outcomes","text_display":"\n\n\\subsection*{8.3.3 Patient reported outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[322,1448],[1173,1448],[1173,1506],[322,1506]],"region":{"top_left_x":322,"top_left_y":1448,"width":852,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57accf10f0f8473e96831a4415a8c5c2","type":"text","conversion_output":true,"text":"The PRO questionnaire used in this trial is SF-36v2 \\({ }^{ TM }\\).","text_display":"\n\nThe PRO questionnaire used in this trial is SF-36v2 \\({ }^{ TM }\\).","confidence":0.99951171875,"confidence_rate":0.9999934000150488},{"cnt":[[322,1543],[1841,1543],[1841,1592],[322,1592]],"region":{"top_left_x":322,"top_left_y":1542,"width":1520,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f62dc9281b043fea1be17c7a75957b0","type":"text","conversion_output":true,"text":"The questionnaire should be completed by the subject as specified in the flow chart, see Section 2,","text_display":"\nThe questionnaire should be completed by the subject as specified in the flow chart, see Section 2,","confidence":0.7814626693725586,"confidence_rate":0.9976317712066078},{"cnt":[[322,1590],[1828,1590],[1828,1641],[322,1641]],"region":{"top_left_x":322,"top_left_y":1589,"width":1507,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"304ff8a6c1994caeb517f3d9e51cf4bd","type":"text","conversion_output":true,"text":"preferably before any other trial-related activities. 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Urinalysis}","confidence":1,"confidence_rate":1},{"cnt":[[322,546],[1749,546],[1749,595],[322,595]],"region":{"top_left_x":322,"top_left_y":545,"width":1427,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8acae60f8c2442b0bfc8709f352308fb","type":"text","conversion_output":true,"text":"Subjects will be asked to bring first morning urine during the trial (see Section 2). The urine","text_display":"\n\nSubjects will be asked to bring first morning urine during the trial (see Section 2). The urine","confidence":1,"confidence_rate":1},{"cnt":[[322,593],[1751,593],[1751,645],[322,645]],"region":{"top_left_x":322,"top_left_y":592,"width":1429,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f099675ce7164ea792856794087686a2","type":"text","conversion_output":true,"text":"samples will be analysed at the central laboratory to determine levels of the following safety","text_display":" samples will be analysed at the central laboratory to determine levels of the following safety","confidence":0.98779296875,"confidence_rate":0.9998759455843587},{"cnt":[[322,645],[677,645],[677,694],[322,694]],"region":{"top_left_x":322,"top_left_y":644,"width":355,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0010d13da164147bd7f9d7a2188bd64","type":"text","conversion_output":true,"text":"laboratory parameters:","text_display":" laboratory parameters:","confidence":1,"confidence_rate":1},{"cnt":[[322,733],[926,733],[926,780],[322,780]],"region":{"top_left_x":322,"top_left_y":732,"width":604,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54adf54b337648fa9311d15aaf2e2e4e","type":"text","conversion_output":true,"text":"- Urinary albumin to creatinine ratio","text_display":"\n- Urinary albumin to creatinine ratio","confidence":1,"confidence_rate":1},{"cnt":[[322,782],[1562,782],[1562,836],[322,836]],"region":{"top_left_x":322,"top_left_y":782,"width":1240,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"818e1868d673430a8f10f9a578ecbec1","type":"text","conversion_output":true,"text":"- Urinalysis by urine dip-stick: erythrocytes, protein, glucose and ketones, pH","text_display":"\n- Urinalysis by urine dip-stick: erythrocytes, protein, glucose and ketones, pH","confidence":0.9794921875,"confidence_rate":0.9997590869586559},{"cnt":[[318,868],[698,868],[698,922],[318,922]],"region":{"top_left_x":317,"top_left_y":867,"width":382,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7272ae4dc694c018cd1adeff0ad6b21","type":"section_header","conversion_output":false,"children_ids":["e876a85135b44fee872d435311dc4391"],"text":"","text_display":""},{"cnt":[[322,872],[690,872],[690,917],[322,917]],"region":{"top_left_x":322,"top_left_y":872,"width":368,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e876a85135b44fee872d435311dc4391","type":"text","conversion_output":true,"parent_id":"f7272ae4dc694c018cd1adeff0ad6b21","text":"8.4.5 Antibodies","text_display":"\n\n\\subsection*{8.4.5 Antibodies}","confidence":1,"confidence_rate":1},{"cnt":[[322,939],[1665,939],[1665,986],[322,986]],"region":{"top_left_x":322,"top_left_y":938,"width":1344,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"258f01b5906448b58448271108854661","type":"text","conversion_output":true,"text":"Blood samples will be drawn during the trial and analysed at specialised laboratory for","text_display":"\n\nBlood samples will be drawn during the trial and analysed at specialised laboratory for","confidence":1,"confidence_rate":1},{"cnt":[[322,988],[1841,988],[1841,1038],[322,1038]],"region":{"top_left_x":322,"top_left_y":988,"width":1520,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"712b99f820454845b8f773eb662e6446","type":"text","conversion_output":true,"text":"determination of serum antibodies to semaglutide, including cross reactivity to endogenous GLP-1","text_display":" determination of serum antibodies to semaglutide, including cross reactivity to endogenous GLP-1","confidence":1,"confidence_rate":1},{"cnt":[[322,1036],[1777,1036],[1777,1085],[322,1085]],"region":{"top_left_x":322,"top_left_y":1035,"width":1455,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f70d4e3a5994e68b7887be160cde25d","type":"text","conversion_output":true,"text":"(see flow chart, section 2). Samples positive for antibodies against semaglutide will be further","text_display":" (see flow chart, section 2). Samples positive for antibodies against semaglutide will be further","confidence":1,"confidence_rate":1},{"cnt":[[322,1085],[1841,1085],[1841,1132],[322,1132]],"region":{"top_left_x":322,"top_left_y":1084,"width":1520,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04b34be557fb454da4f8f71cc3b41452","type":"text","conversion_output":true,"text":"characterised for in vitro neutralising effect towards semaglutide. In addition, samples positive for","text_display":" characterised for in vitro neutralising effect towards semaglutide. In addition, samples positive for","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[322,1130],[1824,1130],[1824,1182],[322,1182]],"region":{"top_left_x":322,"top_left_y":1130,"width":1503,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d629a43b00340a9bce2426186aa7be9","type":"text","conversion_output":true,"text":"antibodies cross-reacting with endogenous GLP-1 will be analysed for in vitro neutralising effect","text_display":" antibodies cross-reacting with endogenous GLP-1 will be analysed for in vitro neutralising effect","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[322,1182],[1745,1182],[1745,1231],[322,1231]],"region":{"top_left_x":322,"top_left_y":1181,"width":1423,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff44c9a1aaa94a028a51be20b48c8085","type":"text","conversion_output":true,"text":"towards endogenous GLP-1. 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All ECGs will undergo central","text_display":"\n\n12-lead ECG will be performed during the trial (see Section 2). 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All such ECGs will undergo central assessment.","text_display":" at other visits than the planned ECG visits. All such ECGs will undergo central assessment.","confidence":1,"confidence_rate":1},{"cnt":[[322,799],[1828,799],[1828,849],[322,849]],"region":{"top_left_x":322,"top_left_y":799,"width":1507,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1d4bd2df292459abcaf1d748ef47bdb","type":"text","conversion_output":true,"text":"An ECG performed for any reason unrelated to the trial within 30 days prior to the randomisation","text_display":"\n\nAn ECG performed for any reason unrelated to the trial within 30 days prior to the randomisation","confidence":1,"confidence_rate":1},{"cnt":[[322,846],[1841,846],[1841,896],[322,896]],"region":{"top_left_x":322,"top_left_y":846,"width":1520,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0d3ad78c5bc4207b068f952727551fd","type":"text","conversion_output":true,"text":"visit is acceptable as Visit 2 data, provided no clinical symptoms suggestive of cardiac 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palpation","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[322,1079],[1179,1079],[1179,1126],[322,1126]],"region":{"top_left_x":322,"top_left_y":1078,"width":858,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc8b1b5c647844d0b0e9542d7458b001","type":"text","conversion_output":true,"text":"The results are recorded as described in Section 8.1.11.","text_display":"\n\nThe results are recorded as described in Section 8.1.11.","confidence":1,"confidence_rate":1},{"cnt":[[318,1164],[814,1164],[814,1214],[318,1214]],"region":{"top_left_x":317,"top_left_y":1164,"width":498,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7bac6be33b14a44811a0e5c40723822","type":"section_header","conversion_output":false,"children_ids":["36bbb0396e5b4a28bb3018324567cfb6"],"text":"","text_display":""},{"cnt":[[322,1164],[810,1164],[810,1210],[322,1210]],"region":{"top_left_x":322,"top_left_y":1164,"width":488,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36bbb0396e5b4a28bb3018324567cfb6","type":"text","conversion_output":true,"parent_id":"f7bac6be33b14a44811a0e5c40723822","text":"8.4.10 Pharmacokinetics","text_display":"\n\n\\subsection*{8.4.10 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The investigator must","text_display":" concentrations of semaglutide at Visits 3-11 (see flow chart, Section 2). The investigator must","confidence":0.994140625,"confidence_rate":0.9999412356418027},{"cnt":[[322,1328],[1721,1328],[1721,1379],[322,1379]],"region":{"top_left_x":322,"top_left_y":1327,"width":1399,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de664a51dc9649c9abeb084fb055343b","type":"text","conversion_output":true,"text":"record the exact time for drawing the blood samples in the laboratory requisition form and","text_display":" record the exact time for drawing the blood samples in the laboratory requisition form and","confidence":0.9990236759185791,"confidence_rate":0.9999897179371111},{"cnt":[[322,1379],[819,1379],[819,1424],[322,1424]],"region":{"top_left_x":322,"top_left_y":1379,"width":497,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55e4117fbc9547f1ab2560c2bf9e5547","type":"text","conversion_output":true,"text":"transcribe the data to the eCRF.","text_display":" transcribe the data to the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[322,1465],[1858,1465],[1858,1515],[322,1515]],"region":{"top_left_x":322,"top_left_y":1465,"width":1537,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd2a2009a52348e5ab00878fd68abb57","type":"text","conversion_output":true,"text":"Subjects on oral treatment will also have PK measured pre-dose and post-dose (trough and peak) at","text_display":"\n\nSubjects on oral treatment will also have PK measured pre-dose and post-dose (trough and peak) at","confidence":0.99853515625,"confidence_rate":0.9999856283612877},{"cnt":[[322,1512],[1798,1512],[1798,1562],[322,1562]],"region":{"top_left_x":322,"top_left_y":1512,"width":1477,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4a01a9900cc444e965bd7564e02d463","type":"text","conversion_output":true,"text":"three visits (see Section 2). At the visits for trough and peak PK measurements, the investigator","text_display":" three visits (see Section 2). At the visits for trough and peak PK measurements, the investigator","confidence":1,"confidence_rate":1},{"cnt":[[322,1560],[1485,1560],[1485,1611],[322,1611]],"region":{"top_left_x":322,"top_left_y":1559,"width":1163,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa85536be90446c19f0bfd1be5305e60","type":"text","conversion_output":true,"text":"needs to ensure that the subjects on oral treatment follow these procedures:","text_display":" needs to ensure that the subjects on oral treatment follow these procedures:","confidence":0.9990234375,"confidence_rate":0.9999879378548738},{"cnt":[[322,1652],[741,1652],[741,1699],[322,1699]],"region":{"top_left_x":322,"top_left_y":1652,"width":420,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b109a4510c1e4ea4a07d006a10624322","type":"text","conversion_output":true,"text":"- Attend the visit fasting","text_display":"\n- Attend the visit 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Calcitonin values \\(\\geq 20 ng / L\\) will be submitted to an independent committee of thyroid","text_display":" Section 2). Calcitonin values \\(\\geq 20 ng / L\\) will be submitted to an independent committee of thyroid","confidence":1,"confidence_rate":1},{"cnt":[[322,647],[1807,647],[1807,690],[322,690]],"region":{"top_left_x":322,"top_left_y":646,"width":1485,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca33759402f948979ebeadbaf158706f","type":"text","conversion_output":true,"text":"experts. The Calcitonin Monitoring Committee (CMC) will provide guidance to the investigator","text_display":" experts. The Calcitonin Monitoring Committee (CMC) will provide guidance to the investigator","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[322,694],[1755,694],[1755,737],[322,737]],"region":{"top_left_x":322,"top_left_y":693,"width":1434,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e7063c1bf9b642dd82e571eb35c47a8e","type":"text","conversion_output":true,"text":"with regards to treatment and further investigations. It is recommended that screening failure","text_display":" with regards to treatment and further investigations. It is recommended that screening failure","confidence":1,"confidence_rate":1},{"cnt":[[322,743],[1854,743],[1854,788],[322,788]],"region":{"top_left_x":322,"top_left_y":743,"width":1533,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"013baf3463974451963e027d7e669dd1","type":"text","conversion_output":true,"text":"subjects with a calcitonin value \\(\\geq 10 ng / L\\) are referred to a thyroid expert for further evaluation. For","text_display":" subjects with a calcitonin value \\(\\geq 10 ng / L\\) are referred to a thyroid expert for further evaluation. For","confidence":0.9990236759185791,"confidence_rate":0.999991506114367},{"cnt":[[322,791],[866,791],[866,836],[322,836]],"region":{"top_left_x":322,"top_left_y":790,"width":544,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0712d8ad746045f6b471128a8f6bc26e","type":"text","conversion_output":true,"text":"details please refer to Appendix A.","text_display":" details please refer to Appendix A.","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[322,877],[853,877],[853,926],[322,926]],"region":{"top_left_x":322,"top_left_y":876,"width":531,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5303405df4a24e8da87021d8509cc7af","type":"section_header","conversion_output":false,"children_ids":["d89baec5b995438581dba96c3b4cfde9"],"text":"","text_display":""},{"cnt":[[322,881],[851,881],[851,922],[322,922]],"region":{"top_left_x":322,"top_left_y":880,"width":529,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d89baec5b995438581dba96c3b4cfde9","type":"text","conversion_output":true,"parent_id":"5303405df4a24e8da87021d8509cc7af","text":"8.5 Laboratory assessments","text_display":"\n\n\\subsection*{8.5 Laboratory assessments}","confidence":1,"confidence_rate":1},{"cnt":[[322,945],[1790,945],[1790,990],[322,990]],"region":{"top_left_x":322,"top_left_y":945,"width":1468,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78449660948748a595ca4477988dd56b","type":"text","conversion_output":true,"text":"The laboratory analyses will mainly be performed by a central laboratory. For analyses of anti-","text_display":"\n\nThe laboratory analyses will mainly be performed by a central laboratory. For analyses of anti","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[322,993],[1790,993],[1790,1038],[322,1038]],"region":{"top_left_x":322,"top_left_y":992,"width":1468,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57183614c8754d28a0f239ec28d473cd","type":"text","conversion_output":true,"text":"semaglutide antibodies (see Section 8.4.5) and semaglutide plasma concentrations (see Section","text_display":"semaglutide antibodies (see Section 8.4.5) and semaglutide plasma concentrations (see Section","confidence":1,"confidence_rate":1},{"cnt":[[322,1044],[1863,1044],[1863,1089],[322,1089]],"region":{"top_left_x":322,"top_left_y":1044,"width":1541,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d56a0a2b74d7472ca590c1db4e0bf096","type":"text","conversion_output":true,"text":"8.4.10) a special laboratory will be used. Also, in the situation described in Section 8.6.2.1 a special","text_display":" 8.4.10) a special laboratory will be used. Also, in the situation described in Section 8.6.2.1 a special","confidence":0.99755859375,"confidence_rate":0.9999775746428119},{"cnt":[[322,1091],[1833,1091],[1833,1137],[322,1137]],"region":{"top_left_x":322,"top_left_y":1091,"width":1511,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd98dc5525334d36a37e739a060fc417","type":"text","conversion_output":true,"text":"laboratory will be used. Laboratory samples comprise both urine and blood samples. Descriptions","text_display":" laboratory will be used. Laboratory samples comprise both urine and blood samples. Descriptions","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[322,1139],[1854,1139],[1854,1188],[322,1188]],"region":{"top_left_x":322,"top_left_y":1138,"width":1533,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a86899de8dd4712adce2087de19baa6","type":"text","conversion_output":true,"text":"of assay methods, laboratory supplies and procedures for collecting, handling, storing and shipping","text_display":" of assay methods, laboratory supplies and procedures for collecting, handling, storing and shipping","confidence":1,"confidence_rate":1},{"cnt":[[322,1188],[1766,1188],[1766,1233],[322,1233]],"region":{"top_left_x":322,"top_left_y":1188,"width":1445,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0b84e1ff16dc4cde8ddc59edf3e2656e","type":"text","conversion_output":true,"text":"samples and information regarding who will perform the assessments will be described in the","text_display":" samples and information regarding who will perform the assessments will be described in the","confidence":1,"confidence_rate":1},{"cnt":[[322,1237],[1852,1237],[1852,1283],[322,1283]],"region":{"top_left_x":322,"top_left_y":1237,"width":1530,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70a89d12df754effa1bfcdbb12379318","type":"text","conversion_output":true,"text":"laboratory manual provided by the central laboratory (for central and special laboratory details, see","text_display":" laboratory manual provided by the central laboratory (for central and special laboratory details, see","confidence":1,"confidence_rate":1},{"cnt":[[322,1285],[552,1285],[552,1330],[322,1330]],"region":{"top_left_x":322,"top_left_y":1284,"width":231,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1bf50d8665974351a64bfc70ec01c8f9","type":"text","conversion_output":true,"text":"Attachment I).","text_display":" Attachment I).","confidence":1,"confidence_rate":1},{"cnt":[[322,1371],[1369,1371],[1369,1416],[322,1416]],"region":{"top_left_x":322,"top_left_y":1370,"width":1047,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c96561c899848df81012bb7d6886e9b","type":"text","conversion_output":true,"text":"Samples will be coded in order to keep subject identity anonymous.","text_display":"\n\nSamples will be coded in order to keep subject identity anonymous.","confidence":1,"confidence_rate":1},{"cnt":[[322,1459],[1807,1459],[1807,1504],[322,1504]],"region":{"top_left_x":322,"top_left_y":1458,"width":1485,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b533ade210a047e886d4f1d77bd0a27e","type":"text","conversion_output":true,"text":"Laboratory samples not collected on the day of the actual visit should preferably be collected on","text_display":"\nLaboratory samples not collected on the day of the actual visit should preferably be collected on","confidence":1,"confidence_rate":1},{"cnt":[[322,1508],[1811,1508],[1811,1553],[322,1553]],"region":{"top_left_x":322,"top_left_y":1508,"width":1490,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd88f06e4b69452f93d01297a210af40","type":"text","conversion_output":true,"text":"another day within the visit window as stated in the flow chart (see Section 2). Please note that a","text_display":" another day within the visit window as stated in the flow chart (see Section 2). Please note that a","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[322,1555],[1618,1555],[1618,1601],[322,1601]],"region":{"top_left_x":322,"top_left_y":1555,"width":1296,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc1480dbf054479f92bd5419096ccce9","type":"text","conversion_output":true,"text":"laboratory sample pertaining to a specific visit must always be reported to that visit.","text_display":" laboratory sample pertaining to a specific visit must always be reported to that visit.","confidence":1,"confidence_rate":1},{"cnt":[[322,1644],[1766,1644],[1766,1689],[322,1689]],"region":{"top_left_x":322,"top_left_y":1643,"width":1445,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b4b5b0c0d1f41478e118417292c172c","type":"text","conversion_output":true,"text":"For some of the samples collected during the trial, subjects must attend the relevant site visits","text_display":"\n\nFor some of the samples collected during the trial, subjects must attend the relevant site visits","confidence":1,"confidence_rate":1},{"cnt":[[322,1693],[995,1693],[995,1738],[322,1738]],"region":{"top_left_x":322,"top_left_y":1692,"width":673,"height":47},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85356419223a4b55a25b2e08beaec72d","type":"text","conversion_output":true,"text":"fasting (fasting is defined in Section 8.1.3).","text_display":" fasting (fasting is defined in Section 8.1.3).","confidence":1,"confidence_rate":1},{"cnt":[[322,1779],[1824,1779],[1824,1824],[322,1824]],"region":{"top_left_x":322,"top_left_y":1778,"width":1503,"height":47},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"253bede0caf646b991d73dccd1ce0b92","type":"text","conversion_output":true,"text":"At three visits (see Section 2), the subjects on oral treatment must attend the relevant site without","text_display":"\n\nAt three visits (see Section 2), the subjects on oral treatment must attend the relevant site without","confidence":1,"confidence_rate":1},{"cnt":[[322,1826],[1815,1826],[1815,1871],[322,1871]],"region":{"top_left_x":322,"top_left_y":1826,"width":1494,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a64e54dadc4e4dbbb475647476bb8ead","type":"text","conversion_output":true,"text":"having taken the trial product the same day to have PK measured pre-dose and post-dose (trough","text_display":" having taken the trial product the same day to have PK measured pre-dose and post-dose (trough","confidence":1,"confidence_rate":1},{"cnt":[[322,1878],[788,1878],[788,1921],[322,1921]],"region":{"top_left_x":322,"top_left_y":1877,"width":467,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44102ad96cff4855a49c1bc3e2a8ad8c","type":"text","conversion_output":true,"text":"and peak), see Section 8.4.10.","text_display":" and peak), see Section 8.4.10.","confidence":1,"confidence_rate":1},{"cnt":[[322,1962],[1826,1962],[1826,2007],[322,2007]],"region":{"top_left_x":322,"top_left_y":1961,"width":1505,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb1f49dcff264515be3b0e491cac810b","type":"text","conversion_output":true,"text":"The central laboratory will provide laboratory results to the investigator on an on-going basis and","text_display":"\n\nThe central laboratory will provide laboratory results to the investigator on an on-going basis and","confidence":1,"confidence_rate":1},{"cnt":[[322,2011],[1794,2011],[1794,2056],[322,2056]],"region":{"top_left_x":322,"top_left_y":2010,"width":1472,"height":47},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35724d79a94847a080d31c0c08e2fcc8","type":"text","conversion_output":true,"text":"the investigator must review all laboratory results for concomitant illnesses and AEs and report","text_display":" the investigator must review all laboratory results for concomitant illnesses and AEs and report","confidence":1,"confidence_rate":1},{"cnt":[[322,2058],[819,2058],[819,2103],[322,2103]],"region":{"top_left_x":322,"top_left_y":2058,"width":497,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"beab3bc0e1ea4c4d9567ada36a25b1c3","type":"text","conversion_output":true,"text":"these according to Section 12.2.","text_display":" these according to Section 12.2.","confidence":1,"confidence_rate":1},{"cnt":[[322,2144],[1858,2144],[1858,2189],[322,2189]],"region":{"top_left_x":322,"top_left_y":2144,"width":1537,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da21025a69af4ab5bd10b7ec307acd0e","type":"text","conversion_output":true,"text":"An exception to this is that anti-semaglutide antibody and semaglutide plasma concentration 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These results will be provided to the","text_display":" will not be available to the investigator during the trial. These results will be provided to the","confidence":1,"confidence_rate":1},{"cnt":[[322,2243],[1549,2243],[1549,2288],[322,2288]],"region":{"top_left_x":322,"top_left_y":2242,"width":1228,"height":47},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c073acf9ce5f427d85540a2d1b5b605c","type":"text","conversion_output":true,"text":"investigator upon request after the completion of the clinical trial report (CTR).","text_display":" investigator upon request after the completion of the clinical trial report (CTR).","confidence":1,"confidence_rate":1},{"cnt":[[322,2329],[1850,2329],[1850,2374],[322,2374]],"region":{"top_left_x":322,"top_left_y":2328,"width":1528,"height":47},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1f829a7baf34d7bac51e9275373793c","type":"text","conversion_output":true,"text":"All laboratory samples will be destroyed at the latest at the completion of the CTR, except samples","text_display":"\n\nAll 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Antibody samples will only be analysed if requested by the health","text_display":"\napproval by health authorities. 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Once the samples are re-examined they will","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[322,623],[1087,623],[1087,672],[322,672]],"region":{"top_left_x":322,"top_left_y":623,"width":766,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38f85ae370cd41c9a75bcb99a8c06e22","type":"text","conversion_output":true,"text":"be sent back to the hospital pathology laboratory.","text_display":" be sent back to the hospital pathology laboratory.","confidence":1,"confidence_rate":1},{"cnt":[[322,709],[1841,709],[1841,761],[322,761]],"region":{"top_left_x":322,"top_left_y":708,"width":1520,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef8a8005b8f941d1b4bfd01a80ec4429","type":"text","conversion_output":true,"text":"The investigator will be informed of the results of central pathology report and if C-cell pathology","text_display":"\n\nThe investigator will be informed of the results of central pathology report and if C-cell pathology","confidence":1,"confidence_rate":1},{"cnt":[[322,758],[1749,758],[1749,810],[322,810]],"region":{"top_left_x":322,"top_left_y":758,"width":1427,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3469e2427ba46c8ba6a1359f8e55f61","type":"text","conversion_output":true,"text":"is confirmed by the EAC, the CMC will provide guidance to the investigator with regards to","text_display":" is confirmed by the EAC, the CMC will provide guidance to the investigator with regards to","confidence":1,"confidence_rate":1},{"cnt":[[322,808],[887,808],[887,857],[322,857]],"region":{"top_left_x":322,"top_left_y":807,"width":566,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5db2923c219648c9a4a07e1b9ecb8974","type":"text","conversion_output":true,"text":"treatment and further investigations.","text_display":" treatment and further investigations.","confidence":1,"confidence_rate":1},{"cnt":[[318,889],[1704,889],[1704,952],[318,952]],"region":{"top_left_x":317,"top_left_y":889,"width":1387,"height":63},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"210d7e6a83204e10840f78ef9b5b5115","type":"section_header","conversion_output":false,"children_ids":["03f228137f504cb3b950fdee96028e26"],"text":"","text_display":""},{"cnt":[[322,896],[1695,896],[1695,947],[322,947]],"region":{"top_left_x":322,"top_left_y":895,"width":1374,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03f228137f504cb3b950fdee96028e26","type":"text","conversion_output":true,"parent_id":"210d7e6a83204e10840f78ef9b5b5115","text":"Thyroid tissue sample collection in case of thyroidectomy (not applicable for Israel)","text_display":"\n\n\\section*{Thyroid tissue sample collection in case of thyroidectomy (not applicable for Israel)}","confidence":1,"confidence_rate":1},{"cnt":[[322,962],[1850,962],[1850,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":962,"width":1528,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f98f16f93e494cf2a1126785c9f5651e","type":"text","conversion_output":true,"text":"If C-cell pathology is confirmed (i.e., hyperplastic or neoplastic thyroid C-cells) the subject will be","text_display":"\n\nIf C-cell pathology is confirmed (i.e., hyperplastic or neoplastic thyroid C-cells) the subject will be","confidence":0.9970703125,"confidence_rate":0.9999728338186853},{"cnt":[[322,1010],[1661,1010],[1661,1059],[322,1059]],"region":{"top_left_x":322,"top_left_y":1009,"width":1339,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c03296aaa3437c9faf9271e52a8448","type":"text","conversion_output":true,"text":"asked to consent to have a sample of the removed thyroid tissue tested for RET Y1062","text_display":" asked to consent to have a sample of the removed thyroid tissue tested for RET Y1062","confidence":0.9990236759185791,"confidence_rate":0.999989024768136},{"cnt":[[322,1057],[1858,1057],[1858,1111],[322,1111]],"region":{"top_left_x":322,"top_left_y":1057,"width":1537,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1950712cc00e4d5186ee1a6ba9176ba9","type":"text","conversion_output":true,"text":"phosphorylation in the thyroid C-cells, if allowed by local law. The tissue sample will be destroyed","text_display":" phosphorylation in the thyroid C-cells, if allowed by local law. The tissue sample will be destroyed","confidence":0.99853515625,"confidence_rate":0.9999860389766703},{"cnt":[[322,1109],[612,1109],[612,1154],[322,1154]],"region":{"top_left_x":322,"top_left_y":1108,"width":291,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7558297df3d646dfbccc016e0acd4dd4","type":"text","conversion_output":true,"text":"after examination.","text_display":" after examination.","confidence":1,"confidence_rate":1},{"cnt":[[314,1188],[1792,1188],[1792,1300],[314,1300]],"region":{"top_left_x":313,"top_left_y":1188,"width":1479,"height":112},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2aa2dc8c3a14a53ae64f7fe9649821b","type":"section_header","conversion_output":false,"children_ids":["d482bfb1ab1645dca94284e5d3790f84","029a5d4691c045579503e20777e057b1"],"text":"","text_display":""},{"cnt":[[322,1195],[1783,1195],[1783,1246],[322,1246]],"region":{"top_left_x":322,"top_left_y":1194,"width":1462,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d482bfb1ab1645dca94284e5d3790f84","type":"text","conversion_output":true,"parent_id":"f2aa2dc8c3a14a53ae64f7fe9649821b","text":"Blood sample for genetic testing in case of confirmed C-cell pathology (not applicable for","text_display":"\n\n\\section*{Blood sample for genetic testing in case of confirmed C-cell pathology (not applicable for","confidence":0.978515625,"confidence_rate":0.999771410089028},{"cnt":[[322,1246],[440,1246],[440,1293],[322,1293]],"region":{"top_left_x":322,"top_left_y":1246,"width":119,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"029a5d4691c045579503e20777e057b1","type":"text","conversion_output":true,"parent_id":"f2aa2dc8c3a14a53ae64f7fe9649821b","text":"Israel)","text_display":" Israel)}","confidence":1,"confidence_rate":1},{"cnt":[[322,1311],[1876,1311],[1876,1360],[322,1360]],"region":{"top_left_x":322,"top_left_y":1310,"width":1554,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3dc9f9c6e1f4640ad622e90e90a6cf7","type":"text","conversion_output":true,"text":"In addition, the subject will also be asked to consent to be tested (blood sample) to identify germline","text_display":"\n\nIn addition, the subject will also be asked to consent to be tested (blood sample) to identify germline","confidence":1,"confidence_rate":1},{"cnt":[[322,1360],[1865,1360],[1865,1412],[322,1412]],"region":{"top_left_x":322,"top_left_y":1359,"width":1543,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac7b347139d845f5a02fa355cfaa9582","type":"text","conversion_output":true,"text":"RET gene mutations associated with MEN2 syndrome. This RET gene mutation detection will only","text_display":" RET gene mutations associated with MEN2 syndrome. This RET gene mutation detection will only","confidence":1,"confidence_rate":1},{"cnt":[[322,1405],[1732,1405],[1732,1459],[322,1459]],"region":{"top_left_x":322,"top_left_y":1405,"width":1410,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec1043af6c8e42e98480985411a8c9f6","type":"text","conversion_output":true,"text":"be conducted if the EAC has confirmed C-cell abnormality (medullary carcinoma or C-cell","text_display":" be conducted if the EAC has confirmed C-cell abnormality (medullary carcinoma or C-cell","confidence":0.9990236759185791,"confidence_rate":0.9999893826542317},{"cnt":[[322,1457],[1566,1457],[1566,1506],[322,1506]],"region":{"top_left_x":322,"top_left_y":1456,"width":1245,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b529aa7e7b449ddb0e0672dfad598f1","type":"text","conversion_output":true,"text":"hyperplasia). The genetic testing will only be performed if allowed by local law.","text_display":" hyperplasia). The genetic testing will only be performed if allowed by local law.","confidence":1,"confidence_rate":1},{"cnt":[[322,1543],[1835,1543],[1835,1592],[322,1592]],"region":{"top_left_x":322,"top_left_y":1542,"width":1513,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31b58d91cf38473585bff2255f5aec47","type":"text","conversion_output":true,"text":"The blood sample should be collected at the first visit to the clinic after the confirmation of C-cell","text_display":"\n\nThe blood sample should be collected at the first visit to the clinic after the confirmation of C-cell","confidence":0.727316553122364,"confidence_rate":0.9970287828996038},{"cnt":[[322,1592],[1725,1592],[1725,1644],[322,1644]],"region":{"top_left_x":322,"top_left_y":1591,"width":1404,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab10f9f9edda4c8c83f35f6bfc7ac966","type":"text","conversion_output":true,"text":"pathology. The extraction of DNA will be performed by the central laboratory whereas the","text_display":" pathology. The extraction of DNA will be performed by the central laboratory whereas the","confidence":1,"confidence_rate":1},{"cnt":[[322,1641],[1824,1641],[1824,1691],[322,1691]],"region":{"top_left_x":322,"top_left_y":1641,"width":1503,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f500f3d0a1fa4d3bb8bce658cfd24c1f","type":"text","conversion_output":true,"text":"identification of gene mutations will be performed by a specialised laboratory. The blood sample","text_display":" identification of gene mutations will be performed by a specialised laboratory. The blood sample","confidence":0.9609375,"confidence_rate":0.9996055638643822},{"cnt":[[322,1689],[1265,1689],[1265,1738],[322,1738]],"region":{"top_left_x":322,"top_left_y":1688,"width":944,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08e85d8fd4bc4d71b97348a81cb53301","type":"text","conversion_output":true,"text":"will be destroyed as soon as the genetic analysis is complete.","text_display":" will be destroyed as soon as the genetic analysis is complete.","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[316,1770],[1424,1770],[1424,1833],[316,1833]],"region":{"top_left_x":315,"top_left_y":1770,"width":1110,"height":63},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"538ba8ad515c4184bba98fab03c3c721","type":"section_header","conversion_output":false,"children_ids":["9d52fcf843b34fa0b1620daabd99b48c"],"text":"","text_display":""},{"cnt":[[322,1777],[1416,1777],[1416,1828],[322,1828]],"region":{"top_left_x":322,"top_left_y":1776,"width":1094,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d52fcf843b34fa0b1620daabd99b48c","type":"text","conversion_output":true,"parent_id":"538ba8ad515c4184bba98fab03c3c721","text":"8.6.2.2 Assessments in case of suspicion of acute pancreatitis","text_display":"\n\n\\subsection*{8.6.2.2 Assessments in case of suspicion of acute pancreatitis}","confidence":0.974798589921148,"confidence_rate":0.9996191113063204},{"cnt":[[322,1839],[1858,1839],[1858,1888],[322,1888]],"region":{"top_left_x":322,"top_left_y":1839,"width":1537,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4127014e0ad4429099021dd86b7c9cf5","type":"text","conversion_output":true,"text":"In case of acute, severe persistent abdominal pain characteristic of acute pancreatitis, the IMP must","text_display":"\n\nIn case of acute, severe persistent abdominal pain characteristic of acute pancreatitis, the IMP must","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[322,1886],[1811,1886],[1811,1938],[322,1938]],"region":{"top_left_x":322,"top_left_y":1886,"width":1490,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c116b2717c643889f09fc99567235ea","type":"text","conversion_output":true,"text":"promptly be interrupted until pancreatitis is excluded (see Section 6.5.2). Appropriate additional","text_display":" promptly be interrupted until pancreatitis is excluded (see Section 6.5.2). Appropriate additional","confidence":0.9980480668600649,"confidence_rate":0.9999810308532753},{"cnt":[[322,1938],[1865,1938],[1865,1987],[322,1987]],"region":{"top_left_x":322,"top_left_y":1937,"width":1543,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfc84a16590f4862a85717917b501b6c","type":"text","conversion_output":true,"text":"examinations should be performed according to local practice. If acute pancreatitis is not confirmed","text_display":" examinations should be performed according to local practice. If acute pancreatitis is not confirmed","confidence":0.9833984375,"confidence_rate":0.999840575443913},{"cnt":[[322,1985],[866,1985],[866,2035],[322,2035]],"region":{"top_left_x":322,"top_left_y":1985,"width":544,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e5e22c35db24d7c84918e2ca9642fa6","type":"text","conversion_output":true,"text":"trial product should be re-initiated.","text_display":" trial product should be re-initiated.","confidence":1,"confidence_rate":1},{"cnt":[[322,2071],[1111,2071],[1111,2121],[322,2121]],"region":{"top_left_x":322,"top_left_y":2071,"width":789,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a710b69771c443e9ad8d49b6a0fd1aac","type":"text","conversion_output":true,"text":"If pancreatitis is confirmed (as a minimum 2 of 3 ):","text_display":"\n\nIf pancreatitis is confirmed (as a minimum 2 of 3 ):","confidence":0.9444160072661703,"confidence_rate":0.9990926575312208},{"cnt":[[322,2123],[844,2123],[844,2172],[322,2172]],"region":{"top_left_x":322,"top_left_y":2122,"width":523,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"868ffcb191a14bc6928ef1578032b267","type":"text","conversion_output":true,"text":"- characteristic abdominal pain","text_display":"\n- characteristic abdominal pain","confidence":1,"confidence_rate":1},{"cnt":[[322,2174],[1315,2174],[1315,2224],[322,2224]],"region":{"top_left_x":322,"top_left_y":2174,"width":993,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c648eb4c05a41c7909a575022a4135b","type":"text","conversion_output":true,"text":"- blood amylase and/or lipase \\(>3 x\\) upper normal range (UNR)","text_display":"\n- blood amylase and/or lipase \\(>3 x\\) upper normal range 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U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,357],[698,357],[698,397],[322,397]],"region":{"top_left_x":322,"top_left_y":356,"width":377,"height":42},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a5a8c92dc46442a2b00e5f1acfe171bf","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[887,262],[1764,262],[1764,406],[887,406]],"region":{"top_left_x":887,"top_left_y":262,"width":877,"height":145},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"018925b4686049b1bf5169690a5445c5","type":"table","conversion_output":true,"text":"CONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 53 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 53 \\text { of } 98\\end{array}\\right|\\)","confidence":0.857458989965387,"confidence_rate":0.9988530319563212},{"cnt":[[322,477],[1867,477],[1867,526],[322,526]],"region":{"top_left_x":322,"top_left_y":476,"width":1545,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c70e5f8b314b477985d0e5681736c811","type":"text","conversion_output":true,"text":"appropriate treatment and careful monitoring of the subject should be initiated. Trial product should","text_display":"\nappropriate treatment and careful monitoring of the subject should be initiated. Trial product should","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[322,524],[1815,524],[1815,578],[322,578]],"region":{"top_left_x":322,"top_left_y":524,"width":1494,"height":54},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a87b2142a8e341b78cb49c7b668af6d6","type":"text","conversion_output":true,"text":"not be re-initiated but subject should remain in the trial. The event should be reported as a MESI","text_display":" not be re-initiated but subject should remain in the trial. The event should be reported as a MESI","confidence":1,"confidence_rate":1},{"cnt":[[322,574],[1287,574],[1287,625],[322,625]],"region":{"top_left_x":322,"top_left_y":573,"width":965,"height":53},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"baf190d76f424554b77485ef36d441e6","type":"text","conversion_output":true,"text":"and will undergo assessment by the EAC (see Section 12.7.2).","text_display":" and will undergo assessment by the EAC (see Section 12.7.2).","confidence":1,"confidence_rate":1},{"cnt":[[318,657],[1502,657],[1502,718],[318,718]],"region":{"top_left_x":317,"top_left_y":657,"width":1185,"height":61},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ddb47c0e9c04785b75893e11170921f","type":"section_header","conversion_output":false,"children_ids":["1cf46e18cfea4bca9b2790b6fc904bee"],"text":"","text_display":""},{"cnt":[[322,662],[1497,662],[1497,711],[322,711]],"region":{"top_left_x":322,"top_left_y":661,"width":1176,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cf46e18cfea4bca9b2790b6fc904bee","type":"text","conversion_output":true,"parent_id":"7ddb47c0e9c04785b75893e11170921f","text":"8.6.2.3 Assessments in case of suspicion of severe hypersensitivity","text_display":"\n\n\\subsection*{8.6.2.3 Assessments in case of suspicion of severe hypersensitivity}","confidence":0.99951171875,"confidence_rate":0.9999932166827553},{"cnt":[[322,724],[1734,724],[1734,776],[322,776]],"region":{"top_left_x":322,"top_left_y":724,"width":1412,"height":52},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e67750f6a86c4eff863f9565fa2ed7db","type":"text","conversion_output":true,"text":"If a severe immediate hypersensitivity reaction to the IMP is suspected, blood sampling for","text_display":"\n\nIf a severe immediate hypersensitivity reaction to the IMP is suspected, blood sampling for","confidence":1,"confidence_rate":1},{"cnt":[[322,773],[1824,773],[1824,823],[322,823]],"region":{"top_left_x":322,"top_left_y":773,"width":1503,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bee7ae6d88be4fad863e77938c3fd3ad","type":"text","conversion_output":true,"text":"assessment of anti-semaglutide \\(\\operatorname{IgE}\\) antibodies and anti-semaglutide binding antibodies should be","text_display":" assessment of anti-semaglutide \\(\\operatorname{IgE}\\) antibodies and anti-semaglutide binding antibodies should be","confidence":0.5170526504516602,"confidence_rate":0.9937965799183209},{"cnt":[[322,821],[1648,821],[1648,870],[322,870]],"region":{"top_left_x":322,"top_left_y":820,"width":1326,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc2b19b5ec724a9b805f02c6805bfe09","type":"text","conversion_output":true,"text":"collected after a suitable washout period (minimum 5 weeks). In these cases, it is also","text_display":" collected after a suitable washout period (minimum 5 weeks). In these cases, it is also","confidence":1,"confidence_rate":1},{"cnt":[[322,870],[1824,870],[1824,922],[322,922]],"region":{"top_left_x":322,"top_left_y":870,"width":1503,"height":52},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3d2e2010b0c493e8c0e683db5563df1","type":"text","conversion_output":true,"text":"recommended to test for tryptase (total and/or mature tryptase) within three hours of the reaction.","text_display":" recommended to test for tryptase (total and/or mature tryptase) within three hours of the reaction.","confidence":1,"confidence_rate":1},{"cnt":[[322,958],[1785,958],[1785,1008],[322,1008]],"region":{"top_left_x":322,"top_left_y":958,"width":1464,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bf29aee082a49519143b3b8a8bf457e","type":"text","conversion_output":true,"text":"Furthermore, a tryptase sample should be taken at the same time as the IgE sample is obtained.","text_display":"\n\nFurthermore, a tryptase sample should be taken at the same time as the IgE sample is obtained.","confidence":0.61865234375,"confidence_rate":0.9951611209783398},{"cnt":[[322,1005],[1777,1005],[1777,1055],[322,1055]],"region":{"top_left_x":322,"top_left_y":1005,"width":1455,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a1473d6adcc4e558505b3a922ebdf4b","type":"text","conversion_output":true,"text":"Tryptase concentrations (if measured) as well as results of anti-semaglutide antibody and IgE-","text_display":" Tryptase concentrations (if measured) as well as results of anti-semaglutide antibody and IgE","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[322,1057],[1381,1057],[1381,1104],[322,1104]],"region":{"top_left_x":322,"top_left_y":1057,"width":1060,"height":48},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e6d787b409040378f9a17f636efc083","type":"text","conversion_output":true,"text":"isotype anti-semaglutide antibodies should be sent to Novo Nordisk.","text_display":"isotype anti-semaglutide antibodies should be sent to Novo Nordisk.","confidence":1,"confidence_rate":1},{"cnt":[[318,1139],[784,1139],[784,1197],[318,1197]],"region":{"top_left_x":317,"top_left_y":1138,"width":468,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae8c74e47387410caa814a36f1148290","type":"section_header","conversion_output":false,"children_ids":["d4eb1153a7b14d1b9d77135463aa0681"],"text":"","text_display":""},{"cnt":[[322,1143],[780,1143],[780,1192],[322,1192]],"region":{"top_left_x":322,"top_left_y":1142,"width":458,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4eb1153a7b14d1b9d77135463aa0681","type":"text","conversion_output":true,"parent_id":"ae8c74e47387410caa814a36f1148290","text":"8.7 Subject compliance","text_display":"\n\n\\subsection*{8.7 Subject compliance}","confidence":1,"confidence_rate":1},{"cnt":[[322,1210],[1794,1210],[1794,1257],[322,1257]],"region":{"top_left_x":322,"top_left_y":1209,"width":1472,"height":48},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00d0e97ac1ce4386a146e0f95b4b47c2","type":"text","conversion_output":true,"text":"Subject compliance will be assessed by monitoring of drug accountability. Prior to visits where","text_display":"\n\nSubject compliance will be assessed by monitoring of drug accountability. Prior to visits where","confidence":1,"confidence_rate":1},{"cnt":[[322,1259],[1863,1259],[1863,1308],[322,1308]],"region":{"top_left_x":322,"top_left_y":1258,"width":1541,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2fde6eb15f204831850feeb8682173ad","type":"text","conversion_output":true,"text":"drug accountability is performed the subject will be asked to return all used, partly used and unused","text_display":" drug accountability is performed the subject will be asked to return all used, partly used and unused","confidence":1,"confidence_rate":1},{"cnt":[[322,1306],[1841,1306],[1841,1356],[322,1356]],"region":{"top_left_x":322,"top_left_y":1306,"width":1520,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8c0582139064cdabcc97fa9b4bf8b6c","type":"text","conversion_output":true,"text":"IMPs. The investigator must assess the amount of IMPs returned compared to what was dispensed","text_display":" IMPs. The investigator must assess the amount of IMPs returned compared to what was dispensed","confidence":1,"confidence_rate":1},{"cnt":[[322,1354],[1508,1354],[1508,1403],[322,1403]],"region":{"top_left_x":322,"top_left_y":1353,"width":1187,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f60c593f2cd4c24ba1f7f80ac6c50cf","type":"text","conversion_output":true,"text":"at the last dispensing visit and, in case of discrepancies, question the subject.","text_display":" at the last dispensing visit and, in case of discrepancies, question the subject.","confidence":1,"confidence_rate":1},{"cnt":[[322,1444],[1790,1444],[1790,1491],[322,1491]],"region":{"top_left_x":322,"top_left_y":1443,"width":1468,"height":49},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5779c88b036f4e3da176b1fd0419e396","type":"text","conversion_output":true,"text":"Throughout the trial the investigator will remind the subjects to follow the trial procedures and","text_display":"\n\nThroughout the trial the investigator will remind the subjects to follow the trial procedures and","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[322,1491],[1697,1491],[1697,1540],[322,1540]],"region":{"top_left_x":322,"top_left_y":1491,"width":1376,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"459944c4364d438c98870b5da52d0313","type":"text","conversion_output":true,"text":"requirements to ensure subject compliance. If a subject is found to be non-compliant, the","text_display":" requirements to ensure subject compliance. If a subject is found to be non-compliant, the","confidence":1,"confidence_rate":1},{"cnt":[[322,1538],[1852,1538],[1852,1588],[322,1588]],"region":{"top_left_x":322,"top_left_y":1538,"width":1530,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4cba3f1050542f8b22fb2827bdea69f","type":"text","conversion_output":true,"text":"investigator will remind the subject of the importance of following the instructions given including","text_display":" investigator will remind the subject of the importance of following the instructions given including","confidence":1,"confidence_rate":1},{"cnt":[[322,1590],[917,1590],[917,1635],[322,1635]],"region":{"top_left_x":322,"top_left_y":1589,"width":596,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb9eb74faf7e4e2380eaecaf81e05c4a","type":"text","conversion_output":true,"text":"taking the trial products as prescribed.","text_display":" taking the trial products as prescribed.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-056","page":56,"lines":[{"cnt":[[327,264],[430,264],[430,292],[327,292]],"region":{"top_left_x":326,"top_left_y":264,"width":104,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"70d87ea6bd3943d9bf9b2e596b29a930","type":"page_info","conversion_output":false,"text":"Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[924,260],[1762,260],[1762,397],[924,397]],"region":{"top_left_x":923,"top_left_y":259,"width":839,"height":139},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5ff6ab77931e430591791dcf886b4495","type":"table","conversion_output":true,"text":"CONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 54 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 54 \\text { of } 98\\end{array}\\right|\\)","confidence":0.879557645226384,"confidence_rate":0.9990427258394303},{"cnt":[[1766,262],[1940,262],[1940,290],[1766,290]],"region":{"top_left_x":1766,"top_left_y":262,"width":175,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"db1b1c84a3b447e7bf01dc5834266cd5","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[327,296],[604,296],[604,324],[327,324]],"region":{"top_left_x":326,"top_left_y":296,"width":278,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dd3b511a827044f89598d5839d456ce1","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[327,331],[617,331],[617,359],[327,359]],"region":{"top_left_x":326,"top_left_y":330,"width":291,"height":29},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"26935d66b976429995b00fd09bf6b8bf","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[327,365],[694,365],[694,389],[327,389]],"region":{"top_left_x":326,"top_left_y":365,"width":368,"height":24},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"665f2ed9aef241acbe0b5b8c7ace97c8","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,486],[718,486],[718,544],[322,544]],"region":{"top_left_x":322,"top_left_y":485,"width":396,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"083a58f3b47d498da3805cd134e5d666","type":"section_header","conversion_output":false,"children_ids":["83b9b2914e3e4615819eb08c5ed22dec"],"text":"","text_display":""},{"cnt":[[327,490],[715,490],[715,539],[327,539]],"region":{"top_left_x":326,"top_left_y":489,"width":390,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83b9b2914e3e4615819eb08c5ed22dec","type":"text","conversion_output":true,"parent_id":"083a58f3b47d498da3805cd134e5d666","text":"9 Trial supplies","text_display":"\n\n\\section*{9 Trial supplies}","confidence":0.99951171875,"confidence_rate":0.9999755802732609},{"cnt":[[327,567],[1772,567],[1772,608],[327,608]],"region":{"top_left_x":326,"top_left_y":567,"width":1447,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"114d8c5451674df5b2b82cdf20ead85f","type":"text","conversion_output":true,"text":"Trial supplies comprise trial products and auxiliary supplies. Additional details regarding trial","text_display":"\n\nTrial supplies comprise trial products and auxiliary supplies. Additional details regarding trial","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[327,614],[1261,614],[1261,655],[327,655]],"region":{"top_left_x":326,"top_left_y":614,"width":936,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1884dc55e34477ea401be5aa230a367","type":"text","conversion_output":true,"text":"supplies can be found in the Trial Materials Manual (TMM).","text_display":" supplies can be found in the Trial Materials Manual (TMM).","confidence":1,"confidence_rate":1},{"cnt":[[327,700],[1489,700],[1489,743],[327,743]],"region":{"top_left_x":326,"top_left_y":700,"width":1163,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"459c1b98505d4b3791de7c6dcc4c8aa4","type":"text","conversion_output":true,"text":"Trial products must not be dispensed to any person not included in the trial.","text_display":"\n\nTrial products must not be dispensed to any person not included in the trial.","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[326,831],[327,786],[1257,788],[1257,833]],"region":{"top_left_x":326,"top_left_y":786,"width":931,"height":48},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6383fbd0f6de4d9b849b3ac465053368","type":"text","conversion_output":true,"text":"For injectable products, the trial product must not be used if:","text_display":"\nFor injectable products, the trial product must not be used if:","confidence":1,"confidence_rate":1},{"cnt":[[327,838],[973,838],[973,883],[327,883]],"region":{"top_left_x":326,"top_left_y":837,"width":648,"height":47},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b5458c6d5a94a8faeffc5d6a3a33c76","type":"text","conversion_output":true,"text":"- it does not appear clear and colourless","text_display":"\n- it does not appear clear and colourless","confidence":1,"confidence_rate":1},{"cnt":[[327,889],[660,889],[660,926],[327,926]],"region":{"top_left_x":326,"top_left_y":889,"width":334,"height":37},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f517332d995422ebd82b42d18845a35","type":"text","conversion_output":true,"text":"- it has been frozen","text_display":"\n- it has been frozen","confidence":1,"confidence_rate":1},{"cnt":[[327,941],[1231,941],[1231,986],[327,986]],"region":{"top_left_x":326,"top_left_y":941,"width":906,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a6166bdb1fa4b83956b8b7bb90e593f","type":"text","conversion_output":true,"text":"- it has been exposed to excessive heat or direct sunlight","text_display":"\n- it has been exposed to excessive heat or direct sunlight","confidence":1,"confidence_rate":1},{"cnt":[[322,1027],[698,1027],[698,1074],[322,1074]],"region":{"top_left_x":322,"top_left_y":1026,"width":377,"height":49},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bc0dfb573464c15976f2c8f9944964c","type":"section_header","conversion_output":false,"children_ids":["ff628121b0764fb78b73bdd79a9a2e67"],"text":"","text_display":""},{"cnt":[[327,1031],[694,1031],[694,1072],[327,1072]],"region":{"top_left_x":326,"top_left_y":1031,"width":368,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff628121b0764fb78b73bdd79a9a2e67","type":"text","conversion_output":true,"parent_id":"4bc0dfb573464c15976f2c8f9944964c","text":"9.1 Trial products","text_display":"\n\n\\subsection*{9.1 Trial products}","confidence":1,"confidence_rate":1},{"cnt":[[327,1096],[1540,1096],[1540,1141],[327,1141]],"region":{"top_left_x":326,"top_left_y":1095,"width":1215,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee40e0100c4c4cf19b5e4c01bf75f6ff","type":"text","conversion_output":true,"text":"The following trial products will be provided by Novo Nordisk A/S, Denmark:","text_display":"\n\nThe following trial products will be provided by Novo Nordisk A/S, Denmark:","confidence":0.99951171875,"confidence_rate":0.9999938950124091},{"cnt":[[322,1182],[904,1182],[904,1229],[322,1229]],"region":{"top_left_x":322,"top_left_y":1181,"width":583,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d92d99eabe040ebb01ce80360cccc9d","type":"figure_label","conversion_output":false,"text":"Table 9-1 Trial products 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pen-injector","confidence":0.99951171875,"confidence_rate":0.9999886419133848},{"cnt":[[327,1757],[582,1757],[582,1794],[327,1794]],"region":{"top_left_x":326,"top_left_y":1757,"width":257,"height":37},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ff9d12bc71845c8aed9015cd0fd4bd4","type":"text","conversion_output":true,"text":"N/A: not applicable","text_display":"\n\nN/A: not applicable","confidence":1,"confidence_rate":1},{"cnt":[[327,1835],[1723,1835],[1723,1880],[327,1880]],"region":{"top_left_x":326,"top_left_y":1834,"width":1398,"height":46},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19f4a087164d48f197fa4988a7c371d8","type":"text","conversion_output":true,"text":"The IMPs for oral use will be packed in 15 mL Duma containers (lid with desiccant). Each","text_display":"\nThe IMPs for oral use will be packed in 15 mL Duma containers (lid with desiccant). Each","confidence":1,"confidence_rate":1},{"cnt":[[327,1886],[1815,1886],[1815,1927],[327,1927]],"region":{"top_left_x":326,"top_left_y":1886,"width":1490,"height":42},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f60157eff7244fee89966271513d5105","type":"text","conversion_output":true,"text":"container will include ten tablets. Subjects in the oral treatment arms will be instructed in how to","text_display":" container will include ten tablets. Subjects in the oral treatment arms will be instructed in how to","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[327,1934],[1813,1934],[1813,1979],[327,1979]],"region":{"top_left_x":326,"top_left_y":1933,"width":1488,"height":46},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b637bc994b5141ca9dc38a75ad152c6c","type":"text","conversion_output":true,"text":"ingest the tablets following the condition rules. All tablets containing semaglutide or placebo are","text_display":" ingest the tablets following the condition rules. All tablets containing semaglutide or placebo are","confidence":1,"confidence_rate":1},{"cnt":[[327,1981],[1240,1981],[1240,2026],[327,2026]],"region":{"top_left_x":326,"top_left_y":1980,"width":914,"height":46},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"058b0a631dc44ef0b75b345f3cce333e","type":"text","conversion_output":true,"text":"identical with regards to visual appearance, taste and smell.","text_display":" identical with regards to visual appearance, taste and smell.","confidence":1,"confidence_rate":1},{"cnt":[[327,2071],[1867,2071],[1867,2112],[327,2112]],"region":{"top_left_x":326,"top_left_y":2071,"width":1541,"height":41},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b28c1133b784f01b5cbbb1a91b999d2","type":"text","conversion_output":true,"text":"The semaglutide, solution for injection will be delivered open-label with the pre-filled PDS290 pen-","text_display":"\n\nThe semaglutide, solution for injection will be delivered open-label with the pre-filled PDS290 pen","confidence":1,"confidence_rate":1},{"cnt":[[327,2118],[1841,2118],[1841,2159],[327,2159]],"region":{"top_left_x":326,"top_left_y":2118,"width":1516,"height":42},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70b756d47618497398d4d09cbc2c6ebd","type":"text","conversion_output":true,"text":"injector. The direction for use of the pen-injector will be given to each subject in the s.c. treatment","text_display":"injector. The direction for use of the pen-injector will be given to each subject in the s.c. treatment","confidence":0.99365234375,"confidence_rate":0.9999410398096767},{"cnt":[[327,2166],[765,2166],[765,2209],[327,2209]],"region":{"top_left_x":326,"top_left_y":2165,"width":439,"height":44},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"557c2c0daf384968b38ef78c77401a7d","type":"text","conversion_output":true,"text":"arm at each dispensing visit.","text_display":" arm at each dispensing visit.","confidence":1,"confidence_rate":1},{"cnt":[[327,2254],[1794,2254],[1794,2297],[327,2297]],"region":{"top_left_x":326,"top_left_y":2253,"width":1468,"height":44},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c324abe29db849c6a63b20e7833e8973","type":"text","conversion_output":true,"text":"For further details, please see the current edition of the IB (Oral Administration of Semaglutide","text_display":"\n\nFor further details, please see the current edition of the IB (Oral Administration of Semaglutide","confidence":1,"confidence_rate":1},{"cnt":[[327,2295],[1025,2295],[1025,2344],[327,2344]],"region":{"top_left_x":326,"top_left_y":2294,"width":699,"height":50},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de602c9b6cd54e3c96644b10486be4c3","type":"text","conversion_output":true,"text":"(NN9924) Edition \\(5^{\\underline{6}}\\) and any updates hereof.","text_display":" (NN9924) Edition \\(5^{\\underline{6}}\\) and any updates hereof.","confidence":0.6365847587585449,"confidence_rate":0.9926234445045032}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-057","page":57,"lines":[{"cnt":[[322,262],[432,262],[432,294],[322,294]],"region":{"top_left_x":322,"top_left_y":262,"width":110,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9fa6c304b6464c718e221b8e020ceaab","type":"page_info","conversion_output":false,"text":"Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[920,254],[1946,254],[1946,402],[920,402]],"region":{"top_left_x":919,"top_left_y":253,"width":1028,"height":149},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"cdc51da9f669423c9a31b5f87a54a2bd","type":"page_info","conversion_output":false,"children_ids":["26dfc763edcc472f99af2c68afc207f3"],"text":"","text_display":""},{"cnt":[[1272,292],[1772,292],[1772,402],[1272,402]],"region":{"top_left_x":1271,"top_left_y":292,"width":502,"height":110},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"26dfc763edcc472f99af2c68afc207f3","type":"table","conversion_output":false,"parent_id":"cdc51da9f669423c9a31b5f87a54a2bd","text":"\\begin{tabular}{lr} \nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 55 of 98\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{lr} \nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 55 of 98\n\\end{tabular}","confidence":0.955078125,"confidence_rate":0.999439643210192},{"cnt":[[597,290],[603,292],[608,296],[608,326],[605,328],[324,328],[322,326],[322,324],[328,309],[391,296],[453,292],[595,290]],"region":{"top_left_x":322,"top_left_y":290,"width":286,"height":38},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e5f98d3f76a44cf6b21f2ebe4013e0d7","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":0.97314453125,"confidence_rate":0.9989535223267342},{"cnt":[[327,327],[621,327],[621,363],[327,363]],"region":{"top_left_x":326,"top_left_y":326,"width":295,"height":38},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4b23f132da284423b79c00fe556a1022","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,357],[698,357],[698,397],[322,397]],"region":{"top_left_x":322,"top_left_y":356,"width":377,"height":42},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9903dc8f140d4173a40e20179337787c","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[322,477],[1792,477],[1792,526],[322,526]],"region":{"top_left_x":322,"top_left_y":476,"width":1470,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a62c8a7623cf4a5b8fbc13063ae50d53","type":"text","conversion_output":true,"text":"Metformin may be used at the discretion of the investigator. Metformin will not be supplied by","text_display":"\n\nMetformin may be used at the discretion of the investigator. Metformin will not be supplied by","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[322,524],[1732,524],[1732,578],[322,578]],"region":{"top_left_x":322,"top_left_y":524,"width":1410,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fe90bd5bdf54118bb742e7edb305ea6","type":"text","conversion_output":true,"text":"Novo Nordisk. However, metformin will be reimbursed if required by the country's Health","text_display":" Novo Nordisk. However, metformin will be reimbursed if required by the country's Health","confidence":1,"confidence_rate":1},{"cnt":[[322,576],[1601,576],[1601,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":1279,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff02bdeb663a4a5a8101c5e50f60e709","type":"text","conversion_output":true,"text":"Authority or independent ethics committee/Institutional Review Board (IEC/IRB).","text_display":" Authority or independent ethics committee/Institutional Review Board (IEC/IRB).","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[318,657],[623,657],[623,718],[318,718]],"region":{"top_left_x":317,"top_left_y":657,"width":307,"height":61},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff59ca85c85c49949e5652e7ea31347f","type":"section_header","conversion_output":false,"children_ids":["07f4f09b36cd4d4eb8787f5728a9631b"],"text":"","text_display":""},{"cnt":[[322,664],[617,664],[617,711],[322,711]],"region":{"top_left_x":322,"top_left_y":663,"width":295,"height":49},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07f4f09b36cd4d4eb8787f5728a9631b","type":"text","conversion_output":true,"parent_id":"ff59ca85c85c49949e5652e7ea31347f","text":"9.2 Labelling","text_display":"\n\n\\subsection*{9.2 Labelling}","confidence":1,"confidence_rate":1},{"cnt":[[322,722],[1803,722],[1803,780],[322,780]],"region":{"top_left_x":322,"top_left_y":721,"width":1481,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de996b1ae94744319739072d36fa3740","type":"text","conversion_output":true,"text":"Labelling of the trial products will be in accordance with Annex \\(13{ }^{12}\\), local regulations and trial","text_display":"\n\nLabelling of the trial products will be in accordance with Annex \\(13{ }^{12}\\), local regulations and trial","confidence":0.6224635988473892,"confidence_rate":0.9958501247334499},{"cnt":[[322,778],[541,778],[541,827],[322,827]],"region":{"top_left_x":322,"top_left_y":777,"width":220,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f64e1ef0c0b4b0b9cab7eac7780fab5","type":"text","conversion_output":true,"text":"requirements.","text_display":" requirements.","confidence":1,"confidence_rate":1},{"cnt":[[322,864],[1876,864],[1876,915],[322,915]],"region":{"top_left_x":322,"top_left_y":863,"width":1554,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b2a2b84204341a881c89aef7a0c07fb","type":"text","conversion_output":true,"text":"Each investigator site will be supplied with sufficient trial products for the trial on an on-going basis","text_display":"\n\nEach investigator site will be supplied with sufficient trial products for the trial on an on-going basis","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[322,913],[1738,913],[1738,965],[322,965]],"region":{"top_left_x":322,"top_left_y":913,"width":1417,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0358554db634e588ef254a73ddfb1f4","type":"text","conversion_output":true,"text":"controlled by the IV/WRS. Dispensing unit numbers (DUNs) will be distributed to the sites","text_display":" controlled by the IV/WRS. Dispensing unit numbers (DUNs) will be distributed to the sites","confidence":0.9990236759185791,"confidence_rate":0.9999896085540316},{"cnt":[[322,962],[993,962],[993,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":962,"width":671,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"082851d990204e519940d4310c7b905f","type":"text","conversion_output":true,"text":"according to enrolment and randomisation.","text_display":" according to enrolment and randomisation.","confidence":1,"confidence_rate":1},{"cnt":[[322,1048],[1798,1048],[1798,1098],[322,1098]],"region":{"top_left_x":322,"top_left_y":1048,"width":1477,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"199a8035595b41ac804c11da610be803","type":"text","conversion_output":true,"text":"The investigator or delegate must document that direction for use of the device is handed out at","text_display":"\n\nThe investigator or delegate must document that direction for use of the device is handed out at","confidence":1,"confidence_rate":1},{"cnt":[[322,1096],[1568,1096],[1568,1147],[322,1147]],"region":{"top_left_x":322,"top_left_y":1095,"width":1247,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d54a42f518e2477c970311069ab84a2a","type":"text","conversion_output":true,"text":"each dispensing visit. This could be by signature in the subject's medical record.","text_display":" each dispensing visit. This could be by signature in the subject's medical record.","confidence":0.99853515625,"confidence_rate":0.9999831505134198},{"cnt":[[316,1182],[591,1182],[591,1240],[316,1240]],"region":{"top_left_x":315,"top_left_y":1181,"width":276,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2666664200644ce8cecbf94644897ec","type":"section_header","conversion_output":false,"children_ids":["e2203227c430409791c4ca500cad6c04"],"text":"","text_display":""},{"cnt":[[322,1186],[587,1186],[587,1235],[322,1235]],"region":{"top_left_x":322,"top_left_y":1185,"width":265,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2203227c430409791c4ca500cad6c04","type":"text","conversion_output":true,"parent_id":"b2666664200644ce8cecbf94644897ec","text":"9.3 Storage","text_display":"\n\n\\subsection*{9.3 Storage}","confidence":1,"confidence_rate":1},{"cnt":[[322,1250],[1828,1250],[1828,1300],[322,1300]],"region":{"top_left_x":322,"top_left_y":1250,"width":1507,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79971a3726f2488193acc045a2520a97","type":"text","conversion_output":true,"text":"Tablets containing the SNAC enhancer are susceptible to degradation in humid environment. It is","text_display":"\n\nTablets containing the SNAC enhancer are susceptible to degradation in humid environment. It is","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[322,1300],[1876,1300],[1876,1351],[322,1351]],"region":{"top_left_x":322,"top_left_y":1299,"width":1554,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3bd62f6467c4b7abe2922fa41776d7a","type":"text","conversion_output":true,"text":"important to protect the tablets by following the storage conditions in Table 9-2. Before opening the","text_display":" important to protect the tablets by following the storage conditions in Table 9-2. Before opening the","confidence":0.9951193332672119,"confidence_rate":0.9999538443097061},{"cnt":[[322,1349],[1876,1349],[1876,1399],[322,1399]],"region":{"top_left_x":322,"top_left_y":1349,"width":1554,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b01a97e71484b5e8a440032b3e63864","type":"text","conversion_output":true,"text":"Duma container for the first time, the container must acclimatise for 1 hour at room temperature due","text_display":" Duma container for the first time, the container must acclimatise for 1 hour at room temperature due","confidence":1,"confidence_rate":1},{"cnt":[[322,1396],[694,1396],[694,1446],[322,1446]],"region":{"top_left_x":322,"top_left_y":1396,"width":372,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef66637db48d4a468f4617a81e7b2965","type":"text","conversion_output":true,"text":"to risk of condensation.","text_display":" to risk of condensation.","confidence":1,"confidence_rate":1},{"cnt":[[318,1480],[1162,1480],[1162,1538],[318,1538]],"region":{"top_left_x":317,"top_left_y":1480,"width":846,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b54a754387ee48308a3b142bb7b16823","type":"figure_label","conversion_output":false,"text":"Table 9-2 Storage conditions for trial products","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[320,1536],[1878,1536],[1878,2213],[320,2213]],"region":{"top_left_x":320,"top_left_y":1536,"width":1558,"height":677},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5734c345e3034344b7828ca95ae39cd4","type":"table","conversion_output":true,"children_ids":["31937584498d40afbc19265cd5bb0d4c","869b31fea70044d1b50c95c1cf780dd0","f6be5239275f4715ba7738df1f164f38","893d5224558a4abd9d54245b302e5453","1e8cfcdfa7e54d66a7ac7a8cf1762acb","5a163a0b696f4285961d41ed028b3c54","afdde0b3140145e296da56b260244077","238c915bd4a6450390bc63719a4260d7","ea605a7551df4fbe99318c7da6daa724","2eed59a4954e4ae29cf6e1d17ca3c661","ec6d7671484840a5aad50efd078818ac","16c9bb2944fd4951871962d712614402","fc1c9e4dd1cb4f6a9bcfe1b23b8824c1","6b694ca530394a6689b6da601a69df4f","1386bba7d1664046aaafc4261eed411c","5ee5e5c2ec4d44f98efd6a5bf036e7e9","5219764a806f415c8879551bdcc80791","15a8ae26bc6647b9b640caa8dd128166","e0e6575517b4447180c8918b6a1d43bc","147592439edf45588413ff758c365baa","195ebeaa071542f6a45d506bffe005ca","4cb43d5b3bc54505807bdcce961723c5","0b213329ef8345a480568e21f1d2aabd","7903977fd83d470486ee5126ea619c36"],"selected_labels":["b54a754387ee48308a3b142bb7b16823"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline Trial product & Storage conditions (not-in-use) & In-use conditions & In-use time* \\\\\n\\hline Semaglutide and placebo tablets & \\begin{tabular}{l}\n- Must be stored in a refrigerator \\(\\left(2^{\\circ} C\\right.\\) to \\(\\left.8^{\\circ} C \\right) /\\left(36^{\\circ} F\\right.\\) to \\(\\left.46^{\\circ} F \\right)\\) \\\\\n- Do not freeze \\\\\n- Protect from light and humidity\n\\end{tabular} & \\begin{tabular}{l}\n- Store below \\(30^{\\circ} C / 86^{\\circ} F\\) \\\\\n- Do not refrigerate \\\\\n- Do not freeze \\\\\n- Protect from light and humidity \\\\\n- Container must be stored with lid tightly closed at all times\n\\end{tabular} & Use within 4 weeks \\\\\n\\hline Semaglutide, solution for injection & \\begin{tabular}{l}\n- Must be stored in a refrigerator \\(\\left(2^{\\circ} C\\right.\\) to \\(\\left.8^{\\circ} C \\right) /\\left(36^{\\circ} F\\right.\\) to \\(\\left.46^{\\circ} F \\right)\\) \\\\\n- Do not freeze \\\\\n- Protect from light\n\\end{tabular} & \\begin{tabular}{l}\n- Store below \\(30^{\\circ} C / 86^{\\circ} F\\) \\\\\n- Do not refrigerate \\\\\n- Do not freeze \\\\\n- Protect from light\n\\end{tabular} & Use within 1 month \\\\\n\\hline Semaglutide placebo, solution for injection (test pen) & \\begin{tabular}{l}\n- Must be stored in a refrigerator \\(\\left(2^{\\circ} C\\right.\\) to \\(\\left.8^{\\circ} C \\right) /\\left(36^{\\circ} F\\right.\\) to \\(\\left.46^{\\circ} F \\right)\\) \\\\\n- Do not freeze \\\\\n- Protect from light\n\\end{tabular} & - For single use only & For single use only \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 9-2 Storage conditions for trial products}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Trial product & Storage conditions (not-in-use) & In-use conditions & In-use time* \\\\\n\\hline Semaglutide and placebo tablets & \\begin{tabular}{l}\n- Must be stored in a refrigerator \\(\\left(2^{\\circ} C\\right.\\) to 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necessarily have a causal relationship with this treatment.","confidence":1,"confidence_rate":1},{"cnt":[[322,853],[1828,853],[1828,900],[322,900]],"region":{"top_left_x":322,"top_left_y":852,"width":1507,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b65b062c53a4f089328f5902852f4cc","type":"text","conversion_output":true,"text":"An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory","text_display":"\n\nAn AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory","confidence":1,"confidence_rate":1},{"cnt":[[322,900],[1760,900],[1760,952],[322,952]],"region":{"top_left_x":322,"top_left_y":900,"width":1438,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"170b428b7f3b4856810ca39ece706cb4","type":"text","conversion_output":true,"text":"finding), symptom or disease temporally associated with the use of a product, whether 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Active management includes active treatment or","text_display":" severity that requires active management. 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(pre-existing","confidence":1,"confidence_rate":1},{"cnt":[[378,1521],[1502,1521],[1502,1568],[378,1568]],"region":{"top_left_x":378,"top_left_y":1521,"width":1124,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"381af9724b0a48bb91ffa116a601e9e7","type":"text","conversion_output":true,"text":"conditions should be reported as medical history or concomitant illness).","text_display":" conditions should be reported as medical history or concomitant illness).","confidence":1,"confidence_rate":1},{"cnt":[[322,1618],[322,1568],[1865,1571],[1865,1620]],"region":{"top_left_x":322,"top_left_y":1568,"width":1543,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a19139c988094ce1b1bad669a3052faa","type":"text","conversion_output":true,"text":"- Pre-planned procedures unless the condition for which the procedure was planned has worsened","text_display":"\n- Pre-planned procedures unless the condition for which the procedure was planned has worsened","confidence":1,"confidence_rate":1},{"cnt":[[378,1620],[1674,1620],[1674,1669],[378,1669]],"region":{"top_left_x":378,"top_left_y":1619,"width":1296,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"469a249a54d9403888bca5d236dc9a85","type":"text","conversion_output":true,"text":"from the first trial-related activity after the subject has signed the informed consent.","text_display":" from the first trial-related activity after the subject has signed the informed consent.","confidence":1,"confidence_rate":1},{"cnt":[[322,1671],[1852,1671],[1852,1721],[322,1721]],"region":{"top_left_x":322,"top_left_y":1671,"width":1530,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a2d7234a3854e24bf77bd15fab07a85","type":"text","conversion_output":true,"text":"- Non-serious hypoglycaemia is an AE, but is reported on a hypoglycaemic episode form 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used when assessing an AE:","confidence":0.994140625,"confidence_rate":0.9999036667962594},{"cnt":[[322,1899],[724,1899],[724,1944],[322,1944]],"region":{"top_left_x":322,"top_left_y":1899,"width":403,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6e4671d8e1046099be88698e7ecf4db","type":"text","conversion_output":true,"text":"- Severity assessment:","text_display":"\n- Severity assessment:","confidence":1,"confidence_rate":1},{"cnt":[[385,1946],[1740,1946],[1740,1996],[385,1996]],"region":{"top_left_x":384,"top_left_y":1946,"width":1357,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff66bfe58d8b4916a4527e1b5a7c7bc8","type":"text","conversion_output":true,"text":"- Mild - no or transient symptoms, no interference with the subject's daily activities,","text_display":"\n- Mild - no or transient symptoms, no interference with the subject's daily 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level observed at the first trial-related activity after the","confidence":1,"confidence_rate":1},{"cnt":[[451,769],[1021,769],[1021,819],[451,819]],"region":{"top_left_x":451,"top_left_y":769,"width":570,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"652f20f9796743459d7eeb2559c8706e","type":"text","conversion_output":true,"text":"subject signed the informed consent.","text_display":" subject signed the informed consent.","confidence":1,"confidence_rate":1},{"cnt":[[387,821],[1837,821],[1837,870],[387,870]],"region":{"top_left_x":386,"top_left_y":820,"width":1451,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"507e04b518104057bddc481996360dd6","type":"text","conversion_output":true,"text":"- Recovering/resolving - This term is only applicable if the subject has completed the trial","text_display":"\n- Recovering/resolving - This term is only applicable if the subject has completed the 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based on appropriate medical judgement -","text_display":" hospitalisation \\({ }^{ b }\\) may be considered an SAE when - based on appropriate medical judgement ","confidence":0.7363904795611234,"confidence_rate":0.9971707251665068},{"cnt":[[380,2024],[1861,2024],[1861,2069],[380,2069]],"region":{"top_left_x":380,"top_left_y":2023,"width":1481,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"240a43f071af44f49f3068b4cd422f39","type":"text","conversion_output":true,"text":"they may jeopardise the subject and may require medical or surgical intervention to prevent one","text_display":"they may jeopardise the subject and may require medical or surgical intervention to prevent 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It does not refer to an event which hypothetically might have","text_display":" risk of death at the time of the event. 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development of drug","text_display":" blood dyscrasiasis or convulsions that do not result in hospitalisation, or development of drug","confidence":1,"confidence_rate":1},{"cnt":[[322,1229],[743,1229],[743,1278],[322,1278]],"region":{"top_left_x":322,"top_left_y":1228,"width":422,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66286f15cb4c4af9a1d08e93ac5c6947","type":"text","conversion_output":true,"text":"dependency or drug abuse.","text_display":" dependency or drug 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the list above will undergo adjudication by an independent EAC","confidence":0.98095703125,"confidence_rate":0.9998018070516378},{"cnt":[[322,662],[647,662],[647,711],[322,711]],"region":{"top_left_x":322,"top_left_y":661,"width":325,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd7096b5226349c6ad38e02675b5e9a7","type":"text","conversion_output":true,"text":"(see Section 12.7.2).","text_display":" (see Section 12.7.2).","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[322,750],[1807,750],[1807,799],[322,799]],"region":{"top_left_x":322,"top_left_y":749,"width":1485,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9855f118cff439aa9a3e97888cbe63a","type":"text","conversion_output":true,"text":"Any event confirmed or suspected to be a MESI must be reported. In case the sponsor identifies","text_display":"\n\nAny event confirmed or suspected to be a MESI must be reported. In case the sponsor identifies","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[322,799],[1781,799],[1781,849],[322,849]],"region":{"top_left_x":322,"top_left_y":799,"width":1460,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68c0ebe3a9cf441f88646451bac61c1f","type":"text","conversion_output":true,"text":"potentially missed MESIs through predefined review of available data, the investigator will be","text_display":" potentially missed MESIs through predefined review of available data, the investigator will be","confidence":1,"confidence_rate":1},{"cnt":[[322,846],[1742,846],[1742,896],[322,896]],"region":{"top_left_x":322,"top_left_y":846,"width":1421,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a86fdde6a9924817ad2d7219b7a122e0","type":"text","conversion_output":true,"text":"asked to reconsider if this is a MESI. However, MESIs should not be reported for screening","text_display":" asked to reconsider if this is a MESI. However, MESIs should not be reported for screening","confidence":1,"confidence_rate":1},{"cnt":[[322,894],[458,894],[458,939],[322,939]],"region":{"top_left_x":322,"top_left_y":893,"width":136,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"105bc4fd778a46aa99d5986bb5bbf399","type":"text","conversion_output":true,"text":"failures.","text_display":" failures.","confidence":1,"confidence_rate":1},{"cnt":[[322,982],[1876,982],[1876,1029],[322,1029]],"region":{"top_left_x":322,"top_left_y":981,"width":1554,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34666b29518740e4a19f47660a7424da","type":"text","conversion_output":true,"text":"For further information regarding definitions of MESIs and an overview of which events that should","text_display":"\n\nFor further information regarding definitions of MESIs and an overview of which events that should","confidence":1,"confidence_rate":1},{"cnt":[[322,1031],[1098,1031],[1098,1081],[322,1081]],"region":{"top_left_x":322,"top_left_y":1031,"width":776,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74c7e4a7c1ad48d3ae5993167572c960","type":"text","conversion_output":true,"text":"undergo adjudication, please refer to Appendix C.","text_display":" undergo adjudication, please refer to Appendix C.","confidence":1,"confidence_rate":1},{"cnt":[[322,1117],[1803,1117],[1803,1167],[322,1167]],"region":{"top_left_x":322,"top_left_y":1117,"width":1481,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8338fed12ca4012aa3a5f6bef7eaf01","type":"text","conversion_output":true,"text":"When reporting a MESI the following forms must be completed: AE form, eSIF, specific MESI","text_display":"\n\nWhen reporting a MESI the following forms must be completed: AE form, eSIF, specific MESI","confidence":1,"confidence_rate":1},{"cnt":[[322,1164],[1830,1164],[1830,1214],[322,1214]],"region":{"top_left_x":322,"top_left_y":1164,"width":1509,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15e40189ab13408fae1dedb2bf952526","type":"text","conversion_output":true,"text":"follow-up questions (MESI form) and if applicable, the Event Adjudication Document Collection","text_display":" follow-up questions (MESI form) and if applicable, the Event Adjudication Document Collection","confidence":1,"confidence_rate":1},{"cnt":[[322,1216],[1085,1216],[1085,1263],[322,1263]],"region":{"top_left_x":322,"top_left_y":1216,"width":763,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6945a39dcd24492cbe316930d6d14589","type":"text","conversion_output":true,"text":"Form (only events for adjudication) in the eCRF.","text_display":" Form (only events for adjudication) in the eCRF.","confidence":0.9990234375,"confidence_rate":0.9999815654595818},{"cnt":[[318,1300],[672,1300],[672,1354],[318,1354]],"region":{"top_left_x":317,"top_left_y":1299,"width":356,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"661329fba7544e669f07528f31dc9926","type":"section_header","conversion_output":false,"children_ids":["3933763f0b8d4f18b4aef9d0a95602b8"],"text":"","text_display":""},{"cnt":[[322,1302],[668,1302],[668,1351],[322,1351]],"region":{"top_left_x":322,"top_left_y":1301,"width":347,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3933763f0b8d4f18b4aef9d0a95602b8","type":"text","conversion_output":true,"parent_id":"661329fba7544e669f07528f31dc9926","text":"Technical complaint","text_display":"\n\n\\section*{Technical complaint}","confidence":1,"confidence_rate":1},{"cnt":[[322,1371],[1742,1371],[1742,1416],[322,1416]],"region":{"top_left_x":322,"top_left_y":1370,"width":1421,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47f6ea7d7a3c44b293379b48fe873fe3","type":"text","conversion_output":true,"text":"A technical complaint is any written, electronic, or oral communication that alleges product","text_display":"\n\nA technical complaint is any written, electronic, or oral communication that alleges product","confidence":1,"confidence_rate":1},{"cnt":[[322,1418],[1841,1418],[1841,1467],[322,1467]],"region":{"top_left_x":322,"top_left_y":1417,"width":1520,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3db254befb8e47cf956054ad87aa108c","type":"text","conversion_output":true,"text":"(medicine or device) defects. The technical complaint may be associated with an AE, but does not","text_display":" (medicine or device) defects. The technical complaint may be associated with an AE, but does not","confidence":1,"confidence_rate":1},{"cnt":[[322,1465],[668,1465],[668,1510],[322,1510]],"region":{"top_left_x":322,"top_left_y":1465,"width":347,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"672af26d82ff45b18ab92122b762bfff","type":"text","conversion_output":true,"text":"concern the AE itself.","text_display":" concern the AE itself.","confidence":1,"confidence_rate":1},{"cnt":[[322,1553],[862,1553],[862,1601],[322,1601]],"region":{"top_left_x":322,"top_left_y":1553,"width":540,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1354dbca3b774466a19d6987594ce8e9","type":"text","conversion_output":true,"text":"Examples of technical complaints:","text_display":"\n\nExamples of technical complaints:","confidence":1,"confidence_rate":1},{"cnt":[[322,1603],[1704,1603],[1704,1652],[322,1652]],"region":{"top_left_x":322,"top_left_y":1602,"width":1382,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2841ff6728854b2b807f0717bb551670","type":"text","conversion_output":true,"text":"- The physical or chemical appearance of trial products (e.g., discoloration, particles or","text_display":"\n- The physical or chemical appearance of trial products (e.g., discoloration, particles or","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[378,1654],[623,1654],[623,1699],[378,1699]],"region":{"top_left_x":378,"top_left_y":1654,"width":246,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b9dfab9af004acb8e2b29e88fa31efd","type":"text","conversion_output":true,"text":"contamination)","text_display":" contamination)","confidence":1,"confidence_rate":1},{"cnt":[[322,1706],[1800,1706],[1800,1755],[322,1755]],"region":{"top_left_x":322,"top_left_y":1705,"width":1479,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6812a17ac63471299ec2de51ef71e05","type":"text","conversion_output":true,"text":"- The packaging material (e.g., leakage, cracks, rubber membrane issues or errors in labelling","text_display":"\n- The packaging material (e.g., leakage, cracks, rubber membrane issues or errors in labelling","confidence":0.99609375,"confidence_rate":0.9999604664448944},{"cnt":[[378,1757],[460,1757],[460,1798],[378,1798]],"region":{"top_left_x":378,"top_left_y":1757,"width":82,"height":42},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb9a02e7df794cff9d85367e59b215e6","type":"text","conversion_output":true,"text":"text)","text_display":" text)","confidence":1,"confidence_rate":1},{"cnt":[[322,1805],[1846,1805],[1846,1854],[322,1854]],"region":{"top_left_x":322,"top_left_y":1804,"width":1524,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b772194ae9d4bf4881eacdf7b068041","type":"text","conversion_output":true,"text":"- Problems related to devices (e.g., to the injection mechanism, dose setting mechanism, glucose","text_display":"\n- Problems related to devices (e.g., to the injection mechanism, dose setting mechanism, glucose","confidence":1,"confidence_rate":1},{"cnt":[[378,1852],[1480,1852],[1480,1901],[378,1901]],"region":{"top_left_x":378,"top_left_y":1851,"width":1103,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa58a346018147e8bd822152707bd6eb","type":"text","conversion_output":true,"text":"measurement, push button or interface between the pen and the needle)","text_display":" measurement, push button or interface between the pen and the needle)","confidence":1,"confidence_rate":1},{"cnt":[[322,1938],[917,1938],[917,1992],[322,1992]],"region":{"top_left_x":322,"top_left_y":1937,"width":596,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2ccc36310a046b7a6fad291a6eea48b","type":"section_header","conversion_output":false,"children_ids":["a059a7faeb6c419193131a6540340f97"],"text":"","text_display":""},{"cnt":[[322,1942],[913,1942],[913,1987],[322,1987]],"region":{"top_left_x":322,"top_left_y":1942,"width":592,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a059a7faeb6c419193131a6540340f97","type":"text","conversion_output":true,"parent_id":"f2ccc36310a046b7a6fad291a6eea48b","text":"12.2 Reporting of adverse events","text_display":"\n\n\\subsection*{12.2 Reporting of adverse events}","confidence":1,"confidence_rate":1},{"cnt":[[322,2007],[1798,2007],[1798,2056],[322,2056]],"region":{"top_left_x":322,"top_left_y":2006,"width":1477,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b1131bcfa08410f9a48c25e5431d44b","type":"text","conversion_output":true,"text":"All events meeting the definition of an AE must be collected and reported. This includes events","text_display":"\n\nAll events meeting the definition of an AE must be collected and reported. This includes events","confidence":1,"confidence_rate":1},{"cnt":[[322,2056],[1858,2056],[1858,2103],[322,2103]],"region":{"top_left_x":322,"top_left_y":2056,"width":1537,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a5641fb2967441fbb2a66d785dee3e7","type":"text","conversion_output":true,"text":"from the first trial-related activity after the subject has signed the informed consent until the end of","text_display":" from the first trial-related activity after the subject has signed the informed consent until the end of","confidence":1,"confidence_rate":1},{"cnt":[[322,2105],[1867,2105],[1867,2153],[322,2153]],"region":{"top_left_x":322,"top_left_y":2105,"width":1545,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6359816148874ec390f29e54b4eda6f4","type":"text","conversion_output":true,"text":"the post-treatment follow-up period. The events must be recorded in the applicable eCRF forms in a","text_display":" the post-treatment follow-up period. The events must be recorded in the applicable eCRF forms in a","confidence":0.990746719184358,"confidence_rate":0.999909748166499},{"cnt":[[322,2153],[1162,2153],[1162,2202],[322,2202]],"region":{"top_left_x":322,"top_left_y":2152,"width":841,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b803410e94244d3e80c556b38812bea1","type":"text","conversion_output":true,"text":"timely manner (see timelines below and Figure 12-1).","text_display":" timely manner (see timelines below and Figure 12-1).","confidence":1,"confidence_rate":1},{"cnt":[[322,2239],[1783,2239],[1783,2288],[322,2288]],"region":{"top_left_x":322,"top_left_y":2238,"width":1462,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"523652ff7e164d0e9f4ba3902fd659da","type":"text","conversion_output":true,"text":"During each contact with the trial site staff, the subject must be asked about AEs and technical","text_display":"\n\nDuring each contact with the trial site staff, the subject must be asked about AEs and technical","confidence":1,"confidence_rate":1},{"cnt":[[322,2288],[1824,2288],[1824,2340],[322,2340]],"region":{"top_left_x":322,"top_left_y":2288,"width":1503,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8390149561a44a929331c5e48e55d71a","type":"text","conversion_output":true,"text":"complaints, for example by asking: \"Have you experienced any problems since the last contact?\"","text_display":" complaints, for example by asking: \"Have you experienced any problems since the last 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& 63 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 63 \\text { of } 98\\end{array}\\right|\\)","confidence":0.5806767591404255,"confidence_rate":0.995951790587445},{"cnt":[[1766,262],[1940,262],[1940,290],[1766,290]],"region":{"top_left_x":1766,"top_left_y":262,"width":175,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ea936614f2804e55a28dddd3e5cb64cd","type":"page_info","conversion_output":false,"text":"Novo 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U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[327,361],[694,361],[694,393],[327,393]],"region":{"top_left_x":326,"top_left_y":360,"width":368,"height":34},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a7e16902f76a458b91a8d3d18e4d0bd3","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,481],[1790,481],[1790,526],[322,526]],"region":{"top_left_x":322,"top_left_y":481,"width":1468,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57b7b35dfeec4dddb46ba5007ada81eb","type":"text","conversion_output":true,"text":"All AEs, either observed by the investigator or reported by the subject, must be reported by the","text_display":"\n\nAll AEs, either observed by the investigator or reported by the subject, must be reported by the","confidence":1,"confidence_rate":1},{"cnt":[[322,529],[1867,529],[1867,574],[322,574]],"region":{"top_left_x":322,"top_left_y":528,"width":1545,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0940df52717c414fa56ba03b7aad4601","type":"text","conversion_output":true,"text":"investigator and evaluated. Novo Nordisk assessment of expectedness is performed according to the","text_display":" investigator and evaluated. Novo Nordisk assessment of expectedness is performed according to the","confidence":1,"confidence_rate":1},{"cnt":[[322,571],[1850,571],[1850,623],[322,623]],"region":{"top_left_x":322,"top_left_y":571,"width":1528,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eda52bf1cfe64fcb84a0fc0487c642d6","type":"text","conversion_output":true,"text":"following reference document: IB (Oral Administration of Semaglutide (NN9924)), Edition \\(5^{6}\\) and","text_display":" following reference document: IB (Oral Administration of Semaglutide (NN9924)), Edition \\(5^{6}\\) and","confidence":0.8718821640200076,"confidence_rate":0.998742983394221},{"cnt":[[322,623],[629,623],[629,672],[322,672]],"region":{"top_left_x":322,"top_left_y":623,"width":308,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e44be018e6c4f5383375fe7fc8e3dd1","type":"text","conversion_output":true,"text":"any updates hereof.","text_display":" any updates hereof.","confidence":1,"confidence_rate":1},{"cnt":[[322,713],[1803,713],[1803,758],[322,758]],"region":{"top_left_x":322,"top_left_y":713,"width":1481,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baf0dacada3f46f5b365f08d63950af2","type":"text","conversion_output":true,"text":"All AEs must be recorded by the investigator on an AE form. The investigator should report the","text_display":"\n\nAll AEs must be recorded by the investigator on an AE form. The investigator should report the","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[322,761],[1794,761],[1794,810],[322,810]],"region":{"top_left_x":322,"top_left_y":760,"width":1472,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e7ed61078a54deba39d00ccc4c2b2cf","type":"text","conversion_output":true,"text":"diagnosis, if available. If no diagnosis is available, the investigator should record each sign and","text_display":" diagnosis, if available. 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In addition, the","confidence":0.9946331977844238,"confidence_rate":0.9999501748039759},{"cnt":[[322,2011],[1762,2011],[1762,2056],[322,2056]],"region":{"top_left_x":322,"top_left_y":2010,"width":1440,"height":47},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e676296bc1144c26883643130a1d4812","type":"text","conversion_output":true,"text":"investigator will be informed of any trial-related SAEs that may warrant a change to any trial","text_display":" investigator will be informed of any trial-related SAEs that may warrant a change to any trial","confidence":0.99560546875,"confidence_rate":0.9999555139634225},{"cnt":[[322,2058],[492,2058],[492,2105],[322,2105]],"region":{"top_left_x":322,"top_left_y":2058,"width":170,"height":48},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"261cfa5ce91845d2b077d938abfb261d","type":"text","conversion_output":true,"text":"procedure.","text_display":" procedure.","confidence":1,"confidence_rate":1},{"cnt":[[322,2144],[1824,2144],[1824,2194],[322,2194]],"region":{"top_left_x":322,"top_left_y":2144,"width":1503,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"357420ed3e6a49ff94b5034948d2f415","type":"text","conversion_output":true,"text":"In accordance with regulatory requirements, Novo Nordisk will inform the regulatory authorities,","text_display":"\n\nIn accordance with regulatory requirements, Novo Nordisk will inform the regulatory authorities,","confidence":1,"confidence_rate":1},{"cnt":[[322,2196],[1751,2196],[1751,2241],[322,2241]],"region":{"top_left_x":322,"top_left_y":2195,"width":1429,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"775a8b31ef074149aca27fe500ad4bb1","type":"text","conversion_output":true,"text":"including EMA, of trial product-related SUSARs. In addition, Novo Nordisk will inform the","text_display":" including EMA, of trial product-related SUSARs. In addition, Novo Nordisk will inform the","confidence":1,"confidence_rate":1},{"cnt":[[322,2239],[1858,2239],[1858,2288],[322,2288]],"region":{"top_left_x":322,"top_left_y":2238,"width":1537,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06df0053d123418ab48fa68920242735","type":"text","conversion_output":true,"text":"IRBs/IECs of trial product-related SUSARs in accordance with local requirement and GCP \\({ }^{1}\\), unless","text_display":" IRBs/IECs of trial product-related SUSARs in accordance with local requirement and GCP \\({ }^{1}\\), unless","confidence":0.81103515625,"confidence_rate":0.9981317128132879},{"cnt":[[322,2290],[1044,2290],[1044,2340],[322,2340]],"region":{"top_left_x":322,"top_left_y":2290,"width":723,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0213595f18754fcdbf735fc884632555","type":"text","conversion_output":true,"text":"locally this is an obligation of the 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NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[327,331],[617,331],[617,359],[327,359]],"region":{"top_left_x":326,"top_left_y":330,"width":291,"height":29},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"32cb74026aa24438bf504ecf5f0f6c27","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[924,311],[1145,308],[1145,333],[924,335]],"region":{"top_left_x":923,"top_left_y":308,"width":223,"height":28},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2e85446fbcb6429d84cfa8787a474ff4","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":0.88525390625,"confidence_rate":0.9928561818730404},{"cnt":[[327,365],[694,365],[694,389],[327,389]],"region":{"top_left_x":326,"top_left_y":365,"width":368,"height":24},"line":7,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"afd751877ad44d9a841517bda5ed9238","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,481],[913,481],[913,526],[322,526]],"region":{"top_left_x":322,"top_left_y":481,"width":592,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"669307e046ff41c6a0af4a3386ff4284","type":"section_header","conversion_output":false,"children_ids":["c3a4ec976574458bbc8fe6b2708f7c00"],"text":"","text_display":""},{"cnt":[[327,486],[913,486],[913,526],[327,526]],"region":{"top_left_x":326,"top_left_y":485,"width":588,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3a4ec976574458bbc8fe6b2708f7c00","type":"text","conversion_output":true,"parent_id":"669307e046ff41c6a0af4a3386ff4284","text":"12.3 Follow-up of adverse events","text_display":"\n\n\\subsection*{12.3 Follow-up of adverse 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medical care is provided to the subject for any AE, including significant laboratory values","confidence":1,"confidence_rate":1},{"cnt":[[327,649],[1779,649],[1779,690],[327,690]],"region":{"top_left_x":326,"top_left_y":648,"width":1453,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72fb78aab74c48ed9e5e1b6a545cfa52","type":"text","conversion_output":true,"text":"related to the trial. The investigator should inform the subject when medical care is needed for","text_display":" related to the trial. The investigator should inform the subject when medical care is needed for","confidence":1,"confidence_rate":1},{"cnt":[[327,696],[1068,696],[1068,737],[327,737]],"region":{"top_left_x":326,"top_left_y":696,"width":742,"height":41},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43e3c916c5884a65b4cdf017d5952174","type":"text","conversion_output":true,"text":"\\(AE ( s )\\) of which the investigator becomes aware.","text_display":" \\(AE ( s )\\) of which the investigator becomes aware.","confidence":0.8480222225189209,"confidence_rate":0.9970606063991897},{"cnt":[[327,782],[1674,782],[1674,823],[327,823]],"region":{"top_left_x":326,"top_left_y":782,"width":1348,"height":41},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"002ff315bd384df6a72e1f730103d984","type":"text","conversion_output":true,"text":"The investigator must record follow-up information by updating the forms in the eCRF.","text_display":"\n\nThe investigator must record follow-up information by updating the forms in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[327,868],[1635,868],[1635,913],[327,913]],"region":{"top_left_x":326,"top_left_y":867,"width":1309,"height":47},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d08b65231b1a4f1b9025a38a211d3550","type":"text","conversion_output":true,"text":"Follow up information must be reported to Novo Nordisk according to the following:","text_display":"\n\nFollow up information must be reported to Novo Nordisk according to the following:","confidence":1,"confidence_rate":1},{"cnt":[[327,958],[1815,958],[1815,999],[327,999]],"region":{"top_left_x":326,"top_left_y":958,"width":1490,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98558a6266394995b4cda776149591d6","type":"text","conversion_output":true,"text":"- SAEs: All SAEs must be followed up until the outcome of the event is \"recovered/resolved\",","text_display":"\n- SAEs: All SAEs must be followed up until the outcome of the event is \"recovered/resolved\",","confidence":0.9736328125,"confidence_rate":0.9997245633454399},{"cnt":[[382,1051],[382,1005],[1867,1008],[1867,1053]],"region":{"top_left_x":382,"top_left_y":1005,"width":1486,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ad8f0fedcf5499aa6433c4bb2490d46","type":"text","conversion_output":true,"text":"\"recovered/resolved with sequelae\" or \"fatal\", and until all queries have been resolved. 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Cases","text_display":" may be closed with the outcome \"recovering/resolving\" or \"not recovered/not resolved\". Cases","confidence":1,"confidence_rate":1},{"cnt":[[382,1154],[1828,1154],[1828,1197],[382,1197]],"region":{"top_left_x":382,"top_left_y":1153,"width":1447,"height":44},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1705524f52b644ed8076fdfc915214cc","type":"text","conversion_output":true,"text":"can be closed with the outcome of \"recovering/resolving\" when the subject has completed the","text_display":" can be closed with the outcome of \"recovering/resolving\" when the subject has completed the","confidence":1,"confidence_rate":1},{"cnt":[[382,1203],[1360,1203],[1360,1244],[382,1244]],"region":{"top_left_x":382,"top_left_y":1203,"width":978,"height":41},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74f6acf434044a53a5ddc4ae23aa21e0","type":"text","conversion_output":true,"text":"follow-up period and is expected by the investigator to recover.","text_display":" follow-up period and is expected by the investigator to recover.","confidence":1,"confidence_rate":1},{"cnt":[[382,1289],[1751,1289],[1751,1330],[382,1330]],"region":{"top_left_x":382,"top_left_y":1289,"width":1369,"height":41},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30ad100fc91948bf82875fc2475b8319","type":"text","conversion_output":true,"text":"The SAE follow-up information should only include new (e.g., corrections or additional)","text_display":"\n\nThe SAE follow-up information should only include new (e.g., corrections or additional)","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[382,1336],[1828,1336],[1828,1379],[382,1379]],"region":{"top_left_x":382,"top_left_y":1336,"width":1447,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ccc31f3798fc42b29f2582733441f734","type":"text","conversion_output":true,"text":"information and must be reported within 24 hours of the investigator's first knowledge of the","text_display":" information and must be reported within 24 hours of the investigator's first knowledge of the","confidence":0.9355781078338623,"confidence_rate":0.9993409039961694},{"cnt":[[382,1386],[1826,1386],[1826,1429],[382,1429]],"region":{"top_left_x":382,"top_left_y":1385,"width":1445,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92b2e6c29321450cb972746396f503f3","type":"text","conversion_output":true,"text":"information. 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Cases of chronic conditions, cancer or AEs ongoing at","text_display":" related to these AEs have been resolved. 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Cases can be closed with the outcome","text_display":" \"recovering/resolving\" or \"not recovered/not resolved\". 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This is also the case for","text_display":" calendar days of the investigator's first knowledge of the information. This is also the case for","confidence":1,"confidence_rate":1},{"cnt":[[382,2148],[1497,2148],[1497,2189],[382,2189]],"region":{"top_left_x":382,"top_left_y":2148,"width":1116,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0093c2ca0f464642bff093543ed9d424","type":"text","conversion_output":true,"text":"previously non-serious AEs which subsequently fulfil the MESI criteria.","text_display":" previously non-serious AEs which subsequently fulfil the MESI criteria.","confidence":1,"confidence_rate":1},{"cnt":[[327,2234],[1867,2234],[1867,2275],[327,2275]],"region":{"top_left_x":326,"top_left_y":2234,"width":1541,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34c3e35636e245aaa012a647a7e1df0e","type":"text","conversion_output":true,"text":"The investigator must record follow-up information on non-serious AEs by updating the AE form in","text_display":"\n\nThe investigator must record follow-up 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U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[698,361],[698,397],[322,397]],"region":{"top_left_x":322,"top_left_y":360,"width":377,"height":38},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4f174a40289249d096e6273baeb0a60f","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,477],[1745,477],[1745,529],[322,529]],"region":{"top_left_x":322,"top_left_y":476,"width":1423,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d866427a2d44628ad2496238ddca7ae","type":"text","conversion_output":true,"text":"The investigator must ensure that the worst case severity and seriousness of an event is kept","text_display":"\n\nThe investigator must ensure that the worst case severity and seriousness of an event is 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A worsening of an unresolved AE must be reported as follow up with re-","text_display":" throughout the trial. A worsening of an unresolved AE must be reported as follow up with re","confidence":1,"confidence_rate":1},{"cnt":[[322,576],[1167,576],[1167,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":845,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"610b620a43fb4b7f9750ca6b5f80818e","type":"text","conversion_output":true,"text":"assessment of severity and/or seriousness of the event.","text_display":"assessment of severity and/or seriousness of the event.","confidence":1,"confidence_rate":1},{"cnt":[[322,662],[1837,662],[1837,711],[322,711]],"region":{"top_left_x":322,"top_left_y":661,"width":1515,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b23bfeaf5fa44265b435b865387e90ce","type":"text","conversion_output":true,"text":"Queries or follow-up requests from Novo Nordisk must be responded to within \\(1 4\\) calendar days","text_display":"\n\nQueries or follow-up requests from Novo Nordisk must be responded to within \\(1 4\\) calendar days","confidence":0.85400390625,"confidence_rate":0.998468944998911},{"cnt":[[322,709],[1721,709],[1721,761],[322,761]],"region":{"top_left_x":322,"top_left_y":708,"width":1399,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abe00bf2282341f7936aad093e18e983","type":"text","conversion_output":true,"text":"from the date of receipt of the request, unless otherwise specified in the follow-up request.","text_display":" from the date of receipt of the request, unless otherwise specified in the follow-up 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} \\\\ \\text { Page: } & 67 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 67 \\text { of } 98\\end{array}\\right|\\)","confidence":0.5526003425351433,"confidence_rate":0.9955835110008292},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"52c0098c5581421e8dc15fbc295f2310","type":"page_info","conversion_output":false,"text":"Novo 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U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[696,361],[696,397],[322,397]],"region":{"top_left_x":322,"top_left_y":360,"width":375,"height":38},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b17d96601bd54d7ba9deac8e500d52bb","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,473],[1571,473],[1571,535],[318,535]],"region":{"top_left_x":317,"top_left_y":472,"width":1254,"height":63},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a63601e84b4425b8546668d0fd14ac7","type":"section_header","conversion_output":false,"children_ids":["b5bac7cd0b604e57a7642ee3db6a3bdf"],"text":"","text_display":""},{"cnt":[[322,481],[1562,481],[1562,529],[322,529]],"region":{"top_left_x":322,"top_left_y":481,"width":1240,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5bac7cd0b604e57a7642ee3db6a3bdf","type":"text","conversion_output":true,"parent_id":"5a63601e84b4425b8546668d0fd14ac7","text":"12.4.2 Collection, storage and shipment of technical complaint samples","text_display":"\n\n\\subsection*{12.4.2 Collection, storage and shipment of technical complaint 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The monitor must coordinate the shipment to","text_display":" calendar days of obtaining the sample at trial site. The monitor must coordinate the shipment to","confidence":1,"confidence_rate":1},{"cnt":[[322,642],[1837,642],[1837,694],[322,694]],"region":{"top_left_x":322,"top_left_y":642,"width":1515,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c067379054a241a4866a325ed52f5403","type":"text","conversion_output":true,"text":"Customer Complaint Center, Novo Nordisk (the address is provided in the investigator's trial file)","text_display":" Customer Complaint Center, Novo Nordisk (the address is provided in the investigator's trial file)","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[322,692],[1854,692],[1854,741],[322,741]],"region":{"top_left_x":322,"top_left_y":691,"width":1533,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c4dcca219d541a8b6cbeeb83c1d8f61","type":"text","conversion_output":true,"text":"and ensure that the sample is sent as soon as possible. A print of the technical complaint form must","text_display":" and ensure that the sample is sent as soon as possible. A print of the technical complaint form must","confidence":1,"confidence_rate":1},{"cnt":[[322,741],[703,741],[703,793],[322,793]],"region":{"top_left_x":322,"top_left_y":741,"width":381,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fd8ffc18c6548f0942baf4581fa1246","type":"text","conversion_output":true,"text":"be sent with the sample.","text_display":" be sent with the sample.","confidence":1,"confidence_rate":1},{"cnt":[[322,827],[1846,827],[1846,879],[322,879]],"region":{"top_left_x":322,"top_left_y":827,"width":1524,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eeaa464311de4958a467ec95aeb6f72f","type":"text","conversion_output":true,"text":"The investigator must ensure that the technical complaint sample contains the code number and, if","text_display":"\n\nThe investigator must ensure that the technical complaint sample contains the code number and, if","confidence":1,"confidence_rate":1},{"cnt":[[322,877],[638,877],[638,922],[322,922]],"region":{"top_left_x":322,"top_left_y":876,"width":317,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b76044d94374461dab02aae2d998dcf5","type":"text","conversion_output":true,"text":"available, the DUN.","text_display":" available, the DUN.","confidence":1,"confidence_rate":1},{"cnt":[[322,962],[1800,962],[1800,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":962,"width":1479,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fd8075f9d6f48cea59962b5998b069b","type":"text","conversion_output":true,"text":"If the technical complaint sample is unobtainable, the investigator must specify on the technical","text_display":"\n\nIf the technical complaint sample is unobtainable, the investigator must specify on the technical","confidence":0.99755859375,"confidence_rate":0.9999760356661515},{"cnt":[[322,1010],[930,1010],[930,1059],[322,1059]],"region":{"top_left_x":322,"top_left_y":1009,"width":609,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e96d0528c7c343e1b78b5a4e73c3af67","type":"text","conversion_output":true,"text":"complaint form why it is unobtainable.","text_display":" complaint form why it is unobtainable.","confidence":1,"confidence_rate":1},{"cnt":[[322,1100],[1717,1100],[1717,1147],[322,1147]],"region":{"top_left_x":322,"top_left_y":1100,"width":1395,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57a8d357f61944aa8f5d015cf74fb6ef","type":"text","conversion_output":true,"text":"Storage of the technical complaint sample must be done in accordance with the conditions","text_display":"\n\nStorage of the technical complaint sample must be done in accordance with the conditions","confidence":1,"confidence_rate":1},{"cnt":[[322,1147],[1768,1147],[1768,1197],[322,1197]],"region":{"top_left_x":322,"top_left_y":1147,"width":1447,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1b6729788ed4e6abd6a40f6e32eb296","type":"text","conversion_output":true,"text":"prescribed for the product. 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The investigator must report any pregnancy in subjects who have received trial","text_display":" during the trial. The investigator must report any pregnancy in subjects who have received trial","confidence":1,"confidence_rate":1},{"cnt":[[322,1448],[501,1448],[501,1497],[322,1497]],"region":{"top_left_x":322,"top_left_y":1448,"width":179,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2480528ec3040678be8d031b9fb51f1","type":"text","conversion_output":true,"text":"product(s).","text_display":" product(s).","confidence":1,"confidence_rate":1},{"cnt":[[322,1534],[1850,1534],[1850,1583],[322,1583]],"region":{"top_left_x":322,"top_left_y":1533,"width":1528,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"431cf9d107b74d8bac47ff108f5187b6","type":"text","conversion_output":true,"text":"The investigator must follow the pregnancy until the pregnancy outcome and the newborn infant is","text_display":"\n\nThe investigator must follow the pregnancy until the pregnancy outcome and the newborn infant is","confidence":1,"confidence_rate":1},{"cnt":[[322,1583],[608,1583],[608,1631],[322,1631]],"region":{"top_left_x":322,"top_left_y":1583,"width":287,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"836d182a0f7f49e1a9031ddda5d68443","type":"text","conversion_output":true,"text":"one month of age.","text_display":" one month of age.","confidence":1,"confidence_rate":1},{"cnt":[[322,1669],[1824,1669],[1824,1717],[322,1717]],"region":{"top_left_x":322,"top_left_y":1669,"width":1503,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48ea9cd5e30d4826af7c8363453be554","type":"text","conversion_output":true,"text":"The investigator must report information about the pregnancy, pregnancy outcome, and health of","text_display":"\n\nThe investigator must report information about the pregnancy, pregnancy outcome, and health of","confidence":1,"confidence_rate":1},{"cnt":[[322,1714],[1843,1714],[1843,1766],[322,1766]],"region":{"top_left_x":322,"top_left_y":1714,"width":1522,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9d8f6ecb56e483aa6f14ffefddf2ab5","type":"text","conversion_output":true,"text":"the newborn infant(s), as well as AEs in connection with the pregnancy, and AEs in the foetus and","text_display":" the newborn infant(s), as well as AEs in connection with the pregnancy, and AEs in the foetus and","confidence":1,"confidence_rate":1},{"cnt":[[322,1766],[574,1766],[574,1811],[322,1811]],"region":{"top_left_x":322,"top_left_y":1766,"width":252,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f06c08cabe604f4e92a0d2faebf06810","type":"text","conversion_output":true,"text":"newborn infant.","text_display":" newborn infant.","confidence":1,"confidence_rate":1},{"cnt":[[322,1852],[1843,1852],[1843,1901],[322,1901]],"region":{"top_left_x":322,"top_left_y":1851,"width":1522,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3858f772bda4439f85e9c92f075c6e04","type":"text","conversion_output":true,"text":"The following must be collected and reported by the investigator to Novo Nordisk - electronically","text_display":"\n\nThe following must be collected and reported by the investigator to Novo Nordisk - electronically","confidence":1,"confidence_rate":1},{"cnt":[[322,1904],[982,1904],[982,1951],[322,1951]],"region":{"top_left_x":322,"top_left_y":1903,"width":660,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c95164a3ff3a4fc1a34a34dcd5d7ab73","type":"text","conversion_output":true,"text":"(e.g., in PDF format), or by fax or courier:","text_display":" (e.g., in PDF format), or by fax or courier:","confidence":1,"confidence_rate":1},{"cnt":[[320,1987],[990,1987],[990,2041],[320,2041]],"region":{"top_left_x":320,"top_left_y":1987,"width":671,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc2399c47c6649fcaf23023beadba3e5","type":"section_header","conversion_output":false,"children_ids":["86d543ce51a84f82ab055747739030a6"],"text":"","text_display":""},{"cnt":[[322,1994],[986,1994],[986,2039],[322,2039]],"region":{"top_left_x":322,"top_left_y":1993,"width":665,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86d543ce51a84f82ab055747739030a6","type":"text","conversion_output":true,"parent_id":"cc2399c47c6649fcaf23023beadba3e5","text":"1. Reporting of pregnancy information","text_display":"\n\n\\section*{1. Reporting of pregnancy information}","confidence":1,"confidence_rate":1},{"cnt":[[380,2037],[1858,2037],[1858,2086],[380,2086]],"region":{"top_left_x":380,"top_left_y":2036,"width":1479,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64325c38728644f2bd8edf057e319073","type":"text","conversion_output":true,"text":"Information about the pregnancy and pregnancy outcome/health of the newborn infant(s) has to","text_display":"\n\nInformation about the pregnancy and pregnancy outcome/health of the newborn infant(s) has to","confidence":1,"confidence_rate":1},{"cnt":[[378,2086],[1240,2086],[1240,2133],[378,2133]],"region":{"top_left_x":378,"top_left_y":2086,"width":862,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"587f1d9127894a58ac1c715821418bcd","type":"text","conversion_output":true,"text":"be reported on Maternal Form 1A and 1B, respectively.","text_display":" be reported on Maternal Form 1A and 1B, respectively.","confidence":1,"confidence_rate":1},{"cnt":[[380,2136],[1807,2136],[1807,2185],[380,2185]],"region":{"top_left_x":380,"top_left_y":2135,"width":1427,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5b6ae73ba0e4f28a848984fd4f3f960","type":"text","conversion_output":true,"text":"When the pregnancy outcome is abnormal (i.e., congenital anomalies, foetal death including","text_display":"\nWhen the pregnancy outcome is abnormal (i.e., congenital anomalies, foetal death including","confidence":0.9965848922729492,"confidence_rate":0.9999639906218448},{"cnt":[[380,2183],[1775,2183],[1775,2232],[380,2232]],"region":{"top_left_x":380,"top_left_y":2182,"width":1395,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c55419a87b4426d9b72ee9b72fd7529","type":"text","conversion_output":true,"text":"spontaneous abortion and/or any anomalies of the foetus observed at gross examination or","text_display":" spontaneous abortion and/or any anomalies of the foetus observed at gross examination or","confidence":1,"confidence_rate":1},{"cnt":[[380,2230],[1850,2230],[1850,2279],[380,2279]],"region":{"top_left_x":380,"top_left_y":2230,"width":1470,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d3a5a77d17e4ee4bb39d2c4f9487544","type":"text","conversion_output":true,"text":"during autopsy), and/or when a congenital anomaly is diagnosed within the first month, further","text_display":" during autopsy), and/or when a congenital anomaly is diagnosed within the first month, further","confidence":1,"confidence_rate":1},{"cnt":[[380,2279],[1712,2279],[1712,2329],[380,2329]],"region":{"top_left_x":380,"top_left_y":2279,"width":1333,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a77739a39a441319bbc8d35dc39f1b1","type":"text","conversion_output":true,"text":"information has to be reported for the female subject on Maternal Form 2. 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The subject did not report any symptoms and","confidence":1,"confidence_rate":1},{"cnt":[[322,672],[1025,672],[1025,724],[322,724]],"region":{"top_left_x":322,"top_left_y":672,"width":703,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aca1c8491e2845a3b63235bd1b759449","type":"text","conversion_output":true,"text":"treatment was continued without any change.","text_display":" treatment was continued without any change.","confidence":1,"confidence_rate":1},{"cnt":[[322,761],[1803,761],[1803,810],[322,810]],"region":{"top_left_x":322,"top_left_y":760,"width":1481,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"902a37637b0149a886bd1c759f77f3bb","type":"text","conversion_output":true,"text":"One case of accidental overdose has been reported in s.c. semaglutide treated subjects. The case","text_display":"\n\nOne case of accidental overdose has been reported in s.c. semaglutide treated subjects. The case","confidence":0.99072265625,"confidence_rate":0.9999077206309377},{"cnt":[[322,808],[1869,808],[1869,857],[322,857]],"region":{"top_left_x":322,"top_left_y":807,"width":1548,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9166fafe4b4645f88d5468db7b17acd5","type":"text","conversion_output":true,"text":"classified as moderate in severity and considered to be probably related to semaglutide was reported","text_display":" classified as moderate in severity and considered to be probably related to semaglutide was reported","confidence":1,"confidence_rate":1},{"cnt":[[322,855],[1678,855],[1678,904],[322,904]],"region":{"top_left_x":322,"top_left_y":855,"width":1356,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"706d8c9e18c449d29b049d221fa6e2c2","type":"text","conversion_output":true,"text":"by a subject enrolled in trial NN9535-1821. No hospitalisation was needed. 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2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[917,254],[1762,254],[1762,406],[917,406]],"region":{"top_left_x":917,"top_left_y":253,"width":845,"height":154},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8477a4ef70e6409cad6d3701a0a39fcb","type":"table","conversion_output":true,"text":"CONFIDENTIAL \\(\\quad\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 70 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\quad\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 70 \\text { of } 98\\end{array}\\right|\\)","confidence":0.4614825195033063,"confidence_rate":0.994288144635179},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2d861794678241c38970e0d42e3c840d","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,477],[1826,477],[1826,526],[322,526]],"region":{"top_left_x":322,"top_left_y":476,"width":1505,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a967f817a8b46a7a57e94e03724f656","type":"text","conversion_output":true,"text":"The EAC works in accordance with written guidelines included in the EAC Charter describing in","text_display":"\n\nThe EAC works in accordance with written guidelines included in the EAC Charter describing 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requirements and the adjudication vendor will","confidence":1,"confidence_rate":1},{"cnt":[[322,662],[1818,662],[1818,711],[322,711]],"region":{"top_left_x":322,"top_left_y":661,"width":1496,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5f7d85b4a3849dda004daa7ed90f510","type":"text","conversion_output":true,"text":"ensure that the EAC gets access to all the documents provided by the investigator. The EAC will","text_display":" ensure that the EAC gets access to all the documents provided by the investigator. The EAC will","confidence":1,"confidence_rate":1},{"cnt":[[322,709],[1863,709],[1863,758],[322,758]],"region":{"top_left_x":322,"top_left_y":708,"width":1541,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92f09a1a9f5645c7b88c25b2130e5663","type":"text","conversion_output":true,"text":"initiate the review and may ask for additional information that the investigator needs to provide if it","text_display":" initiate the review and may ask for additional information that the investigator needs to provide if it","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[322,761],[513,761],[513,804],[322,804]],"region":{"top_left_x":322,"top_left_y":760,"width":192,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e85954f6097b46f3b1f5b885f4e233d5","type":"text","conversion_output":true,"text":"is available.","text_display":" is available.","confidence":0.99951171875,"confidence_rate":0.9999728670071003},{"cnt":[[322,846],[1863,846],[1863,896],[322,896]],"region":{"top_left_x":322,"top_left_y":846,"width":1541,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04a91a48c4e747709be1c7947bef0060","type":"text","conversion_output":true,"text":"The EAC will review copies in English (translated if necessary) of medical documentation received","text_display":"\n\nThe EAC will review copies in English (translated if necessary) of medical documentation received","confidence":1,"confidence_rate":1},{"cnt":[[322,894],[1833,894],[1833,943],[322,943]],"region":{"top_left_x":322,"top_left_y":893,"width":1511,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"180d78266c16401da06c6bc5ee6f9cfb","type":"text","conversion_output":true,"text":"in the adjudication packages (e.g., X-ray images, ECGs, ultrasound images, discharge summaries,","text_display":" in the adjudication packages (e.g., X-ray images, ECGs, ultrasound images, discharge summaries,","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[322,941],[1800,941],[1800,990],[322,990]],"region":{"top_left_x":322,"top_left_y":941,"width":1479,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c985f3afebf74255b238e3f6b991b920","type":"text","conversion_output":true,"text":"pathology reports and death certificates). The investigator must provide medical documentation","text_display":" pathology reports and death certificates). The investigator must provide medical documentation","confidence":1,"confidence_rate":1},{"cnt":[[322,993],[922,993],[922,1038],[322,1038]],"region":{"top_left_x":322,"top_left_y":992,"width":600,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72a7e722992346ceb487f019ee0a2bdd","type":"text","conversion_output":true,"text":"within 4 weeks of event identification.","text_display":" within 4 weeks of event identification.","confidence":1,"confidence_rate":1},{"cnt":[[322,1079],[1858,1079],[1858,1128],[322,1128]],"region":{"top_left_x":322,"top_left_y":1078,"width":1537,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9bab597a1b9f4b94bd3fffb598ddebbf","type":"text","conversion_output":true,"text":"The assessments made by the EAC will be included in the CTR as well as assessments made by the","text_display":"\n\nThe assessments made by the EAC will be included in the CTR as well as assessments made by the","confidence":1,"confidence_rate":1},{"cnt":[[322,1126],[1785,1126],[1785,1175],[322,1175]],"region":{"top_left_x":322,"top_left_y":1125,"width":1464,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ba9d87476404a3ba1547ef1b29ec70f","type":"text","conversion_output":true,"text":"investigator. However, the adjudication made by an EAC, given its independence and in-depth","text_display":" investigator. However, the adjudication made by an EAC, given its independence and in-depth","confidence":1,"confidence_rate":1},{"cnt":[[322,1175],[1775,1175],[1775,1222],[322,1222]],"region":{"top_left_x":322,"top_left_y":1175,"width":1453,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d40fe6e401eb4442a8a3e03b27909a83","type":"text","conversion_output":true,"text":"analysis of each event, will be attributed with greater importance of the two. The outcomes of","text_display":" analysis of each event, will be attributed with greater importance of the two. The outcomes of","confidence":1,"confidence_rate":1},{"cnt":[[322,1225],[1154,1225],[1154,1274],[322,1274]],"region":{"top_left_x":322,"top_left_y":1224,"width":832,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b58e4e943717476683cb7fc245bb1994","type":"text","conversion_output":true,"text":"adjudication will be kept in the clinical trial database.","text_display":" adjudication will be kept in the clinical trial database.","confidence":0.99853515625,"confidence_rate":0.9999763564459245},{"cnt":[[322,1311],[1113,1311],[1113,1360],[322,1360]],"region":{"top_left_x":322,"top_left_y":1310,"width":791,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93c53a5fb1404bc396b5d2180a2ab557","type":"text","conversion_output":true,"text":"The following AEs will be adjudicated in this trial:","text_display":"\n\nThe following AEs will be adjudicated in this 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capturing AEs for adjudication: Direct reporting of MESIs by the","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[322,1944],[1119,1944],[1119,1992],[322,1992]],"region":{"top_left_x":322,"top_left_y":1944,"width":798,"height":48},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bda612089312476eb0839def067df472","type":"text","conversion_output":true,"text":"investigator and by potential missed MESI process.","text_display":" investigator and by potential missed MESI process.","confidence":1,"confidence_rate":1},{"cnt":[[322,2032],[1850,2032],[1850,2082],[322,2082]],"region":{"top_left_x":322,"top_left_y":2032,"width":1528,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2efcf814de4c49f4bccf475f0d7c6c8b","type":"text","conversion_output":true,"text":"Direct reporting of MESI by investigator: For each AE reported in the eCRF, the investigator must","text_display":"\n\nDirect reporting of MESI by investigator: For each AE reported in the eCRF, the investigator must","confidence":0.99853515625,"confidence_rate":0.9999856283612877},{"cnt":[[322,2080],[1343,2080],[1343,2129],[322,2129]],"region":{"top_left_x":322,"top_left_y":2079,"width":1021,"height":51},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0031ca469544021a542871f7f8b7021","type":"text","conversion_output":true,"text":"complete whether the event in his/her opinion is a MESI (yes/no).","text_display":" complete whether the event in his/her opinion is a MESI (yes/no).","confidence":1,"confidence_rate":1},{"cnt":[[322,2166],[587,2166],[587,2215],[322,2215]],"region":{"top_left_x":322,"top_left_y":2165,"width":265,"height":51},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"160f9f8a323c438cb40432d219bc14f4","type":"text","conversion_output":true,"text":"By ticking YES:","text_display":"\n\nBy ticking YES:","confidence":1,"confidence_rate":1},{"cnt":[[322,2217],[1446,2217],[1446,2267],[322,2267]],"region":{"top_left_x":322,"top_left_y":2217,"width":1124,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3cd7bbcbf18c4aa09cafa363ee33a244","type":"text","conversion_output":true,"text":"- The investigator must specify the type of MESI event being reported","text_display":"\n- The investigator must specify the type of MESI event being reported","confidence":1,"confidence_rate":1},{"cnt":[[322,2269],[1854,2269],[1854,2318],[322,2318]],"region":{"top_left_x":322,"top_left_y":2268,"width":1533,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f6df1284c7849b78d3926e7b646c82b","type":"text","conversion_output":true,"text":"- The investigator must complete the event adjudication document collection form ('adjudication","text_display":"\n- The investigator must complete the event adjudication document 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If a document is unobtainable this needs to be specified. The investigator must","text_display":" will be available. If a document is unobtainable this needs to be specified. The investigator must","confidence":1,"confidence_rate":1},{"cnt":[[382,580],[1463,580],[1463,625],[382,625]],"region":{"top_left_x":382,"top_left_y":580,"width":1082,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ade6ea1b2c6a4a548ce4ba3a5f22300d","type":"text","conversion_output":true,"text":"provide medical documentation within 4 weeks of event identification","text_display":" provide medical documentation within 4 weeks of event identification","confidence":1,"confidence_rate":1},{"cnt":[[322,666],[565,666],[565,711],[322,711]],"region":{"top_left_x":322,"top_left_y":666,"width":244,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f495aa584ad74833aa7274dfdb30ae42","type":"text","conversion_output":true,"text":"By ticking NO:","text_display":"\n\nBy ticking NO:","confidence":1,"confidence_rate":1},{"cnt":[[322,718],[1717,718],[1717,763],[322,763]],"region":{"top_left_x":322,"top_left_y":717,"width":1395,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9f09fa33b5f405ba758a73020f5d1ef","type":"text","conversion_output":true,"text":"All NOs within the relevant MESI category are screened for being potential missed MESI.","text_display":"\nAll NOs within the relevant MESI category are screened for being potential missed MESI.","confidence":1,"confidence_rate":1},{"cnt":[[324,769],[1762,769],[1762,810],[324,810]],"region":{"top_left_x":324,"top_left_y":769,"width":1438,"height":41},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9adac2de7d444efac979f632a1e2335","type":"text","conversion_output":true,"text":"- If needed, the investigator will be asked to provide an explanation of why the event is not","text_display":"\n- If needed, the investigator will be asked to provide an explanation of why the event is not","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[382,816],[1016,816],[1016,862],[382,862]],"region":{"top_left_x":382,"top_left_y":816,"width":635,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96468ac6cc094e33bb750514c4d583ca","type":"text","conversion_output":true,"text":"reported as a MESI (alternative etiology)","text_display":" reported as a MESI (alternative etiology)","confidence":1,"confidence_rate":1},{"cnt":[[324,868],[1863,868],[1863,913],[324,913]],"region":{"top_left_x":324,"top_left_y":867,"width":1539,"height":47},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"356ef5400c664394b1b4a4ad91966620","type":"text","conversion_output":true,"text":"- The vendor or EAC can evaluate an event not initially reported as a MESI for adjudication to be","text_display":"\n- The vendor or EAC can evaluate an event not initially reported as a MESI for adjudication to be","confidence":1,"confidence_rate":1},{"cnt":[[382,915],[1858,915],[1858,960],[382,960]],"region":{"top_left_x":382,"top_left_y":915,"width":1477,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e268ca3a77df461c980cd8769fa610ea","type":"text","conversion_output":true,"text":"adjudicated. In this case the investigator must provide data/documents required for adjudication","text_display":" adjudicated. In this case the investigator must provide data/documents required for adjudication","confidence":1,"confidence_rate":1},{"cnt":[[382,965],[1601,965],[1601,1008],[382,1008]],"region":{"top_left_x":382,"top_left_y":964,"width":1219,"height":44},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8c9d39945e6b47b1ad4ddc011e962d1b","type":"text","conversion_output":true,"text":"as soon as possible when receiving a request from Novo Nordisk or the vendor","text_display":" as soon as possible when receiving a request from Novo Nordisk or the vendor","confidence":1,"confidence_rate":1},{"cnt":[[322,1053],[1712,1053],[1712,1096],[322,1096]],"region":{"top_left_x":322,"top_left_y":1052,"width":1391,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8958fb87f26a4896b369fe2f09e707f0","type":"text","conversion_output":true,"text":"A site manual will be provided to each site detailing the specifics surrounding the medical","text_display":"\n\nA site manual will be provided to each site detailing the specifics surrounding the medical","confidence":1,"confidence_rate":1},{"cnt":[[322,1100],[1721,1100],[1721,1145],[322,1145]],"region":{"top_left_x":322,"top_left_y":1100,"width":1399,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d3d1f56799f4b43a1cb45a0941b6f4b","type":"text","conversion_output":true,"text":"documentation that must be provided by site to the adjudication vendor including how this","text_display":" documentation that must be provided by site to the adjudication vendor including how this","confidence":1,"confidence_rate":1},{"cnt":[[322,1147],[870,1147],[870,1192],[322,1192]],"region":{"top_left_x":322,"top_left_y":1147,"width":549,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e9b085ac2fd4649b1f53571a2d48268","type":"text","conversion_output":true,"text":"documentation should be 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2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,477],[827,477],[827,548],[318,548]],"region":{"top_left_x":317,"top_left_y":476,"width":511,"height":72},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f44bb90c17644531b55b584d6dabb1a0","type":"section_header","conversion_output":false,"children_ids":["ab60c813aa8e4783b54fe49ff9371602"],"text":"","text_display":""},{"cnt":[[322,481],[821,481],[821,544],[322,544]],"region":{"top_left_x":322,"top_left_y":481,"width":499,"height":63},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab60c813aa8e4783b54fe49ff9371602","type":"text","conversion_output":true,"parent_id":"f44bb90c17644531b55b584d6dabb1a0","text":"13 Case report forms","text_display":"\n\n\\section*{13 Case report 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This system and support services to the system","text_display":"\n\nNovo Nordisk will provide a system for the eCRF. This system and support services to the system","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[322,610],[778,610],[778,660],[322,660]],"region":{"top_left_x":322,"top_left_y":610,"width":456,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f088a17447c9478fadbba5b9835690da","type":"text","conversion_output":true,"text":"will be supplied by a vendor.","text_display":" will be supplied by a vendor.","confidence":0.99951171875,"confidence_rate":0.9999856353826395},{"cnt":[[322,696],[1811,696],[1811,746],[322,746]],"region":{"top_left_x":322,"top_left_y":696,"width":1490,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"282d742206d7402da2f50947ea39c81f","type":"text","conversion_output":true,"text":"Ensure that all relevant questions are answered and that no empty data field exists. If a test or an","text_display":"\n\nEnsure that all relevant questions are answered and that no empty data field exists. If a test or an","confidence":1,"confidence_rate":1},{"cnt":[[322,748],[1830,748],[1830,797],[322,797]],"region":{"top_left_x":322,"top_left_y":747,"width":1509,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d60af853817f455bbd459d583bc3f69b","type":"text","conversion_output":true,"text":"assessment has not been done and will not be available, or if the question is irrelevant (e.g., is not","text_display":" assessment has not been done and will not be available, or if the question is irrelevant (e.g., is not","confidence":1,"confidence_rate":1},{"cnt":[[322,795],[1326,795],[1326,844],[322,844]],"region":{"top_left_x":322,"top_left_y":794,"width":1004,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c221105130f4d008ce7025232921a46","type":"text","conversion_output":true,"text":"applicable), indicate this according to the data entry instructions.","text_display":" applicable), indicate this according to the data entry instructions.","confidence":1,"confidence_rate":1},{"cnt":[[322,881],[1055,881],[1055,930],[322,930]],"region":{"top_left_x":322,"top_left_y":880,"width":733,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e0a61e1e1714701989a958c2be0860d","type":"text","conversion_output":true,"text":"The following will be provided as paper CRFs:","text_display":"\n\nThe following will be provided as paper CRFs:","confidence":1,"confidence_rate":1},{"cnt":[[322,971],[651,971],[651,1021],[322,1021]],"region":{"top_left_x":322,"top_left_y":971,"width":329,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38d953e2541a480b92fa901771a97a36","type":"text","conversion_output":true,"text":"- Pregnancy forms","text_display":"\n- Pregnancy forms","confidence":1,"confidence_rate":1},{"cnt":[[322,1057],[1807,1057],[1807,1106],[322,1106]],"region":{"top_left_x":322,"top_left_y":1057,"width":1485,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a46c7edcf72425ca837428105d4810f","type":"text","conversion_output":true,"text":"In addition paper AE forms, SIF and technical complaint forms will be provided. These must be","text_display":"\n\nIn addition paper AE forms, SIF and technical complaint forms will be provided. These must be","confidence":0.99267578125,"confidence_rate":0.9999249908487245},{"cnt":[[322,1104],[1476,1104],[1476,1156],[322,1156]],"region":{"top_left_x":322,"top_left_y":1104,"width":1154,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6427d04eb1f0419ca0bea7e1b44b81ef","type":"text","conversion_output":true,"text":"used when access to the eCRF is revoked (i.e., EDC system not available).","text_display":" used when access to the eCRF is revoked (i.e., EDC system not available).","confidence":0.99755859375,"confidence_rate":0.9999686621405054},{"cnt":[[322,1195],[1867,1195],[1867,1244],[322,1244]],"region":{"top_left_x":322,"top_left_y":1194,"width":1545,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7352d7b9b02c42f6bf6707dc1c5e6adb","type":"text","conversion_output":true,"text":"On the paper CRF forms print legibly, using a ballpoint pen. Ensure that all questions are answered,","text_display":"\n\nOn the paper CRF forms print legibly, using a ballpoint pen. Ensure that all questions are answered,","confidence":1,"confidence_rate":1},{"cnt":[[322,1242],[1854,1242],[1854,1291],[322,1291]],"region":{"top_left_x":322,"top_left_y":1241,"width":1533,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd0d98d533e44832a979824a7c0140b6","type":"text","conversion_output":true,"text":"and that no empty data blocks exist. Ensure that no information is recorded outside the data blocks.","text_display":" and that no empty data blocks exist. Ensure that no information is recorded outside the data blocks.","confidence":1,"confidence_rate":1},{"cnt":[[322,1289],[1848,1289],[1848,1338],[322,1338]],"region":{"top_left_x":322,"top_left_y":1289,"width":1526,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2650dae0c79f42fab6b3c3c0b0075f96","type":"text","conversion_output":true,"text":"If a test/assessment has not been done and will not be available, indicate this by writing \"ND\" (not","text_display":" If a test/assessment has not been done and will not be available, indicate this by writing \"ND\" (not","confidence":0.9975595474243164,"confidence_rate":0.9999767294580594},{"cnt":[[322,1336],[1869,1336],[1869,1388],[322,1388]],"region":{"top_left_x":322,"top_left_y":1336,"width":1548,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a21fa9dd52e4322ac836e688cfeb4f6","type":"text","conversion_output":true,"text":"done) in the appropriate answer field in the CRF. If the question is irrelevant (e.g., is not applicable)","text_display":" done) in the appropriate answer field in the CRF. If the question is irrelevant (e.g., is not applicable)","confidence":0.99853515625,"confidence_rate":0.9999866735644114},{"cnt":[[322,1388],[1861,1388],[1861,1437],[322,1437]],"region":{"top_left_x":322,"top_left_y":1387,"width":1539,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c79df1557bf462d8ca54eefe168f58a","type":"text","conversion_output":true,"text":"indicate this by writing \"NA\" (not applicable) in the appropriate answer field. Further guidance can","text_display":" indicate this by writing \"NA\" (not applicable) in the appropriate answer field. Further guidance can","confidence":1,"confidence_rate":1},{"cnt":[[322,1435],[1027,1435],[1027,1480],[322,1480]],"region":{"top_left_x":322,"top_left_y":1435,"width":705,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de3e9041a8574fac833d1d66f641478e","type":"text","conversion_output":true,"text":"be obtained from the instructions in the CRF.","text_display":" be obtained from the instructions in the CRF.","confidence":1,"confidence_rate":1},{"cnt":[[322,1523],[1828,1523],[1828,1573],[322,1573]],"region":{"top_left_x":322,"top_left_y":1523,"width":1507,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40622d119eef47bd961cd0c34f9aba24","type":"text","conversion_output":true,"text":"The investigator must ensure that all information is consistent with the source documentation. By","text_display":"\n\nThe investigator must ensure that all information is consistent with the source documentation. By","confidence":1,"confidence_rate":1},{"cnt":[[322,1573],[1835,1573],[1835,1622],[322,1622]],"region":{"top_left_x":322,"top_left_y":1572,"width":1513,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"279cd3aac1634a36b9b75e032f2b16ee","type":"text","conversion_output":true,"text":"electronically signing the case book in the eCRF, the investigator confirms that the information in","text_display":" electronically signing the case book in the eCRF, the investigator confirms that the information in","confidence":1,"confidence_rate":1},{"cnt":[[322,1620],[1132,1620],[1132,1669],[322,1669]],"region":{"top_left_x":322,"top_left_y":1619,"width":811,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9013c673e0c4fbb9dfd19bfa7dfff44","type":"text","conversion_output":true,"text":"the eCRF and related forms is complete and correct.","text_display":" the eCRF and related forms is complete and 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old and the","text_display":" An audit trail will be maintained in the eCRF application containing as a minimum: the old and the","confidence":1,"confidence_rate":1},{"cnt":[[322,1869],[1867,1869],[1867,1921],[322,1921]],"region":{"top_left_x":322,"top_left_y":1869,"width":1545,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73ecd93dd6af4e4e85102ffc8a880d4d","type":"text","conversion_output":true,"text":"new data, identification of the person entering the data, date and time of the entry and reason for the","text_display":" new data, identification of the person entering the data, date and time of the entry and reason for 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Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,296],[608,296],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":296,"width":287,"height":33},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f5031f49bcad4bcebb1f5e0bd4d60ae9","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,327],[621,327],[621,363],[322,363]],"region":{"top_left_x":322,"top_left_y":326,"width":299,"height":38},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5cf51a1b8cde47c88ca15060744c019c","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,357],[698,357],[698,397],[322,397]],"region":{"top_left_x":322,"top_left_y":356,"width":377,"height":42},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"249aece4a2ee46a284fa353cdff68f35","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[322,477],[1871,477],[1871,526],[322,526]],"region":{"top_left_x":322,"top_left_y":476,"width":1550,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"126fb2ee15214b10a0c7e32afbde6f53","type":"text","conversion_output":true,"text":"At the end of the trial the investigator must ensure that all remaining data have been entered into the","text_display":"\n\nAt the end of the trial the investigator must ensure that all remaining data have been entered into 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98\n\\end{tabular}","confidence":0.6427213677536869,"confidence_rate":0.9962289745647822},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":7,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b2d4e8c5197f4e9c9973c2698d749e26","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,477],[935,477],[935,548],[318,548]],"region":{"top_left_x":317,"top_left_y":476,"width":618,"height":72},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6453ef77faf84d10bb7848d614d3bab8","type":"section_header","conversion_output":false,"children_ids":["ce348117d6cd4925bb5300a7e4279d24"],"text":"","text_display":""},{"cnt":[[322,481],[930,481],[930,544],[322,544]],"region":{"top_left_x":322,"top_left_y":481,"width":609,"height":63},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce348117d6cd4925bb5300a7e4279d24","type":"text","conversion_output":true,"parent_id":"6453ef77faf84d10bb7848d614d3bab8","text":"14 Monitoring procedures","text_display":"\n\n\\section*{14 Monitoring procedures}","confidence":1,"confidence_rate":1},{"cnt":[[322,563],[1757,563],[1757,612],[322,612]],"region":{"top_left_x":322,"top_left_y":562,"width":1436,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0730a968449a4d5c8a4f3f71ec5f63f4","type":"text","conversion_output":true,"text":"During the course of the trial, the monitor will visit the trial site to ensure that the protocol is","text_display":"\n\nDuring the course of the trial, the monitor will visit the trial site to ensure that the protocol is","confidence":1,"confidence_rate":1},{"cnt":[[322,610],[1818,610],[1818,660],[322,660]],"region":{"top_left_x":322,"top_left_y":610,"width":1496,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94cb6b1d8c3a41e29cd57b7135a4daba","type":"text","conversion_output":true,"text":"adhered to, that all issues have been recorded, to perform source data verification and to monitor","text_display":" adhered to, that all issues have been recorded, to perform source data verification and to monitor","confidence":1,"confidence_rate":1},{"cnt":[[322,657],[1867,657],[1867,707],[322,707]],"region":{"top_left_x":322,"top_left_y":657,"width":1545,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b460c18a0e1e4012b1c440095dd0d291","type":"text","conversion_output":true,"text":"drug accountability. The first monitoring visit will be performed as soon as possible after FSFV and","text_display":" drug accountability. The first monitoring visit will be performed as soon as possible after FSFV and","confidence":1,"confidence_rate":1},{"cnt":[[322,707],[1867,707],[1867,758],[322,758]],"region":{"top_left_x":322,"top_left_y":706,"width":1545,"height":53},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1dcb655c362a4fbab34e9d5a7ee354f0","type":"text","conversion_output":true,"text":"no later than 4 weeks after. The monitoring visit intervals will depend on the outcome of the remote","text_display":" no later than 4 weeks after. The monitoring visit intervals will depend on the outcome of the remote","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[322,756],[1828,756],[1828,806],[322,806]],"region":{"top_left_x":322,"top_left_y":756,"width":1507,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c081f1d251e04027a41d615a901feeb1","type":"text","conversion_output":true,"text":"monitoring of the eCRFs, the trial site's recruitment rate and the compliance of the trial site to the","text_display":" monitoring of the eCRFs, the trial site's recruitment rate and the compliance of the trial site to the","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[322,804],[1824,804],[1824,853],[322,853]],"region":{"top_left_x":322,"top_left_y":803,"width":1503,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21f3aaa9b02d43f69410dee9c82d60ea","type":"text","conversion_output":true,"text":"protocol and GCP, but will not exceed 4 weeks during the recruitment period (i.e., from FSFV to","text_display":" protocol and GCP, but will not exceed 4 weeks during the recruitment period (i.e., from FSFV to","confidence":1,"confidence_rate":1},{"cnt":[[322,851],[1837,851],[1837,902],[322,902]],"region":{"top_left_x":322,"top_left_y":850,"width":1515,"height":53},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8af9491d6da4adbab73fc7f26ef052d","type":"text","conversion_output":true,"text":"last subject first visit (LSFV)). After LSFV the monitoring visit intervals will not exceed 8 weeks.","text_display":" last subject first visit (LSFV)). After LSFV the monitoring visit intervals will not exceed 8 weeks.","confidence":1,"confidence_rate":1},{"cnt":[[322,941],[1745,941],[1745,990],[322,990]],"region":{"top_left_x":322,"top_left_y":941,"width":1423,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b859664fd10462cbf27eb2e9eb5f737","type":"text","conversion_output":true,"text":"The monitor must be given direct access to source documents (original documents, data and","text_display":"\n\nThe monitor must be given direct access to source documents (original documents, data and","confidence":1,"confidence_rate":1},{"cnt":[[322,988],[1863,988],[1863,1038],[322,1038]],"region":{"top_left_x":322,"top_left_y":988,"width":1541,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c29467e0a13448fb62fc7c4464728cb","type":"text","conversion_output":true,"text":"records). Direct access includes permission to examine, analyse, verify and reproduce any record(s)","text_display":" records). Direct access includes permission to examine, analyse, verify and reproduce any record(s)","confidence":1,"confidence_rate":1},{"cnt":[[322,1036],[1828,1036],[1828,1085],[322,1085]],"region":{"top_left_x":322,"top_left_y":1035,"width":1507,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0e6e68d9a574df8a9aa84347d6aa029","type":"text","conversion_output":true,"text":"and report(s) that are important to the evaluation of the trial. If the electronic medical record does","text_display":" and report(s) that are important to the evaluation of the trial. If the electronic medical record does","confidence":1,"confidence_rate":1},{"cnt":[[322,1085],[1764,1085],[1764,1137],[322,1137]],"region":{"top_left_x":322,"top_left_y":1084,"width":1442,"height":53},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88767e5f8f9a45af8304496670a6b017","type":"text","conversion_output":true,"text":"not have a visible audit trail, the investigator must provide the monitor with signed and dated","text_display":" not have a visible audit trail, the investigator must provide the monitor with signed and dated","confidence":1,"confidence_rate":1},{"cnt":[[322,1134],[1824,1134],[1824,1184],[322,1184]],"region":{"top_left_x":322,"top_left_y":1134,"width":1503,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0535036ae64c4b5bb23405de52fa96e5","type":"text","conversion_output":true,"text":"printouts. In addition the relevant trial site staff should be available for discussions at monitoring","text_display":" printouts. In addition the relevant trial site staff should be available for discussions at monitoring","confidence":1,"confidence_rate":1},{"cnt":[[322,1182],[1201,1182],[1201,1231],[322,1231]],"region":{"top_left_x":322,"top_left_y":1181,"width":879,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b75c26ef42bc4b65afeefc7275c02f02","type":"text","conversion_output":true,"text":"visits and between monitoring visits (e.g., by telephone).","text_display":" visits and between monitoring visits (e.g., by telephone).","confidence":1,"confidence_rate":1},{"cnt":[[322,1268],[1729,1268],[1729,1319],[322,1319]],"region":{"top_left_x":322,"top_left_y":1267,"width":1408,"height":53},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7372f92be94740d9bd1a16f337f48cb0","type":"text","conversion_output":true,"text":"All data must be verifiable in source documentation other than the eCRF (except for BMI).","text_display":"\n\nAll data must be verifiable in source documentation other than the eCRF (except for BMI).","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[322,1354],[1858,1354],[1858,1405],[322,1405]],"region":{"top_left_x":322,"top_left_y":1353,"width":1537,"height":53},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e2283990678447a9ea05ddcc2aaaa91","type":"text","conversion_output":true,"text":"For all data recorded the source document must be defined in a source document agreement at each","text_display":"\nFor all data recorded the source document must be defined in a source document agreement at each","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[322,1405],[1588,1405],[1588,1454],[322,1454]],"region":{"top_left_x":322,"top_left_y":1405,"width":1266,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fcbd81388ce04592bd6dd0b407f60542","type":"text","conversion_output":true,"text":"trial site. There must only be one source defined at any time for any data element.","text_display":" trial site. There must only be one source defined at any time for any data element.","confidence":1,"confidence_rate":1},{"cnt":[[322,1491],[1871,1491],[1871,1540],[322,1540]],"region":{"top_left_x":322,"top_left_y":1491,"width":1550,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dbc02015d834d7c93ff5c61d80be1fb","type":"text","conversion_output":true,"text":"For screening failures the monitor will ensure that relevant eCRF pages and other trial-related forms","text_display":"\n\nFor screening failures the monitor will ensure that relevant eCRF pages and other trial-related forms","confidence":1,"confidence_rate":1},{"cnt":[[322,1540],[1803,1540],[1803,1590],[322,1590]],"region":{"top_left_x":322,"top_left_y":1540,"width":1481,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa51deed856a486490ac56dc8424b825","type":"text","conversion_output":true,"text":"containing data from screening failures are completed. For screening failures the following data","text_display":" containing data from screening failures are completed. For screening failures the following data","confidence":1,"confidence_rate":1},{"cnt":[[322,1590],[1704,1590],[1704,1639],[322,1639]],"region":{"top_left_x":322,"top_left_y":1589,"width":1382,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc7528fff89c447bbb61654e3d157e4b","type":"text","conversion_output":true,"text":"should be source verified: informed consent, reason for screening failure and AEs, if any.","text_display":" should be source verified: informed consent, reason for screening failure and AEs, if any.","confidence":1,"confidence_rate":1},{"cnt":[[322,1676],[1837,1676],[1837,1725],[322,1725]],"region":{"top_left_x":322,"top_left_y":1675,"width":1515,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6d187a092f24df88e1f2d7d83f2a2b8","type":"text","conversion_output":true,"text":"Source data generated by the trial site can be corrected by another person than the person entering","text_display":"\n\nSource data generated by the trial site can be corrected by another person than the person entering","confidence":0.99755859375,"confidence_rate":0.9999764965133096},{"cnt":[[322,1723],[1858,1723],[1858,1772],[322,1772]],"region":{"top_left_x":322,"top_left_y":1723,"width":1537,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3881d84e2b344bed8e2aa184fad768d7","type":"text","conversion_output":true,"text":"the source data if accepted by local regulations; any correction must be explained, signed and dated","text_display":" the source data if accepted by local regulations; any correction must be explained, signed and dated","confidence":1,"confidence_rate":1},{"cnt":[[322,1775],[896,1775],[896,1824],[322,1824]],"region":{"top_left_x":322,"top_left_y":1774,"width":574,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5737517f00d94c7ab2f67b38c55a1cc1","type":"text","conversion_output":true,"text":"by the person making the correction.","text_display":" by the person making the correction.","confidence":1,"confidence_rate":1},{"cnt":[[322,1858],[1876,1858],[1876,1910],[322,1910]],"region":{"top_left_x":322,"top_left_y":1858,"width":1554,"height":52},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1fa43c8fd6c4b3db76ee8e45782e28f","type":"text","conversion_output":true,"text":"The completed diaries will be collected from the subject at each site visit and must be kept as source","text_display":"\n\nThe completed diaries will be collected from the subject at each site visit and must be kept as source","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[322,1908],[1571,1908],[1571,1957],[322,1957]],"region":{"top_left_x":322,"top_left_y":1907,"width":1249,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0ec28cc424247d5ad2018fdd80d40f1","type":"text","conversion_output":true,"text":"data at the site. The investigator/delegate must transcribe the data into the eCRF.","text_display":" data at the site. The investigator/delegate must transcribe the data into the eCRF.","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[322,1996],[1768,1994],[1768,2045],[322,2047]],"region":{"top_left_x":322,"top_left_y":1993,"width":1447,"height":55},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"568b9e34e08b4a418f08671e33a54890","type":"text","conversion_output":true,"text":"The monitor will ensure that the eCRFs are completed on an ongoing basis and within agreed","text_display":"\n\nThe monitor will ensure that the eCRFs are completed on an ongoing basis and within agreed","confidence":1,"confidence_rate":1},{"cnt":[[322,2041],[483,2041],[483,2086],[322,2086]],"region":{"top_left_x":322,"top_left_y":2041,"width":162,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00a19e960f3d46cc82a3f3df0eb42992","type":"text","conversion_output":true,"text":"timelines.","text_display":" timelines.","confidence":1,"confidence_rate":1},{"cnt":[[322,2131],[1785,2131],[1785,2181],[322,2181]],"region":{"top_left_x":322,"top_left_y":2131,"width":1464,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e0faa7780cf416a838f9b48c4e04018","type":"text","conversion_output":true,"text":"Monitors must review the subject's medical records and other source data (e.g., the diaries and","text_display":"\n\nMonitors must review the subject's medical records and other source data (e.g., the diaries and","confidence":1,"confidence_rate":1},{"cnt":[[322,2179],[1846,2179],[1846,2228],[322,2228]],"region":{"top_left_x":322,"top_left_y":2178,"width":1524,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b43627bc49be41269cd21b2b2ad12cc1","type":"text","conversion_output":true,"text":"PROs) to ensure consistency and/or identify omissions compared to the eCRF. If discrepancies are","text_display":" PROs) to ensure consistency and/or identify omissions compared to the eCRF. If discrepancies are","confidence":1,"confidence_rate":1},{"cnt":[[322,2226],[1175,2226],[1175,2275],[322,2275]],"region":{"top_left_x":322,"top_left_y":2225,"width":854,"height":51},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"deb337cddf47422689b11cbac33c90ce","type":"text","conversion_output":true,"text":"found, the investigator must be questioned about these.","text_display":" found, the investigator must be questioned about these.","confidence":1,"confidence_rate":1},{"cnt":[[322,2316],[1824,2316],[1824,2365],[322,2365]],"region":{"top_left_x":322,"top_left_y":2316,"width":1503,"height":50},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"67f409c3a35a452499a262f8746a6d68","type":"text","conversion_output":true,"text":"A follow-up letter (paper or electronic) will be sent to the investigator following each monitoring","text_display":"\n\nA follow-up letter (paper or electronic) will be sent to the investigator following each monitoring","confidence":1,"confidence_rate":1},{"cnt":[[322,2363],[930,2363],[930,2413],[322,2413]],"region":{"top_left_x":322,"top_left_y":2363,"width":609,"height":50},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9533efe82db44834afb360caed6a753c","type":"text","conversion_output":true,"text":"visit addressing any action to be taken.","text_display":" visit addressing any action to be 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In this model data from oral semaglutide arms using the standard titration scheme will","text_display":" conducted. In this model data from oral semaglutide arms using the standard titration scheme will","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[322,1723],[1777,1723],[1777,1772],[322,1772]],"region":{"top_left_x":322,"top_left_y":1723,"width":1455,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d7339c8d5034307a72d4bb1f6be7fcb","type":"text","conversion_output":true,"text":"be included. One or both of the treatment arms with an end dose of 40 mg using an alternative","text_display":" be included. One or both of the treatment arms with an end dose of 40 mg using an alternative","confidence":1,"confidence_rate":1},{"cnt":[[322,1775],[1846,1775],[1846,1824],[322,1824]],"region":{"top_left_x":322,"top_left_y":1774,"width":1524,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf191a933c4e43c6bdb8b5b19eca219f","type":"text","conversion_output":true,"text":"titration scheme may be included and pooled with the oral semaglutide arm with an end dose of 40","text_display":" titration scheme may be included and pooled with the oral semaglutide arm with an end dose of 40","confidence":1,"confidence_rate":1},{"cnt":[[322,1822],[1820,1822],[1820,1871],[322,1871]],"region":{"top_left_x":322,"top_left_y":1821,"width":1498,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d4655def20d8476686b505e6a83dc3c2","type":"text","conversion_output":true,"text":"mg and using the standard titration scheme, if deemed appropriate based on the planned pairwise","text_display":" mg and using the standard titration scheme, if deemed appropriate based on the planned pairwise","confidence":0.654296875,"confidence_rate":0.9958498700705722},{"cnt":[[322,1869],[1811,1869],[1811,1921],[322,1921]],"region":{"top_left_x":322,"top_left_y":1869,"width":1490,"height":52},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c770bf6634a4fc49f9b8d5c411aa697","type":"text","conversion_output":true,"text":"comparisons between the arms. Data from the placebo arm (corresponding to a dose of zero mg )","text_display":" comparisons between the arms. Data from the placebo arm (corresponding to a dose of zero mg )","confidence":0.9941432476043701,"confidence_rate":0.999943521110082},{"cnt":[[322,1921],[1876,1921],[1876,1968],[322,1968]],"region":{"top_left_x":322,"top_left_y":1920,"width":1554,"height":48},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d69ae8897f0949faa268ac0562348373","type":"text","conversion_output":true,"text":"could be included if deemed appropriate. The model will developed ad hoc after unblinding and aim","text_display":" could be included if deemed appropriate. The model will developed ad hoc after unblinding and aim","confidence":1,"confidence_rate":1},{"cnt":[[322,1968],[1869,1968],[1869,2017],[322,2017]],"region":{"top_left_x":322,"top_left_y":1967,"width":1548,"height":51},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"319bbb9c24ee454aa80b2b17b21740cc","type":"text","conversion_output":true,"text":"for a suitable fit of the dose-response relation using e.g. a linear or a four-parameter logistic relation","text_display":" for a suitable fit of the dose-response relation using e.g. a linear or a four-parameter logistic relation","confidence":1,"confidence_rate":1},{"cnt":[[322,2015],[1184,2015],[1184,2065],[322,2065]],"region":{"top_left_x":322,"top_left_y":2015,"width":862,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce2f8fc9faf943f8a2552f049b83771c","type":"text","conversion_output":true,"text":"of the endpoint of interest vs. the logarithm of the dose.","text_display":" of the endpoint of interest vs. the logarithm of the dose.","confidence":1,"confidence_rate":1},{"cnt":[[318,2101],[844,2101],[844,2157],[318,2157]],"region":{"top_left_x":317,"top_left_y":2101,"width":528,"height":57},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f749c2fb5dda4b9f917b3c685da73b0c","type":"section_header","conversion_output":false,"children_ids":["d77ddd74024f4faab06974bb59584e41"],"text":"","text_display":""},{"cnt":[[322,2105],[840,2105],[840,2151],[322,2151]],"region":{"top_left_x":322,"top_left_y":2105,"width":519,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d77ddd74024f4faab06974bb59584e41","type":"text","conversion_output":true,"parent_id":"f749c2fb5dda4b9f917b3c685da73b0c","text":"17.1 Sample size calculation","text_display":"\n\n\\subsection*{17.1 Sample size 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will be analysed by the standard MMRM.","confidence":0.9907460119575262,"confidence_rate":0.9998524383137575},{"cnt":[[322,2307],[1704,2307],[1704,2357],[322,2357]],"region":{"top_left_x":322,"top_left_y":2307,"width":1382,"height":50},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c6f7dc282d448a8a6e88be2926efa56","type":"text","conversion_output":true,"text":"In order to demonstrate efficacy of oral semaglutide the sample size is based on an initial","text_display":"\n\nIn order to demonstrate efficacy of oral semaglutide the sample size is based on an initial","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[322,2355],[1863,2355],[1863,2404],[322,2404]],"region":{"top_left_x":322,"top_left_y":2354,"width":1541,"height":51},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3640558dc951487cad9ff1585a9adf8f","type":"text","conversion_output":true,"text":"comparison of change from baseline to end of treatment (i.e., after 26 weeks of treatment) in \\(HbA _{1 c}\\)","text_display":" comparison of change from baseline to end of treatment (i.e., after 26 weeks of treatment) in \\(HbA _{1 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2012-004994-16","confidence":1,"confidence_rate":1},{"cnt":[[920,296],[1154,296],[1154,342],[920,342]],"region":{"top_left_x":919,"top_left_y":296,"width":235,"height":46},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b2749ee63ec54346bbb81a9449567d61","type":"text","conversion_output":true,"text":"CONFIDENTIAL","text_display":"\n\nCONFIDENTIAL","confidence":0.98193359375,"confidence_rate":0.9989281280193172},{"cnt":[[1240,254],[1762,254],[1762,404],[1240,404]],"region":{"top_left_x":1239,"top_left_y":253,"width":523,"height":151},"line":7,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"95b8f61b52a64a9da6afd7c4b6ed32ff","type":"table","conversion_output":true,"text":"\\begin{tabular}{|lr|} \nDate: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 78 of 98\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|lr|} \nDate: & 25 June 2013 \\\\\nVersion: & 1.0 \\\\\nStatus: & Final \\\\\nPage: & 78 of 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The SD observed in several phase 3 trials of 26 weeks duration with s.c.","text_display":" the sample size calculation. The SD observed in several phase 3 trials of 26 weeks duration with s.c.","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[322,709],[1803,709],[1803,758],[322,758]],"region":{"top_left_x":322,"top_left_y":708,"width":1481,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5873315fafe74ad684648a12423f802b","type":"text","conversion_output":true,"text":"liraglutide suggests a standard deviation less than \\(1.1 \\%\\). However, as it is uncertain if the added","text_display":" liraglutide suggests a standard deviation less than \\(1.1 \\%\\). However, as it is uncertain if the added","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[322,758],[1712,758],[1712,810],[322,810]],"region":{"top_left_x":322,"top_left_y":758,"width":1391,"height":52},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0792dfb0c574470da43ee091fd3db2bc","type":"text","conversion_output":true,"text":"variation in exposure compared to s.c. liraglutide will transfer to an added variation in the","text_display":" variation in exposure compared to s.c. liraglutide will transfer to an added variation in the","confidence":1,"confidence_rate":1},{"cnt":[[322,808],[1059,808],[1059,857],[322,857]],"region":{"top_left_x":322,"top_left_y":807,"width":738,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41948520c01145bdb3b28aa75210405a","type":"text","conversion_output":true,"text":"therapeutic response, a SD of \\(1.2 \\%\\) is assumed.","text_display":" therapeutic response, a SD of \\(1.2 \\%\\) is assumed.","confidence":0.7365846633911133,"confidence_rate":0.9943543101821879},{"cnt":[[322,894],[1755,894],[1755,943],[322,943]],"region":{"top_left_x":322,"top_left_y":893,"width":1434,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"009fe337ce40486c83ceda7f61853fac","type":"text","conversion_output":true,"text":"In trial NN9535-1821 the withdrawal rate for the doses \\(0.2 mg -0.8 mg\\) was \\(16 \\%-24 \\%\\). 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For completers the treatment","text_display":" expected to be \\(20 \\%\\), equally distributed among treatment arms. 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For similarity between the treatment arms, 67 subjects should be randomised in each of the","text_display":" placebo. For similarity between the treatment arms, 67 subjects should be randomised in each of the","confidence":1,"confidence_rate":1},{"cnt":[[322,1332],[647,1332],[647,1377],[322,1377]],"region":{"top_left_x":322,"top_left_y":1332,"width":325,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f859c1ed4c40464b9b73d6dd52285365","type":"text","conversion_output":true,"text":"nine treatment arms.","text_display":" nine treatment arms.","confidence":1,"confidence_rate":1},{"cnt":[[322,1418],[993,1418],[993,1467],[322,1467]],"region":{"top_left_x":322,"top_left_y":1417,"width":671,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d8d183b05e3490e94ca1809bdea382e","type":"text","conversion_output":true,"text":"In total, 603 subjects are to be randomised.","text_display":"\n\nIn total, 603 subjects are to be randomised.","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[318,1502],[879,1502],[879,1560],[318,1560]],"region":{"top_left_x":317,"top_left_y":1501,"width":562,"height":59},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56320179ca53409a83d89f7c0262f43a","type":"section_header","conversion_output":false,"children_ids":["e189572399be4d09a37f4bd477e5a586"],"text":"","text_display":""},{"cnt":[[322,1508],[874,1508],[874,1553],[322,1553]],"region":{"top_left_x":322,"top_left_y":1508,"width":553,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e189572399be4d09a37f4bd477e5a586","type":"text","conversion_output":true,"parent_id":"56320179ca53409a83d89f7c0262f43a","text":"17.2 Definition of analysis sets","text_display":"\n\n\\subsection*{17.2 Definition of analysis sets}","confidence":1,"confidence_rate":1},{"cnt":[[322,1573],[1863,1573],[1863,1622],[322,1622]],"region":{"top_left_x":322,"top_left_y":1572,"width":1541,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"edff26dab3744bc699dea076cfe55fac","type":"text","conversion_output":true,"text":"Full Analysis Set (FAS): includes all randomised subjects who have received at least one dose and","text_display":"\n\nFull Analysis Set (FAS): includes all randomised subjects who have received at least one dose and","confidence":1,"confidence_rate":1},{"cnt":[[322,1620],[1863,1620],[1863,1669],[322,1669]],"region":{"top_left_x":322,"top_left_y":1619,"width":1541,"height":51},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfa6e7f51c4c4110a3ab544f7a47e777","type":"text","conversion_output":true,"text":"have any post randomisation data. The statistical evaluation of the FAS will follow the intention-to-","text_display":" have any post randomisation data. 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Any decision to","confidence":1,"confidence_rate":1},{"cnt":[[322,1938],[1861,1938],[1861,1989],[322,1989]],"region":{"top_left_x":322,"top_left_y":1937,"width":1539,"height":53},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0074d06dfb24068a32fe4d881a25e04","type":"text","conversion_output":true,"text":"exclude a subject or single observations from the statistical analysis is the joint responsibility of the","text_display":" exclude a subject or single observations from the statistical analysis is the joint responsibility of the","confidence":1,"confidence_rate":1},{"cnt":[[322,1989],[1729,1989],[1729,2039],[322,2039]],"region":{"top_left_x":322,"top_left_y":1989,"width":1408,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c8baf8217be4d7ea623d42fc09d397a","type":"text","conversion_output":true,"text":"members of the study group. 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and","confidence":1,"confidence_rate":1},{"cnt":[[322,1130],[587,1130],[587,1175],[322,1175]],"region":{"top_left_x":322,"top_left_y":1130,"width":265,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57874967d31845cf86e9764cdaf6be6b","type":"text","conversion_output":true,"parent_id":"a1be10f546934b71998cadeccb72694d","text":"free fatty acids.","text_display":" free fatty acids.}","confidence":1,"confidence_rate":1},{"cnt":[[322,1199],[1740,1199],[1740,1244],[322,1244]],"region":{"top_left_x":322,"top_left_y":1198,"width":1419,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe9cdb381bbd4dc18c6da1f849e79be9","type":"text","conversion_output":true,"text":"For each endpoint, the assessments at every week will be log-transformed and subsequently","text_display":"\n\nFor each endpoint, the assessments at every week will be log-transformed and subsequently","confidence":1,"confidence_rate":1},{"cnt":[[322,1246],[1815,1246],[1815,1291],[322,1291]],"region":{"top_left_x":322,"top_left_y":1246,"width":1494,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e237bf659bb944e2a0ed57eb61b45946","type":"text","conversion_output":true,"text":"analysed by the standard MMRM. The estimated differences and corresponding 95\\% confidence","text_display":" analysed by the standard MMRM. The estimated differences and corresponding 95\\% confidence","confidence":0.96923828125,"confidence_rate":0.9996676638206073},{"cnt":[[322,1293],[1833,1293],[1833,1343],[322,1343]],"region":{"top_left_x":322,"top_left_y":1293,"width":1511,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"67b97465e0604079b1bd877a53a2bae2","type":"text","conversion_output":true,"text":"intervals at 26 weeks will be back transformed and presented as ratios together with the two sided","text_display":" intervals at 26 weeks will be back transformed and presented as ratios together with the two sided","confidence":1,"confidence_rate":1},{"cnt":[[322,1345],[471,1345],[471,1390],[322,1390]],"region":{"top_left_x":322,"top_left_y":1344,"width":149,"height":47},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec0757538ca8434e8e73dd4360aa8f0e","type":"text","conversion_output":true,"text":"p -values.","text_display":" p -values.","confidence":0.96044921875,"confidence_rate":0.9976290406001692},{"cnt":[[322,1429],[1830,1429],[1830,1476],[322,1476]],"region":{"top_left_x":322,"top_left_y":1428,"width":1509,"height":48},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"32d1e7ed4aca42da83ee122297104d0c","type":"text","conversion_output":true,"text":"The fasting HOMA endpoints (i.e., fasting HOMA-B and HOMA-IR) will be calculated based on","text_display":"\n\nThe fasting HOMA endpoints (i.e., fasting HOMA-B and HOMA-IR) will be calculated based on","confidence":0.9970715045928955,"confidence_rate":0.999968800573522},{"cnt":[[322,1474],[870,1474],[870,1523],[322,1523]],"region":{"top_left_x":322,"top_left_y":1473,"width":549,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"730aac6a118341ca9e8fde6375e42680","type":"text","conversion_output":true,"text":"fasting insulin and FPG as follows:","text_display":" fasting insulin and FPG as follows:","confidence":1,"confidence_rate":1},{"cnt":[[327,1564],[1519,1564],[1519,1611],[327,1611]],"region":{"top_left_x":326,"top_left_y":1564,"width":1193,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"46f18b7eb2434a8ca417f4802aeab758","type":"text","conversion_output":true,"text":"1. Fasting HOMA-B (\\%) \\(=20 x\\) fasting insulin \\([\\mu U / ml ] /( FPG [ mmol / L ]-3.5)\\)","text_display":"\n1. Fasting HOMA-B (\\%) \\(=20 x\\) fasting insulin \\([\\mu U / ml ] /( FPG [ mmol / L ]-3.5)\\)","confidence":0.717504472939648,"confidence_rate":0.9964367281196096},{"cnt":[[322,1611],[1485,1611],[1485,1661],[322,1661]],"region":{"top_left_x":322,"top_left_y":1611,"width":1163,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75e57e541c9d439bbaf5fb90f9fd55fe","type":"text","conversion_output":true,"text":"2. Fasting HOMA-IR (\\%)= fasting insulin \\([\\mu U / ml ] \\times FPG [ mmol / L ] / 22.5\\)","text_display":"\n2. Fasting HOMA-IR (\\%)= fasting insulin \\([\\mu U / ml ] \\times FPG [ mmol / L ] / 22.5\\)","confidence":0.6043246598590525,"confidence_rate":0.9939503766136998},{"cnt":[[322,1702],[578,1702],[578,1742],[322,1742]],"region":{"top_left_x":322,"top_left_y":1701,"width":256,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"347f0678f18f48c78b9ff76100253876","type":"section_header","conversion_output":false,"children_ids":["ec6903adbfc44f83a7cada64f8a85118"],"text":"","text_display":""},{"cnt":[[322,1706],[574,1706],[574,1738],[322,1738]],"region":{"top_left_x":322,"top_left_y":1705,"width":252,"height":34},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec6903adbfc44f83a7cada64f8a85118","type":"text","conversion_output":true,"parent_id":"347f0678f18f48c78b9ff76100253876","text":"PRO outcomes","text_display":"\n\n\\section*{PRO outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[322,1766],[1760,1766],[1760,1809],[322,1809]],"region":{"top_left_x":322,"top_left_y":1766,"width":1438,"height":43},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"855e70b269334e8881462a33bb96809f","type":"text","conversion_output":true,"text":"The outcomes from the SF-36 in terms of total scores overall and within each domain will be","text_display":"\n\nThe outcomes from the SF-36 in terms of total scores overall and within each domain will be","confidence":1,"confidence_rate":1},{"cnt":[[322,1818],[1515,1818],[1515,1863],[322,1863]],"region":{"top_left_x":322,"top_left_y":1817,"width":1193,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c3ba4b0e2f54e0a8394d294bf71cf92","type":"text","conversion_output":true,"text":"calculated and each of these scores will be analysed by the standard MMRM.","text_display":" calculated and each of these scores will be analysed by the standard MMRM.","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[322,1904],[788,1904],[788,1953],[322,1953]],"region":{"top_left_x":322,"top_left_y":1903,"width":467,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"638f8cccc2ef4bf9ba7ade4636ad1906","type":"section_header","conversion_output":false,"children_ids":["d74ba70eaa0c4057a90303eb6a467ba2"],"text":"","text_display":""},{"cnt":[[327,1904],[784,1904],[784,1949],[327,1949]],"region":{"top_left_x":326,"top_left_y":1903,"width":459,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d74ba70eaa0c4057a90303eb6a467ba2","type":"text","conversion_output":true,"parent_id":"638f8cccc2ef4bf9ba7ade4636ad1906","text":"17.4.2 Safety endpoints","text_display":"\n\n\\subsection*{17.4.2 Safety endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[322,1972],[1721,1972],[1721,2017],[322,2017]],"region":{"top_left_x":322,"top_left_y":1972,"width":1399,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1e447e1457f45f18e59bf57d35a9924","type":"text","conversion_output":true,"text":"All safety endpoints will be summarised and analysed using the safety analysis set. Unless","text_display":"\n\nAll safety endpoints will be summarised and analysed using the safety analysis set. Unless","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[322,2020],[1601,2020],[1601,2065],[322,2065]],"region":{"top_left_x":322,"top_left_y":2019,"width":1279,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea1448e4a92e41108c13c4374f983995","type":"text","conversion_output":true,"text":"otherwise specified safety endpoints will be analysed by descriptive statistics only.","text_display":" otherwise specified safety endpoints will be analysed by descriptive statistics only.","confidence":0.9956073760986328,"confidence_rate":0.9999510867538558},{"cnt":[[320,2105],[582,2105],[582,2151],[320,2151]],"region":{"top_left_x":320,"top_left_y":2105,"width":263,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83dda4ac0e1449f7b3b1e7cbdf3375f8","type":"section_header","conversion_output":false,"children_ids":["d1347c29c44c4b56860f35ea11d1f903"],"text":"","text_display":""},{"cnt":[[322,2110],[578,2110],[578,2146],[322,2146]],"region":{"top_left_x":322,"top_left_y":2109,"width":256,"height":38},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1347c29c44c4b56860f35ea11d1f903","type":"text","conversion_output":true,"parent_id":"83dda4ac0e1449f7b3b1e7cbdf3375f8","text":"Adverse events","text_display":"\n\n\\section*{Adverse events}","confidence":1,"confidence_rate":1},{"cnt":[[322,2174],[1762,2174],[1762,2219],[322,2219]],"region":{"top_left_x":322,"top_left_y":2174,"width":1440,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a94587cb8b804b658d0aaaffe6c3b36a","type":"text","conversion_output":true,"text":"All AEs will be coded using the most recent version of the Medical Dictionary for regulatory","text_display":"\n\nAll AEs will be coded using the most recent version of the Medical Dictionary for regulatory","confidence":1,"confidence_rate":1},{"cnt":[[322,2221],[1798,2221],[1798,2271],[322,2271]],"region":{"top_left_x":322,"top_left_y":2221,"width":1477,"height":50},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6333c7a480474a18a005213c86475b71","type":"text","conversion_output":true,"text":"Activities (MedDRA) coding. A TEAE is defined as an event that has onset date (or increase in","text_display":" Activities (MedDRA) coding. A TEAE is defined as an event that has onset date (or increase in","confidence":1,"confidence_rate":1},{"cnt":[[322,2271],[1846,2271],[1846,2318],[322,2318]],"region":{"top_left_x":322,"top_left_y":2270,"width":1524,"height":49},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65095d31bd484562be93e5d95ba78cf1","type":"text","conversion_output":true,"text":"severity) on or after the first day of exposure to randomised treatment and no later than the follow-","text_display":" severity) on or after the first day of exposure to randomised treatment and no later than the follow","confidence":0.9970715045928955,"confidence_rate":0.9999723325352052},{"cnt":[[322,2320],[1850,2320],[1850,2365],[322,2365]],"region":{"top_left_x":322,"top_left_y":2320,"width":1528,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4299fc1c9f8484baf0a514328611117","type":"text","conversion_output":true,"text":"up visit. TEAEs are summarised descriptively, whereas non-treatment emergent AEs are presented","text_display":"up visit. TEAEs are summarised descriptively, whereas non-treatment emergent AEs are presented","confidence":1,"confidence_rate":1},{"cnt":[[322,2368],[492,2368],[492,2413],[322,2413]],"region":{"top_left_x":322,"top_left_y":2367,"width":170,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01b002c4ecf141e2b6204b4444536519","type":"text","conversion_output":true,"text":"in listings.","text_display":" in 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& 81 \\text { of } 98\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 25 June 2013 } \\\\ \\text { Version: } & 1.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 81 \\text { of } 98\\end{array}\\right|\\)","confidence":0.7316828169837075,"confidence_rate":0.9976713113653704},{"cnt":[[1766,258],[1944,258],[1944,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":257,"width":179,"height":38},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"467b9cbb70b64a60b79c348f0895e392","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,294],[608,294],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":294,"width":287,"height":35},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"19cacee9af3443d2ab383929d10fa20c","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,327],[621,327],[621,363],[322,363]],"region":{"top_left_x":322,"top_left_y":326,"width":299,"height":38},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"99dacf95983c4823945482ac9113e437","type":"page_info","conversion_output":false,"text":"UTN: U1111-1136-4716","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[698,361],[698,397],[322,397]],"region":{"top_left_x":322,"top_left_y":360,"width":377,"height":38},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b500fd89141c4057bc7d8d5e71d6ef76","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,473],[1429,473],[1429,535],[318,535]],"region":{"top_left_x":317,"top_left_y":472,"width":1112,"height":63},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"545070b4f16f42a5ac8cd60325e115dd","type":"section_header","conversion_output":false,"children_ids":["890e9b5ab0de4e1abafd7be4b868d1ed"],"text":"","text_display":""},{"cnt":[[322,481],[1422,481],[1422,531],[322,531]],"region":{"top_left_x":322,"top_left_y":481,"width":1101,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"890e9b5ab0de4e1abafd7be4b868d1ed","type":"text","conversion_output":true,"parent_id":"545070b4f16f42a5ac8cd60325e115dd","text":"Number of confirmed treatment emergent hypoglycaemic episodes","text_display":"\n\n\\section*{Number of confirmed treatment emergent hypoglycaemic episodes}","confidence":0.9970724578015506,"confidence_rate":0.9999555792316009},{"cnt":[[322,546],[1837,546],[1837,595],[322,595]],"region":{"top_left_x":322,"top_left_y":545,"width":1515,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c8a732a91574d48b177492123e3f7fc","type":"text","conversion_output":true,"text":"A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode occurs","text_display":"\n\nA hypoglycaemic episode will be defined as treatment emergent if the onset of the episode occurs","confidence":1,"confidence_rate":1},{"cnt":[[322,593],[1725,593],[1725,642],[322,642]],"region":{"top_left_x":322,"top_left_y":592,"width":1404,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0dd45df59344dd2afc3b7034f6efeff","type":"text","conversion_output":true,"text":"on or after the first day of trial product administration and no later than the follow-up 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ADA classification of hypoglycaemia (see Figure 17-1).","text_display":" hypoglycaemia and the ADA classification of hypoglycaemia (see Figure 17-1).","confidence":1,"confidence_rate":1},{"cnt":[[318,812],[771,812],[771,870],[318,870]],"region":{"top_left_x":317,"top_left_y":812,"width":455,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41eaa3a2cab94776b61a00ee8045b8cb","type":"section_header","conversion_output":false,"children_ids":["a3a0c6eba3284ef08fee67a51c573904"],"text":"","text_display":""},{"cnt":[[322,816],[767,816],[767,866],[322,866]],"region":{"top_left_x":322,"top_left_y":816,"width":445,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3a0c6eba3284ef08fee67a51c573904","type":"text","conversion_output":true,"parent_id":"41eaa3a2cab94776b61a00ee8045b8cb","text":"Confirmed hypoglycaemia","text_display":"\n\n\\section*{Confirmed hypoglycaemia}","confidence":1,"confidence_rate":1},{"cnt":[[322,885],[1777,885],[1777,935],[322,935]],"region":{"top_left_x":322,"top_left_y":885,"width":1455,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54474af421c8410ba538dc3326473acd","type":"text","conversion_output":true,"text":"In normal physiology, symptoms of hypoglycaemia occur below a plasma glucose level of 3.1","text_display":"\n\nIn normal physiology, symptoms of hypoglycaemia occur below a plasma glucose level of 3.1","confidence":1,"confidence_rate":1},{"cnt":[[322,928],[1846,928],[1846,984],[322,984]],"region":{"top_left_x":322,"top_left_y":928,"width":1524,"height":56},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cfae22f12444cf6965662d6406e9984","type":"text","conversion_output":true,"text":"\\(mmol / L (56 mg / dL )^{13}\\). Therefore, Novo Nordisk has included hypoglycaemia with plasma glucose","text_display":" \\(mmol / L (56 mg / dL )^{13}\\). 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investigator must ensure the subject ample time to come to a decision whether or not to","text_display":"\n\nThe investigator must ensure the subject ample time to come to a decision whether or not to","confidence":1,"confidence_rate":1},{"cnt":[[322,524],[672,524],[672,578],[322,578]],"region":{"top_left_x":322,"top_left_y":524,"width":351,"height":54},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cffe15f0b1b45a389f0aafbf1e4e3ea","type":"text","conversion_output":true,"text":"participate in the trial.","text_display":" participate in the trial.","confidence":1,"confidence_rate":1},{"cnt":[[322,612],[1843,612],[1843,664],[322,664]],"region":{"top_left_x":322,"top_left_y":612,"width":1522,"height":52},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd5ae6e2183840cca37d647ac1f09d6a","type":"text","conversion_output":true,"text":"A voluntary, signed and personally dated informed consent form will be obtained from the 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The written informed consent must be signed and personally dated by the person who","text_display":" requirements. The written informed consent must be signed and personally dated by the person who","confidence":1,"confidence_rate":1},{"cnt":[[322,894],[1244,894],[1244,943],[322,943]],"region":{"top_left_x":322,"top_left_y":893,"width":922,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ca01958fbd7449e860e2f92d5c1cb76","type":"text","conversion_output":true,"text":"seeks the informed consent before any trial-related activity.","text_display":" seeks the informed consent before any trial-related activity.","confidence":1,"confidence_rate":1},{"cnt":[[322,982],[1772,982],[1772,1029],[322,1029]],"region":{"top_left_x":322,"top_left_y":981,"width":1451,"height":49},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51d8301749bb4f0f9430b46d9597a041","type":"text","conversion_output":true,"text":"If information becomes available that may be relevant to the subject's willingness to continue","text_display":"\n\nIf information becomes available that may be relevant to the subject's willingness to continue","confidence":1,"confidence_rate":1},{"cnt":[[322,1031],[1833,1031],[1833,1081],[322,1081]],"region":{"top_left_x":322,"top_left_y":1031,"width":1511,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d48aff0306594ba3a2b2f08befc2f28b","type":"text","conversion_output":true,"text":"participating in the trial, the investigator must inform the subject in a timely manner and a revised","text_display":" participating in the trial, the investigator must inform the subject in a timely manner and a revised","confidence":1,"confidence_rate":1},{"cnt":[[322,1079],[1747,1079],[1747,1128],[322,1128]],"region":{"top_left_x":322,"top_left_y":1078,"width":1425,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8dccf394363d46299e2f742034ef0fe2","type":"text","conversion_output":true,"text":"written subject information must be provided 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There may be various clinical conditions not identified so far which mildly or","confidence":1,"confidence_rate":1},{"cnt":[[322,1405],[1085,1405],[1085,1450],[322,1450]],"region":{"top_left_x":322,"top_left_y":1405,"width":763,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"511100e041d74462b2a07b14837eb1a0","type":"text","conversion_output":true,"text":"moderately affect calcitonin secretion by C-cells.","text_display":" moderately affect calcitonin secretion by C-cells.","confidence":0.99951171875,"confidence_rate":0.9999911200303706}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-104","page":104,"lines":[{"cnt":[[322,262],[475,262],[475,294],[322,294]],"region":{"top_left_x":322,"top_left_y":262,"width":153,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"473d6619b00142c8b7ade39f65a5e884","type":"page_info","conversion_output":false,"text":"Semaglutide","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[924,254],[1762,254],[1762,397],[924,397]],"region":{"top_left_x":923,"top_left_y":253,"width":839,"height":145},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4259a0e3660e4372ac79e72295457636","type":"table","conversion_output":true,"text":"CONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 21 January 2014 } \\\\ \\text { Version: } & 3.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 4 \\text { of } 6\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 21 January 2014 } \\\\ \\text { Version: } & 3.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 4 \\text { of } 6\\end{array}\\right|\\)","confidence":0.6686271646914718,"confidence_rate":0.9970227469336189},{"cnt":[[1766,262],[1940,262],[1940,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":262,"width":175,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9f4728f7859d43849b6b01ca10763a86","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,296],[608,296],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":296,"width":287,"height":33},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dea7a58de9724154a4d5774d4988868f","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,331],[595,331],[595,363],[322,363]],"region":{"top_left_x":322,"top_left_y":330,"width":274,"height":34},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"719610c012004afd8b578900dd3b238e","type":"page_info","conversion_output":false,"text":"Protocol - Appendix C","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[694,361],[694,393],[322,393]],"region":{"top_left_x":322,"top_left_y":360,"width":372,"height":34},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"372a9a8c4b4f48b9a19bbaa046d48482","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[318,518],[1798,518],[1798,587],[318,587]],"region":{"top_left_x":317,"top_left_y":517,"width":1482,"height":70},"line":7,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"0fb25032f5874f2dab789bc848baf9e4","type":"section_header","conversion_output":false,"children_ids":["cf8a2ffcc2ec4ad7aa7313b2a5b500e5"],"text":"","text_display":""},{"cnt":[[322,522],[1794,522],[1794,582],[322,582]],"region":{"top_left_x":322,"top_left_y":522,"width":1472,"height":61},"line":8,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"cf8a2ffcc2ec4ad7aa7313b2a5b500e5","type":"text","conversion_output":true,"parent_id":"0fb25032f5874f2dab789bc848baf9e4","text":"2 Calcitonin and C-cell abnormalities - evaluation and follow-up","text_display":"\n\n\\section*{2 Calcitonin and C-cell abnormalities - evaluation and follow-up}","confidence":0.9883153438568115,"confidence_rate":0.9998271699630775},{"cnt":[[322,602],[1850,602],[1850,647],[322,647]],"region":{"top_left_x":322,"top_left_y":601,"width":1528,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca1033cff2c542a3827c9e9a2d935373","type":"text","conversion_output":true,"text":"Subjects with a personal or family history of medullar thyroid cancer (MTC) or multiple endocrine","text_display":"\n\nSubjects with a personal or family history of medullar thyroid cancer (MTC) or multiple endocrine","confidence":1,"confidence_rate":1},{"cnt":[[322,649],[1854,649],[1854,698],[322,698]],"region":{"top_left_x":322,"top_left_y":648,"width":1533,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"755b7782c47142e9ae5a59d72523864f","type":"text","conversion_output":true,"text":"neoplasia syndrome type 2 (MEN2) or with a screening calcitonin \\(\\geq 50 ng / L\\) will be excluded from","text_display":" neoplasia syndrome type 2 (MEN2) or with a screening calcitonin \\(\\geq 50 ng / L\\) will be excluded from","confidence":1,"confidence_rate":1},{"cnt":[[322,700],[458,700],[458,741],[322,741]],"region":{"top_left_x":322,"top_left_y":700,"width":136,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"010b446e280f4570815f93dc933ac5ec","type":"text","conversion_output":true,"text":"the trial.","text_display":" the trial.","confidence":1,"confidence_rate":1},{"cnt":[[322,786],[1828,786],[1828,831],[322,831]],"region":{"top_left_x":322,"top_left_y":786,"width":1507,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4245dc5e12b14e20bee19b8d30995326","type":"text","conversion_output":true,"text":"A blood sample will be drawn at pre-specified trial visits for measurement of calcitonin. In case a","text_display":"\n\nA blood sample will be drawn at pre-specified trial visits for measurement of calcitonin. In case a","confidence":1,"confidence_rate":1},{"cnt":[[322,834],[1729,834],[1729,881],[322,881]],"region":{"top_left_x":322,"top_left_y":833,"width":1408,"height":48},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38594631f1994b938094dcc48048afe4","type":"text","conversion_output":true,"text":"subject has an increased calcitonin value \\(\\geq 10 ng / L\\) the algorithm outlined below should be","text_display":" subject has an increased calcitonin value \\(\\geq 10 ng / L\\) the algorithm outlined below should be","confidence":1,"confidence_rate":1},{"cnt":[[322,881],[1622,881],[1622,930],[322,930]],"region":{"top_left_x":322,"top_left_y":880,"width":1301,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14a20eb7412a471fa95a262f52ba90f3","type":"text","conversion_output":true,"text":"followed. The algorithm applies for all calcitonin values including screening values.","text_display":" followed. The algorithm applies for all calcitonin values including screening values.","confidence":1,"confidence_rate":1},{"cnt":[[322,971],[1714,971],[1714,1016],[322,1016]],"region":{"top_left_x":322,"top_left_y":971,"width":1393,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbfaed283b5f4cdfb6ba8c6a0aed7f49","type":"text","conversion_output":true,"text":"All calcitonin values \\(\\geq 20 ng / L\\) will be submitted to an independent Calcitonin Monitoring","text_display":"\n\nAll calcitonin values \\(\\geq 20 ng / L\\) will be submitted to an independent Calcitonin Monitoring","confidence":1,"confidence_rate":1},{"cnt":[[322,1018],[1781,1018],[1781,1068],[322,1068]],"region":{"top_left_x":322,"top_left_y":1018,"width":1460,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36e78c6778a148458c96aa2e57cad691","type":"text","conversion_output":true,"text":"Committee (CMC) of thyroid experts, together with relevant supplementary data, i.e. subject's","text_display":" Committee (CMC) of thyroid experts, together with relevant supplementary data, i.e. subject's","confidence":0.99755859375,"confidence_rate":0.9999750575422747},{"cnt":[[322,1066],[1820,1066],[1820,1115],[322,1115]],"region":{"top_left_x":322,"top_left_y":1065,"width":1498,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d12ce5df808b4c0ebb829dfce3295709","type":"text","conversion_output":true,"text":"demographics, diabetes history, concomitant medical history, concomitant medications, smoking","text_display":" demographics, diabetes history, concomitant medical history, concomitant medications, smoking","confidence":1,"confidence_rate":1},{"cnt":[[322,1113],[1613,1113],[1613,1162],[322,1162]],"region":{"top_left_x":322,"top_left_y":1112,"width":1292,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35ba6d33823a40dda3612b20b2931c13","type":"text","conversion_output":true,"text":"status as well as information about relevant adverse events reported during the trial.","text_display":" status as well as information about relevant adverse events reported during the trial.","confidence":1,"confidence_rate":1},{"cnt":[[322,1203],[1828,1203],[1828,1248],[322,1248]],"region":{"top_left_x":322,"top_left_y":1203,"width":1507,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3d03cc010c749b2beadb6bf46ad672c","type":"text","conversion_output":true,"text":"The CMC will provide recommendations to the investigators with regards to further investigation","text_display":"\n\nThe CMC will provide recommendations to the investigators with regards to further investigation","confidence":1,"confidence_rate":1},{"cnt":[[322,1250],[1609,1250],[1609,1298],[322,1298]],"region":{"top_left_x":322,"top_left_y":1250,"width":1288,"height":48},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"840edb60015440a4a9366cd2f337e3fd","type":"text","conversion_output":true,"text":"and treatment of the individual subject. The CMC will be blinded to trial treatment.","text_display":" and treatment of the individual subject. The CMC will be blinded to trial treatment.","confidence":1,"confidence_rate":1},{"cnt":[[322,1336],[1861,1336],[1861,1386],[322,1386]],"region":{"top_left_x":322,"top_left_y":1336,"width":1539,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd8976e509ee4b42a88a0e61706ac71f","type":"text","conversion_output":true,"text":"The summary for the rationale for the use of specific calcitonin values to trigger medical evaluation","text_display":"\n\nThe summary for the rationale for the use of specific calcitonin values to trigger medical evaluation","confidence":1,"confidence_rate":1},{"cnt":[[322,1386],[1137,1386],[1137,1433],[322,1433]],"region":{"top_left_x":322,"top_left_y":1385,"width":815,"height":49},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a893594c23f84d52a2b552aaf3aed77f","type":"text","conversion_output":true,"text":"and an overview of the algorithm is provided below:","text_display":" and an overview of the algorithm is provided below:","confidence":1,"confidence_rate":1},{"cnt":[[318,1470],[703,1470],[703,1523],[318,1523]],"region":{"top_left_x":317,"top_left_y":1469,"width":386,"height":55},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"058c2ca39f614671a1467deee48dba70","type":"section_header","conversion_output":false,"children_ids":["fc812dad71c94c6eaf88864916c6a4c2"],"text":"","text_display":""},{"cnt":[[322,1474],[698,1474],[698,1519],[322,1519]],"region":{"top_left_x":322,"top_left_y":1473,"width":377,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc812dad71c94c6eaf88864916c6a4c2","type":"text","conversion_output":true,"parent_id":"058c2ca39f614671a1467deee48dba70","text":"2.1 \\(C T \\geq 1 0 0 ~ n g / L\\)","text_display":"\n\n\\section*{2.1 \\(C T \\geq 1 0 0 ~ n g / L\\)}","confidence":0.5822039714580148,"confidence_rate":0.9808663309508218},{"cnt":[[322,1543],[1846,1543],[1846,1588],[322,1588]],"region":{"top_left_x":322,"top_left_y":1542,"width":1524,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70a0c320a9d14a7b9b2e6f9caa8725f9","type":"text","conversion_output":true,"text":"The value will be submitted to the CMC and the subject should be discontinued from trial product.","text_display":"\n\nThe value will be submitted to the CMC and the subject should be discontinued from trial product.","confidence":1,"confidence_rate":1},{"cnt":[[322,1590],[1850,1590],[1850,1635],[322,1635]],"region":{"top_left_x":322,"top_left_y":1589,"width":1528,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87b465085e874208919e14afd087306a","type":"text","conversion_output":true,"text":"If the value is a screening value the subject can not be randomised and the subject must be referred","text_display":" If the value is a screening value the subject can not be randomised and the subject must be referred","confidence":1,"confidence_rate":1},{"cnt":[[322,1637],[668,1637],[668,1687],[322,1687]],"region":{"top_left_x":322,"top_left_y":1637,"width":347,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6027986428f1425f94f1abfb247a021a","type":"text","conversion_output":true,"text":"to a thyroid specialist.","text_display":" to a thyroid specialist.","confidence":1,"confidence_rate":1},{"cnt":[[322,1719],[1760,1719],[1760,1772],[322,1772]],"region":{"top_left_x":322,"top_left_y":1718,"width":1438,"height":55},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d252aec6d12e4aebb42f12e9c0abdb31","type":"text","conversion_output":true,"text":"These values were found in \\(0.15 \\%\\) of the population published by Constante et al \\({ }^{1}\\) and in one","text_display":"\n\nThese values were found in \\(0.15 \\%\\) of the population published by Constante et al \\({ }^{1}\\) and in one","confidence":0.7877267992967063,"confidence_rate":0.9978332240315214},{"cnt":[[322,1775],[1807,1775],[1807,1820],[322,1820]],"region":{"top_left_x":322,"top_left_y":1774,"width":1485,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3539bba2c54a45a3ada908fcedd60274","type":"text","conversion_output":true,"text":"subject (on active comparator) in the liraglutide development program. For a calcitonin value of","text_display":" subject (on active comparator) in the liraglutide development program. For a calcitonin value of","confidence":1,"confidence_rate":1},{"cnt":[[322,1822],[1876,1822],[1876,1869],[322,1869]],"region":{"top_left_x":322,"top_left_y":1821,"width":1554,"height":49},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6eccd8745a8f48cf8c049f36fd2be09c","type":"text","conversion_output":true,"text":"\\(\\geq 100 ng / L\\), the subject should be assumed to have significant C-cell disease and a high likelihood of","text_display":" \\(\\geq 100 ng / L\\), the subject should be assumed to have significant C-cell disease and a high likelihood of","confidence":0.515625,"confidence_rate":0.9939964978181263},{"cnt":[[322,1869],[1736,1869],[1736,1919],[322,1919]],"region":{"top_left_x":322,"top_left_y":1869,"width":1414,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81c5f39fbe2b4d159c9f1b57497fc81d","type":"text","conversion_output":true,"text":"having medullary carcinoma of the thyroid. Diagnostic evaluation should consist of thyroid","text_display":" having medullary carcinoma of the thyroid. Diagnostic evaluation should consist of thyroid","confidence":1,"confidence_rate":1},{"cnt":[[322,1921],[1710,1921],[1710,1966],[322,1966]],"region":{"top_left_x":322,"top_left_y":1920,"width":1389,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"053ec9e47e2641f48ff91d82b109d345","type":"text","conversion_output":true,"text":"ultrasound, fine needle aspiration of any nodules \\(>1 cm\\) and potentially surgery with neck","text_display":" ultrasound, fine needle aspiration of any nodules \\(>1 cm\\) and potentially surgery with neck","confidence":1,"confidence_rate":1},{"cnt":[[322,1968],[1854,1968],[1854,2015],[322,2015]],"region":{"top_left_x":322,"top_left_y":1967,"width":1533,"height":49},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3308bea9bd3e494a96f5cb982aa8bba1","type":"text","conversion_output":true,"text":"dissection. Family history of MTC or MEN2 should be evoked and a RET proto-oncogene analysis","text_display":" dissection. Family history of MTC or MEN2 should be evoked and a RET proto-oncogene analysis","confidence":1,"confidence_rate":1},{"cnt":[[322,2015],[655,2015],[655,2065],[322,2065]],"region":{"top_left_x":322,"top_left_y":2015,"width":334,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"385e75c3f55942e899d9a702b87cb4ad","type":"text","conversion_output":true,"text":"should be performed.","text_display":" should be performed.","confidence":0.9794921875,"confidence_rate":0.9991715026880774},{"cnt":[[318,2101],[853,2101],[853,2155],[318,2155]],"region":{"top_left_x":317,"top_left_y":2101,"width":536,"height":54},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f7ec74ee66c41379c922656934cefe9","type":"section_header","conversion_output":false,"children_ids":["372940bf8eaa48eaa46a817a7c47c119"],"text":"","text_display":""},{"cnt":[[322,2105],[849,2105],[849,2151],[322,2151]],"region":{"top_left_x":322,"top_left_y":2105,"width":527,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"372940bf8eaa48eaa46a817a7c47c119","type":"text","conversion_output":true,"parent_id":"0f7ec74ee66c41379c922656934cefe9","text":"\\(2.2 C T \\geq 5 0\\) and \\(< 1 0 0 ~ n g / L\\)","text_display":"\n\n\\section*{\\(2.2 C T \\geq 5 0\\) and \\(< 1 0 0 ~ n g / L\\)}","confidence":0.3269145692220421,"confidence_rate":0.9702342512581008},{"cnt":[[322,2170],[1837,2170],[1837,2219],[322,2219]],"region":{"top_left_x":322,"top_left_y":2169,"width":1515,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab6ed210833d479fae3fc037ed75bcab","type":"text","conversion_output":true,"text":"The value will be submitted to the CMC and the investigator will receive guidance from the CMC","text_display":"\n\nThe value will be submitted to the CMC and the investigator will receive guidance from the CMC","confidence":1,"confidence_rate":1},{"cnt":[[322,2219],[1850,2219],[1850,2267],[322,2267]],"region":{"top_left_x":322,"top_left_y":2219,"width":1528,"height":48},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"498bc824d63545fa97adcc20b7c65d27","type":"text","conversion_output":true,"text":"with regards to continuation of trial product. If the value is a screening value the subject can not be","text_display":" with regards to continuation of trial product. If the value is a screening value the subject can not be","confidence":0.9931671619415283,"confidence_rate":0.9999365178596985},{"cnt":[[322,2269],[1386,2269],[1386,2314],[322,2314]],"region":{"top_left_x":322,"top_left_y":2268,"width":1064,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"329ca15f63ea45bebbbf89b8b3bb2ec5","type":"text","conversion_output":true,"text":"randomised and the subject should be referred to a thyroid specialist.","text_display":" randomised and the subject should be referred to a thyroid specialist.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"443b238e-00c1-4251-905e-64aeefdfca11-105","page":105,"lines":[{"cnt":[[322,262],[475,262],[475,294],[322,294]],"region":{"top_left_x":322,"top_left_y":262,"width":153,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f520c5f12d534c6583a6e390ea905e69","type":"page_info","conversion_output":false,"text":"Semaglutide","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[922,258],[1762,258],[1762,397],[922,397]],"region":{"top_left_x":921,"top_left_y":257,"width":841,"height":141},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"25168341999b4804af5ae60f2f3b27ee","type":"table","conversion_output":true,"text":"CONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 21 January 2014 } \\\\ \\text { Version: } & 3.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 5 \\text { of } 6\\end{array}\\right|\\)","text_display":"\n\nCONFIDENTIAL \\(\\left|\\begin{array}{lr}\\text { Date: } & \\text { 21 January 2014 } \\\\ \\text { Version: } & 3.0 \\\\ \\text { Status: } & \\text { Final } \\\\ \\text { Page: } & 5 \\text { of } 6\\end{array}\\right|\\)","confidence":0.5829818924541903,"confidence_rate":0.9960109467368469},{"cnt":[[1766,262],[1940,262],[1940,294],[1766,294]],"region":{"top_left_x":1766,"top_left_y":262,"width":175,"height":33},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7ff5342660484f658175f870a2ef4e26","type":"page_info","conversion_output":false,"text":"Novo Nordisk","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,296],[608,296],[608,329],[322,329]],"region":{"top_left_x":322,"top_left_y":296,"width":287,"height":33},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9133535bcf19495bb9794784d8ee107e","type":"page_info","conversion_output":false,"text":"Trial ID: NN9924-3790","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,331],[595,331],[595,363],[322,363]],"region":{"top_left_x":322,"top_left_y":330,"width":274,"height":34},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a72d754494374220867f3c08912dd2e7","type":"page_info","conversion_output":false,"text":"Protocol - Appendix C","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,361],[694,361],[694,393],[322,393]],"region":{"top_left_x":322,"top_left_y":360,"width":372,"height":34},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"99887f20ef284db0a7a2f75dd1471263","type":"page_info","conversion_output":false,"text":"EudraCT No.: 2012-004994-16","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[327,481],[1757,481],[1757,526],[327,526]],"region":{"top_left_x":326,"top_left_y":481,"width":1432,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dd28efe8ab741b6b51fa258097580f4","type":"text","conversion_output":true,"text":"These values were found in \\(0.18 \\%\\) of a population with thyroid nodular disease published by","text_display":"\n\nThese values were found in \\(0.18 \\%\\) of a population with thyroid nodular disease published by","confidence":0.9795570373535156,"confidence_rate":0.9997892588192263},{"cnt":[[324,524],[1824,524],[1824,574],[324,574]],"region":{"top_left_x":324,"top_left_y":524,"width":1501,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea026ef82aaf4bf4b80345432158993e","type":"text","conversion_output":true,"text":"Constante et al \\({ }^{1}\\) Diagnostic evaluation will likely include ultrasound examination and if available","text_display":" Constante et al \\({ }^{1}\\) Diagnostic evaluation will likely include ultrasound examination and if available","confidence":0.7408490180969238,"confidence_rate":0.9973722443233394},{"cnt":[[322,576],[1863,576],[1863,625],[322,625]],"region":{"top_left_x":322,"top_left_y":575,"width":1541,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f58e2193e3d0435a893f1495cbe14d5a","type":"text","conversion_output":true,"text":"and if there is no contraindication, subjects should undergo a pentagastrin stimulation test (Europe).","text_display":" and if there is no contraindication, subjects should undergo a pentagastrin stimulation test (Europe).","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[324,625],[1824,625],[1824,672],[324,672]],"region":{"top_left_x":324,"top_left_y":625,"width":1501,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"477c9e73e1e142b1a879be43e325d931","type":"text","conversion_output":true,"text":"Subjects with positive pentagastrin stimulation tests will be considered to undergo surgery. In the","text_display":" Subjects with positive pentagastrin stimulation tests will be considered to undergo surgery. In the","confidence":1,"confidence_rate":1},{"cnt":[[322,675],[1818,675],[1818,722],[322,722]],"region":{"top_left_x":322,"top_left_y":674,"width":1496,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e025e02c61c483bab53ee78de6b51e2","type":"text","conversion_output":true,"text":"US where pentagastrin is not available, thyroid ultrasound and fine needle aspiration biopsy may","text_display":" US where pentagastrin is not available, thyroid ultrasound and fine needle aspiration biopsy may","confidence":1,"confidence_rate":1},{"cnt":[[322,722],[1347,722],[1347,769],[322,769]],"region":{"top_left_x":322,"top_left_y":721,"width":1026,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97e08e83838b44e589e6cda3b3b64df9","type":"text","conversion_output":true,"text":"add important clinical information informing the need for surgery.","text_display":" add important clinical information informing the need for surgery.","confidence":1,"confidence_rate":1},{"cnt":[[318,804],[827,804],[827,862],[318,862]],"region":{"top_left_x":317,"top_left_y":803,"width":511,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"669c7d338506435fb99c9e0a6befba2e","type":"section_header","conversion_output":false,"children_ids":["29a0094095c441c8b49810ba20d80a80"],"text":"","text_display":""},{"cnt":[[322,810],[821,810],[821,857],[322,857]],"region":{"top_left_x":322,"top_left_y":809,"width":499,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29a0094095c441c8b49810ba20d80a80","type":"text","conversion_output":true,"parent_id":"669c7d338506435fb99c9e0a6befba2e","text":"2.3 CT \\(\\geq 2 0\\) and \\(< 5 0 ~ n g / L\\)","text_display":"\n\n\\subsection*{2.3 CT \\(\\geq 2 0\\) and \\(< 5 0 ~ n g / L\\)}","confidence":0.2496493041732051,"confidence_rate":0.9674994412006274},{"cnt":[[322,877],[1781,877],[1781,924],[322,924]],"region":{"top_left_x":322,"top_left_y":876,"width":1460,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d5a2fd8ffa94f8cadbc5294f715a8de","type":"text","conversion_output":true,"text":"The value will be submitted to the CMC. If the subject is a screen failure the subject should be","text_display":"\n\nThe value will be submitted to the CMC. If the subject is a screen failure the subject should be","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[322,924],[1139,924],[1139,973],[322,973]],"region":{"top_left_x":322,"top_left_y":923,"width":817,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b372a8e064f477e858e33d51528ca11","type":"text","conversion_output":true,"text":"referred to a thyroid specialist for further evaluation.","text_display":" referred to a thyroid specialist for further evaluation.","confidence":1,"confidence_rate":1},{"cnt":[[322,1005],[1858,1005],[1858,1059],[322,1059]],"region":{"top_left_x":322,"top_left_y":1005,"width":1537,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a07345c56e1640bebf42ed7dc5ab76c7","type":"text","conversion_output":true,"text":"These values are expected to be found in up to \\(1 \\%\\) of subjects. Based on data from Constante et al \\({ }^{1}\\),","text_display":"\n\nThese values are expected to be found in up to \\(1 \\%\\) of subjects. Based on data from Constante et al \\({ }^{1}\\),","confidence":0.8905018237419426,"confidence_rate":0.9990259358158925},{"cnt":[[322,1061],[1790,1061],[1790,1106],[322,1106]],"region":{"top_left_x":322,"top_left_y":1061,"width":1468,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfc56a6720c74059b0b087a2613ddc38","type":"text","conversion_output":true,"text":"the predictive value of calcitonin levels \\(\\geq 20\\) and \\(<50 ng / L\\) clinically significant C -cell disease","text_display":" the predictive value of calcitonin levels \\(\\geq 20\\) and \\(<50 ng / L\\) clinically significant C -cell disease","confidence":0.8843896115431562,"confidence_rate":0.9989681161502582},{"cnt":[[322,1109],[1807,1109],[1807,1156],[322,1156]],"region":{"top_left_x":322,"top_left_y":1108,"width":1485,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a63b81b87af645dda1eb2c26bb3a6cc0","type":"text","conversion_output":true,"text":"begins to fall. However, up to \\(25 \\%\\) of these subjects had a positive pentagastrin stimulation test.","text_display":" begins to fall. However, up to \\(25 \\%\\) of these subjects had a positive pentagastrin stimulation test.","confidence":0.99853515625,"confidence_rate":0.9999861706835268},{"cnt":[[322,1156],[1818,1156],[1818,1205],[322,1205]],"region":{"top_left_x":322,"top_left_y":1155,"width":1496,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cf346858aae47a785a4ca0467534a5d","type":"text","conversion_output":true,"text":"The likelihood of having a medullary carcinoma \\(>1 cm\\) with calcitonin in this range is extremely","text_display":" The likelihood of having a medullary carcinoma \\(>1 cm\\) with calcitonin in this range is extremely","confidence":0.9980480668600649,"confidence_rate":0.9999813921669941},{"cnt":[[322,1207],[397,1207],[397,1248],[322,1248]],"region":{"top_left_x":322,"top_left_y":1207,"width":76,"height":42},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26af5506df6a4e289786838a5df2e4dc","type":"text","conversion_output":true,"text":"low.","text_display":" low.","confidence":1,"confidence_rate":1},{"cnt":[[318,1289],[831,1289],[831,1345],[318,1345]],"region":{"top_left_x":317,"top_left_y":1289,"width":515,"height":56},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66d56c2f0ee74202908cc3abd57ba685","type":"section_header","conversion_output":false,"children_ids":["073782f6e587484c94104f6eaa4ac31c"],"text":"","text_display":""},{"cnt":[[322,1293],[827,1293],[827,1343],[322,1343]],"region":{"top_left_x":322,"top_left_y":1293,"width":506,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"073782f6e587484c94104f6eaa4ac31c","type":"text","conversion_output":true,"parent_id":"66d56c2f0ee74202908cc3abd57ba685","text":"2.4 CT \\(\\geq 10\\) and \\(<20 ng / L\\)","text_display":"\n\n\\subsection*{2.4 CT \\(\\geq 10\\) and \\(<20 ng / L\\)}","confidence":0.3651469297700045,"confidence_rate":0.9716258839300377},{"cnt":[[322,1362],[1691,1362],[1691,1407],[322,1407]],"region":{"top_left_x":322,"top_left_y":1362,"width":1369,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4eec48809bf84f9d8bc73114549a34f4","type":"text","conversion_output":true,"text":"Confounding factors should be evaluated. If drugs potentially affecting calcitonin can be","text_display":"\n\nConfounding factors should be evaluated. If drugs potentially affecting calcitonin can be","confidence":1,"confidence_rate":1},{"cnt":[[322,1409],[1828,1409],[1828,1457],[322,1457]],"region":{"top_left_x":322,"top_left_y":1409,"width":1507,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc755c5ebdab4be4b57efd6dd2517f8c","type":"text","conversion_output":true,"text":"discontinued safely, calcitonin can be repeated after a washout period. Gastrin levels return to the","text_display":" discontinued safely, calcitonin can be repeated after a washout period. Gastrin levels return to the","confidence":1,"confidence_rate":1},{"cnt":[[322,1457],[1779,1457],[1779,1506],[322,1506]],"region":{"top_left_x":322,"top_left_y":1456,"width":1457,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97cca6d4d5354754917b961cd4e50899","type":"text","conversion_output":true,"text":"normal range by \\(\\sim 10\\) days after stopping proton pump inhibitors (PPIs). No further actions are","text_display":" normal range by \\(\\sim 10\\) days after stopping proton pump inhibitors (PPIs). No further actions are","confidence":1,"confidence_rate":1},{"cnt":[[322,1506],[1470,1506],[1470,1553],[322,1553]],"region":{"top_left_x":322,"top_left_y":1506,"width":1148,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8f88fd9f0544785b8f3b9052f0d3187","type":"text","conversion_output":true,"text":"needed during the trial if the next calcitonin values remain below \\(20 ng / L\\).","text_display":" needed during the trial if the next calcitonin values remain below \\(20 ng / L\\).","confidence":1,"confidence_rate":1},{"cnt":[[322,1594],[1858,1594],[1858,1639],[322,1639]],"region":{"top_left_x":322,"top_left_y":1594,"width":1537,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a74197d04d74ab6874268788264fe75","type":"text","conversion_output":true,"text":"If the subject is a screening failure or if the value is the last one taken in the trial, the subject should","text_display":"\n\nIf the subject is a screening failure or if the value is the last one taken in the trial, the subject should","confidence":1,"confidence_rate":1},{"cnt":[[322,1641],[1351,1641],[1351,1691],[322,1691]],"region":{"top_left_x":322,"top_left_y":1641,"width":1030,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78fd044d512748a68d2ec1dbffa99ced","type":"text","conversion_output":true,"text":"preferably be referred to a thyroid specialist for further evaluation.","text_display":" preferably be referred to a thyroid specialist for further evaluation.","confidence":1,"confidence_rate":1},{"cnt":[[322,1723],[1854,1723],[1854,1777],[322,1777]],"region":{"top_left_x":322,"top_left_y":1723,"width":1533,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95cd4b6e3e8e47bca2310aca41740d91","type":"text","conversion_output":true,"text":"These values may be found in \\(\\sim 2.5\\) to \\(4 \\%\\) of the trial population. Costante et al \\({ }^{1}\\) had 216 patients in","text_display":"\n\nThese values may be found in \\(\\sim 2.5\\) to \\(4 \\%\\) of the trial population. 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During the past 4 weeks, how much did pain interfere with your normal","text_display":"\n8. During the past 4 weeks, how much did pain interfere with your normal","confidence":0.994140625,"confidence_rate":0.9999265450918315},{"cnt":[[391,636],[1592,636],[1592,690],[391,690]],"region":{"top_left_x":391,"top_left_y":635,"width":1201,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5bfa541f27d453a910add197093ada5","type":"text","conversion_output":true,"text":"work (including both work outside the home and housework)?","text_display":" work (including both work outside the home and housework)?","confidence":1,"confidence_rate":1},{"cnt":[[464,718],[1732,718],[1732,939],[464,939]],"region":{"top_left_x":464,"top_left_y":717,"width":1268,"height":222},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1c512dadf8145beaea4a70aec935230","type":"table","conversion_output":true,"text":"\\begin{tabular}{|ccccc|}\n\\hline Not at all & A little bit & Moderately & Quite a bit & Extremely \\\\\n\\(\\square_{1}\\) & \\(\\square_{2}\\) & \\(\\square_{3}\\) & \\(\\square_{4}\\) & \\(\\square_{5}\\)\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|ccccc|}\n\\hline Not at all & A little bit & Moderately & Quite a bit & Extremely \\\\\n\\(\\square_{1}\\) & \\(\\square_{2}\\) & \\(\\square_{3}\\) & \\(\\square_{4}\\) & \\(\\square_{5}\\)\n\\end{tabular}","confidence":0.9810692885011005,"confidence_rate":0.999882754165666},{"cnt":[[322,999],[1833,999],[1833,1053],[322,1053]],"region":{"top_left_x":322,"top_left_y":999,"width":1511,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f5c70153a4345bb9bec3843055f05d6","type":"text","conversion_output":true,"text":"9. These questions are about how you feel and how things have been with you","text_display":"\n9. These questions are about how you feel and how things have been with you","confidence":1,"confidence_rate":1},{"cnt":[[391,1051],[1846,1051],[1846,1102],[391,1102]],"region":{"top_left_x":391,"top_left_y":1050,"width":1455,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88b93ee7b401415ba6cb7d934896bc88","type":"text","conversion_output":true,"text":"during the past 4 weeks. For each question, please give the one answer that","text_display":" during the past 4 weeks. 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& Event Title & Definition & Rationale \\\\\n\\hline 7 & \\begin{tabular}{l}\nNeoplasm \\\\\n(excluding thyroid neoplasms)\n\\end{tabular} & \\begin{tabular}{l}\nAll types of neoplasms must be reported including: \\\\\n- Malign neoplasm \\\\\n- In situ neoplasm \\\\\n- Benign neoplasm \\\\\n- Neoplasms of uncertain or unknown behaviour\n\\end{tabular} & Neoplasm is an event Novo Nordisk follows closely for GLP-1 analogues due to nonclinical findings in rats and mice treated with GLP-1 agonists. \\\\\n\\hline 8 & Thyroid disease (including thyroid neoplasms) & All disorders of thyroid gland must be reported & Thyroid C-cells carcinogenicity has been reported in rats and mice treated with GLP-1 agonists in nonclinical studies \\\\\n\\hline 9 & Medication errors concerning trial products & \\begin{tabular}{l}\n1. Administration of wrong drug or use of wrong device \\\\\n2. Wrong route of administration, such as intramuscular instead of subcutaneous \\\\\n3. Administration of a high dose with the intention to cause harm, e.g. suicide attempt \\\\\n4. 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The investigator can at any time during the","text_display":" could potentially invalidate the data and trial results. 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