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John Gallagher, M.D.","text_display":"\n\nInvestigators: Andrew Chang, M.D; David Esses, M.D; E. 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2014-4156","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[1504,99],[2058,99],[2058,135],[1504,135]],"region":{"top_left_x":1503,"top_left_y":98,"width":556,"height":38},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2240916ec22b4bdbacb873e73a9b78bd","type":"page_info","conversion_output":false,"text":"IRB APPROVAL DATE: 05/27/2015","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,245],[1807,245],[1807,299],[309,299]],"region":{"top_left_x":309,"top_left_y":244,"width":1498,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d54f6ad1c91a4020909c16a05bcd652b","type":"text","conversion_output":true,"text":"to be superior to acetaminophen alone in 17 of 20 studies. \\({ }^{13}\\) The combination of ibuprofen","text_display":"\nto be superior to acetaminophen alone in 17 of 20 studies. \\({ }^{13}\\) The combination of ibuprofen","confidence":1,"confidence_rate":1},{"cnt":[[309,348],[1792,348],[1792,397],[309,397]],"region":{"top_left_x":309,"top_left_y":348,"width":1483,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e6088f2a5634269a01ee0de7cdd49a4","type":"text","conversion_output":true,"text":"and acetaminophen published since that review has been found to be more effective than","text_display":" and acetaminophen published since that review has been found to be more effective than","confidence":1,"confidence_rate":1},{"cnt":[[309,434],[1721,434],[1721,492],[309,492]],"region":{"top_left_x":309,"top_left_y":433,"width":1412,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"995824852dae4a8d8bca7c0716e7de0d","type":"text","conversion_output":true,"text":"each drug alone in 4 out of 5 trials of patients following dental surgery. \\({ }^{14-17}\\) Only one","text_display":" each drug alone in 4 out of 5 trials of patients following dental surgery. \\({ }^{14-17}\\) Only one","confidence":1,"confidence_rate":1},{"cnt":[[309,541],[1560,541],[1560,589],[309,589]],"region":{"top_left_x":309,"top_left_y":541,"width":1251,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7155e636a46041c6a9c7ade6f9c32565","type":"text","conversion_output":true,"text":"small ED study that examined the effect of the 800 mg ibuprofen \\(/ 1000 mg\\)","text_display":" small ED study that examined the effect of the 800 mg ibuprofen \\(/ 1000 mg\\)","confidence":0.9385063648223877,"confidence_rate":0.9992356459895302},{"cnt":[[309,636],[1760,636],[1760,683],[309,683]],"region":{"top_left_x":309,"top_left_y":635,"width":1451,"height":49},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1bfb497256f436cbcdcb56a68f44a73","type":"text","conversion_output":true,"text":"acetaminophen combination on musculoskeletal pain one hour after administration did","text_display":" acetaminophen combination on musculoskeletal pain one hour after administration did","confidence":1,"confidence_rate":1},{"cnt":[[309,722],[1313,722],[1313,780],[309,780]],"region":{"top_left_x":309,"top_left_y":721,"width":1004,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25a372ee0d5d49e19d9e8f71a2fee60b","type":"text","conversion_output":true,"text":"not find it to be superior to either of the component drugs. \\({ }^{18}\\)","text_display":" not find it to be superior to either of the component drugs. \\({ }^{18}\\)","confidence":1,"confidence_rate":1},{"cnt":[[434,829],[1781,829],[1781,874],[434,874]],"region":{"top_left_x":433,"top_left_y":829,"width":1349,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34a61cbbccdd4d07baaab42a59cab6fb","type":"text","conversion_output":true,"text":"We could find only one direct comparison between an ibuprofen/acetaminophen","text_display":"\n\nWe could find only one direct comparison between an ibuprofen/acetaminophen","confidence":1,"confidence_rate":1},{"cnt":[[309,924],[1764,924],[1764,971],[309,971]],"region":{"top_left_x":309,"top_left_y":923,"width":1455,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5747b444814e4cafbe0b8d100ad1aa41","type":"text","conversion_output":true,"text":"combination and an oral opioid combination. Patients who received 400 mg ibuprofen/","text_display":" combination and an oral opioid combination. Patients who received 400 mg ibuprofen/","confidence":1,"confidence_rate":1},{"cnt":[[312,1018],[1798,1018],[1798,1068],[312,1068]],"region":{"top_left_x":311,"top_left_y":1018,"width":1488,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4b2e1d19f2f4b2591b5943e890395f1","type":"text","conversion_output":true,"text":"1000 acetaminophen following extraction of a third molar had significantly less pain and","text_display":" 1000 acetaminophen following extraction of a third molar had significantly less pain and","confidence":1,"confidence_rate":1},{"cnt":[[309,1113],[1779,1113],[1779,1162],[309,1162]],"region":{"top_left_x":309,"top_left_y":1112,"width":1470,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5733efe702c453babb2346f79ad6630","type":"text","conversion_output":true,"text":"greater pain relief in the 12 hour period after analgesic administration than patients who","text_display":" greater pain relief in the 12 hour period after analgesic administration than patients who","confidence":1,"confidence_rate":1},{"cnt":[[309,1203],[1175,1203],[1175,1261],[309,1261]],"region":{"top_left_x":309,"top_left_y":1203,"width":867,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f7ff371d4ea42cbbb88a2fdbc1c0bc0","type":"text","conversion_output":true,"text":"received 30 mg codeine \\(/ 1000 mg\\) acetaminophen. \\({ }^{14}\\)","text_display":" received 30 mg codeine \\(/ 1000 mg\\) acetaminophen. \\({ }^{14}\\)","confidence":0.99512362270616,"confidence_rate":0.9999301695009001},{"cnt":[[434,1306],[1807,1306],[1807,1356],[434,1356]],"region":{"top_left_x":433,"top_left_y":1306,"width":1374,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d2db958bec24e1a9d6e381dc189860b","type":"text","conversion_output":true,"text":"For this proposed study, we wished to look at the comparative efficacy of a single","text_display":"\n\nFor this proposed study, we wished to look at the comparative efficacy of a single","confidence":1,"confidence_rate":1},{"cnt":[[309,1401],[1764,1401],[1764,1450],[309,1450]],"region":{"top_left_x":309,"top_left_y":1400,"width":1455,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9d3aa2ac84c4e4fb2362b3af84dfc76","type":"text","conversion_output":true,"text":"dose of 4 oral analgesics given while the patient is still in the ED. We believe this will","text_display":" dose of 4 oral analgesics given while the patient is still in the ED. We believe this will","confidence":0.8868831787388558,"confidence_rate":0.9987758314458275},{"cnt":[[309,1500],[1790,1500],[1790,1549],[309,1549]],"region":{"top_left_x":309,"top_left_y":1499,"width":1481,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d469e165a11b46c7a02953b9f0e66c0e","type":"text","conversion_output":true,"text":"enhance our understanding of these commonly prescribed oral analgesics by eliminating","text_display":" enhance our understanding of these commonly prescribed oral analgesics by eliminating","confidence":1,"confidence_rate":1},{"cnt":[[309,1594],[1663,1594],[1663,1644],[309,1644]],"region":{"top_left_x":309,"top_left_y":1594,"width":1354,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41fea3b4db6c44d5a2c65d2577d823e8","type":"text","conversion_output":true,"text":"recall bias,which may have played a role in driving our prior findings comparing","text_display":" recall bias,which may have played a role in driving our prior findings comparing","confidence":0.99658203125,"confidence_rate":0.9999597205365387},{"cnt":[[309,1691],[1790,1691],[1790,1738],[309,1738]],"region":{"top_left_x":309,"top_left_y":1690,"width":1481,"height":49},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6843eaa443da42feadf96b280a6573d4","type":"text","conversion_output":true,"text":"acetaminophen/codeine vs. hydrocodone/acetaminophen and oxycodone/acetaminophen","text_display":" acetaminophen/codeine vs. hydrocodone/acetaminophen and oxycodone/acetaminophen","confidence":1,"confidence_rate":1},{"cnt":[[309,1788],[1766,1788],[1766,1833],[309,1833]],"region":{"top_left_x":309,"top_left_y":1787,"width":1458,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc7a3a5bc81b4d30a4fdfe71d8c4e277","type":"text","conversion_output":true,"text":"toward the null of no difference among the 3 combination analgesics when assessed 24","text_display":" toward the null of no difference among the 3 combination analgesics when assessed 24","confidence":0.99462890625,"confidence_rate":0.9999408196640538},{"cnt":[[309,1882],[501,1882],[501,1923],[309,1923]],"region":{"top_left_x":309,"top_left_y":1882,"width":192,"height":41},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec070444c4a04420a33512c0a7b4e3ab","type":"text","conversion_output":true,"text":"hours later.","text_display":" hours 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null","confidence":1,"confidence_rate":1},{"cnt":[[305,443],[1755,443],[1755,492],[305,492]],"region":{"top_left_x":305,"top_left_y":442,"width":1451,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46a58e1b6955414fbeff4f3e4c3f4bbf","type":"text","conversion_output":true,"text":"hypothesis that there are no differences between the effect of the medications on mean","text_display":" hypothesis that there are no differences between the effect of the medications on mean","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[307,539],[1813,539],[1813,589],[307,589]],"region":{"top_left_x":307,"top_left_y":539,"width":1507,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43a855b7963f415688651d9b122e8f31","type":"text","conversion_output":true,"text":"change in pain from baseline to 2 hours post-baseline with a significance level of 0.05 . If","text_display":" change in pain from baseline to 2 hours post-baseline with a significance level of 0.05 . If","confidence":1,"confidence_rate":1},{"cnt":[[307,636],[1807,636],[1807,685],[307,685]],"region":{"top_left_x":307,"top_left_y":635,"width":1500,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea3368075ecc44999bb4699c2458dc4e","type":"text","conversion_output":true,"text":"there is evidence to reject the null hypothesis we will conduct the set of t-tests comparing","text_display":" there is evidence to reject the null hypothesis we will conduct the set of t-tests comparing","confidence":0.611328125,"confidence_rate":0.9949394311917529},{"cnt":[[307,730],[1772,730],[1772,780],[307,780]],"region":{"top_left_x":307,"top_left_y":730,"width":1466,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12a0efb4fc254815b472a5ac7979bab2","type":"text","conversion_output":true,"text":"all pairwise mean differences in pain. The Bonferroni method will be used to adjust the","text_display":" all pairwise mean differences in pain. The Bonferroni method will be used to adjust the","confidence":1,"confidence_rate":1},{"cnt":[[305,827],[1794,827],[1794,874],[305,874]],"region":{"top_left_x":305,"top_left_y":827,"width":1489,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56024c2c06164d498bd872ec368e500a","type":"text","conversion_output":true,"text":"overall significance level of 0.05 in order to account for multiple comparisons. The data","text_display":" overall significance level of 0.05 in order to account for multiple comparisons. The data","confidence":1,"confidence_rate":1},{"cnt":[[307,924],[1682,924],[1682,973],[307,973]],"region":{"top_left_x":307,"top_left_y":923,"width":1376,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fca6888767154f64ab8e158843624ed7","type":"text","conversion_output":true,"text":"will be presented as the difference between each pair of means and the set of \\(95 \\%\\)","text_display":" will be presented as the difference between each pair of means and the set of \\(95 \\%\\)","confidence":0.6178622245788574,"confidence_rate":0.9943514278210609},{"cnt":[[307,1018],[1803,1018],[1803,1068],[307,1068]],"region":{"top_left_x":307,"top_left_y":1018,"width":1496,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0789832a81a4803adca0255f1a7466d","type":"text","conversion_output":true,"text":"simultaneous Bonferroni CIs around the differences. SPSS version 22 (Chicago, IL.) will","text_display":" simultaneous Bonferroni CIs around the differences. SPSS version 22 (Chicago, IL.) will","confidence":0.9990236759185791,"confidence_rate":0.9999897179371111},{"cnt":[[305,1113],[1747,1113],[1747,1162],[305,1162]],"region":{"top_left_x":305,"top_left_y":1112,"width":1442,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dccb5a46547f4e17a2b5d8e52abef9c7","type":"text","conversion_output":true,"text":"be used to conduct all data analyses. Data will be stored in an identified format in the","text_display":" be used to conduct all data analyses. Data will be stored in an identified format in the","confidence":1,"confidence_rate":1},{"cnt":[[305,1212],[1351,1212],[1351,1261],[305,1261]],"region":{"top_left_x":305,"top_left_y":1211,"width":1047,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2172905f7f845168031b7c260f3fba9","type":"text","conversion_output":true,"text":"event that a metaanalysis of studies is performed in the future.","text_display":" event that a metaanalysis of studies is performed in the future.","confidence":1,"confidence_rate":1},{"cnt":[[305,1396],[733,1396],[733,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1396,"width":428,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e06c88ec492547e1bb6261923d8dbaef","type":"section_header","conversion_output":false,"children_ids":["e5c3ed3ec2104ca5b5a924d2cfe4795b"],"text":"","text_display":""},{"cnt":[[309,1401],[728,1401],[728,1450],[309,1450]],"region":{"top_left_x":309,"top_left_y":1400,"width":420,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5c3ed3ec2104ca5b5a924d2cfe4795b","type":"text","conversion_output":true,"parent_id":"e06c88ec492547e1bb6261923d8dbaef","text":"Sample Size Calculation","text_display":"\n\n\\section*{Sample Size Calculation}","confidence":1,"confidence_rate":1},{"cnt":[[432,1497],[1760,1497],[1760,1549],[432,1549]],"region":{"top_left_x":431,"top_left_y":1497,"width":1329,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edd39ca5b92b4e1c9b0df9587b5c726a","type":"text","conversion_output":true,"text":"The following parameters were used to calculate the sample size: an overall 2-","text_display":"\n\nThe following parameters were used to calculate the sample size: an overall 2","confidence":0.9990234375,"confidence_rate":0.9999882285072625},{"cnt":[[305,1594],[1751,1594],[1751,1644],[305,1644]],"region":{"top_left_x":305,"top_left_y":1594,"width":1446,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"423a0340302e4fe59a30d264d5a340af","type":"text","conversion_output":true,"text":"sided significance level of 0.05 ( 0.008 for each t -test using the Bonferroni correction),","text_display":"sided significance level of 0.05 ( 0.008 for each t -test using the Bonferroni correction),","confidence":0.8400804183929722,"confidence_rate":0.9983878041755698},{"cnt":[[305,1691],[1712,1691],[1712,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1690,"width":1408,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11095c65cfaf490b9d5f63fc59c4ce20","type":"text","conversion_output":true,"text":"power of \\(80 \\%, 1.3\\) NRS unit or greater difference in change in pain between groups","text_display":" power of \\(80 \\%, 1.3\\) NRS unit or greater difference in change in pain between groups","confidence":0.3922540871537472,"confidence_rate":0.9894217399307941},{"cnt":[[305,1785],[1811,1785],[1811,1835],[305,1835]],"region":{"top_left_x":305,"top_left_y":1785,"width":1507,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb56557bbd2942cda22d80ba9d562c54","type":"text","conversion_output":true,"text":"based on a standard definition of the minimal clinically significant difference in pain, and","text_display":" based on a standard definition of the minimal clinically significant difference in pain, and","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,1882],[1751,1882],[1751,1931],[305,1931]],"region":{"top_left_x":305,"top_left_y":1882,"width":1446,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d76ee4f3a90340a2987b05bb3f4d16be","type":"text","conversion_output":true,"text":"a within group standard deviation of 2.6 based on estimates of variability of change in","text_display":" a within group standard deviation of 2.6 based on estimates of variability of change in","confidence":0.9887747764587402,"confidence_rate":0.999881178619305},{"cnt":[[305,1977],[1697,1977],[1697,2026],[305,2026]],"region":{"top_left_x":305,"top_left_y":1976,"width":1393,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e6a1749de464fa6955142489e0e8ae9","type":"text","conversion_output":true,"text":"pain in response to oral opioid analgesics. Using these parameters 100 patients are","text_display":" pain in response to oral opioid analgesics. Using these parameters 100 patients are","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[305,2071],[1708,2071],[1708,2123],[305,2123]],"region":{"top_left_x":305,"top_left_y":2071,"width":1404,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"069ce93e7d254ddf974bd53e88fd6310","type":"text","conversion_output":true,"text":"needed in each group for a total of 400 patients. We will plan to continue to enroll","text_display":" needed in each group for a total of 400 patients. We will plan to continue to enroll","confidence":1,"confidence_rate":1},{"cnt":[[305,2170],[1738,2170],[1738,2219],[305,2219]],"region":{"top_left_x":305,"top_left_y":2169,"width":1434,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7dcbf2353ad4b498a6472e52cb1e62b","type":"text","conversion_output":true,"text":"patients until we have 400 patients with usable data (not missing primary outcome or","text_display":" patients until we have 400 patients with usable data (not missing primary outcome or","confidence":1,"confidence_rate":1},{"cnt":[[305,2264],[1781,2264],[1781,2314],[305,2314]],"region":{"top_left_x":305,"top_left_y":2264,"width":1477,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d917baeede8e41dfa6b516b7b9ec677e","type":"text","conversion_output":true,"text":"other critical data points). 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We used","text_display":"\n\n20 additional subjects to order to reach our target sample size of 400 patients. We used","confidence":1,"confidence_rate":1},{"cnt":[[309,350],[1439,350],[1439,397],[309,397]],"region":{"top_left_x":309,"top_left_y":350,"width":1131,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adedcc7dc7b14595987bc59578974342","type":"text","conversion_output":true,"text":"nQuery Advisor 7.0 (Los Angeles, CA) to calculate the sample size.","text_display":" nQuery Advisor 7.0 (Los Angeles, CA) to calculate the sample size.","confidence":0.99560546875,"confidence_rate":0.9999404853442438},{"cnt":[[305,537],[776,537],[776,595],[305,595]],"region":{"top_left_x":305,"top_left_y":537,"width":471,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ca48a7e429b4e19ac2b7f3e363ee4a1","type":"section_header","conversion_output":false,"children_ids":["8475f4cd3666423eabd9cadc76b4826a"],"text":"","text_display":""},{"cnt":[[309,541],[771,541],[771,591],[309,591]],"region":{"top_left_x":309,"top_left_y":541,"width":463,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8475f4cd3666423eabd9cadc76b4826a","type":"text","conversion_output":true,"parent_id":"1ca48a7e429b4e19ac2b7f3e363ee4a1","text":"Data safety and monitoring","text_display":"\n\n\\section*{Data safety and monitoring}","confidence":0.99365234375,"confidence_rate":0.999794605345316},{"cnt":[[309,638],[1807,638],[1807,685],[309,685]],"region":{"top_left_x":309,"top_left_y":638,"width":1498,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a87aea0aa364b47ae6a28b610088596","type":"text","conversion_output":true,"text":"Data monitoring committee and interim analysis. This committee will be composed of Dr.","text_display":"\n\nData monitoring committee and interim analysis. This committee will be composed of Dr.","confidence":0.9306640625,"confidence_rate":0.9992106753955752},{"cnt":[[309,735],[1798,735],[1798,780],[309,780]],"region":{"top_left_x":309,"top_left_y":734,"width":1490,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66cfa78966f648e8bf1ca5382eacee5a","type":"text","conversion_output":true,"text":"Polly Bijur, PhD, a statistician and epidemiologist, and Dr. Benjamin Friedman who will","text_display":" Polly Bijur, PhD, a statistician and epidemiologist, and Dr. Benjamin Friedman who will","confidence":1,"confidence_rate":1},{"cnt":[[309,829],[1807,829],[1807,879],[309,879]],"region":{"top_left_x":309,"top_left_y":829,"width":1498,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da181367c797490fae22cc6f7f011bba","type":"text","conversion_output":true,"text":"meet quarterly tomonitor adverse events, recruitment, and enrollmentAn interim analysis,","text_display":" meet quarterly tomonitor adverse events, recruitment, and enrollmentAn interim analysis,","confidence":1,"confidence_rate":1},{"cnt":[[309,924],[1811,924],[1811,973],[309,973]],"region":{"top_left_x":309,"top_left_y":923,"width":1503,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd0cca26d93b4865bde776dfa91204e3","type":"text","conversion_output":true,"text":"which will be approved by the DSMC prior to randomization, will be conducted after 200","text_display":" which will be approved by the DSMC prior to randomization, will be conducted after 200","confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[309,1023],[1807,1023],[1807,1070],[309,1070]],"region":{"top_left_x":309,"top_left_y":1022,"width":1498,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1295a2f98e774db7934734e084c4ed99","type":"text","conversion_output":true,"text":"subjects (50 in each treatment arm) with analyzable data have been enrolled. The purpose","text_display":" subjects (50 in each treatment arm) with analyzable data have been enrolled. The purpose","confidence":0.9946331977844238,"confidence_rate":0.9999421387145366},{"cnt":[[309,1117],[1742,1117],[1742,1164],[309,1164]],"region":{"top_left_x":309,"top_left_y":1117,"width":1434,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b376d16a523449e7b6116f0ab8b1b1af","type":"text","conversion_output":true,"text":"of the interim analysis is to identify one or more treatments that are clearly inferior or","text_display":" of the interim analysis is to identify one or more treatments that are clearly inferior or","confidence":0.9985356330871582,"confidence_rate":0.9999845744332286},{"cnt":[[309,1212],[1687,1212],[1687,1261],[309,1261]],"region":{"top_left_x":309,"top_left_y":1211,"width":1378,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01da9d4e071c4459bbdb1863b38983e7","type":"text","conversion_output":true,"text":"superior to the others. A clinically important difference in change in pain has been","text_display":" superior to the others. A clinically important difference in change in pain has been","confidence":1,"confidence_rate":1},{"cnt":[[309,1308],[1790,1308],[1790,1351],[309,1351]],"region":{"top_left_x":309,"top_left_y":1308,"width":1481,"height":44},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2c658e6281c4df99ecb1320312e05c3","type":"text","conversion_output":true,"text":"defined as 2 units or more on an NRS scale or 20 mm or more on a VAS score. We will","text_display":" defined as 2 units or more on an NRS scale or 20 mm or more on a VAS score. We will","confidence":0.9970722198486328,"confidence_rate":0.9999694580238778},{"cnt":[[309,1405],[1699,1405],[1699,1452],[309,1452]],"region":{"top_left_x":309,"top_left_y":1405,"width":1391,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7e78c4960534a92b5091659c6bda400","type":"text","conversion_output":true,"text":"examine the point estimates of the change in pain. If one or more arms has a mean","text_display":" examine the point estimates of the change in pain. 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