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The first 2 weeks of each","confidence":0.99853515625,"confidence_rate":0.999987577045958},{"cnt":[[168,1474],[1751,1474],[1751,1523],[168,1523]],"region":{"top_left_x":167,"top_left_y":1473,"width":1584,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f630f6e6e3b441d6a76e0828a208bf20","type":"text","conversion_output":true,"text":"study phase will be the washout period with study treatment received during the last 4 weeks.","text_display":" study phase will be the washout period with study treatment received during the last 4 weeks.","confidence":1,"confidence_rate":1},{"cnt":[[168,1577],[1869,1577],[1869,1624],[168,1624]],"region":{"top_left_x":167,"top_left_y":1576,"width":1703,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82d1a49192904d758fc5ddc4117ddc52","type":"text","conversion_output":true,"text":"The over-arching hypothesis is that, compared to placebo, treatment with inorganic nitrite will lead to","text_display":"\n\nThe over-arching hypothesis is that, compared to placebo, treatment with inorganic nitrite will lead to","confidence":1,"confidence_rate":1},{"cnt":[[168,1629],[1489,1629],[1489,1676],[168,1676]],"region":{"top_left_x":167,"top_left_y":1628,"width":1322,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70e4d4a68d774a7a872889e23dfd3b22","type":"text","conversion_output":true,"text":"improved exercise capacity as assessed by cardiopulmonary exercise testing.","text_display":" improved exercise capacity as assessed by cardiopulmonary exercise testing.","confidence":1,"confidence_rate":1},{"cnt":[[168,1723],[518,1723],[518,1772],[168,1772]],"region":{"top_left_x":167,"top_left_y":1723,"width":351,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f0ad50ca9764286bf00c8162047c99f","type":"section_header","conversion_output":false,"children_ids":["f759e50b12774320895999d286f54673"],"text":"","text_display":""},{"cnt":[[168,1727],[513,1727],[513,1768],[168,1768]],"region":{"top_left_x":167,"top_left_y":1727,"width":347,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f759e50b12774320895999d286f54673","type":"text","conversion_output":true,"parent_id":"2f0ad50ca9764286bf00c8162047c99f","text":"2.2 Randomization","text_display":"\n\n\\subsection*{2.2 Randomization}","confidence":1,"confidence_rate":1},{"cnt":[[168,1830],[1987,1830],[1987,1878],[168,1878]],"region":{"top_left_x":167,"top_left_y":1830,"width":1821,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae87804697c34bb7b3b1b4d53e62205d","type":"text","conversion_output":true,"text":"Patients are randomized in a \\(1: 1\\) ratio to a specific treatment receipt order: inorganic nitrite in study phase 1","text_display":"\n\nPatients are randomized in a \\(1: 1\\) ratio to a specific treatment receipt order: inorganic nitrite in study phase 1","confidence":0.9497313499450684,"confidence_rate":0.999566681103783},{"cnt":[[168,1878],[1904,1878],[1904,1927],[168,1927]],"region":{"top_left_x":167,"top_left_y":1877,"width":1737,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"194baa553813469f8d8254c71601908f","type":"text","conversion_output":true,"text":"and Placebo in study phase 2 OR Placebo in study phase 1 and inorganic nitrite in study phase 2 . The","text_display":" and Placebo in study phase 2 OR Placebo in study phase 1 and inorganic nitrite in study phase 2 . The","confidence":0.7490234375,"confidence_rate":0.9974902416427264},{"cnt":[[168,1929],[1727,1929],[1727,1979],[168,1979]],"region":{"top_left_x":167,"top_left_y":1929,"width":1561,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc02fec8c6694dd09af177a34b87e99b","type":"text","conversion_output":true,"text":"randomization scheme consists of a permuted block design with stratification by clinical site.","text_display":" randomization scheme consists of a permuted block design with stratification by clinical site.","confidence":1,"confidence_rate":1},{"cnt":[[168,2028],[488,2028],[488,2075],[168,2075]],"region":{"top_left_x":167,"top_left_y":2028,"width":321,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b517044799e541998727310efcf2046c","type":"section_header","conversion_output":false,"children_ids":["cef085c1f08e4f14a65b8f48e73576ae"],"text":"","text_display":""},{"cnt":[[168,2032],[483,2032],[483,2071],[168,2071]],"region":{"top_left_x":167,"top_left_y":2032,"width":317,"height":40},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cef085c1f08e4f14a65b8f48e73576ae","type":"text","conversion_output":true,"parent_id":"b517044799e541998727310efcf2046c","text":"2.3 Data Sources","text_display":"\n\n\\subsection*{2.3 Data Sources}","confidence":1,"confidence_rate":1},{"cnt":[[168,2133],[1919,2133],[1919,2181],[168,2181]],"region":{"top_left_x":167,"top_left_y":2133,"width":1752,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9320204ec3a45b9a74d932b4c9fdf42","type":"text","conversion_output":true,"text":"A database of case report form and biomarker core lab data will be created in Inform, and the data then","text_display":"\n\nA database of case report form and biomarker core lab data will be created in Inform, and the data then","confidence":1,"confidence_rate":1},{"cnt":[[168,2183],[1880,2183],[1880,2230],[168,2230]],"region":{"top_left_x":167,"top_left_y":2182,"width":1713,"height":49},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f05f7d7b1af4718b78bb81a9cd88bb1","type":"text","conversion_output":true,"text":"transferred to SAS for analysis. 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The","confidence":1,"confidence_rate":1},{"cnt":[[168,2286],[1897,2286],[1897,2333],[168,2333]],"region":{"top_left_x":167,"top_left_y":2285,"width":1731,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdcfc9dbc2d04bb3ba3e806c5ab63f4f","type":"text","conversion_output":true,"text":"accelerometer data was provided by the Accelerometer Core Lab located at Mayo Clinic. The core lab","text_display":" accelerometer data was provided by the Accelerometer Core Lab located at Mayo Clinic. The core lab","confidence":1,"confidence_rate":1},{"cnt":[[168,2333],[1916,2333],[1916,2383],[168,2383]],"region":{"top_left_x":167,"top_left_y":2333,"width":1750,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6107bf66bbc40689fb073ebac01b1da","type":"text","conversion_output":true,"text":"provided both cleaned and raw data for download. The data is stored on Solaris server uxctstp01 in the","text_display":" provided both cleaned and raw data for download. The data is stored on Solaris server uxctstp01 in the","confidence":1,"confidence_rate":1},{"cnt":[[168,2385],[608,2385],[608,2434],[168,2434]],"region":{"top_left_x":167,"top_left_y":2384,"width":442,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0138e54fd4774c0d8d5ce455443771a5","type":"text","conversion_output":true,"text":"folder /hf_net/INDIE/data.","text_display":" folder /hf_net/INDIE/data.","confidence":0.9824597691185772,"confidence_rate":0.9994293279424007},{"cnt":[[168,2486],[924,2486],[924,2539],[168,2539]],"region":{"top_left_x":167,"top_left_y":2485,"width":757,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"106ec0f08de34f259b5fb1d50134bdec","type":"section_header","conversion_output":false,"children_ids":["0d9ec58369ee42c5a3e2a0fbc7323dd4"],"text":"","text_display":""},{"cnt":[[168,2488],[922,2488],[922,2537],[168,2537]],"region":{"top_left_x":167,"top_left_y":2487,"width":755,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d9ec58369ee42c5a3e2a0fbc7323dd4","type":"text","conversion_output":true,"parent_id":"106ec0f08de34f259b5fb1d50134bdec","text":"3. 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Given the crossover design of the study, each patient will have endpoints measured at","text_display":" tertiary endpoints. Given the crossover design of the study, each patient will have endpoints measured at","confidence":1,"confidence_rate":1},{"cnt":[[168,365],[1901,365],[1901,415],[168,415]],"region":{"top_left_x":167,"top_left_y":365,"width":1735,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d649a0dcd1940488e1ea2e075f01274","type":"text","conversion_output":true,"text":"two times; the first at the conclusion of Phase 1 (Visit 2) treatment and the second at the conclusion of","text_display":" two times; the first at the conclusion of Phase 1 (Visit 2) treatment and the second at the conclusion of","confidence":0.9970715045928955,"confidence_rate":0.9999740464267123},{"cnt":[[170,417],[1601,417],[1601,462],[170,462]],"region":{"top_left_x":169,"top_left_y":416,"width":1432,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de41cf8533874efc9798acb3ec9c82de","type":"text","conversion_output":true,"text":"Phase 2 treatment (Visit 3). All endpoints will be analyzed on an intent-to-treat basis.","text_display":" Phase 2 treatment (Visit 3). All endpoints will be analyzed on an intent-to-treat basis.","confidence":0.9990236759185791,"confidence_rate":0.999989825041388},{"cnt":[[172,520],[1901,520],[1901,565],[172,565]],"region":{"top_left_x":171,"top_left_y":519,"width":1731,"height":47},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9267978870d4b21805a90b86c5893c6","type":"text","conversion_output":true,"text":"However, as described in subsequent sections of this document, some patients may be excluded from","text_display":"\n\nHowever, as described in subsequent sections of this document, some patients may be excluded from","confidence":1,"confidence_rate":1},{"cnt":[[172,569],[1946,569],[1946,614],[172,614]],"region":{"top_left_x":171,"top_left_y":569,"width":1776,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0807758e00d640f7ba5c3dd741641195","type":"text","conversion_output":true,"text":"certain analyses if key data elements are missing. With the extensive efforts being made in collaboration","text_display":" certain analyses if key data elements are missing. With the extensive efforts being made in collaboration","confidence":1,"confidence_rate":1},{"cnt":[[168,619],[1951,619],[1951,664],[168,664]],"region":{"top_left_x":167,"top_left_y":618,"width":1784,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b36997004d064d568714d2f69f947166","type":"text","conversion_output":true,"text":"with the clinical sites to ensure data quality and completeness, it is expected that exclusion of patients for","text_display":" with the clinical sites to ensure data quality and completeness, it is expected that exclusion of patients for","confidence":1,"confidence_rate":1},{"cnt":[[170,670],[1987,670],[1987,715],[170,715]],"region":{"top_left_x":169,"top_left_y":670,"width":1819,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cadf55161b7642e8b1429a31296b0622","type":"text","conversion_output":true,"text":"any endpoint analysis will be minimal. The specific endpoint descriptions in Sections 8 through 10 describe","text_display":" any endpoint analysis will be minimal. The specific endpoint descriptions in Sections 8 through 10 describe","confidence":0.9975602623308077,"confidence_rate":0.9999792992085125},{"cnt":[[168,722],[1635,722],[1635,767],[168,767]],"region":{"top_left_x":167,"top_left_y":721,"width":1468,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85dcaafcde594cc8808fad98d5281bb5","type":"text","conversion_output":true,"text":"the circumstances that would lead to a patient being excluded from a specific analysis.","text_display":" the circumstances that would lead to a patient being excluded from a specific analysis.","confidence":1,"confidence_rate":1},{"cnt":[[168,816],[625,816],[625,870],[168,870]],"region":{"top_left_x":167,"top_left_y":816,"width":459,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e57458268be74f11be6fcd67d89d3aa1","type":"section_header","conversion_output":false,"children_ids":["66da38eedc6f442fa1d81f07e2c5def1"],"text":"","text_display":""},{"cnt":[[168,821],[621,821],[621,866],[168,866]],"region":{"top_left_x":167,"top_left_y":820,"width":454,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66da38eedc6f442fa1d81f07e2c5def1","type":"text","conversion_output":true,"parent_id":"e57458268be74f11be6fcd67d89d3aa1","text":"4. General Methodology","text_display":"\n\n\\section*{4. 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Secondary analyses will be performed using","confidence":0.9907307624816895,"confidence_rate":0.9999242917747372},{"cnt":[[168,1274],[1061,1274],[1061,1326],[168,1326]],"region":{"top_left_x":167,"top_left_y":1274,"width":895,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b51994bdf2a440f82845fc5e2088ecb","type":"text","conversion_output":true,"text":"paired t -tests and appropriate general linear models.","text_display":" paired t -tests and appropriate general linear models.","confidence":0.9080763700185344,"confidence_rate":0.9985176106573943},{"cnt":[[168,1375],[1981,1375],[1981,1424],[168,1424]],"region":{"top_left_x":167,"top_left_y":1375,"width":1814,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9eed0b25cb8543a3a40ee369df7b6fa5","type":"text","conversion_output":true,"text":"Interpretation of Results: A higher peak VO2 indicates an improved exercise capacity in the inorganic nitrite","text_display":"\n\nInterpretation of Results: A higher peak VO2 indicates an improved exercise capacity in the inorganic nitrite","confidence":0.7869269682560116,"confidence_rate":0.997900279149091},{"cnt":[[168,1427],[488,1427],[488,1476],[168,1476]],"region":{"top_left_x":167,"top_left_y":1426,"width":321,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c211f0491774212b23d04862a645ba9","type":"text","conversion_output":true,"text":"period vs placebo.","text_display":" period vs placebo.","confidence":1,"confidence_rate":1},{"cnt":[[163,1517],[849,1517],[849,1571],[163,1571]],"region":{"top_left_x":163,"top_left_y":1516,"width":686,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f97740b02f364dbf97fe4efc2249ceef","type":"section_header","conversion_output":false,"children_ids":["66d4263e02e34f5b9db61cdb58affcf9"],"text":"","text_display":""},{"cnt":[[168,1521],[844,1521],[844,1566],[168,1566]],"region":{"top_left_x":167,"top_left_y":1521,"width":678,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66d4263e02e34f5b9db61cdb58affcf9","type":"text","conversion_output":true,"parent_id":"f97740b02f364dbf97fe4efc2249ceef","text":"9. Secondary Endpoint Descriptions","text_display":"\n\n\\section*{9. 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Only complete days are used and there should be 21 days in","text_display":" time periods are study weeks 4-6 and 10-12. Only complete days are used and there should be 21 days in","confidence":0.994140625,"confidence_rate":0.9999465777134849},{"cnt":[[168,2020],[483,2020],[483,2069],[168,2069]],"region":{"top_left_x":167,"top_left_y":2019,"width":317,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed79e03a0570492d80e33d5ace16ead9","type":"text","conversion_output":true,"text":"the dosing period.","text_display":" the dosing period.","confidence":1,"confidence_rate":1},{"cnt":[[168,2118],[1938,2118],[1938,2170],[168,2170]],"region":{"top_left_x":167,"top_left_y":2118,"width":1771,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68453215b6824aebab2802e651c29c2c","type":"text","conversion_output":true,"text":"Additional Covariates: period effect, sequence effect, baseline daily average AAU, and random effect of","text_display":"\n\nAdditional Covariates: period effect, sequence effect, baseline daily average AAU, and random effect of","confidence":1,"confidence_rate":1},{"cnt":[[168,2170],[299,2170],[299,2219],[168,2219]],"region":{"top_left_x":167,"top_left_y":2169,"width":132,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80a920f95b524a62b3538db773394ca7","type":"text","conversion_output":true,"text":"patient","text_display":" patient","confidence":1,"confidence_rate":1},{"cnt":[[168,2271],[1624,2271],[1624,2322],[168,2322]],"region":{"top_left_x":167,"top_left_y":2270,"width":1458,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab6730d7829e4e069e973386169a4b53","type":"text","conversion_output":true,"text":"Handling of Dropouts and Missing Data: No adjustment for missing data will be made.","text_display":"\n\nHandling of Dropouts and Missing Data: No adjustment for missing data will be made.","confidence":1,"confidence_rate":1},{"cnt":[[168,2372],[1968,2372],[1968,2421],[168,2421]],"region":{"top_left_x":167,"top_left_y":2371,"width":1801,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b431603ded4431d9d0400d0e0a17687","type":"text","conversion_output":true,"text":"Sensitivity Analysis: For this sensitivity analysis, each average will be divided by the study phase 114 day","text_display":"\nSensitivity Analysis: For this sensitivity analysis, each average will be divided by the study phase 114 day","confidence":0.8887798523064703,"confidence_rate":0.9989840878597488},{"cnt":[[168,2423],[1985,2423],[1985,2473],[168,2473]],"region":{"top_left_x":167,"top_left_y":2423,"width":1819,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a65a6aca90d345e9bb5a609e04f53f6c","type":"text","conversion_output":true,"text":"baseline period average daily AAU (approximately study weeks \\(1-2\\) ) to create a ratio. Values greater than 1","text_display":" baseline period average daily AAU (approximately study weeks \\(1-2\\) ) to create a ratio. Values greater than 1","confidence":0.8894256511703134,"confidence_rate":0.9989726389712948},{"cnt":[[168,2475],[623,2475],[623,2524],[168,2524]],"region":{"top_left_x":167,"top_left_y":2475,"width":457,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40bad167b7b84e1794d21c0111e4e6d6","type":"text","conversion_output":true,"text":"indicate increased activity.","text_display":" indicate increased activity.","confidence":1,"confidence_rate":1},{"cnt":[[168,2552],[754,2552],[754,2589],[168,2589]],"region":{"top_left_x":167,"top_left_y":2552,"width":588,"height":37},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39e04926cb024f69b96ec7fd226c8ffc","type":"page_info","conversion_output":false,"text":"INDIE - A Heart Failure Network Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1629,2552],[1940,2552],[1940,2597],[1629,2597]],"region":{"top_left_x":1628,"top_left_y":2552,"width":313,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5341ca00b2af4989832491ffee68c779","type":"page_info","conversion_output":false,"text":"FINAL (11 April 2017)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999812155418875}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"891075d1-b60e-43c2-9ebf-b03e781c2ea4-07","page":7,"lines":[{"cnt":[[1358,125],[2009,125],[2009,165],[1358,165]],"region":{"top_left_x":1357,"top_left_y":124,"width":652,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f770c9288db4479399ff61bc4c09cd1d","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan Amendment 1 (INDIE)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1904,163],[2013,163],[2013,200],[1904,200]],"region":{"top_left_x":1903,"top_left_y":163,"width":111,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81a2dabab11c4d2c890f4dace85dfabd","type":"page_info","conversion_output":false,"text":"Page 7","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,264],[1962,264],[1962,312],[168,312]],"region":{"top_left_x":167,"top_left_y":264,"width":1795,"height":48},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"648c9127d5e44090a773805b66ad0417","type":"text","conversion_output":true,"text":"Statistical Tests: A mixed model (PROC MIXED in SAS) will be used to estimate and statistically compare","text_display":"\n\nStatistical Tests: A mixed model (PROC MIXED in SAS) will be used to estimate and statistically compare","confidence":1,"confidence_rate":1},{"cnt":[[168,314],[2004,314],[2004,363],[168,363]],"region":{"top_left_x":167,"top_left_y":313,"width":1838,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"538acb4b078e40308715466416cbf039","type":"text","conversion_output":true,"text":"the response to inorganic nitrite versus placebo on daily activity level. Secondary analyses will be performed","text_display":" the response to inorganic nitrite versus placebo on daily activity level. Secondary analyses will be performed","confidence":1,"confidence_rate":1},{"cnt":[[168,365],[1164,365],[1164,415],[168,415]],"region":{"top_left_x":167,"top_left_y":365,"width":998,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f39b301cf3a6424b9d5d8376da65137d","type":"text","conversion_output":true,"text":"using paired t -tests and appropriate general linear models.","text_display":" using paired t -tests and appropriate general linear models.","confidence":0.950394868850708,"confidence_rate":0.9992836689507055},{"cnt":[[168,466],[1886,466],[1886,518],[168,518]],"region":{"top_left_x":167,"top_left_y":466,"width":1720,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcf490f194874df4800b838ac4ca6f64","type":"text","conversion_output":true,"text":"Interpretation of Results: Higher AAU indicates more activity in the inorganic nitrite period vs placebo.","text_display":"\n\nInterpretation of Results: Higher AAU indicates more activity in the inorganic nitrite period vs placebo.","confidence":1,"confidence_rate":1},{"cnt":[[161,559],[707,559],[707,621],[161,621]],"region":{"top_left_x":161,"top_left_y":558,"width":546,"height":63},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce10b0219243455eb4e173c27393174a","type":"section_header","conversion_output":false,"children_ids":["26be1a6324854568a8f09b3ff815d85a"],"text":"","text_display":""},{"cnt":[[168,567],[700,567],[700,617],[168,617]],"region":{"top_left_x":167,"top_left_y":567,"width":534,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26be1a6324854568a8f09b3ff815d85a","type":"text","conversion_output":true,"parent_id":"ce10b0219243455eb4e173c27393174a","text":"9.2 - Secondary Endpoint \\#2","text_display":"\n\n\\section*{9.2 - Secondary Endpoint \\#2}","confidence":1,"confidence_rate":1},{"cnt":[[168,666],[1936,666],[1936,720],[168,720]],"region":{"top_left_x":167,"top_left_y":666,"width":1769,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"656c6b91721c41e39328b6d280c2fa4d","type":"text","conversion_output":true,"text":"Endpoint Description: Kansas City Cardiomyopathy Questionnaire Overall and Clinical Summary Scores","text_display":"\n\nEndpoint Description: Kansas City Cardiomyopathy Questionnaire Overall and Clinical Summary Scores","confidence":1,"confidence_rate":1},{"cnt":[[168,769],[1957,769],[1957,819],[168,819]],"region":{"top_left_x":167,"top_left_y":769,"width":1791,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34fd1ef01cd24c1d91f36cd10fef3f8f","type":"text","conversion_output":true,"text":"Response Variable Definition: Visit 2 and Visit 3 KCCQ scores, classified as to treatment received in prior","text_display":"\nResponse Variable Definition: Visit 2 and Visit 3 KCCQ scores, classified as to treatment received in prior","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[168,821],[1755,821],[1755,870],[168,870]],"region":{"top_left_x":167,"top_left_y":820,"width":1589,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf6eb23159904684ac32dac2a7c66562","type":"text","conversion_output":true,"text":"treatment period. Each summary score will be an individual endpoint and have its own model.","text_display":" treatment period. Each summary score will be an individual endpoint and have its own model.","confidence":1,"confidence_rate":1},{"cnt":[[168,920],[1970,920],[1970,971],[168,971]],"region":{"top_left_x":167,"top_left_y":919,"width":1804,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cce079cc3dc04dbd88e3ccf52a2125e0","type":"text","conversion_output":true,"text":"Additional Covariates: Baseline KCCQ score (as appropriate), period effect, sequence effect, and random","text_display":"\n\nAdditional Covariates: Baseline KCCQ score (as appropriate), period effect, sequence effect, and random","confidence":1,"confidence_rate":1},{"cnt":[[168,971],[445,971],[445,1021],[168,1021]],"region":{"top_left_x":167,"top_left_y":971,"width":278,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8559216a3c444aa6bdd94d48ebd61d18","type":"text","conversion_output":true,"text":"effect of patient","text_display":" effect of patient","confidence":1,"confidence_rate":1},{"cnt":[[168,1070],[1622,1070],[1622,1124],[168,1124]],"region":{"top_left_x":167,"top_left_y":1069,"width":1456,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23eb75e828cd447e9e758ea75c1f675e","type":"text","conversion_output":true,"text":"Handling of Dropouts and Missing Data: No adjustment for missing data will be made.","text_display":"\n\nHandling of Dropouts and Missing Data: No adjustment for missing data will be made.","confidence":1,"confidence_rate":1},{"cnt":[[168,1173],[1828,1173],[1828,1222],[168,1222]],"region":{"top_left_x":167,"top_left_y":1173,"width":1662,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2739fb4998b4b94827cfcc40c1b91c7","type":"text","conversion_output":true,"text":"Sensitivity Analysis: Due to the short washout period of the study drug, a separate analysis will be","text_display":"\nSensitivity Analysis: Due to the short washout period of the study drug, a separate analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[168,1225],[1910,1225],[1910,1274],[168,1274]],"region":{"top_left_x":167,"top_left_y":1224,"width":1743,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18ec8c446eec498fb84511dc735ca76b","type":"text","conversion_output":true,"text":"performed removing those patients that discontinued active study treatment prior to the next study visit","text_display":" performed removing those patients that discontinued active study treatment prior to the next study visit","confidence":1,"confidence_rate":1},{"cnt":[[168,1274],[982,1274],[982,1326],[168,1326]],"region":{"top_left_x":167,"top_left_y":1274,"width":815,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59fa63c15a5546a1919e56aeb38d35d5","type":"text","conversion_output":true,"text":"where the KCCQ questionnaire was completed.","text_display":" where the KCCQ questionnaire was completed.","confidence":1,"confidence_rate":1},{"cnt":[[168,1375],[1962,1375],[1962,1424],[168,1424]],"region":{"top_left_x":167,"top_left_y":1374,"width":1795,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d17b7c8f9c4b4cf7928fae374f91e48a","type":"text","conversion_output":true,"text":"Statistical Tests: A mixed model (PROC MIXED in SAS) will be used to estimate and statistically compare","text_display":"\n\nStatistical Tests: A mixed model (PROC MIXED in SAS) will be used to estimate and statistically compare","confidence":1,"confidence_rate":1},{"cnt":[[168,1427],[2000,1427],[2000,1476],[168,1476]],"region":{"top_left_x":167,"top_left_y":1426,"width":1834,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4de2c65eee1f4fc385c11e04f11f5d09","type":"text","conversion_output":true,"text":"the response to inorganic nitrite versus placebo on each KCCQ summary score. 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