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Although electroconvulsive therapy has well-established efficacy in the treatment of PD, its use is","text_display":" patients. Although electroconvulsive therapy has well-established efficacy in the treatment of PD, its use is","confidence":1,"confidence_rate":1},{"cnt":[[120,314],[1884,314],[1884,359],[120,359]],"region":{"top_left_x":120,"top_left_y":313,"width":1765,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f05aaf8e42e349eb962e85132bb02b2d","type":"text","conversion_output":true,"text":"limited by several factors. As a result, the pharmacologic treatment of PD is common. Expert guidelines","text_display":" limited by several factors. As a result, the pharmacologic treatment of PD is common. 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This goal will be addressed through a 36 -week double-blind RCT, in","text_display":" treatment with sertraline and olanzapine. This goal will be addressed through a 36 -week double-blind RCT, in","confidence":0.900390625,"confidence_rate":0.9991035936189336},{"cnt":[[120,1059],[1962,1059],[1962,1106],[120,1106]],"region":{"top_left_x":120,"top_left_y":1059,"width":1842,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d303aad1e4434048a8fd9b41758d63ce","type":"text","conversion_output":true,"text":"which placebo is substituted for olanzapine in half the study group, following a period of sustained remission.","text_display":" which placebo is substituted for olanzapine in half the study group, following a period of sustained remission.","confidence":1,"confidence_rate":1},{"cnt":[[120,1104],[1893,1104],[1893,1149],[120,1149]],"region":{"top_left_x":120,"top_left_y":1104,"width":1773,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55091575039a4ffaaba54ee6d41d46c6","type":"text","conversion_output":true,"text":"We hypothesize that sertraline+olanzapine will be more efficacious than sertraline+placebo in preventing","text_display":" We hypothesize that sertraline+olanzapine will be more efficacious than sertraline+placebo in preventing","confidence":1,"confidence_rate":1},{"cnt":[[120,1147],[1962,1147],[1962,1192],[120,1192]],"region":{"top_left_x":120,"top_left_y":1147,"width":1842,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc258e193931412f8715733f130a9ba9","type":"text","conversion_output":true,"text":"relapse of PD. This study provides the unique opportunity to systematically assess the effect of antipsychotic","text_display":" relapse of PD. This study provides the unique opportunity to systematically assess the effect of antipsychotic","confidence":1,"confidence_rate":1},{"cnt":[[120,1190],[1985,1190],[1985,1240],[120,1240]],"region":{"top_left_x":120,"top_left_y":1190,"width":1866,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8eb1766a0e04492b6f41e860ca22aad","type":"text","conversion_output":true,"text":"discontinuation (as opposed to switching from one antipsychotic to another) on olanzapine-related weight gain","text_display":" discontinuation (as opposed to switching from one antipsychotic to another) on olanzapine-related weight gain","confidence":1,"confidence_rate":1},{"cnt":[[120,1233],[1794,1233],[1794,1280],[120,1280]],"region":{"top_left_x":120,"top_left_y":1233,"width":1674,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e75a4bd8b0ae4a9bb699c6045659fce3","type":"text","conversion_output":true,"text":"and metabolic disturbance. Additional innovative aims of the study are to examine age and genetic","text_display":" and metabolic disturbance. Additional innovative aims of the study are to examine age and genetic","confidence":1,"confidence_rate":1},{"cnt":[[120,1278],[1899,1278],[1899,1326],[120,1326]],"region":{"top_left_x":120,"top_left_y":1278,"width":1780,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd9dcc0ad9834b82addfc1eae352b7f5","type":"text","conversion_output":true,"text":"polymorphisms as predictors/moderators of treatment variability, potentially leading to more personalized","text_display":" polymorphisms as predictors/moderators of treatment variability, potentially leading to more personalized","confidence":1,"confidence_rate":1},{"cnt":[[120,1323],[1957,1323],[1957,1369],[120,1369]],"region":{"top_left_x":120,"top_left_y":1323,"width":1838,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52fe967ac9564cd28a1c68cdff4cdeda","type":"text","conversion_output":true,"text":"treatment of PD, and to employ population pharmacokinetics to determine the magnitude and consistency of","text_display":" treatment of PD, and to employ population pharmacokinetics to determine the magnitude and consistency of","confidence":1,"confidence_rate":1},{"cnt":[[120,1366],[1964,1366],[1964,1414],[120,1414]],"region":{"top_left_x":120,"top_left_y":1366,"width":1844,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7248588088647e0bc56a6254265ad4f","type":"text","conversion_output":true,"text":"exposure to study drugs. Olanzapine is selected because it is the only atypical antipsychotic with established","text_display":" exposure to study drugs. Olanzapine is selected because it is the only atypical antipsychotic with established","confidence":1,"confidence_rate":1},{"cnt":[[120,1412],[1876,1412],[1876,1457],[120,1457]],"region":{"top_left_x":120,"top_left_y":1411,"width":1756,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e73a1c9f0ac450db417edaecb0e29a3","type":"text","conversion_output":true,"text":"efficacy and tolerability in the treatment of both younger and older adults with PD. This research will be","text_display":" efficacy and tolerability in the treatment of both younger and older adults with PD. This research will be","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[120,1452],[1979,1452],[1979,1502],[120,1502]],"region":{"top_left_x":120,"top_left_y":1452,"width":1859,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae55d6b3e80644ffb57ae01a98f21e9d","type":"text","conversion_output":true,"text":"transformative, by providing clinicians with a much-needed evidence base to guide the continuation treatment","text_display":" transformative, by providing clinicians with a much-needed evidence base to guide the continuation treatment","confidence":1,"confidence_rate":1},{"cnt":[[120,1500],[1141,1500],[1141,1545],[120,1545]],"region":{"top_left_x":120,"top_left_y":1499,"width":1021,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5300972b716e4066ae87c4a9192d1e5c","type":"text","conversion_output":true,"text":"of one of the most disabling and lethal psychiatric disorders.","text_display":" of one of the most disabling and lethal psychiatric disorders.","confidence":1,"confidence_rate":1},{"cnt":[[1977,2578],[2009,2578],[2009,2628],[1977,2628]],"region":{"top_left_x":1976,"top_left_y":2578,"width":33,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82ee3f34a7fc490ead0d1fcdf042273c","type":"page_info","conversion_output":false,"text":"\\(\\underline{2}\\)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-05","page":5,"lines":[{"cnt":[[889,122],[1233,122],[1233,174],[889,174]],"region":{"top_left_x":889,"top_left_y":122,"width":345,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f89e200945384a7bb14719c83da133a1","type":"section_header","conversion_output":false,"children_ids":["4c051690119140a5871d5e85e4e1069c"],"text":"","text_display":""},{"cnt":[[894,129],[1229,129],[1229,170],[894,170]],"region":{"top_left_x":893,"top_left_y":128,"width":336,"height":42},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c051690119140a5871d5e85e4e1069c","type":"text","conversion_output":true,"parent_id":"f89e200945384a7bb14719c83da133a1","text":"2. SPECIFIC AIMS","text_display":"\n\n\\section*{2. SPECIFIC AIMS}","confidence":0.9960966110229492,"confidence_rate":0.9998137779565912},{"cnt":[[120,168],[1974,168],[1974,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":1855,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d89f79ee465c4d7a8cd0c9da34bc64ab","type":"text","conversion_output":true,"text":"2.1 INTRODUCTION TO STUDY AIMS: Major depression with psychotic features (psychotic depression; PD)","text_display":"\n2.1 INTRODUCTION TO STUDY AIMS: Major depression with psychotic features (psychotic depression; PD)","confidence":1,"confidence_rate":1},{"cnt":[[120,211],[1983,211],[1983,260],[120,260]],"region":{"top_left_x":120,"top_left_y":210,"width":1864,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b42f535d7474749bcd7469cb529d71f","type":"text","conversion_output":true,"text":"is a severe disorder associated with considerable morbidity and mortality. \\({ }^{1}\\) Although ECT has well-established","text_display":" is a severe disorder associated with considerable morbidity and mortality. \\({ }^{1}\\) Although ECT has well-established","confidence":1,"confidence_rate":1},{"cnt":[[120,254],[2000,254],[2000,305],[120,305]],"region":{"top_left_x":120,"top_left_y":253,"width":1881,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c5308d54baa44b8b509d16c09ee86fc","type":"text","conversion_output":true,"text":"efficacy as a treatment for PD, \\({ }^{2,3}\\) its use is limited by several factors: a high rate of relapse following completion","text_display":" efficacy as a treatment for PD, \\({ }^{2,3}\\) its use is limited by several factors: a high rate of relapse following completion","confidence":0.6385748006869107,"confidence_rate":0.9966333756228707},{"cnt":[[120,296],[1953,296],[1953,350],[120,350]],"region":{"top_left_x":120,"top_left_y":296,"width":1833,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5886e3a81a64ab8affe0b4d7e3f8232","type":"text","conversion_output":true,"text":"of ECT, \\({ }^{4,5}\\) lower rates of response in non-academic centers, \\({ }^{6}\\) significant disparities in its availability, \\({ }^{7}\\) and the","text_display":" of ECT, \\({ }^{4,5}\\) lower rates of response in non-academic centers, \\({ }^{6}\\) significant disparities in its availability, \\({ }^{7}\\) and the","confidence":0.615234375,"confidence_rate":0.9968093641800936},{"cnt":[[120,348],[1850,348],[1850,393],[120,393]],"region":{"top_left_x":120,"top_left_y":348,"width":1730,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbcfed8acc4a4ff0b155c3e18df3c5fa","type":"text","conversion_output":true,"text":"fact that many patients prefer pharmacologic treatment, because they find the concept of ECT and the","text_display":" fact that many patients prefer pharmacologic treatment, because they find the concept of ECT and the","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1931,391],[1931,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1812,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73664f1340f04031a92d056eaab903b1","type":"text","conversion_output":true,"text":"potential side effect of cognitive impairment unacceptable. Because of these limitations, the pharmacologic","text_display":" potential side effect of cognitive impairment unacceptable. Because of these limitations, the pharmacologic","confidence":1,"confidence_rate":1},{"cnt":[[120,430],[1790,430],[1790,479],[120,479]],"region":{"top_left_x":120,"top_left_y":429,"width":1670,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47cd4aff94ba4bcd85ba8298b2a71dab","type":"text","conversion_output":true,"text":"treatment of PD is common. \\({ }^{8}\\) Expert guidelines recommend the combination of antidepressant and","text_display":" treatment of PD is common. \\({ }^{8}\\) Expert guidelines recommend the combination of antidepressant and","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[120,473],[1985,473],[1985,522],[120,522]],"region":{"top_left_x":120,"top_left_y":472,"width":1866,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9464ebd5d4c74ba39705b0a5373a9da5","type":"text","conversion_output":true,"text":"antipsychotic medications as an alternative to ECT in the treatment of PD. \\({ }^{9,10}\\) The recently completed Study of","text_display":" antipsychotic medications as an alternative to ECT in the treatment of PD. \\({ }^{9,10}\\) The recently completed Study of","confidence":1,"confidence_rate":1},{"cnt":[[120,518],[1987,518],[1987,569],[120,569]],"region":{"top_left_x":120,"top_left_y":517,"width":1868,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee0e46588c8d4c05aedb368fb62cc9cb","type":"text","conversion_output":true,"text":"the Pharmacotherapy of Psychotic Depression (STOP-PD) \\({ }^{11}\\), which involved collaboration of the current group","text_display":" the Pharmacotherapy of Psychotic Depression (STOP-PD) \\({ }^{11}\\), which involved collaboration of the current group","confidence":1,"confidence_rate":1},{"cnt":[[120,565],[1792,565],[1792,612],[120,612]],"region":{"top_left_x":120,"top_left_y":565,"width":1672,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0081a38c8c145d4a58a03640a104ba4","type":"text","conversion_output":true,"text":"of principal investigators, was the first NIMH-funded RCT to examine the efficacy and tolerability of","text_display":" of principal investigators, was the first NIMH-funded RCT to examine the efficacy and tolerability of","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[1966,610],[1966,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1846,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"496d17bf25b64294915480c9ad2383f6","type":"text","conversion_output":true,"text":"combination therapy using newer antidepressant and antipsychotic medications in the acute treatment of PD.","text_display":" combination therapy using newer antidepressant and antipsychotic medications in the acute treatment of PD.","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[1989,653],[1989,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1870,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05a7721fac384d05b6cc2d9608019477","type":"text","conversion_output":true,"text":"The combination of sertraline and olanzapine was significantly more efficacious than olanzapine monotherapy,","text_display":" The combination of sertraline and olanzapine was significantly more efficacious than olanzapine monotherapy,","confidence":1,"confidence_rate":1},{"cnt":[[120,692],[1906,692],[1906,743],[120,743]],"region":{"top_left_x":120,"top_left_y":691,"width":1786,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e20e0978fad4b36a82429c169c8fd16","type":"text","conversion_output":true,"text":"and the two treatments had comparable tolerability. \\({ }^{11}\\) Nevertheless, both treatments were associated with","text_display":" and the two treatments had comparable tolerability. \\({ }^{11}\\) Nevertheless, both treatments were associated with","confidence":1,"confidence_rate":1},{"cnt":[[120,735],[1068,735],[1068,788],[120,788]],"region":{"top_left_x":120,"top_left_y":734,"width":948,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"673f9416002a49828f923768ffe70d04","type":"text","conversion_output":true,"text":"increases in weight and lipids over the 12 -week study. \\({ }^{11}\\)","text_display":" increases in weight and lipids over the 12 -week study. \\({ }^{11}\\)","confidence":0.821864128112793,"confidence_rate":0.9972789838068217},{"cnt":[[185,786],[1974,786],[1974,831],[185,831]],"region":{"top_left_x":184,"top_left_y":786,"width":1791,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfc904524e6d41248174a1b9549ef287","type":"text","conversion_output":true,"text":"Once an episode of major depression responds to antidepressant medication, the antidepressant must be","text_display":"\n\nOnce an episode of major depression responds to antidepressant medication, the antidepressant must be","confidence":1,"confidence_rate":1},{"cnt":[[120,825],[1858,825],[1858,879],[120,879]],"region":{"top_left_x":120,"top_left_y":824,"width":1739,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96913d867df6480eae9743e252f06450","type":"text","conversion_output":true,"text":"continued to prevent relapse. \\({ }^{12}\\) However, it is not known whether antipsychotic medication needs to be","text_display":" continued to prevent relapse. \\({ }^{12}\\) However, it is not known whether antipsychotic medication needs to be","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1936,872],[1936,920],[120,920]],"region":{"top_left_x":120,"top_left_y":872,"width":1816,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14d89c36617f48fd9033ff32b493ffda","type":"text","conversion_output":true,"text":"continued once an episode of PD has responded to combined antidepressant-antipsychotic treatment. This","text_display":" continued once an episode of PD has responded to combined antidepressant-antipsychotic treatment. This","confidence":1,"confidence_rate":1},{"cnt":[[120,917],[1893,917],[1893,965],[120,965]],"region":{"top_left_x":120,"top_left_y":917,"width":1773,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3ea31eae7074b399a1574929fad1ea6","type":"text","conversion_output":true,"text":"issue is of profound clinical importance. On the one hand, the unnecessary continuation of antipsychotic","text_display":" issue is of profound clinical importance. On the one hand, the unnecessary continuation of antipsychotic","confidence":1,"confidence_rate":1},{"cnt":[[120,962],[1966,962],[1966,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":962,"width":1846,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa660e3585644dbb930785477e88f724","type":"text","conversion_output":true,"text":"medication exposes a patient to adverse effects, some of which have considerable public health significance.","text_display":" medication exposes a patient to adverse effects, some of which have considerable public health significance.","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[2000,1005],[2000,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1005,"width":1881,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49c1ed087db14ecf86cb05966556c958","type":"text","conversion_output":true,"text":"On the other hand, premature discontinuation of antipsychotic medication has the potential risk of early relapse","text_display":" On the other hand, premature discontinuation of antipsychotic medication has the potential risk of early relapse","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[2002,1048],[2002,1094],[120,1094]],"region":{"top_left_x":120,"top_left_y":1048,"width":1883,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c701487fdb744a7ba10f0d530326323","type":"text","conversion_output":true,"text":"of a severe, disabling disorder. The main goal of this collaborative Renewal Application, therefore, is to assess","text_display":" of a severe, disabling disorder. The main goal of this collaborative Renewal Application, therefore, is to assess","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1916,1091],[1916,1139],[120,1139]],"region":{"top_left_x":120,"top_left_y":1091,"width":1797,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbe13f537c654674b059c6ac0c47ba29","type":"text","conversion_output":true,"text":"the benefits and risks of continuing olanzapine in older and younger persons with PD, once the episode of","text_display":" the benefits and risks of continuing olanzapine in older and younger persons with PD, once the episode of","confidence":1,"confidence_rate":1},{"cnt":[[120,1137],[1966,1137],[1966,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1136,"width":1846,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94e804ff2572410fbadc6fb7227fd8f2","type":"text","conversion_output":true,"text":"depression has responded to treatment with sertraline and olanzapine. This goal will be addressed through a","text_display":" depression has responded to treatment with sertraline and olanzapine. This goal will be addressed through a","confidence":1,"confidence_rate":1},{"cnt":[[122,1182],[1916,1182],[1916,1227],[122,1227]],"region":{"top_left_x":122,"top_left_y":1181,"width":1795,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"745a2a0455b343368f3e6adff6e40a53","type":"text","conversion_output":true,"text":"RCT, in which placebo is substituted for olanzapine in half the study group, following a period of sustained","text_display":" RCT, in which placebo is substituted for olanzapine in half the study group, following a period of sustained","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1938,1225],[1938,1272],[120,1272]],"region":{"top_left_x":120,"top_left_y":1224,"width":1818,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81130683c91a45c8be98d384e36a1fd2","type":"text","conversion_output":true,"text":"remission. Specifically, we propose a three-phase study. In the Acute Phase, participants will receive open-","text_display":" remission. Specifically, we propose a three-phase study. In the Acute Phase, participants will receive open","confidence":1,"confidence_rate":1},{"cnt":[[120,1268],[1962,1268],[1962,1315],[120,1315]],"region":{"top_left_x":120,"top_left_y":1267,"width":1842,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0be42f7aecde4699b7717ee4d0962f43","type":"text","conversion_output":true,"text":"label sertraline and olanzapine for a maximum of 12 weeks. Subjects who respond to treatment will enter the","text_display":"label sertraline and olanzapine for a maximum of 12 weeks. Subjects who respond to treatment will enter the","confidence":1,"confidence_rate":1},{"cnt":[[120,1313],[1996,1313],[1996,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1312,"width":1876,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bafc5862b40f43978ef72c199750075e","type":"text","conversion_output":true,"text":"Stabilization Phase, where they will continue to receive open-label sertraline and olanzapine for an additional 8","text_display":" Stabilization Phase, where they will continue to receive open-label sertraline and olanzapine for an additional 8","confidence":1,"confidence_rate":1},{"cnt":[[120,1358],[1996,1358],[1996,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1357,"width":1876,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da7916d6be9a43709e6d16ae2788e515","type":"text","conversion_output":true,"text":"weeks. Participants who meet remission criteria will then be randomized to 36 weeks of double-blind treatment","text_display":" weeks. 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antidepressants, a single group of","text_display":" for the acute treatment of PD. \\({ }^{9,10}\\) Following the availability of SSRI and SNRI antidepressants, a single group of","confidence":0.9990234375,"confidence_rate":0.9999924260779239},{"cnt":[[120,696],[2007,696],[2007,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1887,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d0cc4f4bae14d4c84e2020e3adcec26","type":"text","conversion_output":true,"text":"investigators reported a high rate of response of PD to monotherapy with SSRIs and venlafaxine, based on 3","text_display":" investigators reported a high rate of response of PD to monotherapy with SSRIs and venlafaxine, based on 3","confidence":1,"confidence_rate":1},{"cnt":[[120,735],[2009,735],[2009,788],[120,788]],"region":{"top_left_x":120,"top_left_y":734,"width":1889,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b46ec17c31034e8689cff30a5beab40b","type":"text","conversion_output":true,"text":"separate RCTs. \\({ }^{22-24}\\) The findings of these studies are, however, limited by the fact that none included a","text_display":" separate RCTs. \\({ }^{22-24}\\) The findings of these studies are, however, limited by the fact that none included a","confidence":1,"confidence_rate":1},{"cnt":[[120,784],[2007,784],[2007,834],[120,834]],"region":{"top_left_x":120,"top_left_y":784,"width":1887,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7c2e4bc5d404014927a3673df407e6f","type":"text","conversion_output":true,"text":"placebo-control group, and they lacked a validated measure of psychosis, raising the possibility that persons","text_display":" placebo-control group, and they lacked a validated measure of psychosis, raising the possibility that persons","confidence":1,"confidence_rate":1},{"cnt":[[116,825],[2007,825],[2007,879],[116,879]],"region":{"top_left_x":116,"top_left_y":824,"width":1891,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d0bce99350e44989db5aff953517562","type":"text","conversion_output":true,"text":"with non-delusional ideation may have been inadvertently included in the studies. \\({ }^{25}\\) Also, these findings have","text_display":" with non-delusional ideation may have been inadvertently included in the studies. \\({ }^{25}\\) Also, these findings have","confidence":1,"confidence_rate":1},{"cnt":[[116,868],[2007,868],[2007,922],[116,922]],"region":{"top_left_x":116,"top_left_y":867,"width":1891,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1c5ed1ebb814f6fbfadbeb6227ed8ee","type":"text","conversion_output":true,"text":"not been replicated in studies by other groups of investigators. \\({ }^{26-28}\\) Thus, the efficacy of SSRI and SNRI","text_display":" not been replicated in studies by other groups of investigators. \\({ }^{26-28}\\) Thus, the efficacy of SSRI and SNRI","confidence":1,"confidence_rate":1},{"cnt":[[116,915],[2007,915],[2007,965],[116,965]],"region":{"top_left_x":116,"top_left_y":915,"width":1891,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab656c0ef2374f3f91defb6248cb322e","type":"text","conversion_output":true,"text":"monotherapy to treat PD is uncertain, and combined antidepressant-antipsychotic medication remains the","text_display":" monotherapy to treat PD is uncertain, and combined antidepressant-antipsychotic medication remains the","confidence":1,"confidence_rate":1},{"cnt":[[116,958],[1399,958],[1399,1008],[116,1008]],"region":{"top_left_x":116,"top_left_y":958,"width":1283,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"846b0e01e7f84e39b83507a4be999500","type":"text","conversion_output":true,"text":"pharmacologic treatment for PD that is recommended by expert guidelines.","text_display":" pharmacologic treatment for PD that is recommended by expert guidelines.","confidence":1,"confidence_rate":1},{"cnt":[[116,1003],[2004,1003],[2004,1051],[116,1051]],"region":{"top_left_x":116,"top_left_y":1003,"width":1889,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d58aba0000e84a1e8c46cceca986685b","type":"text","conversion_output":true,"text":"3.3 Longer Term Treatment of PD: The Conundrum. Little is known about the continuation and maintenance","text_display":"\n3.3 Longer Term Treatment of PD: The Conundrum. Little is known about the continuation and maintenance","confidence":0.99755859375,"confidence_rate":0.9999771554820448},{"cnt":[[116,1048],[1807,1048],[1807,1094],[116,1094]],"region":{"top_left_x":116,"top_left_y":1048,"width":1691,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc1fee6e9b9d42bbb10c76293dc23f52","type":"text","conversion_output":true,"text":"treatment of PD. Once an episode of major depression responds to antidepressant medication, the","text_display":" treatment of PD. Once an episode of major depression responds to antidepressant medication, the","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[116,1087],[2004,1087],[2004,1141],[116,1141]],"region":{"top_left_x":116,"top_left_y":1087,"width":1889,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a334230cee8a4a2ca760679d35f323fc","type":"text","conversion_output":true,"text":"antidepressant needs to be continued to prevent relapse and recurrence of depression. \\({ }^{12,29,30}\\) However, it is not","text_display":" antidepressant needs to be continued to prevent relapse and recurrence of depression. \\({ }^{12,29,30}\\) However, it is not","confidence":0.99951171875,"confidence_rate":0.999996184378388},{"cnt":[[116,1137],[1906,1137],[1906,1184],[116,1184]],"region":{"top_left_x":116,"top_left_y":1136,"width":1790,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dbdb3af1e914270b3e0c9a3582d291c","type":"text","conversion_output":true,"text":"known whether antipsychotic medication needs to be continued once an episode of PD has responded to","text_display":" known whether antipsychotic medication needs to be continued once an episode of PD has responded to","confidence":1,"confidence_rate":1},{"cnt":[[116,1182],[1785,1182],[1785,1227],[116,1227]],"region":{"top_left_x":116,"top_left_y":1181,"width":1670,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75b826d98c274928b8fc0eb9a2455c32","type":"text","conversion_output":true,"text":"combined antidepressant-antipsychotic treatment. On the one hand, premature discontinuation of","text_display":" combined antidepressant-antipsychotic treatment. On the one hand, premature discontinuation of","confidence":1,"confidence_rate":1},{"cnt":[[116,1225],[1946,1225],[1946,1274],[116,1274]],"region":{"top_left_x":116,"top_left_y":1224,"width":1831,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb9e1e6182d74a0c8771d2cc2ed0583d","type":"text","conversion_output":true,"text":"antipsychotic medication has the potential risk of relapse of a severe, disabling disorder. On the other hand,","text_display":" antipsychotic medication has the potential risk of relapse of a severe, disabling disorder. On the other hand,","confidence":1,"confidence_rate":1},{"cnt":[[116,1268],[1962,1268],[1962,1317],[116,1317]],"region":{"top_left_x":116,"top_left_y":1267,"width":1846,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"989c91bec0e04e1dbc7e219bffd07df3","type":"text","conversion_output":true,"text":"the unnecessary continuation of antipsychotic medication exposes a patient to potential adverse effects. The","text_display":" the unnecessary continuation of antipsychotic medication exposes a patient to potential adverse effects. The","confidence":1,"confidence_rate":1},{"cnt":[[116,1311],[1381,1311],[1381,1360],[116,1360]],"region":{"top_left_x":116,"top_left_y":1310,"width":1266,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4aa1e69506e14636bba167d6b5568f93","type":"text","conversion_output":true,"text":"two sides of this very significant clinical conundrum will now be discussed.","text_display":" two sides of this very significant clinical conundrum will now be discussed.","confidence":1,"confidence_rate":1},{"cnt":[[116,1354],[1927,1354],[1927,1403],[116,1403]],"region":{"top_left_x":116,"top_left_y":1353,"width":1812,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c248891f2cf24f59a6bb9d8838702b99","type":"text","conversion_output":true,"text":"3.4 Relapse of PD. Naturalistic observational studies of PD report relapse rates of \\(17 \\%-50 \\%\\) (mean \\(=30 \\%\\) )","text_display":"\n3.4 Relapse of PD. Naturalistic observational studies of PD report relapse rates of \\(17 \\%-50 \\%\\) (mean \\(=30 \\%\\) )","confidence":0.9315825331473206,"confidence_rate":0.9993839247179833},{"cnt":[[116,1449],[116,1393],[1880,1396],[1880,1452]],"region":{"top_left_x":115,"top_left_y":1393,"width":1765,"height":60},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63deda1ee00a493e91c23296abfb3773","type":"text","conversion_output":true,"text":"over 12 -months of follow-up. \\({ }^{31-36}\\) Studies that have specifically examined the frequency of relapse of PD","text_display":" over 12 -months of follow-up. \\({ }^{31-36}\\) Studies that have specifically examined the frequency of relapse of PD","confidence":0.998046875,"confidence_rate":0.999984233714323},{"cnt":[[116,1444],[1882,1444],[1882,1491],[116,1491]],"region":{"top_left_x":116,"top_left_y":1443,"width":1767,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0260c8861764825b58195e1b9999fcd","type":"text","conversion_output":true,"text":"following a course of ECT have, with one exception, found 12 -month rates of \\(35-50 \\%\\), despite adequate","text_display":" following a course of ECT have, with one exception, found 12 -month rates of \\(35-50 \\%\\), despite adequate","confidence":0.986328125,"confidence_rate":0.9998781826790568},{"cnt":[[116,1482],[1949,1482],[1949,1536],[116,1536]],"region":{"top_left_x":116,"top_left_y":1482,"width":1833,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"943298ed967441238dbf715b4931db7d","type":"text","conversion_output":true,"text":"continuation pharmacotherapy. \\({ }^{37-40}\\) The high rate of relapse after the discontinuation of ECT, and the lack of","text_display":" continuation pharmacotherapy. \\({ }^{37-40}\\) The high rate of relapse after the discontinuation of ECT, and the lack of","confidence":1,"confidence_rate":1},{"cnt":[[116,1532],[1893,1532],[1893,1579],[116,1579]],"region":{"top_left_x":116,"top_left_y":1531,"width":1777,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3046afd209f5476487bf1d2c720f4f14","type":"text","conversion_output":true,"text":"clarity regarding optimal continuation treatment following ECT, underscores the importance of examining","text_display":" clarity regarding optimal continuation treatment following ECT, underscores the importance of examining","confidence":1,"confidence_rate":1},{"cnt":[[116,1575],[1190,1575],[1190,1622],[116,1622]],"region":{"top_left_x":116,"top_left_y":1574,"width":1075,"height":49},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44919e6f64bf4406aaafa4cd3900c79c","type":"text","conversion_output":true,"text":"pharmacologic approaches to the longer-term treatment of PD.","text_display":" pharmacologic approaches to the longer-term treatment of PD.","confidence":1,"confidence_rate":1},{"cnt":[[245,1620],[1974,1620],[1974,1669],[245,1669]],"region":{"top_left_x":244,"top_left_y":1619,"width":1731,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bde678a0eec2479aaa68aebdcd226636","type":"text","conversion_output":true,"text":"There are few data on the relation between discontinuation of antipsychotic medication and relapse of","text_display":"\n\nThere are few data on the relation between discontinuation of antipsychotic medication and relapse of","confidence":1,"confidence_rate":1},{"cnt":[[120,1659],[1981,1659],[1981,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1658,"width":1861,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"445247761229439ab676f2f7f5038094","type":"text","conversion_output":true,"text":"PD. In a chart review of persons with PD who had responded to pharmacotherapy, Aronson et al. \\({ }^{32}\\) found that","text_display":" PD. In a chart review of persons with PD who had responded to pharmacotherapy, Aronson et al. \\({ }^{32}\\) found that","confidence":1,"confidence_rate":1},{"cnt":[[116,1706],[1957,1706],[1957,1755],[116,1755]],"region":{"top_left_x":116,"top_left_y":1705,"width":1842,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1597f6db91674a4ea8e3bb1437261039","type":"text","conversion_output":true,"text":"approximately \\(35 \\%\\) of relapses occurred following the discontinuation of antipsychotic medication in persons","text_display":" approximately \\(35 \\%\\) of relapses occurred following the discontinuation of antipsychotic medication in persons","confidence":0.9956097602844238,"confidence_rate":0.9999617406874081},{"cnt":[[116,1749],[1931,1749],[1931,1798],[116,1798]],"region":{"top_left_x":116,"top_left_y":1748,"width":1816,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8bc0b15d9804d628eb6d9718ed6e01c","type":"text","conversion_output":true,"text":"who continued to take antidepressant medication; the 3 months after antipsychotic discontinuation was the","text_display":" who continued to take antidepressant medication; the 3 months after antipsychotic discontinuation was the","confidence":1,"confidence_rate":1},{"cnt":[[116,1796],[1936,1796],[1936,1846],[116,1846]],"region":{"top_left_x":116,"top_left_y":1796,"width":1820,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da429cba84dd4f5ea44bdba3b43dc440","type":"text","conversion_output":true,"text":"period of greatest risk of relapse. The only prospective study of antipsychotic discontinuation in PD found a","text_display":" period of greatest risk of relapse. The only prospective study of antipsychotic discontinuation in PD found a","confidence":1,"confidence_rate":1},{"cnt":[[116,1839],[1966,1839],[1966,1886],[116,1886]],"region":{"top_left_x":116,"top_left_y":1839,"width":1850,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1f3118f281b49fc871e68d4d180e7a4","type":"text","conversion_output":true,"text":"frequency of relapse of \\(27 \\%\\) over 8 months in 30 mid-life adults who had recovered with combined fluoxetine","text_display":" frequency of relapse of \\(27 \\%\\) over 8 months in 30 mid-life adults who had recovered with combined fluoxetine","confidence":0.8740234375,"confidence_rate":0.9988785618878594},{"cnt":[[116,1878],[1989,1878],[1989,1931],[116,1931]],"region":{"top_left_x":116,"top_left_y":1877,"width":1874,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"218f5d6bc6414450b61e6c5c4b63a175","type":"text","conversion_output":true,"text":"and perphenazine; \\({ }^{41}\\) the findings of this single study are, however, limited by its open and uncontrolled design,","text_display":" and perphenazine; \\({ }^{41}\\) the findings of this single study are, however, limited by its open and uncontrolled design,","confidence":0.99951171875,"confidence_rate":0.999996184378388},{"cnt":[[116,1921],[1972,1921],[1972,1974],[116,1974]],"region":{"top_left_x":116,"top_left_y":1920,"width":1857,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8414cc29ce2474b9bb953389963bbf4","type":"text","conversion_output":true,"text":"the relatively small number of patients, and the absence of older patients who, based on studies of non-PD, \\({ }^{42}\\)","text_display":" the relatively small number of patients, and the absence of older patients who, based on studies of non-PD, \\({ }^{42}\\)","confidence":1,"confidence_rate":1},{"cnt":[[116,1972],[900,1972],[900,2020],[116,2020]],"region":{"top_left_x":116,"top_left_y":1972,"width":785,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b2e723e5d9d4a0f80eda716097aa43a","type":"text","conversion_output":true,"text":"may conceivably be at greater risk of relapse.","text_display":" may conceivably be at greater risk of relapse.","confidence":1,"confidence_rate":1},{"cnt":[[245,2015],[1962,2015],[1962,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2015,"width":1718,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5148e7476ef84c59a03baa4dd18659a3","type":"text","conversion_output":true,"text":"Finally, a few uncontrolled studies have examined relapse in persons with PD who are maintained on","text_display":"\n\nFinally, a few uncontrolled studies have examined relapse in persons with PD who are maintained on","confidence":1,"confidence_rate":1},{"cnt":[[116,2054],[1919,2054],[1919,2108],[116,2108]],"region":{"top_left_x":116,"top_left_y":2053,"width":1803,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27816f2e854a4c58a21c5e42eaf3a9ef","type":"text","conversion_output":true,"text":"the treatment to which they responded. \\({ }^{39,43,44}\\) In contrast with the aforementioned findings, relapse rates in","text_display":" the treatment to which they responded. \\({ }^{39,43,44}\\) In contrast with the aforementioned findings, relapse rates in","confidence":1,"confidence_rate":1},{"cnt":[[116,2101],[1979,2101],[1979,2151],[116,2151]],"region":{"top_left_x":116,"top_left_y":2101,"width":1863,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6960be9999b747269fc1646f918bf89a","type":"text","conversion_output":true,"text":"these studies range from only \\(0 \\%\\) to \\(6 \\%\\) over 12 months. Although the findings of these studies are limited by","text_display":" these studies range from only \\(0 \\%\\) to \\(6 \\%\\) over 12 months. Although the findings of these studies are limited by","confidence":1,"confidence_rate":1},{"cnt":[[116,2144],[1996,2144],[1996,2196],[116,2196]],"region":{"top_left_x":116,"top_left_y":2144,"width":1880,"height":52},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66ac5698fe6343ce83c86c697f856a55","type":"text","conversion_output":true,"text":"relatively small numbers of patients and uncontrolled design, they suggest a low risk of relapse in patients with","text_display":" relatively small numbers of patients and uncontrolled design, they suggest a low risk of relapse in patients with","confidence":1,"confidence_rate":1},{"cnt":[[116,2189],[1571,2189],[1571,2237],[116,2237]],"region":{"top_left_x":116,"top_left_y":2189,"width":1455,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be39b35bad0f480b8a0ceb69a1d29427","type":"text","conversion_output":true,"text":"PD who are maintained on the treatment regimen that was associated with response.","text_display":" PD who are maintained on the treatment regimen that was associated with response.","confidence":1,"confidence_rate":1},{"cnt":[[116,2230],[1962,2230],[1962,2282],[116,2282]],"region":{"top_left_x":116,"top_left_y":2230,"width":1846,"height":52},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"480226c92bb74a1ebcfaa2508b04a090","type":"text","conversion_output":true,"text":"3.5 Atypical Antipsychotics in the Treatment of PD: Choice of Olanzapine. Atypical antipsychotics have","text_display":"\n3.5 Atypical Antipsychotics in the Treatment of PD: Choice of Olanzapine. Atypical antipsychotics have","confidence":1,"confidence_rate":1},{"cnt":[[116,2277],[1998,2277],[1998,2327],[116,2327]],"region":{"top_left_x":116,"top_left_y":2277,"width":1883,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4a7af4d8383470d9be252bd9eda97e6","type":"text","conversion_output":true,"text":"become the first-line treatment of psychosis. Olanzapine is the only atypical with RCT-evidence of efficacy and","text_display":" become the first-line treatment of psychosis. Olanzapine is the only atypical with RCT-evidence of efficacy and","confidence":1,"confidence_rate":1},{"cnt":[[116,2316],[1811,2316],[1811,2370],[116,2370]],"region":{"top_left_x":116,"top_left_y":2316,"width":1696,"height":54},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceaf40b13b97474aaea6c7864ee8b554","type":"text","conversion_output":true,"text":"tolerability in the treatment of both younger and older persons with PD. \\({ }^{11,45} In\\) STOP-PD, only \\(5 \\%\\) of","text_display":" tolerability in the treatment of both younger and older persons with PD. \\({ }^{11,45} In\\) STOP-PD, only \\(5 \\%\\) of","confidence":0.7615769704319632,"confidence_rate":0.9977515890383896},{"cnt":[[116,2363],[1996,2363],[1996,2415],[116,2415]],"region":{"top_left_x":116,"top_left_y":2363,"width":1880,"height":52},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d802e8ae1c3f497983c7d455956d8cc7","type":"text","conversion_output":true,"text":"participants withdrew from the 12 -week study because of side effects. \\({ }^{1}\\) Nevertheless, olanzapine is associated","text_display":" participants withdrew from the 12 -week study because of side effects. \\({ }^{1}\\) Nevertheless, olanzapine is associated","confidence":0.96875,"confidence_rate":0.9997539163431283},{"cnt":[[116,2402],[2002,2402],[2002,2460],[116,2460]],"region":{"top_left_x":116,"top_left_y":2401,"width":1887,"height":59},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73f05e8fbe7941438c81fbefa90ddfb7","type":"text","conversion_output":true,"text":"with weight gain and metabolic effects. \\({ }^{11,46}\\) Our choice of olanzapine for the proposed study is based on careful","text_display":" with weight gain and metabolic effects. \\({ }^{11,46}\\) Our choice of olanzapine for the proposed study is based on careful","confidence":1,"confidence_rate":1},{"cnt":[[116,2454],[1923,2454],[1923,2503],[116,2503]],"region":{"top_left_x":116,"top_left_y":2453,"width":1807,"height":50},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5257a27f0f1f473385f5cc3008de47cd","type":"text","conversion_output":true,"text":"consideration of alternative atypical antipsychotics that have less severe metabolic effects but do not have","text_display":" consideration of alternative atypical antipsychotics that have less severe metabolic effects but do not have","confidence":1,"confidence_rate":1},{"cnt":[[116,2496],[1979,2496],[1979,2546],[116,2546]],"region":{"top_left_x":116,"top_left_y":2496,"width":1863,"height":50},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d955ac2f12fe483ebc9bf0bde6aa74e7","type":"text","conversion_output":true,"text":"documented efficacy for the treatment of PD. Without evidence, efficacy of other atypical antipsychotics in PD","text_display":" documented efficacy for the treatment of PD. Without evidence, efficacy of other atypical antipsychotics in PD","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[1972,2578],[2009,2578],[2009,2628],[1972,2628]],"region":{"top_left_x":1972,"top_left_y":2578,"width":37,"height":50},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d85317ad38c84ffaaf9edd99570ab1a0","type":"page_info","conversion_output":false,"text":"\\(\\underline{4}\\)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9998779073293896}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-07","page":7,"lines":[{"cnt":[[120,125],[1893,125],[1893,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1773,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e3a771dd9fe4331a8fe7507ea4f1a3a","type":"text","conversion_output":true,"text":"cannot be assumed; for example, olanzapine has been found to be more effective than other atypicals in","text_display":"\ncannot be assumed; for example, olanzapine has been found to be more effective than other atypicals in","confidence":1,"confidence_rate":1},{"cnt":[[120,163],[1901,163],[1901,217],[120,217]],"region":{"top_left_x":120,"top_left_y":163,"width":1782,"height":54},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5daa3f5d5098456190c4962774e1cb09","type":"text","conversion_output":true,"text":"several RCTs of the treatment of schizophrenia. \\({ }^{47-51}\\) Each atypical antipsychotic has a number of adverse","text_display":" several RCTs of the treatment of schizophrenia. \\({ }^{47-51}\\) Each atypical antipsychotic has a number of adverse","confidence":1,"confidence_rate":1},{"cnt":[[120,208],[1888,208],[1888,260],[120,260]],"region":{"top_left_x":120,"top_left_y":208,"width":1769,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2f0fbeb7f384708bfe9381bf8cf8f8a","type":"text","conversion_output":true,"text":"effects, some of which are potentially problematic in the treatment of PD, especially in older patients. \\({ }^{52-54}\\)","text_display":" effects, some of which are potentially problematic in the treatment of PD, especially in older patients. \\({ }^{52-54}\\)","confidence":0.99951171875,"confidence_rate":0.9999959636403931},{"cnt":[[120,258],[1966,258],[1966,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1846,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d6fb1b811604a64891ca6ec83af329f","type":"text","conversion_output":true,"text":"Although aripiprazole and ziprasidone have a low incidence of clinically significant weight gain and metabolic","text_display":" Although aripiprazole and ziprasidone have a low incidence of clinically significant weight gain and metabolic","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,296],[1968,296],[1968,350],[120,350]],"region":{"top_left_x":120,"top_left_y":296,"width":1848,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dec50e01e7cb4d94ac953a8773545dfc","type":"text","conversion_output":true,"text":"dysregulation, \\({ }^{52,53}\\) there are few data on the efficacy, tolerability, and safety of these drugs in older persons. \\({ }^{54}\\)","text_display":" dysregulation, \\({ }^{52,53}\\) there are few data on the efficacy, tolerability, and safety of these drugs in older persons. \\({ }^{54}\\)","confidence":0.99951171875,"confidence_rate":0.9999964608722185},{"cnt":[[120,346],[1871,346],[1871,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1752,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21fa1799e503404ba7c01a76a52eee2e","type":"text","conversion_output":true,"text":"Ziprasidone's potential for QTc interval prolongation is a potential concern in older persons with cardiac","text_display":" Ziprasidone's potential for QTc interval prolongation is a potential concern in older persons with cardiac","confidence":1,"confidence_rate":1},{"cnt":[[120,387],[1968,387],[1968,436],[120,436]],"region":{"top_left_x":120,"top_left_y":386,"width":1848,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36a697994e8c4bd9a2cb8c97bedcda58","type":"text","conversion_output":true,"text":"disease \\({ }^{54}\\) and would potentially result in the exclusion of many older patients who would otherwise be eligible","text_display":" disease \\({ }^{54}\\) and would potentially result in the exclusion of many older patients who would otherwise be eligible","confidence":1,"confidence_rate":1},{"cnt":[[120,430],[1938,430],[1938,479],[120,479]],"region":{"top_left_x":120,"top_left_y":429,"width":1818,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba4d0113fd124eb2a1fb2068606f16e5","type":"text","conversion_output":true,"text":"for the study. Both ziprasidone and aripiprazole are associated with activation and insomnia, \\({ }^{52-54}\\) and in the","text_display":" for the study. Both ziprasidone and aripiprazole are associated with activation and insomnia, \\({ }^{52-54}\\) and in the","confidence":1,"confidence_rate":1},{"cnt":[[120,473],[1957,473],[1957,524],[120,524]],"region":{"top_left_x":120,"top_left_y":472,"width":1838,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62a0db928bcc4f1da248cd44dfd5534d","type":"text","conversion_output":true,"text":"case of aripirazole, akathisia and nausea. \\({ }^{52-54}\\) In a recent open-label pilot study of combined aripiprazole and","text_display":" case of aripirazole, akathisia and nausea. \\({ }^{52-54}\\) In a recent open-label pilot study of combined aripiprazole and","confidence":0.99951171875,"confidence_rate":0.9999961543341811},{"cnt":[[120,520],[1983,520],[1983,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1864,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbea7c21ebda4d55b5d7e5815ca4584d","type":"text","conversion_output":true,"text":"citalopram in 16 younger adults with PD, \\(63 \\%\\) of participants developed akathisia on a mean daily aripiprazole","text_display":" citalopram in 16 younger adults with PD, \\(63 \\%\\) of participants developed akathisia on a mean daily aripiprazole","confidence":0.9941489668563008,"confidence_rate":0.9999510993831596},{"cnt":[[120,563],[1940,563],[1940,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1821,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0d145fdec07446493e81d7b5bed989f","type":"text","conversion_output":true,"text":"dose of \\(14.4 \\pm 5.5 mg .^{55}\\) The tolerability of aripiprazole and ziprasidone in persons with agitation (a frequent","text_display":" dose of \\(14.4 \\pm 5.5 mg .^{55}\\) The tolerability of aripiprazole and ziprasidone in persons with agitation (a frequent","confidence":0.9702432086924091,"confidence_rate":0.9997602786718643},{"cnt":[[120,610],[1815,610],[1815,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1696,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1c85e909f8e4b3fa3575b3e91c2ef47","type":"text","conversion_output":true,"text":"symptom of PD) is unclear. In addition, patients with PD are at high risk of attempted and completed","text_display":" symptom of PD) is unclear. In addition, patients with PD are at high risk of attempted and completed","confidence":1,"confidence_rate":1},{"cnt":[[120,649],[1983,649],[1983,700],[120,700]],"region":{"top_left_x":120,"top_left_y":648,"width":1864,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b42f6cc88ca64b619ef988d969ac48a8","type":"text","conversion_output":true,"text":"suicide. \\({ }^{20,21}\\) It is unknown whether the activating effects of aripiprazole and ziprasidone, especially when given","text_display":" suicide. \\({ }^{20,21}\\) It is unknown whether the activating effects of aripiprazole and ziprasidone, especially when given","confidence":0.99951171875,"confidence_rate":0.9999962139567942},{"cnt":[[120,696],[1987,696],[1987,743],[120,743]],"region":{"top_left_x":120,"top_left_y":696,"width":1868,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db9aee4ada454f3f817c6ba887dd7f89","type":"text","conversion_output":true,"text":"in combination with an SSRI, would increase the risk of suicidality in persons with PD. In light of the efficacy of","text_display":" in combination with an SSRI, would increase the risk of suicidality in persons with PD. In light of the efficacy of","confidence":1,"confidence_rate":1},{"cnt":[[120,735],[1858,735],[1858,786],[120,786]],"region":{"top_left_x":120,"top_left_y":734,"width":1739,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a353ebcd7264fdda16217f56a4cbee5","type":"text","conversion_output":true,"text":"the sertraline/olanzapine combination in STOP-PD, \\({ }^{11}\\) and the good overall tolerability and safety of this","text_display":" the sertraline/olanzapine combination in STOP-PD, \\({ }^{11}\\) and the good overall tolerability and safety of this","confidence":1,"confidence_rate":1},{"cnt":[[120,782],[1919,782],[1919,831],[120,831]],"region":{"top_left_x":120,"top_left_y":782,"width":1799,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d66bbf3be65414d86bacd5c4889e427","type":"text","conversion_output":true,"text":"treatment, \\({ }^{11}\\) we have chosen to continue to study this regimen rather than simply assuming that a different","text_display":" treatment, \\({ }^{11}\\) we have chosen to continue to study this regimen rather than simply assuming that a different","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1996,829],[1996,874],[120,874]],"region":{"top_left_x":120,"top_left_y":829,"width":1876,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb748097458d4fbd8d8358847cf2c5aa","type":"text","conversion_output":true,"text":"antidepressant-antipsychotic combination would be comparably efficacious and better tolerated in younger and","text_display":" antidepressant-antipsychotic combination would be comparably efficacious and better tolerated in younger and","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1996,872],[1996,920],[120,920]],"region":{"top_left_x":120,"top_left_y":872,"width":1876,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6411290a9e0c4d98b7031727beb78852","type":"text","conversion_output":true,"text":"older patients. Finally, olanzapine accounts for \\(25 \\%\\) of sales of atypical antipsychotics in the United States and","text_display":" older patients. Finally, olanzapine accounts for \\(25 \\%\\) of sales of atypical antipsychotics in the United States and","confidence":0.9985356330871582,"confidence_rate":0.9999878889977525},{"cnt":[[120,911],[1871,911],[1871,965],[120,965]],"region":{"top_left_x":120,"top_left_y":910,"width":1752,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8178ec32ad4b4f7fa3f9e7a4b6fc3f49","type":"text","conversion_output":true,"text":"\\(30 \\%\\) of sales worldwide. \\({ }^{56}\\) These figures have remained constant over the past 4 years. \\({ }^{56}\\) This ongoing,","text_display":" \\(30 \\%\\) of sales worldwide. \\({ }^{56}\\) These figures have remained constant over the past 4 years. \\({ }^{56}\\) This ongoing,","confidence":1,"confidence_rate":1},{"cnt":[[120,962],[1846,962],[1846,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":962,"width":1726,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95a5482dd51d47cc842d14065818fe72","type":"text","conversion_output":true,"text":"widespread use of olanzapine, despite its known metabolic effects, underscores the importance of the","text_display":" widespread use of olanzapine, despite its known metabolic effects, underscores the importance of the","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[1992,1005],[1992,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1005,"width":1872,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9ac5d0e788d49dbac9623eff33df3e8","type":"text","conversion_output":true,"text":"proposed study, to provide patients and clinicians with the best available evidence about the risks and benefits","text_display":" proposed study, to provide patients and clinicians with the best available evidence about the risks and benefits","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1222,1048],[1222,1094],[120,1094]],"region":{"top_left_x":120,"top_left_y":1048,"width":1103,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d6afda3736c4123bf0d230d9c57f86f","type":"text","conversion_output":true,"text":"of discontinuing this medication in the long-term treatment of PD.","text_display":" of discontinuing this medication in the long-term treatment of PD.","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1876,1091],[1876,1137],[120,1137]],"region":{"top_left_x":120,"top_left_y":1091,"width":1756,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b8a57a3ac8041b5b19772694b435c0c","type":"text","conversion_output":true,"text":"3.6 Personalizing the Treatment of PD: Pharmacogenetic Considerations. As with other psychiatric","text_display":"\n3.6 Personalizing the Treatment of PD: Pharmacogenetic Considerations. As with other psychiatric","confidence":1,"confidence_rate":1},{"cnt":[[120,1130],[1800,1130],[1800,1182],[120,1182]],"region":{"top_left_x":120,"top_left_y":1130,"width":1681,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00e7a179ef0946968122442f9d095f2c","type":"text","conversion_output":true,"text":"disorders, the pharmacologic treatment of PD is associated with considerable treatment variability. \\({ }^{8}\\)","text_display":" disorders, the pharmacologic treatment of PD is associated with considerable treatment variability. \\({ }^{8}\\)","confidence":1,"confidence_rate":1},{"cnt":[[122,1182],[1972,1182],[1972,1227],[122,1227]],"region":{"top_left_x":122,"top_left_y":1181,"width":1851,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9926007816114c20b69f9893fed93ce4","type":"text","conversion_output":true,"text":"Pharmacogenetic findings have the potential to result in more personalized treatment and possibly preventive","text_display":" Pharmacogenetic findings have the potential to result in more personalized treatment and possibly preventive","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1940,1225],[1940,1270],[120,1270]],"region":{"top_left_x":120,"top_left_y":1224,"width":1821,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b90972e8cc045cf9119de118b03dba6","type":"text","conversion_output":true,"text":"strategies. Because the number of individuals recruited to a clinical trial is insufficient to conduct a genome-","text_display":" strategies. Because the number of individuals recruited to a clinical trial is insufficient to conduct a genome","confidence":1,"confidence_rate":1},{"cnt":[[120,1263],[1921,1263],[1921,1315],[120,1315]],"region":{"top_left_x":120,"top_left_y":1263,"width":1801,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b405991d286347abaa806295e05b6388","type":"text","conversion_output":true,"text":"wide association study, \\({ }^{57}\\) we will use a candidate-gene approach to explore the following important issues:","text_display":"wide association study, \\({ }^{57}\\) we will use a candidate-gene approach to explore the following important issues:","confidence":1,"confidence_rate":1},{"cnt":[[122,1313],[1998,1313],[1998,1360],[122,1360]],"region":{"top_left_x":122,"top_left_y":1312,"width":1877,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"657f63455dfd4f2cbd62a04e2d1a7945","type":"text","conversion_output":true,"text":"1) Genetic predictors of relapse of either mood disorders or primary psychotic disorders are currently unknown.","text_display":"\n1) Genetic predictors of relapse of either mood disorders or primary psychotic disorders are currently unknown.","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[122,1358],[1867,1358],[1867,1403],[122,1403]],"region":{"top_left_x":122,"top_left_y":1357,"width":1745,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"492a6f59e5e549908cba3a62b7905f84","type":"text","conversion_output":true,"text":"We will therefore explore this issue in relation to the proposed study. We assume that the withdrawal of","text_display":" We will therefore explore this issue in relation to the proposed study. We assume that the withdrawal of","confidence":1,"confidence_rate":1},{"cnt":[[120,1401],[1936,1401],[1936,1446],[120,1446]],"region":{"top_left_x":120,"top_left_y":1400,"width":1816,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d32e42f475e740f396f8d6863fabed0f","type":"text","conversion_output":true,"text":"olanzapine will remove pharmacologic antagonism of principally D2 and 5HT2A postsynaptic receptors; the","text_display":" olanzapine will remove pharmacologic antagonism of principally D2 and 5HT2A postsynaptic receptors; the","confidence":1,"confidence_rate":1},{"cnt":[[120,1439],[1951,1439],[1951,1489],[120,1489]],"region":{"top_left_x":120,"top_left_y":1439,"width":1831,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddb585363853468b958be1af4524aeaa","type":"text","conversion_output":true,"text":"synaptic system will then adapt using autoreceptor mechanisms that might include \\(5 HT 1 A .^{58-60}\\) We therefore","text_display":" synaptic system will then adapt using autoreceptor mechanisms that might include \\(5 HT 1 A .^{58-60}\\) We therefore","confidence":0.4229265268659219,"confidence_rate":0.9931934542304672},{"cnt":[[120,1489],[1893,1489],[1893,1534],[120,1534]],"region":{"top_left_x":120,"top_left_y":1488,"width":1773,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6d5d51fff3c407a8a2f6795814266f9","type":"text","conversion_output":true,"text":"hypothesize that the genes producing these receptors will be of primary interest as potentially involved in","text_display":" hypothesize that the genes producing these receptors will be of primary interest as potentially involved in","confidence":1,"confidence_rate":1},{"cnt":[[120,1532],[1974,1532],[1974,1577],[120,1577]],"region":{"top_left_x":120,"top_left_y":1531,"width":1855,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d2e8282ef7c4ae19297952c3fd796c6","type":"text","conversion_output":true,"text":"relapse of PD following discontinuation of olanzapine. Of note, the 5HT1A-1019 C/G polymorphism has been","text_display":" relapse of PD following discontinuation of olanzapine. Of note, the 5HT1A-1019 C/G polymorphism has been","confidence":0.6933274269104004,"confidence_rate":0.9966455204046738},{"cnt":[[120,1573],[2002,1573],[2002,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1572,"width":1883,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08f0a8cdda8e409498a0b340052ced1a","type":"text","conversion_output":true,"text":"implicated in vulnerability to both depression and psychosis, \\({ }^{61,62}\\) and the Taq1A and -141ins/del polymorphisms","text_display":" implicated in vulnerability to both depression and psychosis, \\({ }^{61,62}\\) and the Taq1A and -141ins/del polymorphisms","confidence":0.8355890773236752,"confidence_rate":0.9985754733721824},{"cnt":[[120,1616],[1311,1616],[1311,1665],[120,1665]],"region":{"top_left_x":120,"top_left_y":1615,"width":1191,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fc8a4ac021a4266ade73c9b3f133a6c","type":"text","conversion_output":true,"text":"of the D2 gene have been associated with vulnerability to psychosis. \\({ }^{63}\\)","text_display":" of the D2 gene have been associated with vulnerability to psychosis. \\({ }^{63}\\)","confidence":1,"confidence_rate":1},{"cnt":[[120,1663],[1996,1663],[1996,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1662,"width":1876,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad5625b7aa2844afa56be7776d503bfd","type":"text","conversion_output":true,"text":"2) Several genetic polymorphisms (5HT2C-759C/T, 5HTTLPR s allele, SNAP 25, Leptin -2584 A/G, ADR \\(\\alpha 2 a\\) -","text_display":"\n2) Several genetic polymorphisms (5HT2C-759C/T, 5HTTLPR s allele, SNAP 25, Leptin -2584 A/G, ADR \\(\\alpha 2 a\\) ","confidence":0.19942178909141928,"confidence_rate":0.985832876700615},{"cnt":[[122,1706],[1964,1706],[1964,1755],[122,1755]],"region":{"top_left_x":122,"top_left_y":1705,"width":1842,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"330bde199f764694ad994daf052e2fef","type":"text","conversion_output":true,"text":"1291C/G, INSIG2) have been associated with antipsychotic-related weight gain. \\({ }^{64-77}\\) However, it is not known","text_display":"1291C/G, INSIG2) have been associated with antipsychotic-related weight gain. \\({ }^{64-77}\\) However, it is not known","confidence":0.816185474395752,"confidence_rate":0.9983500321855292},{"cnt":[[120,1755],[1996,1755],[1996,1800],[120,1800]],"region":{"top_left_x":120,"top_left_y":1755,"width":1876,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ec34eeca6104f01aca9d82683e61a0f","type":"text","conversion_output":true,"text":"whether these polymorphisms predict reversal of weight gain following discontinuation of the antipsychotic. We","text_display":" whether these polymorphisms predict reversal of weight gain following discontinuation of the antipsychotic. We","confidence":1,"confidence_rate":1},{"cnt":[[120,1800],[666,1800],[666,1846],[120,1846]],"region":{"top_left_x":120,"top_left_y":1800,"width":547,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9384e1e1b68946eda7b592342f0e1507","type":"text","conversion_output":true,"text":"will explore this important issue.","text_display":" will explore this important issue.","confidence":1,"confidence_rate":1},{"cnt":[[120,1843],[1927,1843],[1927,1888],[120,1888]],"region":{"top_left_x":120,"top_left_y":1843,"width":1808,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce67e1c490134ea7a7c294dcf21d4ad8","type":"text","conversion_output":true,"text":"3) There have been no published studies of the pharmacogenetics of response or remission in PD. We will","text_display":"\n3) There have been no published studies of the pharmacogenetics of response or remission in PD. We will","confidence":0.998046875,"confidence_rate":0.9999818979894378},{"cnt":[[120,1886],[1970,1886],[1970,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1886,"width":1851,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"966f461f381043dba51fca14ff3346f9","type":"text","conversion_output":true,"text":"therefore explore whether genetic polymorphisms that have been associated with antidepressant response in","text_display":" therefore explore whether genetic polymorphisms that have been associated with antidepressant response in","confidence":1,"confidence_rate":1},{"cnt":[[120,1925],[1968,1925],[1968,1979],[120,1979]],"region":{"top_left_x":120,"top_left_y":1925,"width":1848,"height":54},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89a35547a79941718604324a9114d1b6","type":"text","conversion_output":true,"text":"non-PD (5HTTLPR s and lg alleles, 5HT2A-1438G/A, FKBP5, CRHR1) \\({ }^{78-86}\\) and antipsychotic response (D2 -","text_display":" non-PD (5HTTLPR s and lg alleles, 5HT2A-1438G/A, FKBP5, CRHR1) \\({ }^{78-86}\\) and antipsychotic response (D2 ","confidence":0.2815132193749089,"confidence_rate":0.9891321087142592},{"cnt":[[122,1968],[1841,1968],[1841,2020],[122,2020]],"region":{"top_left_x":122,"top_left_y":1967,"width":1720,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57ac29cf57024321878cb5dedd77d313","type":"text","conversion_output":true,"text":"\\(141 ins /\\) del and Taq1A, D3 ser9gly, SNAP 25) and weight gain in schizophrenia \\({ }^{64-77,87-93}\\) pertain to PD.","text_display":"\\(141 ins /\\) del and Taq1A, D3 ser9gly, SNAP 25) and weight gain in schizophrenia \\({ }^{64-77,87-93}\\) pertain to PD.","confidence":0.6492096678193775,"confidence_rate":0.9964064759545991},{"cnt":[[245,2017],[2002,2017],[2002,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2017,"width":1759,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e6037dbfbcc4b8fbc4a9f0bb556f4ae","type":"text","conversion_output":true,"text":"Finally, it is important to note that we will participate in the NIMH Human Genetics Initiative so that cell","text_display":"\n\nFinally, it is important to note that we will participate in the NIMH Human Genetics Initiative so that cell","confidence":1,"confidence_rate":1},{"cnt":[[120,2062],[2004,2062],[2004,2108],[120,2108]],"region":{"top_left_x":120,"top_left_y":2062,"width":1885,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d874abd896bd45aebbb028233ae04485","type":"text","conversion_output":true,"text":"lines, DNA, and genetic data from this very well characterized sample will be available to the wider scientific","text_display":" lines, DNA, and genetic data from this very well characterized sample will be available to the wider scientific","confidence":1,"confidence_rate":1},{"cnt":[[120,2101],[2004,2101],[2004,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2101,"width":1885,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac04e6c6b675468ab1778cd2e452345b","type":"text","conversion_output":true,"text":"community. For example, there is emerging evidence that certain genes (e.g.DISC1, \\({ }^{94}\\) CACNA1C \\({ }^{95}\\) )may confer","text_display":" community. For example, there is emerging evidence that certain genes (e.g.DISC1, \\({ }^{94}\\) CACNA1C \\({ }^{95}\\) )may confer","confidence":0.998535871389322,"confidence_rate":0.9999889000502842},{"cnt":[[120,2148],[2004,2148],[2004,2196],[120,2196]],"region":{"top_left_x":120,"top_left_y":2148,"width":1885,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac40d3568f0b41d888af1fe4a4eb49a1","type":"text","conversion_output":true,"text":"risk for severe psychiatric illness, as opposed to specific disorders. The genetic data from our study will provide","text_display":" risk for severe psychiatric illness, as opposed to specific disorders. The genetic data from our study will provide","confidence":1,"confidence_rate":1},{"cnt":[[120,2194],[2004,2194],[2004,2241],[120,2241]],"region":{"top_left_x":120,"top_left_y":2193,"width":1885,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07e475c380004649b21c4fd14de1a275","type":"text","conversion_output":true,"text":"scientists with the unique opportunity to include persons with psychotic depression in analyses pertaining to","text_display":" scientists with the unique opportunity to include persons with psychotic depression in analyses pertaining to","confidence":1,"confidence_rate":1},{"cnt":[[120,2239],[591,2239],[591,2284],[120,2284]],"region":{"top_left_x":120,"top_left_y":2238,"width":471,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b255167a4f954d50aca076977a805e51","type":"text","conversion_output":true,"text":"these 'susceptibility genes'.","text_display":" these 'susceptibility genes'.","confidence":0.98779296875,"confidence_rate":0.9996388255629708},{"cnt":[[935,2279],[1190,2279],[1190,2327],[935,2327]],"region":{"top_left_x":934,"top_left_y":2279,"width":257,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3452b16ff5fe4f4d8a184ae83fe554ff","type":"section_header","conversion_output":false,"children_ids":["b9ef43941e044de889ebe3420c365de1"],"text":"","text_display":""},{"cnt":[[941,2282],[1188,2282],[1188,2322],[941,2322]],"region":{"top_left_x":941,"top_left_y":2281,"width":248,"height":42},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9ef43941e044de889ebe3420c365de1","type":"text","conversion_output":true,"parent_id":"3452b16ff5fe4f4d8a184ae83fe554ff","text":"INNOVATION","text_display":"\n\n\\section*{INNOVATION}","confidence":1,"confidence_rate":1},{"cnt":[[131,2325],[1854,2325],[1854,2370],[131,2370]],"region":{"top_left_x":131,"top_left_y":2324,"width":1724,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f7d490952b348959c467065a6cbf649","type":"text","conversion_output":true,"text":"3.7 In addition to being transformative, the proposed research is innovative in several important ways:","text_display":"\n3.7 In addition to being transformative, the proposed research is innovative in several important ways:","confidence":1,"confidence_rate":1},{"cnt":[[122,2368],[1807,2368],[1807,2417],[122,2417]],"region":{"top_left_x":122,"top_left_y":2367,"width":1685,"height":50},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"088e810c468943469d650d71d890db7f","type":"text","conversion_output":true,"text":"- By focusing on PD, this study provides the unique opportunity to assess the effect of antipsychotic","text_display":"\n- By focusing on PD, this study provides the unique opportunity to assess the effect of antipsychotic","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[120,2415],[1919,2415],[1919,2460],[120,2460]],"region":{"top_left_x":120,"top_left_y":2414,"width":1799,"height":46},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ec78ad1646f4aeab7e47558d6777ba0","type":"text","conversion_output":true,"text":"discontinuation (as opposed to switching from one antipsychotic to another, which is the case in studies of","text_display":" discontinuation (as opposed to switching from one antipsychotic to another, which is the case in studies of","confidence":0.9990234375,"confidence_rate":0.999991276469766},{"cnt":[[120,2458],[1467,2458],[1467,2503],[120,2503]],"region":{"top_left_x":120,"top_left_y":2457,"width":1348,"height":46},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a8e0de240e14a2385bd7216982573fe","type":"text","conversion_output":true,"text":"schizophrenia) on treatment-associated weight gain and metabolic disturbance;","text_display":" schizophrenia) on treatment-associated weight gain and metabolic disturbance;","confidence":1,"confidence_rate":1},{"cnt":[[1977,2578],[2007,2578],[2007,2628],[1977,2628]],"region":{"top_left_x":1976,"top_left_y":2578,"width":31,"height":50},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce97f4b871cb4fe980f1dd41eb214b85","type":"page_info","conversion_output":false,"text":"\\(\\underline{5}\\)","text_display":"","confidence":0.9970722198486328,"confidence_rate":0.99926724997161}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-08","page":8,"lines":[{"cnt":[[120,125],[1914,125],[1914,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1795,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a43d0c14acee4d3e931dee4db2680056","type":"text","conversion_output":true,"text":"- The study is unique in its inclusion of both younger and older adults. This novel approach will allow us to","text_display":"\n- The study is unique in its inclusion of both younger and older adults. This novel approach will allow us to","confidence":1,"confidence_rate":1},{"cnt":[[120,168],[1216,168],[1216,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":1097,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfa8eb19e0c249e8906aad8d3c511c5b","type":"text","conversion_output":true,"text":"address age-related questions pertaining to treatment variability;","text_display":" address age-related questions pertaining to treatment variability;","confidence":1,"confidence_rate":1},{"cnt":[[120,213],[1951,213],[1951,262],[120,262]],"region":{"top_left_x":120,"top_left_y":212,"width":1831,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2a4025609cd46d7a6fe8707d41c8c4c","type":"text","conversion_output":true,"text":"- An innovative aspect of the design is to include persons in the RCT who have achieved 'near-remission' of","text_display":"\n- An innovative aspect of the design is to include persons in the RCT who have achieved 'near-remission' of","confidence":0.99853515625,"confidence_rate":0.9999869115349181},{"cnt":[[120,258],[1876,258],[1876,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1756,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffbc57ce180140f59a4e9f98c97750ed","type":"text","conversion_output":true,"text":"depressive symptoms. This will allow us to examine whether substantial, but not complete, resolution of","text_display":" depressive symptoms. This will allow us to examine whether substantial, but not complete, resolution of","confidence":1,"confidence_rate":1},{"cnt":[[120,301],[1992,301],[1992,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1872,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2ee45e0ddcc45e7b2914f8a43c60762","type":"text","conversion_output":true,"text":"depressive symptoms in PD increases the risk of relapse following discontinuation of antipsychotic medication,","text_display":" depressive symptoms in PD increases the risk of relapse following discontinuation of antipsychotic medication,","confidence":1,"confidence_rate":1},{"cnt":[[120,348],[1970,348],[1970,397],[120,397]],"region":{"top_left_x":120,"top_left_y":348,"width":1851,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4e0e220570f4c29b603741c7586ef76","type":"text","conversion_output":true,"text":"- Studying genetic predictors of relapse of PD will be highly innovative. Moreover, this will be the first study to","text_display":"\n- Studying genetic predictors of relapse of PD will be highly innovative. Moreover, this will be the first study to","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1992,391],[1992,440],[120,440]],"region":{"top_left_x":120,"top_left_y":391,"width":1872,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21d66a3a1ebd476fae5fc2960c423e43","type":"text","conversion_output":true,"text":"examine whether genetic polymorphisms that predict antipsychotic-related weight gain also predict weight loss","text_display":" examine whether genetic polymorphisms that predict antipsychotic-related weight gain also predict weight loss","confidence":1,"confidence_rate":1},{"cnt":[[120,438],[786,438],[786,483],[120,483]],"region":{"top_left_x":120,"top_left_y":438,"width":667,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a5efc53af9540809a1237059cdfb6fb","type":"text","conversion_output":true,"text":"following antipsychotic discontinuation;","text_display":" following antipsychotic discontinuation;","confidence":1,"confidence_rate":1},{"cnt":[[120,481],[2002,481],[2002,529],[120,529]],"region":{"top_left_x":120,"top_left_y":481,"width":1883,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8625a9ca1c3b411c8f92b7fd9ec71ee7","type":"text","conversion_output":true,"text":"- Population pharmacokinetics will be used to evaluate drug exposure, which will allow for a more informed and","text_display":"\n- Population pharmacokinetics will be used to evaluate drug exposure, which will allow for a more informed and","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,524],[975,524],[975,574],[120,574]],"region":{"top_left_x":120,"top_left_y":524,"width":856,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0f3ccb4da4d42a59f6526f7df277b07","type":"text","conversion_output":true,"text":"sophisticated interpretation of the study's findings;","text_display":" sophisticated interpretation of the study's findings;","confidence":1,"confidence_rate":1},{"cnt":[[120,571],[1981,571],[1981,617],[120,617]],"region":{"top_left_x":120,"top_left_y":571,"width":1861,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbe36e15874242bf909523c12afae310","type":"text","conversion_output":true,"text":"- This study will continue work started in STOP-PD in developing innovative assessment instruments, such as","text_display":"\n- This study will continue work started in STOP-PD in developing innovative assessment instruments, such as","confidence":1,"confidence_rate":1},{"cnt":[[120,614],[1867,614],[1867,664],[120,664]],"region":{"top_left_x":120,"top_left_y":614,"width":1747,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"833be968dd6241f9b88c1639b9b74328","type":"text","conversion_output":true,"text":"the Delusion Assessment Scale, \\({ }^{96}\\) in this population. During the course of STOP-PD, we developed the","text_display":" the Delusion Assessment Scale, \\({ }^{96}\\) in this population. During the course of STOP-PD, we developed the","confidence":1,"confidence_rate":1},{"cnt":[[120,662],[1944,662],[1944,707],[120,707]],"region":{"top_left_x":120,"top_left_y":661,"width":1825,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6fdac527c1e45a7a7da96f5e4e29b20","type":"text","conversion_output":true,"text":"Resolution of Delusions Scale (RODS) to evaluate change in a person's insight, as a delusion resolves with","text_display":" Resolution of Delusions Scale (RODS) to evaluate change in a person's insight, as a delusion resolves with","confidence":0.994631290435791,"confidence_rate":0.9999515041230366},{"cnt":[[120,705],[1893,705],[1893,752],[120,752]],"region":{"top_left_x":120,"top_left_y":704,"width":1773,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac21be7852054d468ab59edfa91c2522","type":"text","conversion_output":true,"text":"treatment. In the proposed study, we will assess the psychometric properties of the RODS. If metrics are","text_display":" treatment. In the proposed study, we will assess the psychometric properties of the RODS. If metrics are","confidence":1,"confidence_rate":1},{"cnt":[[120,748],[1923,748],[1923,797],[120,797]],"region":{"top_left_x":120,"top_left_y":747,"width":1803,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"062baee0e7524b08ad5fda77c9eca905","type":"text","conversion_output":true,"text":"acceptable, we will use the RODS in exploratory analyses to determine to what extent insight into the prior","text_display":" acceptable, we will use the RODS in exploratory analyses to determine to what extent insight into the prior","confidence":1,"confidence_rate":1},{"cnt":[[120,795],[1403,795],[1403,840],[120,840]],"region":{"top_left_x":120,"top_left_y":794,"width":1283,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3a625ee73864684b06216ae66a4c722","type":"text","conversion_output":true,"text":"delusional belief is associated with stability of remission and risk of relapse;","text_display":" delusional belief is associated with stability of remission and risk of relapse;","confidence":1,"confidence_rate":1},{"cnt":[[120,838],[1940,838],[1940,883],[120,883]],"region":{"top_left_x":120,"top_left_y":837,"width":1821,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1bc6946239a4ba5abf1be93c777763d","type":"text","conversion_output":true,"text":"- A novel feature of the assessment is the use of a behavioral sign-based measure of psychomotor function","text_display":"\n- A novel feature of the assessment is the use of a behavioral sign-based measure of psychomotor function","confidence":1,"confidence_rate":1},{"cnt":[[120,877],[1968,877],[1968,930],[120,930]],"region":{"top_left_x":120,"top_left_y":876,"width":1848,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67f3df75e7b444fca50acbff54521523","type":"text","conversion_output":true,"text":"(the 'CORE \\({ }^{, 97}\\) ) to examine the effect of psychomotor change, which is common in PD, on treatment outcome;","text_display":" (the 'CORE \\({ }^{, 97}\\) ) to examine the effect of psychomotor change, which is common in PD, on treatment outcome;","confidence":0.4672788228254383,"confidence_rate":0.9937318829215299},{"cnt":[[120,924],[1949,924],[1949,973],[120,973]],"region":{"top_left_x":120,"top_left_y":923,"width":1829,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d099432369c4a609377c9acc1ba0aee","type":"text","conversion_output":true,"text":"- If the proposed study is funded, we are committed to promptly submitting a competing supplement that will","text_display":"\n- If the proposed study is funded, we are committed to promptly submitting a competing supplement that will","confidence":1,"confidence_rate":1},{"cnt":[[120,967],[2004,967],[2004,1016],[120,1016]],"region":{"top_left_x":120,"top_left_y":966,"width":1885,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbe1380c1d764850aecc6b9c0a5b4743","type":"text","conversion_output":true,"text":"have a cognitive neuroscience focus, integrating neuropsychology and neuroimaging, to study the relationships","text_display":" have a cognitive neuroscience focus, integrating neuropsychology and neuroimaging, to study the relationships","confidence":0.99755859375,"confidence_rate":0.9999785582005648},{"cnt":[[120,1010],[924,1010],[924,1059],[120,1059]],"region":{"top_left_x":120,"top_left_y":1009,"width":804,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8421a50ac1d44019dc90960b5e54c82","type":"text","conversion_output":true,"text":"between age, brain function, and course of PD.","text_display":" between age, brain function, and course of PD.","confidence":1,"confidence_rate":1},{"cnt":[[945,1053],[1179,1053],[1179,1106],[945,1106]],"region":{"top_left_x":945,"top_left_y":1052,"width":235,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce2200a74d29401781871258d1ebdbbe","type":"section_header","conversion_output":false,"children_ids":["76bd042813cc4fc2a4db90ae0d93ae4d"],"text":"","text_display":""},{"cnt":[[950,1057],[1175,1057],[1175,1102],[950,1102]],"region":{"top_left_x":949,"top_left_y":1057,"width":227,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76bd042813cc4fc2a4db90ae0d93ae4d","type":"text","conversion_output":true,"parent_id":"ce2200a74d29401781871258d1ebdbbe","text":"APPROACH","text_display":"\n\n\\section*{APPROACH}","confidence":1,"confidence_rate":1},{"cnt":[[116,1096],[1491,1096],[1491,1149],[116,1149]],"region":{"top_left_x":116,"top_left_y":1095,"width":1376,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b42f89ba6024d3daca4ab880bdebe4e","type":"section_header","conversion_output":false,"children_ids":["542c02a725cb46558d9aa16966024d3a"],"text":"","text_display":""},{"cnt":[[120,1100],[1487,1100],[1487,1145],[120,1145]],"region":{"top_left_x":120,"top_left_y":1100,"width":1367,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"542c02a725cb46558d9aa16966024d3a","type":"text","conversion_output":true,"parent_id":"3b42f89ba6024d3daca4ab880bdebe4e","text":"3.8 PROGRESS REPORT ON STOP-PD (Dates of Award: 6/1/2002-5/31/2007).","text_display":"\n\n\\subsection*{3.8 PROGRESS REPORT ON STOP-PD (Dates of Award: 6/1/2002-5/31/2007).}","confidence":0.99951171875,"confidence_rate":0.9999933096045984},{"cnt":[[120,1143],[1962,1143],[1962,1192],[120,1192]],"region":{"top_left_x":120,"top_left_y":1142,"width":1842,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b026d2b32580422b976ef0c7a602464d","type":"text","conversion_output":true,"text":"STOP-PD was a 12 -week double-blind RCT that compared the efficacy, tolerability, and safety of olanzapine","text_display":"\n\nSTOP-PD was a 12 -week double-blind RCT that compared the efficacy, tolerability, and safety of olanzapine","confidence":0.9931671619415283,"confidence_rate":0.9999398589245048},{"cnt":[[120,1188],[2000,1188],[2000,1235],[120,1235]],"region":{"top_left_x":120,"top_left_y":1188,"width":1881,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20f18a2c53cf4b57a3cec1fa0394e8d2","type":"text","conversion_output":true,"text":"plus sertraline ('combination therapy') with olanzapine plus placebo ('olanzapine monotherapy') in younger and","text_display":" plus sertraline ('combination therapy') with olanzapine plus placebo ('olanzapine monotherapy') in younger and","confidence":1,"confidence_rate":1},{"cnt":[[120,1233],[1852,1233],[1852,1278],[120,1278]],"region":{"top_left_x":120,"top_left_y":1233,"width":1732,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d07ad58bacff425c9b6bbc987faeaaf3","type":"text","conversion_output":true,"text":"older persons with major depressive disorder and delusions ± hallucinations. The study addressed the","text_display":" older persons with major depressive disorder and delusions ± hallucinations. The study addressed the","confidence":0.93798828125,"confidence_rate":0.9993904922692455},{"cnt":[[120,1276],[1867,1276],[1867,1323],[120,1323]],"region":{"top_left_x":120,"top_left_y":1276,"width":1747,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55312f7823204a6083c820451f2bdd69","type":"text","conversion_output":true,"text":"following hypotheses: 1) combined olanzapine and sertraline would be more efficacious than combined","text_display":" following hypotheses: 1) combined olanzapine and sertraline would be more efficacious than combined","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[120,1319],[1949,1319],[1949,1369],[120,1369]],"region":{"top_left_x":120,"top_left_y":1319,"width":1829,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3a89d6d2d3145fa9959d903592d94b7","type":"text","conversion_output":true,"text":"olanzapine and placebo; 2 ) the younger age group would have a higher rate of remission than the older age","text_display":" olanzapine and placebo; 2 ) the younger age group would have a higher rate of remission than the older age","confidence":0.7060546875,"confidence_rate":0.9969514756592968},{"cnt":[[120,1364],[2004,1364],[2004,1412],[120,1412]],"region":{"top_left_x":120,"top_left_y":1364,"width":1885,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"979fa4a585d14c0aa3970da696dd7184","type":"text","conversion_output":true,"text":"group; 3) treatment would be less well tolerated by older than younger participants. Full details of this study are","text_display":" group; 3) treatment would be less well tolerated by older than younger participants. Full details of this study are","confidence":0.99853515625,"confidence_rate":0.9999877840939273},{"cnt":[[120,1405],[1308,1405],[1308,1454],[120,1454]],"region":{"top_left_x":120,"top_left_y":1405,"width":1189,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86541b59cd9a48129d20cb6486d67a59","type":"text","conversion_output":true,"text":"reported in Arch Gen Psychiatry 2009;66 (8):838-47. \\({ }^{11}\\) To summarize:","text_display":" reported in Arch Gen Psychiatry 2009;66 (8):838-47. \\({ }^{11}\\) To summarize:","confidence":0.9975605006329715,"confidence_rate":0.9999705729655889},{"cnt":[[120,1452],[1904,1452],[1904,1497],[120,1497]],"region":{"top_left_x":120,"top_left_y":1452,"width":1784,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2be39060dec5430db490b6603b517cdf","type":"text","conversion_output":true,"text":"- The study's recruitment goal was met, with 259 patients randomized to treatment ( \\(n =142 \\geq 60\\) years and","text_display":"\n- The study's recruitment goal was met, with 259 patients randomized to treatment ( \\(n =142 \\geq 60\\) years and","confidence":0.9912109375,"confidence_rate":0.9999239001877759},{"cnt":[[120,1495],[1646,1495],[1646,1543],[120,1543]],"region":{"top_left_x":120,"top_left_y":1495,"width":1526,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12b388c1ec814c7a8a4258213474e2ac","type":"text","conversion_output":true,"text":"\\(n =117<60\\) years) (Cornell: \\(n =56\\); Massachusetts: \\(n =59\\); Pittsburgh: \\(n =63\\); Toronto: \\(n =81\\) ).","text_display":" \\(n =117<60\\) years) (Cornell: \\(n =56\\); Massachusetts: \\(n =59\\); Pittsburgh: \\(n =63\\); Toronto: \\(n =81\\) ).","confidence":0.9907552641128436,"confidence_rate":0.9999232448163653},{"cnt":[[120,1538],[1992,1538],[1992,1588],[120,1588]],"region":{"top_left_x":120,"top_left_y":1538,"width":1872,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1119c5ceedfa4fce9abb717dffca6986","type":"text","conversion_output":true,"text":"- Combination therapy was associated with a higher remission rate over the trial than olanzapine monotherapy","text_display":"\n- Combination therapy was associated with a higher remission rate over the trial than olanzapine monotherapy","confidence":0.99462890625,"confidence_rate":0.9999523412248076},{"cnt":[[120,1583],[1957,1583],[1957,1631],[120,1631]],"region":{"top_left_x":120,"top_left_y":1583,"width":1838,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a583a9f198d24e5c8ac97e8fb7f588bd","type":"text","conversion_output":true,"text":"\\(( OR =1.28,95 \\% Cl =1.12-1.47, p <.001) .41 .9 \\%\\) of randomized combination participants were in remission at","text_display":" \\(( OR =1.28,95 \\% Cl =1.12-1.47, p <.001) .41 .9 \\%\\) of randomized combination participants were in remission at","confidence":0.5089714806526899,"confidence_rate":0.9939341181976395},{"cnt":[[120,1624],[1858,1624],[1858,1678],[120,1678]],"region":{"top_left_x":120,"top_left_y":1624,"width":1739,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9850ae2057fe406f805234b8297d29b8","type":"text","conversion_output":true,"text":"their last assessment compared to \\(23.9 \\%\\) of olanzapine monotherapy participants \\(\\left(\\chi^{2}{ }_{1}=9.53, p =0.002\\right.\\);","text_display":" their last assessment compared to \\(23.9 \\%\\) of olanzapine monotherapy participants \\(\\left(\\chi^{2}{ }_{1}=9.53, p =0.002\\right.\\);","confidence":0.8754349743242542,"confidence_rate":0.9989447285985814},{"cnt":[[120,1674],[1884,1674],[1884,1721],[120,1721]],"region":{"top_left_x":120,"top_left_y":1673,"width":1765,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4b90fab523144d98d96417e933282fe","type":"text","conversion_output":true,"text":"NNT=5.6). Of the participants who completed 12 weeks of treatment, the remission rate was \\(66.7 \\%\\) with","text_display":" NNT=5.6). Of the participants who completed 12 weeks of treatment, the remission rate was \\(66.7 \\%\\) with","confidence":0.9980478286743164,"confidence_rate":0.9999823958369762},{"cnt":[[120,1714],[1525,1714],[1525,1764],[120,1764]],"region":{"top_left_x":120,"top_left_y":1714,"width":1406,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a6c2febeee84f6a8988630ce82e953f","type":"text","conversion_output":true,"text":"combined treatment versus \\(49.2 \\%\\) with monotherapy ( \\(x ^{2}{ }_{1}=4.4, p =0.036\\); NNT=5.7).","text_display":" combined treatment versus \\(49.2 \\%\\) with monotherapy ( \\(x ^{2}{ }_{1}=4.4, p =0.036\\); NNT=5.7).","confidence":0.6974718189368014,"confidence_rate":0.996700015040938},{"cnt":[[120,1762],[1897,1762],[1897,1811],[120,1811]],"region":{"top_left_x":120,"top_left_y":1761,"width":1778,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c0f62ffa83f424b834077890eadac9a","type":"text","conversion_output":true,"text":"- Younger and older participants did not differ in rate of remission ( \\(OR =1.05,95 \\% Cl =0.80-1.37, p =0.75\\) ).","text_display":"\n- Younger and older participants did not differ in rate of remission ( \\(OR =1.05,95 \\% Cl =0.80-1.37, p =0.75\\) ).","confidence":0.4817008102963882,"confidence_rate":0.9939815550487927},{"cnt":[[120,1807],[1747,1807],[1747,1854],[120,1854]],"region":{"top_left_x":120,"top_left_y":1806,"width":1627,"height":49},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c259d81353a24f50a9a3760f581557d2","type":"text","conversion_output":true,"text":"- There was no significant difference between age groups in overall tolerability of treatment or in","text_display":"\n- There was no significant difference between age groups in overall tolerability of treatment or in","confidence":0.99658203125,"confidence_rate":0.9999670791635416},{"cnt":[[120,1850],[1992,1850],[1992,1897],[120,1897]],"region":{"top_left_x":120,"top_left_y":1849,"width":1872,"height":49},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d39d044070d2435fb3ae1f563f563cb2","type":"text","conversion_output":true,"text":"extrapyramidal side effect scores. Both age groups had statistically significant increases in weight, cholesterol,","text_display":" extrapyramidal side effect scores. Both age groups had statistically significant increases in weight, cholesterol,","confidence":1,"confidence_rate":1},{"cnt":[[120,1895],[1955,1895],[1955,1940],[120,1940]],"region":{"top_left_x":120,"top_left_y":1894,"width":1836,"height":47},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca547fc2c5be4129bcde427f4e085ea8","type":"text","conversion_output":true,"text":"and triglycerides. Of note, older subjects had significantly less weight gain than younger subjects ( \\(7.3 \\pm 10.3\\)","text_display":" and triglycerides. Of note, older subjects had significantly less weight gain than younger subjects ( \\(7.3 \\pm 10.3\\)","confidence":0.6070196628570557,"confidence_rate":0.9956306778148143},{"cnt":[[120,1938],[1912,1938],[1912,1987],[120,1987]],"region":{"top_left_x":120,"top_left_y":1937,"width":1793,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03720d298a654805b0a3bfbd2e7b0ba2","type":"text","conversion_output":true,"text":"lbs versus \\(13.9 \\pm 4.0 lbs\\) respectively; \\(F _{1,226}=14.51, p =0.0002\\) ). A statistically significant increase in fasting","text_display":" lbs versus \\(13.9 \\pm 4.0 lbs\\) respectively; \\(F _{1,226}=14.51, p =0.0002\\) ). A statistically significant increase in fasting","confidence":0.9717318823095411,"confidence_rate":0.9997891740370776},{"cnt":[[120,1981],[1904,1981],[1904,2030],[120,2030]],"region":{"top_left_x":120,"top_left_y":1980,"width":1784,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96b8e615fe454f3aa7af48307bc53a87","type":"text","conversion_output":true,"text":"plasma glucose levels occurred in younger subjects only (mean change of \\(8.4 \\pm 41.3 mg / dL\\) from a mean","text_display":" plasma glucose levels occurred in younger subjects only (mean change of \\(8.4 \\pm 41.3 mg / dL\\) from a mean","confidence":1,"confidence_rate":1},{"cnt":[[120,2024],[2002,2024],[2002,2073],[120,2073]],"region":{"top_left_x":120,"top_left_y":2023,"width":1883,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edc8a6c7d136488fa7946c84dba28a61","type":"text","conversion_output":true,"text":"baseline of \\(93.6 \\pm 20.4 mg / dL , t _{211}=2.65, p =0.009\\) ). Only \\(5 \\%\\) of participants withdrew from the study because of","text_display":" baseline of \\(93.6 \\pm 20.4 mg / dL , t _{211}=2.65, p =0.009\\) ). Only \\(5 \\%\\) of participants withdrew from the study because of","confidence":0.984375,"confidence_rate":0.9998842099617712},{"cnt":[[120,2071],[397,2071],[397,2112],[120,2112]],"region":{"top_left_x":120,"top_left_y":2071,"width":278,"height":41},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcb6c8aca229483987e2d1cb04a1fe17","type":"text","conversion_output":true,"text":"adverse effects.","text_display":" adverse effects.","confidence":1,"confidence_rate":1},{"cnt":[[116,2108],[1553,2108],[1553,2163],[116,2163]],"region":{"top_left_x":116,"top_left_y":2107,"width":1438,"height":57},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eb36cfbc357432a89c4447de42d18a5","type":"section_header","conversion_output":false,"children_ids":["4d4b1cf2880c431fa440b38dfaf2e96b"],"text":"","text_display":""},{"cnt":[[120,2114],[1549,2114],[1549,2159],[120,2159]],"region":{"top_left_x":120,"top_left_y":2114,"width":1430,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d4b1cf2880c431fa440b38dfaf2e96b","type":"text","conversion_output":true,"parent_id":"5eb36cfbc357432a89c4447de42d18a5","text":"Unpublished Pilot Data from STOP-PD that is Relevant to the Proposed Study:","text_display":"\n\n\\section*{Unpublished Pilot Data from STOP-PD that is Relevant to the Proposed Study:}","confidence":1,"confidence_rate":1},{"cnt":[[120,2157],[1940,2157],[1940,2204],[120,2204]],"region":{"top_left_x":120,"top_left_y":2157,"width":1821,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75b4b88b4922448b960f70546afca129","type":"text","conversion_output":true,"text":"- As an unfunded pilot project, blood was obtained at week 12/termination in a sub-set of participants ( \\(n =66\\)","text_display":"\n- As an unfunded pilot project, blood was obtained at week 12/termination in a sub-set of participants ( \\(n =66\\)","confidence":0.617746114730835,"confidence_rate":0.9958562150999014},{"cnt":[[120,2200],[1979,2198],[1979,2247],[120,2249]],"region":{"top_left_x":120,"top_left_y":2198,"width":1859,"height":52},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f444de8542a498e98bd63ae01dd3d41","type":"text","conversion_output":true,"text":"young and \\(n =102\\) old) for future pharmacokinetic analyses. Since younger and older groups differed in weight","text_display":" young and \\(n =102\\) old) for future pharmacokinetic analyses. Since younger and older groups differed in weight","confidence":1,"confidence_rate":1},{"cnt":[[120,2245],[1852,2245],[1852,2292],[120,2292]],"region":{"top_left_x":120,"top_left_y":2245,"width":1732,"height":48},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77aba837a3aa476c96ecbe9e2741d1e2","type":"text","conversion_output":true,"text":"gain, we used population pharmacokinetics to explore whether younger and older groups differed in: i)","text_display":" gain, we used population pharmacokinetics to explore whether younger and older groups differed in: i)","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[120,2290],[1957,2290],[1957,2335],[120,2335]],"region":{"top_left_x":120,"top_left_y":2290,"width":1838,"height":46},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"438cf1e17caa469da32b65d4d0b8c6a4","type":"text","conversion_output":true,"text":"variability of exposure, which could indicate poorer adherence with olanzapine in one group versus the other","text_display":" variability of exposure, which could indicate poorer adherence with olanzapine in one group versus the other","confidence":1,"confidence_rate":1},{"cnt":[[120,2333],[1815,2333],[1815,2380],[120,2380]],"region":{"top_left_x":120,"top_left_y":2333,"width":1696,"height":48},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6feadfeb7cca49a0b71d0f006c2535fd","type":"text","conversion_output":true,"text":"[105,106], and ii) magnitude of exposure. Younger and older groups did not differ in either variability","text_display":" [105,106], and ii) magnitude of exposure. Younger and older groups did not differ in either variability","confidence":0.9761443138122559,"confidence_rate":0.9997764616459489},{"cnt":[[122,2376],[1955,2376],[1955,2426],[122,2426]],"region":{"top_left_x":122,"top_left_y":2376,"width":1834,"height":50},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72be1ada4eae4af08ad9aea43dff077a","type":"text","conversion_output":true,"text":"\\(\\left(0.98 \\pm 0.27\\right.\\) vs. \\(\\left.0.96 \\pm 0.30 ; t _{[166]}=0.36, p =0.72\\right)\\) or magnitude \\(\\left(1128.9 \\pm 737.6 ug / mL\\right.\\) h vs. \\(1027.1 \\pm 477.6 ug / mL ^{*} h\\);","text_display":" \\(\\left(0.98 \\pm 0.27\\right.\\) vs. \\(\\left.0.96 \\pm 0.30 ; t _{[166]}=0.36, p =0.72\\right)\\) or magnitude \\(\\left(1128.9 \\pm 737.6 ug / mL\\right.\\) h vs. \\(1027.1 \\pm 477.6 ug / mL ^{*} h\\);","confidence":0.3722199230699784,"confidence_rate":0.9935193118287631},{"cnt":[[120,2423],[1981,2423],[1981,2469],[120,2469]],"region":{"top_left_x":120,"top_left_y":2423,"width":1861,"height":46},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e16c52c46ec740ce81c30fcb08caa9cb","type":"text","conversion_output":true,"text":"unequal variances \\(t _{[102]}=1.0, p =.32\\) ) of exposure, suggesting that the age-related difference in weight gain was","text_display":" unequal variances \\(t _{[102]}=1.0, p =.32\\) ) of exposure, suggesting that the age-related difference in weight gain was","confidence":0.9941489668563008,"confidence_rate":0.9999555447949668},{"cnt":[[120,2466],[1712,2466],[1712,2512],[120,2512]],"region":{"top_left_x":120,"top_left_y":2466,"width":1593,"height":46},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b3c3d98337f4110bb31d2893750e8de","type":"text","conversion_output":true,"text":"not explained by exposure. The proposed study will examine drug exposure in all participants.","text_display":" not explained by exposure. The proposed study will examine drug exposure in all participants.","confidence":1,"confidence_rate":1},{"cnt":[[1972,2578],[2009,2578],[2009,2628],[1972,2628]],"region":{"top_left_x":1972,"top_left_y":2578,"width":37,"height":50},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4aaf30b66b9456483b576ae472ab054","type":"page_info","conversion_output":false,"text":"6","text_display":"","confidence":0.83642578125,"confidence_rate":0.83642578125}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-09","page":9,"lines":[{"cnt":[[120,125],[1863,125],[1863,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1743,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3964d00ea0b4ad1a55a9ffee84e7755","type":"text","conversion_output":true,"text":"- Participants who were in remission with either combination therapy or olanzapine monotherapy at the","text_display":"\n- Participants who were in remission with either combination therapy or olanzapine monotherapy at the","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[120,168],[1985,168],[1985,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":1866,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"279ee72794d54c0489514190f373a77c","type":"text","conversion_output":true,"text":"completion of STOP-PD were invited to participate in a 3 -month double-blind stabilization phase, during which","text_display":" completion of STOP-PD were invited to participate in a 3 -month double-blind stabilization phase, during which","confidence":0.9659943601582199,"confidence_rate":0.9997068456634526},{"cnt":[[120,215],[1996,215],[1996,262],[120,262]],"region":{"top_left_x":120,"top_left_y":214,"width":1876,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95a84b5f089c4848a19dc14c6ae4fd2c","type":"text","conversion_output":true,"text":"they continued their acute phase treatment. The stabilization phase was designed to collect pilot data on: i) the","text_display":" they continued their acute phase treatment. The stabilization phase was designed to collect pilot data on: i) the","confidence":1,"confidence_rate":1},{"cnt":[[120,258],[1962,258],[1962,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1842,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8b619e7ddd3427a9710e043ced8880b","type":"text","conversion_output":true,"text":"stability of remission, and ii) the course of side effects. 74 persons ( \\(n =29\\) young and \\(n =45\\) old) participated in","text_display":" stability of remission, and ii) the course of side effects. 74 persons ( \\(n =29\\) young and \\(n =45\\) old) participated in","confidence":0.9990236759185791,"confidence_rate":0.9999926556585772},{"cnt":[[120,301],[1934,301],[1934,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1814,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e8458e3668d45d2adc40e7880fd3628","type":"text","conversion_output":true,"text":"this phase. Of the 48 patients who experienced remission with combination treatment, \\(10.4 \\%\\) subsequently","text_display":" this phase. Of the 48 patients who experienced remission with combination treatment, \\(10.4 \\%\\) subsequently","confidence":1,"confidence_rate":1},{"cnt":[[120,346],[1992,346],[1992,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1872,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1f81e05f4a74e8e92acec20874b27f2","type":"text","conversion_output":true,"text":"had a relapse of major depression, psychosis, or both. Participants continued to gain weight in the stabilization","text_display":" had a relapse of major depression, psychosis, or both. Participants continued to gain weight in the stabilization","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1985,391],[1985,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1866,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3945ffb2be44496a99260663aa7c626","type":"text","conversion_output":true,"text":"phase, but at a slower rate than during STOP-PD (approximately \\(1.5 lbs / month\\) in stabilization, compared with","text_display":" phase, but at a slower rate than during STOP-PD (approximately \\(1.5 lbs / month\\) in stabilization, compared with","confidence":0.5611887273844332,"confidence_rate":0.9952370153764623},{"cnt":[[120,434],[1944,434],[1944,479],[120,479]],"region":{"top_left_x":120,"top_left_y":433,"width":1825,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2d59c3a2784445b816890553efa540b","type":"text","conversion_output":true,"text":"\\(4.4 lbs /\\) month in STOP-PD). Tests of fixed effects for changes in metabolic variables during the 6 months of","text_display":" \\(4.4 lbs /\\) month in STOP-PD). Tests of fixed effects for changes in metabolic variables during the 6 months of","confidence":0.9321892153226372,"confidence_rate":0.9994000137033779},{"cnt":[[120,477],[1979,477],[1979,526],[120,526]],"region":{"top_left_x":120,"top_left_y":476,"width":1859,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9e9ffe6bf844043902b8db088e35ef7","type":"text","conversion_output":true,"text":"both STOP-PD and the stabilization phase found a statistically significant age x time effect for glucose ( \\(F _{3,149}=\\)","text_display":" both STOP-PD and the stabilization phase found a statistically significant age x time effect for glucose ( \\(F _{3,149}=\\)","confidence":0.5222043212576788,"confidence_rate":0.9951632547006605},{"cnt":[[120,520],[1940,520],[1940,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1821,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8315fc805b5b4e84ad0ff29f84746dc5","type":"text","conversion_output":true,"text":"3.16, \\(p <0.03\\) ), and trends in age x time effects for triglycerides ( \\(p =0.08\\) ), total cholesterol ( \\(p =0.07\\) ), and LDL","text_display":" 3.16, \\(p <0.03\\) ), and trends in age x time effects for triglycerides ( \\(p =0.08\\) ), total cholesterol ( \\(p =0.07\\) ), and LDL","confidence":0.44019479212192414,"confidence_rate":0.9943570989656121},{"cnt":[[120,563],[1996,563],[1996,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1876,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a26c1cae3dfe4e00a039062c0145c826","type":"text","conversion_output":true,"text":"cholesterol ( \\(p =0.09\\) ). The younger remitters experienced more of an increase in these metabolic variables than","text_display":" cholesterol ( \\(p =0.09\\) ). The younger remitters experienced more of an increase in these metabolic variables than","confidence":0.36186779325362295,"confidence_rate":0.9917028397005825},{"cnt":[[120,610],[1921,610],[1921,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1801,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5d9fae4ac344f0e9af4446a9da15ede","type":"text","conversion_output":true,"text":"the older remitters. Thus, whereas there was no significant difference between age groups in elevations of","text_display":" the older remitters. Thus, whereas there was no significant difference between age groups in elevations of","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[1927,653],[1927,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1808,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed82f22f4ac740db86df600b80c5e517","type":"text","conversion_output":true,"text":"glucose and lipids by the end of STOP-PD, differences started to emerge after 6 months of treatment. This","text_display":" glucose and lipids by the end of STOP-PD, differences started to emerge after 6 months of treatment. This","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1957,696],[1957,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1838,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f87b21303c384aa6b8eeb78199c19386","type":"text","conversion_output":true,"text":"suggests that older age may moderate olanzapine-associated metabolic dysfunction, but that this effect may","text_display":" suggests that older age may moderate olanzapine-associated metabolic dysfunction, but that this effect may","confidence":1,"confidence_rate":1},{"cnt":[[120,741],[1916,741],[1916,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":1797,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ef5c8cb89e543f3bd15a9b4409f0a29","type":"text","conversion_output":true,"text":"not be apparent until later in the course of treatment. Thus, Aim 3, which pertains to the acute/stabilization","text_display":" not be apparent until later in the course of treatment. Thus, Aim 3, which pertains to the acute/stabilization","confidence":1,"confidence_rate":1},{"cnt":[[120,786],[1785,786],[1785,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1666,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15c9d9d7f88a4c73a28ca00478b92936","type":"text","conversion_output":true,"text":"phases of treatment (which the majority of participants are expected to complete within 16 weeks),","text_display":" phases of treatment (which the majority of participants are expected to complete within 16 weeks),","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1968,829],[1968,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1848,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14957385534a4fe2a0e346c9536fe6a2","type":"text","conversion_output":true,"text":"hypothesizes that older age will moderate weight gain only, whereas Aim 4, which pertains to the longer-term","text_display":" hypothesizes that older age will moderate weight gain only, whereas Aim 4, which pertains to the longer-term","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1871,872],[1871,920],[120,920]],"region":{"top_left_x":120,"top_left_y":872,"width":1752,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecf18c22cc0c44be9b16ece9b287dbaa","type":"text","conversion_output":true,"text":"treatment of PD, explores whether older age moderates change in both weight and metabolic variables.","text_display":" treatment of PD, explores whether older age moderates change in both weight and metabolic variables.","confidence":1,"confidence_rate":1},{"cnt":[[116,911],[864,911],[864,965],[116,965]],"region":{"top_left_x":116,"top_left_y":910,"width":748,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5e47914bb9644b1bb15e80d29b1e589","type":"section_header","conversion_output":false,"children_ids":["c8e504d18d8245dcbffd611b0cb792f0"],"text":"","text_display":""},{"cnt":[[120,915],[862,915],[862,956],[120,956]],"region":{"top_left_x":120,"top_left_y":915,"width":742,"height":42},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8e504d18d8245dcbffd611b0cb792f0","type":"text","conversion_output":true,"parent_id":"a5e47914bb9644b1bb15e80d29b1e589","text":"3.9 RESEARCH DESIGN AND METHODS","text_display":"\n\n\\subsection*{3.9 RESEARCH DESIGN AND METHODS}","confidence":1,"confidence_rate":1},{"cnt":[[118,990],[826,990],[826,1931],[118,1931]],"region":{"top_left_x":118,"top_left_y":990,"width":708,"height":941},"line":21,"column":0,"font_size":31,"is_printed":true,"is_handwritten":false,"id":"f82afdbac4e148959f8accb92d00d6f2","type":"column","conversion_output":false,"children_ids":["d6d8128dfdec4b58ac9d07d26bef42f4","279d9654ac1244fab0316590c1b1e5f3"],"text":"","text_display":""},{"cnt":[[131,993],[776,993],[776,1042],[131,1042]],"region":{"top_left_x":131,"top_left_y":992,"width":645,"height":50},"line":22,"column":1,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6d8128dfdec4b58ac9d07d26bef42f4","type":"figure_label","conversion_output":false,"parent_id":"f82afdbac4e148959f8accb92d00d6f2","text":"Figure 1: Study Design \\& Subject Flow","text_display":"","confidence":0.99169921875,"confidence_rate":0.9998015572024007},{"cnt":[[120,1044],[823,1044],[823,1927],[120,1927]],"region":{"top_left_x":120,"top_left_y":1044,"width":703,"height":884},"line":23,"column":1,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"279d9654ac1244fab0316590c1b1e5f3","type":"diagram","conversion_output":true,"parent_id":"f82afdbac4e148959f8accb92d00d6f2","selected_labels":["d6d8128dfdec4b58ac9d07d26bef42f4"],"text":"","text_display":"\n\n\\begin{figure}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 1: Study Design \\& Subject Flow}\n\\includegraphics[alt={},max 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General Overview. 392 patients ( \\(n =196\\) aged \\(18-59\\) years","text_display":"\n\n\\subsection*{3.9.1 General Overview. 392 patients ( \\(n =196\\) aged \\(18-59\\) years}","confidence":0.837582655629376,"confidence_rate":0.9977303318204797},{"cnt":[[846,1005],[1983,1005],[1983,1051],[846,1051]],"region":{"top_left_x":846,"top_left_y":1005,"width":1138,"height":46},"line":27,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a01c135bf0649cdbc990567e42557eb","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"and \\(n =196\\) aged \\(\\geq 60\\) years) with non-bipolar major depression with","text_display":"\nand \\(n =196\\) aged \\(\\geq 60\\) years) with non-bipolar major depression with","confidence":0.9985356330871582,"confidence_rate":0.999981212482309},{"cnt":[[846,1048],[1983,1048],[1983,1096],[846,1096]],"region":{"top_left_x":846,"top_left_y":1048,"width":1138,"height":48},"line":28,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ff423132746487a9ffb6df026c67609","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"psychotic features (delusions, with or without hallucinations) will be","text_display":" psychotic features (delusions, with or without hallucinations) will be","confidence":1,"confidence_rate":1},{"cnt":[[846,1094],[1798,1094],[1798,1139],[846,1139]],"region":{"top_left_x":846,"top_left_y":1093,"width":953,"height":46},"line":29,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3cb882fbafc4d95ac7e035c28d10087","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"enrolled, across 4 sites, in open-label treatment with the","text_display":" enrolled, across 4 sites, in open-label treatment with the","confidence":1,"confidence_rate":1},{"cnt":[[846,1137],[1824,1137],[1824,1184],[846,1184]],"region":{"top_left_x":846,"top_left_y":1136,"width":979,"height":48},"line":30,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3560199b8da5420ba552f4c63396c3d8","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"combination of sertraline (target dose of \\(150 mg /\\) day ) and","text_display":" combination of sertraline (target dose of \\(150 mg /\\) day ) 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Participants who no longer","text_display":" olanzapine (target dose of \\(15 mg /\\) day ). Participants who no longer","confidence":0.3648120164871216,"confidence_rate":0.9876281184818974},{"cnt":[[846,1225],[1912,1225],[1912,1270],[846,1270]],"region":{"top_left_x":846,"top_left_y":1224,"width":1067,"height":46},"line":32,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5066a35885d8444d9a1bf83164c35d8c","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"have delusions and hallucinations and either a) have a 17-item","text_display":" have delusions and hallucinations and either a) have a 17-item","confidence":0.88232421875,"confidence_rate":0.9981331522608596},{"cnt":[[846,1263],[1931,1263],[1931,1315],[846,1315]],"region":{"top_left_x":846,"top_left_y":1263,"width":1086,"height":52},"line":33,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e501672d6ee74b218e1fc62a4074c000","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"Hamilton Depression Rating Scale (HAM-D) \\({ }^{98}\\) score of \\(\\leq 10\\) for 2","text_display":" Hamilton Depression Rating Scale (HAM-D) \\({ }^{98}\\) score of \\(\\leq 10\\) for 2","confidence":0.9839344024658203,"confidence_rate":0.9997950077440022},{"cnt":[[846,1313],[1921,1313],[1921,1360],[846,1360]],"region":{"top_left_x":846,"top_left_y":1312,"width":1075,"height":48},"line":34,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9532486940c341bc81083e88de5c1585","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"consecutive assessments ('full-remission'), or b) are rated 'very","text_display":" consecutive assessments ('full-remission'), or b) are rated 'very","confidence":1,"confidence_rate":1},{"cnt":[[846,1358],[1828,1358],[1828,1403],[846,1403]],"region":{"top_left_x":846,"top_left_y":1357,"width":983,"height":46},"line":35,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a76af43b47de48ff93235b4a5080eeee","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"much improved' or 'much improved' on the Clinical Global","text_display":" much improved' or 'much improved' on the Clinical Global","confidence":0.99462890625,"confidence_rate":0.9999117158655917},{"cnt":[[846,1396],[1944,1396],[1944,1446],[846,1446]],"region":{"top_left_x":846,"top_left_y":1396,"width":1099,"height":50},"line":36,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cbb629828a8422bac14e77c39ec8e68","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"Impression (CGI) Scale \\({ }^{99}\\) and have a HAM-D score of 11-15 and","text_display":" Impression (CGI) Scale \\({ }^{99}\\) and have a HAM-D score of 11-15 and","confidence":1,"confidence_rate":1},{"cnt":[[846,1444],[1962,1444],[1962,1489],[846,1489]],"region":{"top_left_x":846,"top_left_y":1443,"width":1116,"height":46},"line":37,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef661256d5f943dcaeecd8ae4c61698c","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"have \\(\\geq 50 \\%\\) reduction in the baseline HAM-D score during the last","text_display":" have \\(\\geq 50 \\%\\) reduction in the baseline HAM-D score during the last","confidence":0.99951171875,"confidence_rate":0.9999931211434043},{"cnt":[[846,1487],[1850,1487],[1850,1536],[846,1536]],"region":{"top_left_x":846,"top_left_y":1486,"width":1004,"height":51},"line":38,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee0cca945b7c4bc899ac8fc59e708fd5","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"two assessments of the Acute Phase ('near-remission') will","text_display":" two assessments of the Acute Phase ('near-remission') will","confidence":1,"confidence_rate":1},{"cnt":[[846,1532],[1949,1532],[1949,1577],[846,1577]],"region":{"top_left_x":846,"top_left_y":1531,"width":1103,"height":46},"line":39,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d7f826ebc8a49fa906ce015f39664bd","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"continue with open-label sertraline and olanzapine for an 8-week","text_display":" continue with open-label sertraline and olanzapine for an 8-week","confidence":0.98486328125,"confidence_rate":0.9997789744557571},{"cnt":[[846,1577],[1850,1577],[1850,1622],[846,1622]],"region":{"top_left_x":846,"top_left_y":1576,"width":1004,"height":47},"line":40,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da796dc6afe94e1b924b4548d3660e93","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"stabilization phase. 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Participants who","text_display":" phase as soon as they meet full-remission criteria. Participants who","confidence":1,"confidence_rate":1},{"cnt":[[846,1710],[1962,1710],[1962,1749],[846,1749]],"region":{"top_left_x":846,"top_left_y":1710,"width":1116,"height":39},"line":43,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2577d52829d49469f28a8ace95c8057","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"continue to meet full-remission or near-remission criteria and who","text_display":" continue to meet full-remission or near-remission criteria and who","confidence":1,"confidence_rate":1},{"cnt":[[846,1745],[1974,1745],[1974,1798],[846,1798]],"region":{"top_left_x":846,"top_left_y":1744,"width":1129,"height":55},"line":44,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11ad5edfed514abd96d65a7b5e388f08","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"have a Mini-Mental State Examination (MMSE) \\({ }^{100}\\) score \\(\\geq 24\\) at the","text_display":" have a Mini-Mental State Examination (MMSE) \\({ }^{100}\\) score \\(\\geq 24\\) at the","confidence":0.9975595474243164,"confidence_rate":0.9999702024520788},{"cnt":[[846,1796],[1957,1796],[1957,1841],[846,1841]],"region":{"top_left_x":846,"top_left_y":1796,"width":1112,"height":46},"line":45,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbc096b23a8c437592ab3f8a37c41733","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"end of the stabilization phase will enter the 36-week double-blind,","text_display":" end of the stabilization phase will enter the 36-week double-blind,","confidence":0.978515625,"confidence_rate":0.9996983993245939},{"cnt":[[846,1839],[1949,1839],[1949,1888],[846,1888]],"region":{"top_left_x":846,"top_left_y":1839,"width":1103,"height":50},"line":46,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd862a3246ef4c37be73c8d2f6dcba2d","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"placebo-controlled olanzapine discontinuation phase ('the RCT').","text_display":" placebo-controlled olanzapine discontinuation phase ('the RCT').","confidence":1,"confidence_rate":1},{"cnt":[[846,1927],[1927,1927],[1927,1974],[846,1974]],"region":{"top_left_x":846,"top_left_y":1927,"width":1082,"height":48},"line":47,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6dfa7521e6a45e68a75303dd41e1fd9","type":"text","conversion_output":true,"parent_id":"4b8062453e3140b79ad276e8ed0a9a77","text":"Participants in full-remission or near-remission at the end of the","text_display":"\n\nParticipants in full-remission or near-remission at the end of the","confidence":1,"confidence_rate":1},{"cnt":[[120,1972],[1996,1972],[1996,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1972,"width":1876,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3190641dfeb146969fd2a0d4dd12a11c","type":"text","conversion_output":true,"text":"stabilization phase who have a MMSE total score below 24 may be allowed to enter the RCT when specifically","text_display":" stabilization phase who have a MMSE total score below 24 may be allowed to enter the RCT when specifically","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[120,2015],[1974,2015],[1974,2062],[120,2062]],"region":{"top_left_x":120,"top_left_y":2015,"width":1855,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f95e05680bd40acb54ede9c3bc7bb1e","type":"text","conversion_output":true,"text":"approved on a case-by-case basis by the Study's Steering Committee, if the steering committee believes that","text_display":" approved on a case-by-case basis by the Study's Steering Committee, if the steering committee believes that","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[2002,2058],[2002,2105],[120,2105]],"region":{"top_left_x":120,"top_left_y":2058,"width":1883,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52720cf890434d78891f350bd1441d1d","type":"text","conversion_output":true,"text":"the lower MMSE score is not caused by clinically significant cognitive impairment and the participant is capable","text_display":" the lower MMSE score is not caused by clinically significant cognitive impairment and the participant is capable","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[120,2101],[1962,2101],[1962,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2101,"width":1842,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"934dddcbdfeb46c388c9b81c92d35892","type":"text","conversion_output":true,"text":"of giving informed consent to participate in the RCT. Participants who achieved near-remission at the end of","text_display":" of giving informed consent to participate in the RCT. Participants who achieved near-remission at the end of","confidence":1,"confidence_rate":1},{"cnt":[[120,2144],[1824,2144],[1824,2189],[120,2189]],"region":{"top_left_x":120,"top_left_y":2144,"width":1705,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8fcaf92ed8747cfad519f2575a95e80","type":"text","conversion_output":true,"text":"the Acute Phase and who have a Ham-D score \\(>15\\) but no delusions or hallucinations at the Week 8","text_display":" the Acute Phase and who have a Ham-D score \\(>15\\) but no delusions or hallucinations at the Week 8","confidence":0.9465351104736328,"confidence_rate":0.9994614468957186},{"cnt":[[120,2189],[1916,2189],[1916,2237],[120,2237]],"region":{"top_left_x":120,"top_left_y":2189,"width":1797,"height":48},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05ee22b329454dc09bd5456a28fd2c0b","type":"text","conversion_output":true,"text":"stabilization visit can have two additional weekly stabilization visits. These visits will be used to determine","text_display":" stabilization visit can have two additional weekly stabilization visits. These visits will be used to determine","confidence":1,"confidence_rate":1},{"cnt":[[120,2234],[1931,2234],[1931,2279],[120,2279]],"region":{"top_left_x":120,"top_left_y":2234,"width":1812,"height":46},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"881722f94d6d492d8823d2d60afcc1a1","type":"text","conversion_output":true,"text":"whether the increase in HAM-D score above the partial remission cut-off was transient and ensure that two","text_display":" whether the increase in HAM-D score above the partial remission cut-off was transient and ensure that two","confidence":1,"confidence_rate":1},{"cnt":[[120,2277],[1944,2277],[1944,2327],[120,2327]],"region":{"top_left_x":120,"top_left_y":2277,"width":1825,"height":50},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc79522f0f5a4249823191e3c6ecd2a1","type":"text","conversion_output":true,"text":"consecutive weeks of partial remission criteria are met prior to entry in to the RCT. The Steering Committee","text_display":" consecutive weeks of partial remission criteria are met prior to entry in to the RCT. The Steering Committee","confidence":1,"confidence_rate":1},{"cnt":[[120,2322],[1869,2322],[1869,2370],[120,2370]],"region":{"top_left_x":120,"top_left_y":2322,"width":1750,"height":48},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67c663cdfa274d3ab15ce3f2c6da6742","type":"text","conversion_output":true,"text":"must discuss and agree to this extension. If the Ham-D score does not return to \\(\\leq 15\\) at each of the two","text_display":" must discuss and agree to this extension. If the Ham-D score does not return to \\(\\leq 15\\) at each of the two","confidence":1,"confidence_rate":1},{"cnt":[[120,2368],[1474,2368],[1474,2413],[120,2413]],"region":{"top_left_x":120,"top_left_y":2367,"width":1354,"height":46},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df2765daf25749c38bcebe8ca95adf13","type":"text","conversion_output":true,"text":"additional stabilization visits, the participant will not be eligible to enter the RCT.","text_display":" additional stabilization visits, the participant will not be eligible to enter the RCT.","confidence":1,"confidence_rate":1},{"cnt":[[120,2454],[1987,2454],[1987,2503],[120,2503]],"region":{"top_left_x":120,"top_left_y":2453,"width":1868,"height":50},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a387bb88de354398af972f4cf10566e7","type":"text","conversion_output":true,"text":"Participants will be randomized to either continue olanzapine or to switch from olanzapine to placebo following","text_display":"\n\nParticipants will be randomized to either continue olanzapine or to switch from olanzapine to placebo following","confidence":1,"confidence_rate":1},{"cnt":[[120,2496],[1899,2496],[1899,2546],[120,2546]],"region":{"top_left_x":120,"top_left_y":2496,"width":1780,"height":50},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3500275c65824b50b1f26d7fc71a80fd","type":"text","conversion_output":true,"text":"a 4-week placebo-controlled taper of the olanzapine. All participants will take open-label sertraline for the","text_display":" a 4-week placebo-controlled taper of the olanzapine. All participants will take open-label sertraline for the","confidence":0.7216796875,"confidence_rate":0.9971429148318277},{"cnt":[[1972,2578],[2009,2578],[2009,2628],[1972,2628]],"region":{"top_left_x":1972,"top_left_y":2578,"width":37,"height":50},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56360301f7f94c30abd915f8ce50a290","type":"page_info","conversion_output":false,"text":"\\(\\underline{7}\\)","text_display":"","confidence":0.75732421875,"confidence_rate":0.9328685704469681}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-10","page":10,"lines":[{"cnt":[[120,125],[1914,125],[1914,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1795,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acaa0d089e3a48b1b0beeeba2065217b","type":"text","conversion_output":true,"text":"duration of the RCT. Randomization will be stratified according to age group ( \\(18-59\\) years and 60 years or","text_display":"\nduration of the RCT. Randomization will be stratified according to age group ( \\(18-59\\) years and 60 years or","confidence":1,"confidence_rate":1},{"cnt":[[120,172],[1867,172],[1867,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":1747,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0687442e971645f78967f58b80d55d6a","type":"text","conversion_output":true,"text":"older) and stabilization phase outcome ('full-remission' versus 'near-remission'). Relapse is the primary","text_display":" older) and stabilization phase outcome ('full-remission' versus 'near-remission'). Relapse is the primary","confidence":0.990234375,"confidence_rate":0.9999107892390773},{"cnt":[[120,215],[1998,215],[1998,260],[120,260]],"region":{"top_left_x":120,"top_left_y":214,"width":1879,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a4dd020124043e9822a9b26c6599ccb","type":"text","conversion_output":true,"text":"outcome. Participants who experience a relapse will be immediately referred to a designated psychiatrist at the","text_display":" outcome. Participants who experience a relapse will be immediately referred to a designated psychiatrist at the","confidence":0.9990234375,"confidence_rate":0.9999915772798866},{"cnt":[[120,260],[1373,260],[1373,303],[120,303]],"region":{"top_left_x":120,"top_left_y":259,"width":1253,"height":44},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fcce8a237ab486eaf050307f1d1fdc6","type":"text","conversion_output":true,"text":"research site, who is not affiliated with the study, for clinical management.","text_display":" research site, who is not affiliated with the study, for clinical management.","confidence":1,"confidence_rate":1},{"cnt":[[116,296],[836,296],[836,350],[116,350]],"region":{"top_left_x":116,"top_left_y":296,"width":720,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af51ae965eea4f0fb4d8e8cf2fa81686","type":"section_header","conversion_output":false,"children_ids":["96fbbcda5edc4e66b506bb9cd3de6015"],"text":"","text_display":""},{"cnt":[[120,301],[831,301],[831,346],[120,346]],"region":{"top_left_x":120,"top_left_y":300,"width":712,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96fbbcda5edc4e66b506bb9cd3de6015","type":"text","conversion_output":true,"parent_id":"af51ae965eea4f0fb4d8e8cf2fa81686","text":"3.9.2 Participant Recruitment and Flow","text_display":"\n\n\\subsection*{3.9.2 Participant Recruitment and Flow}","confidence":1,"confidence_rate":1},{"cnt":[[120,346],[1962,346],[1962,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1842,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19159d5c7c7d48fb9a4bba461f12a7d9","type":"text","conversion_output":true,"text":"Overview: Recruitment will begin after 4 months of start-up time and will extend for 38 months (to the end of","text_display":"\n\nOverview: Recruitment will begin after 4 months of start-up time and will extend for 38 months (to the end of","confidence":1,"confidence_rate":1},{"cnt":[[120,389],[1970,389],[1970,436],[120,436]],"region":{"top_left_x":120,"top_left_y":388,"width":1851,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcb9f73a014d4814b7e04e0a22b0f1b9","type":"text","conversion_output":true,"text":"month 6 of Year 04). The RCT will begin in month 8 of Year 01 and extend 47 months (to the end of month 7","text_display":" month 6 of Year 04). The RCT will begin in month 8 of Year 01 and extend 47 months (to the end of month 7","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1998,434],[1998,483],[120,483]],"region":{"top_left_x":120,"top_left_y":433,"width":1879,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d58ee86ff3a4496b815a4076d1028bc2","type":"text","conversion_output":true,"text":"of Year 05). The final 5 months of Year 05 will be used for the completion of data cleaning, data analyses, and","text_display":" of Year 05). The final 5 months of Year 05 will be used for the completion of data cleaning, data analyses, and","confidence":0.9975600242614746,"confidence_rate":0.9999799759600713},{"cnt":[[120,477],[440,477],[440,524],[120,524]],"region":{"top_left_x":120,"top_left_y":476,"width":321,"height":49},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7aedbe3fff9548e780e49c7cb1c53c5c","type":"text","conversion_output":true,"text":"write-up of results.","text_display":" write-up of results.","confidence":1,"confidence_rate":1},{"cnt":[[846,520],[1278,520],[1278,565],[846,565]],"region":{"top_left_x":846,"top_left_y":519,"width":433,"height":47},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ed1cc42ddf04840845b75452102b003","type":"figure_label","conversion_output":false,"text":"Figure 2: Study Time Line","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[1665,610],[1665,778],[120,778]],"region":{"top_left_x":120,"top_left_y":610,"width":1546,"height":168},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82999537486a441ab8177198ec9d0075","type":"table","conversion_output":true,"selected_labels":["4ed1cc42ddf04840845b75452102b003"],"text":"\\begin{tabular}{|c|c|c|}\n\\hline \\begin{tabular}{c} \n4-months \\\\\nstart-up\n\\end{tabular} & \\begin{tabular}{c} \n51-month Acute, Stabilization, \\& RCT phases \\\\\n(Including 38 months recruitment)\n\\end{tabular} & \\begin{tabular}{c} \n5-months \\\\\nanalysis \\& \\\\\nwrite-up\n\\end{tabular}\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 2: Study Time Line}\n\\begin{tabular}{|c|c|c|}\n\\hline \\begin{tabular}{c} \n4-months \\\\\nstart-up\n\\end{tabular} & \\begin{tabular}{c} \n51-month Acute, Stabilization, \\& RCT phases \\\\\n(Including 38 months recruitment)\n\\end{tabular} & \\begin{tabular}{c} \n5-months \\\\\nanalysis \\& \\\\\nwrite-up\n\\end{tabular}\n\\end{tabular}\n\\end{table}","confidence":0.6346791950965607,"confidence_rate":0.9977954645736208},{"cnt":[[120,773],[1979,773],[1979,819],[120,819]],"region":{"top_left_x":120,"top_left_y":773,"width":1859,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7557608d8fc3442694f640c77739938a","type":"text","conversion_output":true,"text":"Recruitment into Open-Label Acute Phase: This study will use the same methods of recruitment and at the","text_display":"\n\nRecruitment into Open-Label Acute Phase: This study will use the same methods of recruitment and at the","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[120,812],[1979,812],[1979,866],[120,866]],"region":{"top_left_x":120,"top_left_y":812,"width":1859,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ccd226766094ab69e7cc0da0f0a749c","type":"text","conversion_output":true,"text":"same study sites that were successfully used in STOP-PD. \\({ }^{11}\\) In addition, we will systematically screen at sites","text_display":" same study sites that were successfully used in STOP-PD. \\({ }^{11}\\) In addition, we will systematically screen at sites","confidence":1,"confidence_rate":1},{"cnt":[[120,862],[1910,862],[1910,909],[120,909]],"region":{"top_left_x":120,"top_left_y":861,"width":1790,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce9428f15fe94d62b6896e1dfd0e8550","type":"text","conversion_output":true,"text":"that are affiliated with the study's academic centers, some of which are community settings. Individuals at","text_display":" that are affiliated with the study's academic centers, some of which are community settings. Individuals at","confidence":1,"confidence_rate":1},{"cnt":[[120,904],[1871,904],[1871,952],[120,952]],"region":{"top_left_x":120,"top_left_y":904,"width":1752,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b95688896ddd41d4962522630c3c2476","type":"text","conversion_output":true,"text":"these affiliate sites who are eligible for, and consent to, the study will then participate in the study at the","text_display":" these affiliate sites who are eligible for, and consent to, the study will then participate in the study at the","confidence":1,"confidence_rate":1},{"cnt":[[120,947],[1955,947],[1955,999],[120,999]],"region":{"top_left_x":120,"top_left_y":947,"width":1836,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c209c45f683f4a2093e3d088d14e3783","type":"text","conversion_output":true,"text":"primary academic center. This approach will facilitate target enrollment and will extend generalizability of the","text_display":" primary academic center. This approach will facilitate target enrollment and will extend generalizability of the","confidence":1,"confidence_rate":1},{"cnt":[[120,993],[1921,993],[1921,1042],[120,1042]],"region":{"top_left_x":120,"top_left_y":992,"width":1801,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6eb89f3e49904bc89035348dfa402fa2","type":"text","conversion_output":true,"text":"study's findings by recruiting persons from 'less academically-oriented settings'. Entry criteria (see Section","text_display":" study's findings by recruiting persons from 'less academically-oriented settings'. Entry criteria (see Section","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,1036],[1951,1036],[1951,1085],[120,1085]],"region":{"top_left_x":120,"top_left_y":1035,"width":1831,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77f3ef82b8b746d9890d02c71e17b529","type":"text","conversion_output":true,"text":"4.2.1) will be the same as those used in STOP-PD which achieved its recruitment goal. Given that the acute","text_display":" 4.2.1) will be the same as those used in STOP-PD which achieved its recruitment goal. Given that the acute","confidence":0.9970703125,"confidence_rate":0.9999735680300983},{"cnt":[[120,1079],[1949,1079],[1949,1128],[120,1128]],"region":{"top_left_x":120,"top_left_y":1078,"width":1829,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59343c75990b4a32859c659bb717d60f","type":"text","conversion_output":true,"text":"phase of the proposed study will use open-label combination treatment, we anticipate that more patients will","text_display":" phase of the proposed study will use open-label combination treatment, we anticipate that more patients will","confidence":1,"confidence_rate":1},{"cnt":[[120,1124],[1983,1124],[1983,1171],[120,1171]],"region":{"top_left_x":120,"top_left_y":1123,"width":1864,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7baf493f530e4473bbfb8a63c0371f98","type":"text","conversion_output":true,"text":"agree to participate in the proposed study compared with STOP-PD where participants had a 50:50 chance of","text_display":" agree to participate in the proposed study compared with STOP-PD where participants had a 50:50 chance of","confidence":0.9619140625,"confidence_rate":0.9996470608029028},{"cnt":[[120,1169],[1871,1169],[1871,1216],[120,1216]],"region":{"top_left_x":120,"top_left_y":1168,"width":1752,"height":49},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cafbbae01a90446898ce32ade082d03c","type":"text","conversion_output":true,"text":"being randomized to olanzapine plus placebo. Based on 38 months of recruitment, the recruitment goal","text_display":" being randomized to olanzapine plus placebo. Based on 38 months of recruitment, the recruitment goal","confidence":1,"confidence_rate":1},{"cnt":[[120,1212],[1253,1212],[1253,1261],[120,1261]],"region":{"top_left_x":120,"top_left_y":1211,"width":1133,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"667c6a5babb54e2693293192620eb1bf","type":"text","conversion_output":true,"text":"equates to an average 2.6 participants enrolled per site per month.","text_display":" equates to an average 2.6 participants enrolled per site per month.","confidence":1,"confidence_rate":1},{"cnt":[[120,1255],[1962,1255],[1962,1302],[120,1302]],"region":{"top_left_x":120,"top_left_y":1254,"width":1842,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3457af8cbdb94eee989cbf34d85f6dc9","type":"text","conversion_output":true,"text":"Enrollment in the Stabilization and RCT Phases: In the double-blind combination treatment arm of STOP-","text_display":"\nEnrollment in the Stabilization and RCT Phases: In the double-blind combination treatment arm of STOP","confidence":1,"confidence_rate":1},{"cnt":[[120,1298],[1906,1298],[1906,1349],[120,1349]],"region":{"top_left_x":120,"top_left_y":1297,"width":1786,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14146933a3a94489a860c5202628815a","type":"text","conversion_output":true,"text":"PD, 63/129 (48.8\\%) participants who were randomized to combination treatment met remission criteria at","text_display":"PD, 63/129 (48.8\\%) participants who were randomized to combination treatment met remission criteria at","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[120,1345],[1953,1345],[1953,1394],[120,1394]],"region":{"top_left_x":120,"top_left_y":1344,"width":1833,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2faa22a04704ebaacc380d5e03c2907","type":"text","conversion_output":true,"text":"some point during treatment, based on the criterion of a Schedule for Affective Disorders and Schizophrenia","text_display":" some point during treatment, based on the criterion of a Schedule for Affective Disorders and Schizophrenia","confidence":1,"confidence_rate":1},{"cnt":[[120,1384],[2000,1384],[2000,1437],[120,1437]],"region":{"top_left_x":120,"top_left_y":1383,"width":1881,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ac42b5d88444b179037b54218ec07b1","type":"text","conversion_output":true,"text":"(SADS) \\({ }^{101}\\) delusion item score of 1 ('definitely not delusional') and a minimum of 2 consecutive assessments of","text_display":" (SADS) \\({ }^{101}\\) delusion item score of 1 ('definitely not delusional') and a minimum of 2 consecutive assessments of","confidence":0.99951171875,"confidence_rate":0.9999963000030714},{"cnt":[[120,1431],[1996,1431],[1996,1480],[120,1480]],"region":{"top_left_x":120,"top_left_y":1430,"width":1876,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"089058a1104946a88e74b5cbfcf9f699","type":"text","conversion_output":true,"text":"a 17 -item HAM-D score \\(\\leq 10\\). In addition, 10/129 \\((7.8 \\%)\\) combination treatment participants had the absence of","text_display":" a 17 -item HAM-D score \\(\\leq 10\\). In addition, 10/129 \\((7.8 \\%)\\) combination treatment participants had the absence of","confidence":0.622867944650352,"confidence_rate":0.9961584485276673},{"cnt":[[120,1474],[1983,1474],[1983,1523],[120,1523]],"region":{"top_left_x":120,"top_left_y":1473,"width":1864,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55c8c322e0c647b29b69cbf5627039f8","type":"text","conversion_output":true,"text":"delusions, a CGI improvement score of 'very much' or 'much' improved, and a 17-item HAM-D score of 11-15.","text_display":" delusions, a CGI improvement score of 'very much' or 'much' improved, and a 17-item HAM-D score of 11-15.","confidence":0.98828125,"confidence_rate":0.9998928425076647},{"cnt":[[120,1521],[1846,1521],[1846,1566],[120,1566]],"region":{"top_left_x":120,"top_left_y":1521,"width":1726,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be65e0b396494dc88872b9543c389e96","type":"text","conversion_output":true,"text":"Thus, \\(56.6 \\%\\) of participants who were randomized to combination treatment experienced remission of","text_display":" Thus, \\(56.6 \\%\\) of participants who were randomized to combination treatment experienced remission of","confidence":1,"confidence_rate":1},{"cnt":[[120,1560],[1901,1560],[1901,1609],[120,1609]],"region":{"top_left_x":120,"top_left_y":1559,"width":1782,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b1da23a2df34812a5daa830f8e2da94","type":"text","conversion_output":true,"text":"delusions and remission or substantial improvement of depressive symptoms. Given that treatment in the","text_display":" delusions and remission or substantial improvement of depressive symptoms. Given that treatment in the","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[120,1607],[1895,1607],[1895,1656],[120,1656]],"region":{"top_left_x":120,"top_left_y":1607,"width":1775,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b99c49151a3466b8d901dd37ffe55e4","type":"text","conversion_output":true,"text":"acute phase of the proposed study will be open-label, we anticipate that remission/near-remission will be","text_display":" acute phase of the proposed study will be open-label, we anticipate that remission/near-remission will be","confidence":1,"confidence_rate":1},{"cnt":[[120,1650],[1985,1650],[1985,1699],[120,1699]],"region":{"top_left_x":120,"top_left_y":1650,"width":1866,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af484142af8848a7afc9e1e9b2e196ad","type":"text","conversion_output":true,"text":"higher and drop-out due to withdrawal of consent will be lower than under the double-blind, placebo-controlled","text_display":" higher and drop-out due to withdrawal of consent will be lower than under the double-blind, placebo-controlled","confidence":1,"confidence_rate":1},{"cnt":[[120,1693],[1910,1693],[1910,1742],[120,1742]],"region":{"top_left_x":120,"top_left_y":1692,"width":1790,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81ad07014b044fa4b6621ba8ae585d9b","type":"text","conversion_output":true,"text":"conditions of STOP-PD. \\({ }^{11}\\) We therefore predict that \\(60 \\%\\) of participants in the proposed study will achieve","text_display":" conditions of STOP-PD. \\({ }^{11}\\) We therefore predict that \\(60 \\%\\) of participants in the proposed study will achieve","confidence":0.994631290435791,"confidence_rate":0.9999565882578425},{"cnt":[[120,1740],[1916,1740],[1916,1790],[120,1790]],"region":{"top_left_x":120,"top_left_y":1740,"width":1797,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b2887913e054c8d85f69b0d3a1ec609","type":"text","conversion_output":true,"text":"remission of psychosis and either remission or substantial improvement in depressive symptoms, allowing","text_display":" remission of psychosis and either remission or substantial improvement in depressive symptoms, allowing","confidence":1,"confidence_rate":1},{"cnt":[[120,1783],[1983,1783],[1983,1833],[120,1833]],"region":{"top_left_x":120,"top_left_y":1783,"width":1864,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29e3c431ba064470a52cf6c3a1e763af","type":"text","conversion_output":true,"text":"them to proceed to the stabilization phase. Nevertheless, we plan to recruit 392 patients to the acute phase of","text_display":" them to proceed to the stabilization phase. Nevertheless, we plan to recruit 392 patients to the acute phase of","confidence":1,"confidence_rate":1},{"cnt":[[120,1826],[1987,1826],[1987,1876],[120,1876]],"region":{"top_left_x":120,"top_left_y":1826,"width":1868,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36cea4f8c14c4b07858fbf749b48ee53","type":"text","conversion_output":true,"text":"the study, which will facilitate reaching our target recruitment to the RCT should remission plus near-remission","text_display":" the study, which will facilitate reaching our target recruitment to the RCT should remission plus near-remission","confidence":1,"confidence_rate":1},{"cnt":[[120,1869],[763,1869],[763,1919],[120,1919]],"region":{"top_left_x":120,"top_left_y":1869,"width":643,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84231b4bc90f43368f9572791b0d3345","type":"text","conversion_output":true,"text":"in the acute phase be as low as \\(50 \\%\\).","text_display":" in the acute phase be as low as \\(50 \\%\\).","confidence":1,"confidence_rate":1},{"cnt":[[245,1914],[1970,1914],[1970,1962],[245,1962]],"region":{"top_left_x":244,"top_left_y":1914,"width":1727,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a53ca1ab1bb24aa9a98e87d1ed9dae8d","type":"text","conversion_output":true,"text":"In the STOP-PD stabilization phase, \\(10 \\%\\) of participants who experienced remission with combination","text_display":"\n\nIn the STOP-PD stabilization phase, \\(10 \\%\\) of participants who experienced remission with combination","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[120,1955],[1949,1955],[1949,2007],[120,2007]],"region":{"top_left_x":120,"top_left_y":1955,"width":1829,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb04461e01174dfa97d2dc7c483571fb","type":"text","conversion_output":true,"text":"treatment had a relapse (Section 3.8). In contrast, Rothschild et al. \\({ }^{41}\\) found that none of the patients with PD","text_display":" treatment had a relapse (Section 3.8). In contrast, Rothschild et al. \\({ }^{41}\\) found that none of the patients with PD","confidence":0.67578125,"confidence_rate":0.9969190405723668},{"cnt":[[120,2002],[1936,2002],[1936,2052],[120,2052]],"region":{"top_left_x":120,"top_left_y":2002,"width":1816,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"912ccf3653e74cfca950d3c7a2ed7602","type":"text","conversion_output":true,"text":"who responded to combined fluoxetine and perphenazine had a relapse or dropped out during 12 weeks of","text_display":" who responded to combined fluoxetine and perphenazine had a relapse or dropped out during 12 weeks of","confidence":0.99609375,"confidence_rate":0.9999640933114391},{"cnt":[[120,2045],[1966,2045],[1966,2095],[120,2095]],"region":{"top_left_x":120,"top_left_y":2045,"width":1846,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a4545d3a6d147ae8a2554183342eeb5","type":"text","conversion_output":true,"text":"open-label continuation treatment. Based on these data, we estimate that approximately \\(10 \\%\\) of acute phase","text_display":" open-label continuation treatment. Based on these data, we estimate that approximately \\(10 \\%\\) of acute phase","confidence":1,"confidence_rate":1},{"cnt":[[120,2090],[1927,2090],[1927,2138],[120,2138]],"region":{"top_left_x":120,"top_left_y":2090,"width":1808,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4108d345d7f64b05b31848c82136dce0","type":"text","conversion_output":true,"text":"full/near-remitters will not complete the 8-week open-label stabilization phase of the proposed study, either","text_display":" full/near-remitters will not complete the 8-week open-label stabilization phase of the proposed study, either","confidence":0.8863406181335449,"confidence_rate":0.9989421918264616},{"cnt":[[120,2133],[1914,2133],[1914,2185],[120,2185]],"region":{"top_left_x":120,"top_left_y":2133,"width":1795,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d45c1f9005504aefaf3682f73317a026","type":"text","conversion_output":true,"text":"because of relapse or discontinuation. Thus, we predict that 176 participants will be available for the RCT.","text_display":" because of relapse or discontinuation. Thus, we predict that 176 participants will be available for the RCT.","confidence":1,"confidence_rate":1},{"cnt":[[116,2174],[939,2174],[939,2230],[116,2230]],"region":{"top_left_x":116,"top_left_y":2174,"width":823,"height":57},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afe21b0591b14d1abe5789e7ad729ccc","type":"section_header","conversion_output":false,"children_ids":["5026bc581efb4887aa6b7bb85944fa63"],"text":"","text_display":""},{"cnt":[[120,2179],[935,2179],[935,2226],[120,2226]],"region":{"top_left_x":120,"top_left_y":2178,"width":815,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5026bc581efb4887aa6b7bb85944fa63","type":"text","conversion_output":true,"parent_id":"afe21b0591b14d1abe5789e7ad729ccc","text":"3.9.3 Justification for Aspects of the Design:","text_display":"\n\n\\subsection*{3.9.3 Justification for Aspects of the Design:}","confidence":1,"confidence_rate":1},{"cnt":[[120,2221],[1949,2221],[1949,2271],[120,2271]],"region":{"top_left_x":120,"top_left_y":2221,"width":1829,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6f624e230c74e22965fc1ba3b962ff5","type":"text","conversion_output":true,"text":"Duration of Acute Treatment: Although most studies of the acute treatment of PD have been of \\(6-8\\) weeks","text_display":"\n\nDuration of Acute Treatment: Although most studies of the acute treatment of PD have been of \\(6-8\\) weeks","confidence":0.8192868232727051,"confidence_rate":0.9981896311992333},{"cnt":[[120,2260],[1989,2260],[1989,2314],[120,2314]],"region":{"top_left_x":120,"top_left_y":2260,"width":1870,"height":54},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf11381ca04d452e9370585a47f2c383","type":"text","conversion_output":true,"text":"duration, \\({ }^{8}\\) a maximum of 12 weeks of acute treatment is more suitable for this study for several reasons. First,","text_display":" duration, \\({ }^{8}\\) a maximum of 12 weeks of acute treatment is more suitable for this study for several reasons. First,","confidence":1,"confidence_rate":1},{"cnt":[[120,2310],[1854,2310],[1854,2357],[120,2357]],"region":{"top_left_x":120,"top_left_y":2309,"width":1735,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b92940450814557b5a4427de3d846bf","type":"text","conversion_output":true,"text":"one of the goals of the acute phase is to maximize the chance of achieving remission of delusions and","text_display":" one of the goals of the acute phase is to maximize the chance of achieving remission of delusions and","confidence":1,"confidence_rate":1},{"cnt":[[120,2355],[1888,2355],[1888,2402],[120,2402]],"region":{"top_left_x":120,"top_left_y":2354,"width":1769,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65a89ea8f32f4d4faae7aadee63c9557","type":"text","conversion_output":true,"text":"antidepressant response, in order for participants to enter the RCT. In STOP-PD, \\(1 / 3\\) of participants who","text_display":" antidepressant response, in order for participants to enter the RCT. In STOP-PD, \\(1 / 3\\) of participants who","confidence":0.98486328125,"confidence_rate":0.9998638266991651},{"cnt":[[120,2398],[1992,2398],[1992,2445],[120,2445]],"region":{"top_left_x":120,"top_left_y":2397,"width":1872,"height":48},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cfc788202f1446f84a77a56d0318fba","type":"text","conversion_output":true,"text":"experienced remission with combined sertraline and olanzapine did not do so until between weeks 6 and 12 of","text_display":" experienced remission with combined sertraline and olanzapine did not do so until between weeks 6 and 12 of","confidence":1,"confidence_rate":1},{"cnt":[[120,2443],[1944,2443],[1944,2490],[120,2490]],"region":{"top_left_x":120,"top_left_y":2442,"width":1825,"height":49},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0048f3689054c5488ab87d618cbb255","type":"text","conversion_output":true,"text":"treatment. Second, studies of 6-8 weeks typically use one cross-sectional assessment of \\(\\geq 50 \\%\\) decrease in","text_display":" treatment. Second, studies of 6-8 weeks typically use one cross-sectional assessment of \\(\\geq 50 \\%\\) decrease in","confidence":0.9970724582672119,"confidence_rate":0.9999738232411441},{"cnt":[[120,2488],[1927,2488],[1927,2533],[120,2533]],"region":{"top_left_x":120,"top_left_y":2487,"width":1808,"height":47},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"730ea4afca1a42b8bb9f12dfd56bdbb2","type":"text","conversion_output":true,"text":"severity of depression as the primary outcome criterion. The acute treatment outcome criterion that will be","text_display":" severity of depression as the primary outcome criterion. The acute treatment outcome criterion that will be","confidence":1,"confidence_rate":1},{"cnt":[[120,2531],[1867,2531],[1867,2580],[120,2580]],"region":{"top_left_x":120,"top_left_y":2530,"width":1747,"height":51},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d2cc552bef94cc695baffad684799e1","type":"text","conversion_output":true,"text":"used in this study requires a longer period of observation. On the other hand, the decision to limit acute","text_display":" used in this study requires a longer period of observation. On the other hand, the decision to limit acute","confidence":1,"confidence_rate":1},{"cnt":[[1977,2578],[2007,2578],[2007,2628],[1977,2628]],"region":{"top_left_x":1976,"top_left_y":2578,"width":31,"height":50},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2fe924d874ac4ee7936f1402761645de","type":"page_info","conversion_output":false,"text":"8","text_display":"","confidence":0.99951171875,"confidence_rate":0.99951171875}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-11","page":11,"lines":[{"cnt":[[120,125],[2000,125],[2000,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1881,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"993aa613322648fe81471e3f4b90d5ac","type":"text","conversion_output":true,"text":"treatment to a maximum of 12 weeks is based on study time frame considerations (completion of the study in 5","text_display":"\ntreatment to a maximum of 12 weeks is based on study time frame considerations (completion of the study in 5","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,168],[1858,168],[1858,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":1739,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c85a254b57b4775a79537dfbfb89073","type":"text","conversion_output":true,"text":"years) and the fact that patients who do not experience remission of psychosis and at least substantial","text_display":" years) and the fact that patients who do not experience remission of psychosis and at least substantial","confidence":1,"confidence_rate":1},{"cnt":[[120,215],[1914,215],[1914,262],[120,262]],"region":{"top_left_x":120,"top_left_y":214,"width":1795,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79a1cf003e964c319195261a4013e1af","type":"text","conversion_output":true,"text":"improvement in depression following 12 weeks of intensive antidepressant-antipsychotic treatment should","text_display":" improvement in depression following 12 weeks of intensive antidepressant-antipsychotic treatment should","confidence":1,"confidence_rate":1},{"cnt":[[120,258],[1171,258],[1171,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1051,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf6373c3898548039ea09a242d6af410","type":"text","conversion_output":true,"text":"probably be considered for additional or alternative treatment.","text_display":" probably be considered for additional or alternative treatment.","confidence":1,"confidence_rate":1},{"cnt":[[120,296],[1989,296],[1989,348],[120,348]],"region":{"top_left_x":120,"top_left_y":296,"width":1870,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2dc7f5987f04df88bb03e1bd28fedd0","type":"text","conversion_output":true,"text":"Duration of Stabilization Phase: There are no data, and there is no consensus among experts, \\({ }^{102}\\) about how","text_display":"\nDuration of Stabilization Phase: There are no data, and there is no consensus among experts, \\({ }^{102}\\) about how","confidence":1,"confidence_rate":1},{"cnt":[[120,346],[1760,346],[1760,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1640,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"555cea6c549b4776b80a4bfbce567def","type":"text","conversion_output":true,"text":"long to continue antipsychotic medication, once an episode of PD has responded to combination","text_display":" long to continue antipsychotic medication, once an episode of PD has responded to combination","confidence":1,"confidence_rate":1},{"cnt":[[120,389],[1893,389],[1893,436],[120,436]],"region":{"top_left_x":120,"top_left_y":388,"width":1773,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b30da0c96284048be01fab530a883b3","type":"text","conversion_output":true,"text":"pharmacotherapy. However, a survey of 50 experts in the treatment of late-life depression found that the","text_display":" pharmacotherapy. However, a survey of 50 experts in the treatment of late-life depression found that the","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[120,430],[1972,430],[1972,479],[120,479]],"region":{"top_left_x":120,"top_left_y":429,"width":1853,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40e7a7b925ca4b0e82b9879c0fe9a067","type":"text","conversion_output":true,"text":"majority would not recommend stopping antipsychotic medication immediately after remission of PD. \\({ }^{102}\\) In the","text_display":" majority would not recommend stopping antipsychotic medication immediately after remission of PD. \\({ }^{102}\\) In the","confidence":0.998046875,"confidence_rate":0.9999841055341574},{"cnt":[[120,477],[1927,477],[1927,526],[120,526]],"region":{"top_left_x":120,"top_left_y":476,"width":1808,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72b09aeaf8c94107917443d3921ac043","type":"text","conversion_output":true,"text":"absence of data to the contrary, we believe that it is prudent to allow for a period of stability of remission of","text_display":" absence of data to the contrary, we believe that it is prudent to allow for a period of stability of remission of","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[1970,520],[1970,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1851,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3a072d3ea3a4343a62853fc3d8f509e","type":"text","conversion_output":true,"text":"psychosis prior to withdrawal of the antipsychotic. On the other hand, continuation of the antipsychotic for too","text_display":" psychosis prior to withdrawal of the antipsychotic. On the other hand, continuation of the antipsychotic for too","confidence":1,"confidence_rate":1},{"cnt":[[120,563],[1998,563],[1998,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1879,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b71505b0c6fc4c3d83a4c07b97da0ef5","type":"text","conversion_output":true,"text":"long exposes a patient to the hazards of ongoing weight gain and metabolic dysfunction. We therefore chose 8","text_display":" long exposes a patient to the hazards of ongoing weight gain and metabolic dysfunction. We therefore chose 8","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[1957,610],[1957,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1838,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31c4f075df4a481e86bd4ad62a259d7e","type":"text","conversion_output":true,"text":"weeks for the stabilization period to strike a balance between assuring sustained remission of the psychosis,","text_display":" weeks for the stabilization period to strike a balance between assuring sustained remission of the psychosis,","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[1543,653],[1543,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1423,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e17367d3d36a4866ac7b448c1676761d","type":"text","conversion_output":true,"text":"while minimizing the duration of exposure to weight gain and metabolic disturbance.","text_display":" while minimizing the duration of exposure to weight gain and metabolic disturbance.","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1970,696],[1970,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1851,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9eec824e67ce4b67acf1698aebd143d5","type":"text","conversion_output":true,"text":"Discontinuation Design: The primary aim of this study is to assess whether olanzapine, in combination with","text_display":"\nDiscontinuation Design: The primary aim of this study is to assess whether olanzapine, in combination with","confidence":0.99853515625,"confidence_rate":0.9999867936215969},{"cnt":[[120,741],[1940,741],[1940,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":1821,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45e47154e24b4ca7bf3267c9d4209a23","type":"text","conversion_output":true,"text":"antidepressant medication, prevents relapse of PD. This question can be addressed through a double-blind","text_display":" antidepressant medication, prevents relapse of PD. This question can be addressed through a double-blind","confidence":1,"confidence_rate":1},{"cnt":[[120,784],[1953,784],[1953,831],[120,831]],"region":{"top_left_x":120,"top_left_y":784,"width":1833,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8501a01ec85a427b8795957d49d4d37e","type":"text","conversion_output":true,"text":"RCT, in which placebo is substituted for olanzapine in half the study participants, at a fixed point in time. We","text_display":" RCT, in which placebo is substituted for olanzapine in half the study participants, at a fixed point in time. We","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1927,829],[1927,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1808,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3018a7fba2f49289df3a278e9e31b21","type":"text","conversion_output":true,"text":"also considered a placebo-controlled sequential discontinuation design, whereby placebo is substituted for","text_display":" also considered a placebo-controlled sequential discontinuation design, whereby placebo is substituted for","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1919,872],[1919,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1799,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0f4255f369a46f7957cdbb80e0b2c1f","type":"text","conversion_output":true,"text":"olanzapine at different time points. Although a sequential discontinuation design could provide information","text_display":" olanzapine at different time points. Although a sequential discontinuation design could provide information","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[1979,915],[1979,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1859,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"596667f01b3b4dc28834ceddb1eab3a7","type":"text","conversion_output":true,"text":"about how long to continue olanzapine once an episode of PD has remitted, we believe that the first step is to","text_display":" about how long to continue olanzapine once an episode of PD has remitted, we believe that the first step is to","confidence":1,"confidence_rate":1},{"cnt":[[120,958],[2007,958],[2007,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":958,"width":1887,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8aade4824727474985d0200a29ac4bbd","type":"text","conversion_output":true,"text":"determine whether or not antipsychotic medication is of any benefit in preventing relapse of PD. If antipsychotic","text_display":" determine whether or not antipsychotic medication is of any benefit in preventing relapse of PD. If antipsychotic","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[120,1003],[1779,1003],[1779,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1003,"width":1659,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"defeb5e39b8e4f4e81491cb5a25c69ea","type":"text","conversion_output":true,"text":"medication is found to be beneficial, the next step would then be to assess the optimal duration of","text_display":" medication is found to be beneficial, the next step would then be to assess the optimal duration of","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1979,1048],[1979,1096],[120,1096]],"region":{"top_left_x":120,"top_left_y":1048,"width":1859,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adc1592e486145aab5d5bafba41a6def","type":"text","conversion_output":true,"text":"antipsychotic treatment. A sequential discontinuation design would require many more study participants than","text_display":" antipsychotic treatment. A sequential discontinuation design would require many more study participants than","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1979,1091],[1979,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1859,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fac2c388f63640ca81503dd600edd5be","type":"text","conversion_output":true,"text":"the design that we propose, and would therefore be more challenging in terms of recruitment and more costly","text_display":" the design that we propose, and would therefore be more challenging in terms of recruitment and more costly","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[120,1137],[565,1137],[565,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1136,"width":446,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23fe9323f4594d37bfe2daa4eac95604","type":"text","conversion_output":true,"text":"than the current proposal.","text_display":" than the current proposal.","confidence":1,"confidence_rate":1},{"cnt":[[120,1179],[1989,1179],[1989,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1179,"width":1870,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"895b76cf9da4476ebbf21750faf336e7","type":"text","conversion_output":true,"text":"Duration of the RCT: Limited data from naturalistic studies of PD suggest that when antipsychotic medication","text_display":"\nDuration of the RCT: Limited data from naturalistic studies of PD suggest that when antipsychotic medication","confidence":1,"confidence_rate":1},{"cnt":[[120,1220],[2002,1220],[2002,1274],[120,1274]],"region":{"top_left_x":120,"top_left_y":1220,"width":1883,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0037dbaf96c411d9806974001b07107","type":"text","conversion_output":true,"text":"is discontinued, the 3 months after discontinuation is the period of greatest risk of relapse. \\({ }^{32,41}\\) The choice of 36","text_display":" is discontinued, the 3 months after discontinuation is the period of greatest risk of relapse. \\({ }^{32,41}\\) The choice of 36","confidence":1,"confidence_rate":1},{"cnt":[[120,1268],[1910,1268],[1910,1317],[120,1317]],"region":{"top_left_x":120,"top_left_y":1267,"width":1790,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ade5c1fb5e7423cb89a6489834613cc","type":"text","conversion_output":true,"text":"weeks for the proposed RCT therefore: a) covers the period of greatest risk of relapse of PD following the","text_display":" weeks for the proposed RCT therefore: a) covers the period of greatest risk of relapse of PD following the","confidence":1,"confidence_rate":1},{"cnt":[[120,1311],[1944,1311],[1944,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1310,"width":1825,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f098d02aba584f4ca272c8755608dd92","type":"text","conversion_output":true,"text":"discontinuation of the antipsychotic, yet allows for a period of observation beyond that time, b) saves on the","text_display":" discontinuation of the antipsychotic, yet allows for a period of observation beyond that time, b) saves on the","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,1354],[1910,1354],[1910,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1353,"width":1790,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf4f9ecc8e814b47915930d6bd14cb23","type":"text","conversion_output":true,"text":"cost that would be associated with a longer study, and c) allows the study to be completed within 5 years.","text_display":" cost that would be associated with a longer study, and c) allows the study to be completed within 5 years.","confidence":0.9921875,"confidence_rate":0.9999312025643624},{"cnt":[[120,1401],[1949,1401],[1949,1448],[120,1448]],"region":{"top_left_x":120,"top_left_y":1400,"width":1829,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d20027256894fa4af0aba03c344f690","type":"text","conversion_output":true,"text":"Duration of Antipsychotic Taper: In the aformentioned open-label study of the withdrawal of antipsychotic","text_display":"\nDuration of Antipsychotic Taper: In the aformentioned open-label study of the withdrawal of antipsychotic","confidence":1,"confidence_rate":1},{"cnt":[[120,1439],[1931,1439],[1931,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1439,"width":1812,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd5f836b7f3042f8bb6e8797f48ce049","type":"text","conversion_output":true,"text":"medication in PD, Rothschild et al. \\({ }^{41}\\) tapered antipsychotic medication over a period of 4 weeks. No patient","text_display":" medication in PD, Rothschild et al. \\({ }^{41}\\) tapered antipsychotic medication over a period of 4 weeks. No patient","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1742,1487],[1742,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1623,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b254e23cb5c04e15a0e805d951ae0a6a","type":"text","conversion_output":true,"text":"experienced discontinuation side effects or re-emergence of psychosis during the 4 -week taper.","text_display":" experienced discontinuation side effects or re-emergence of psychosis during the 4 -week taper.","confidence":0.98779296875,"confidence_rate":0.9998807629443354},{"cnt":[[120,1525],[1794,1525],[1794,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1525,"width":1674,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9305c32c3fc54c05b39dab628f9a589a","type":"text","conversion_output":true,"text":"Stratification by Age: PD is prevalent in older adults with major depression. \\({ }^{16,17,103,104}\\) Age-related","text_display":"\nStratification by Age: PD is prevalent in older adults with major depression. \\({ }^{16,17,103,104}\\) Age-related","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[120,1575],[1944,1575],[1944,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1574,"width":1825,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4f3a6f9cb7b4174951cf507c92ff97c","type":"text","conversion_output":true,"text":"pharmacodynamic and pharmacokinetic changes may result in age-related differences in treatment efficacy","text_display":" pharmacodynamic and pharmacokinetic changes may result in age-related differences in treatment efficacy","confidence":1,"confidence_rate":1},{"cnt":[[120,1620],[1985,1620],[1985,1669],[120,1669]],"region":{"top_left_x":120,"top_left_y":1619,"width":1866,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48927f902ffe4fab96eccf91d6fcbe8d","type":"text","conversion_output":true,"text":"and tolerability. It is therefore important to include a sufficient number of older persons in order to examine the","text_display":" and tolerability. It is therefore important to include a sufficient number of older persons in order to examine the","confidence":1,"confidence_rate":1},{"cnt":[[120,1663],[1038,1663],[1038,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1662,"width":918,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b29475f0402409c848eea163d1d9a64","type":"text","conversion_output":true,"text":"relation between age, efficacy, tolerability, and safety.","text_display":" relation between age, efficacy, tolerability, and safety.","confidence":1,"confidence_rate":1},{"cnt":[[120,1706],[1938,1706],[1938,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1705,"width":1818,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1804adaae5f4b67b830a97b8f035590","type":"text","conversion_output":true,"text":"Remission Criteria to Enter the RCT: Studies of major depression have found that partial improvement in","text_display":"\nRemission Criteria to Enter the RCT: Studies of major depression have found that partial improvement in","confidence":0.9990236759185791,"confidence_rate":0.9999909555872323},{"cnt":[[120,1745],[1923,1745],[1923,1798],[120,1798]],"region":{"top_left_x":120,"top_left_y":1744,"width":1803,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c75e9d588834048a4ef9db8d96a4bfc","type":"text","conversion_output":true,"text":"depressive symptoms may increase the risk of subsequent relapse of depression. \\({ }^{105}\\) We therefore believe","text_display":" depressive symptoms may increase the risk of subsequent relapse of depression. \\({ }^{105}\\) We therefore believe","confidence":1,"confidence_rate":1},{"cnt":[[120,1796],[1846,1796],[1846,1843],[120,1843]],"region":{"top_left_x":120,"top_left_y":1796,"width":1726,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34b833bbadcd4a06b093c6fd6f83cad8","type":"text","conversion_output":true,"text":"that, in addition to experiencing full remission of psychosis, participants should experience substantial","text_display":" that, in addition to experiencing full remission of psychosis, participants should experience substantial","confidence":1,"confidence_rate":1},{"cnt":[[120,1839],[1979,1839],[1979,1888],[120,1888]],"region":{"top_left_x":120,"top_left_y":1839,"width":1859,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"044d7222cb214a7e919d903961f58bd1","type":"text","conversion_output":true,"text":"improvement in depressive symptoms prior to changes being made to the treatment to which they responded.","text_display":" improvement in depressive symptoms prior to changes being made to the treatment to which they responded.","confidence":1,"confidence_rate":1},{"cnt":[[120,1882],[1893,1882],[1893,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1882,"width":1773,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d24cd4d02d442f698ea7afb55c37840","type":"text","conversion_output":true,"text":"There were patients in STOP-PD who experienced remission of psychosis and were rated by a research","text_display":" There were patients in STOP-PD who experienced remission of psychosis and were rated by a research","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[120,1927],[1953,1927],[1953,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1927,"width":1833,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a95cf4ddc8844f8c9e1fa513210e9dd5","type":"text","conversion_output":true,"text":"psychiatrist as 'very much improved' or 'much improved' on the CGI, yet had a final visit HAM-D score in the","text_display":" psychiatrist as 'very much improved' or 'much improved' on the CGI, yet had a final visit HAM-D score in the","confidence":1,"confidence_rate":1},{"cnt":[[120,1972],[1996,1972],[1996,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1972,"width":1876,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77697888eca64d8ab3bc75c136045abc","type":"text","conversion_output":true,"text":"range of 11-15, which still represented \\(\\geq 50 \\%\\) improvement in the baseline HAM-D score. Given that patients in","text_display":" range of 11-15, which still represented \\(\\geq 50 \\%\\) improvement in the baseline HAM-D score. Given that patients in","confidence":0.8089869616465725,"confidence_rate":0.998174319631417},{"cnt":[[120,2015],[1979,2015],[1979,2065],[120,2065]],"region":{"top_left_x":120,"top_left_y":2015,"width":1859,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0558fefc44f40d58db73cd5691a904d","type":"text","conversion_output":true,"text":"this study will continue with an antidepressant throughout the RCT, and may therefore continue to experience","text_display":" this study will continue with an antidepressant throughout the RCT, and may therefore continue to experience","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[1944,2058],[1944,2108],[120,2108]],"region":{"top_left_x":120,"top_left_y":2058,"width":1825,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80bcd12161d0459995cc80e2e1371dae","type":"text","conversion_output":true,"text":"improvement in depression beyond the acute/stabilization phases of treatment, we will include persons with","text_display":" improvement in depression beyond the acute/stabilization phases of treatment, we will include persons with","confidence":1,"confidence_rate":1},{"cnt":[[120,2103],[1899,2103],[1899,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2103,"width":1780,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a001189d124c4af2acd107a169e6425f","type":"text","conversion_output":true,"text":"substantial improvement in depressive symptoms, even though the symptoms may not have reached the","text_display":" substantial improvement in depressive symptoms, even though the symptoms may not have reached the","confidence":1,"confidence_rate":1},{"cnt":[[120,2142],[1809,2142],[1809,2194],[120,2194]],"region":{"top_left_x":120,"top_left_y":2141,"width":1689,"height":53},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c06d5d6c4b14dc8b9bda06ab26a3006","type":"text","conversion_output":true,"text":"conventional < 8-10 HAM-D cut point for remission used in studies of non-psychotic depression. \\({ }^{29,30}\\)","text_display":" conventional < 8-10 HAM-D cut point for remission used in studies of non-psychotic depression. \\({ }^{29,30}\\)","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[120,2189],[1957,2189],[1957,2239],[120,2239]],"region":{"top_left_x":120,"top_left_y":2189,"width":1838,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76ba38e334c24ae1a1f47e09f85fb656","type":"text","conversion_output":true,"text":"MMSE Score \\(\\geq 2 4\\) to Enter the Stabilization Phase: Persons with clinically significant cognitive impairment","text_display":"\nMMSE Score \\(\\geq 2 4\\) to Enter the Stabilization Phase: Persons with clinically significant cognitive impairment","confidence":0.905042068567127,"confidence_rate":0.9991619156599643},{"cnt":[[120,2234],[1985,2234],[1985,2282],[120,2282]],"region":{"top_left_x":120,"top_left_y":2234,"width":1866,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ade3d8c96a2346a18e8597ac491682d1","type":"text","conversion_output":true,"text":"prior to the index episode of PD will be excluded from the study (Section 4.2.1). In addition, participants with a","text_display":" prior to the index episode of PD will be excluded from the study (Section 4.2.1). In addition, participants with a","confidence":1,"confidence_rate":1},{"cnt":[[120,2277],[1927,2277],[1927,2327],[120,2327]],"region":{"top_left_x":120,"top_left_y":2277,"width":1808,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"451367be7df54523a7315205e0c17700","type":"text","conversion_output":true,"text":"MMSE score <24 at the end of the stabilization phase will be excluded from participation in the RCT (since","text_display":" MMSE score <24 at the end of the stabilization phase will be excluded from participation in the RCT (since","confidence":0.9448403567075729,"confidence_rate":0.9994889657534911},{"cnt":[[120,2322],[1992,2322],[1992,2370],[120,2370]],"region":{"top_left_x":120,"top_left_y":2322,"width":1872,"height":48},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c19928225d144f7bb0b0251dbf49b29","type":"text","conversion_output":true,"text":"poor cognitive performance at that stage of the study can not be explained by depression or psychosis), unless","text_display":" poor cognitive performance at that stage of the study can not be explained by depression or psychosis), unless","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,2368],[1927,2368],[1927,2413],[120,2413]],"region":{"top_left_x":120,"top_left_y":2367,"width":1808,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf87c2d229584dd4a158f6785c857ec1","type":"text","conversion_output":true,"text":"a MMSE score of <24 is explained by factors other than cognitive impairment, such as low education level,","text_display":" a MMSE score of <24 is explained by factors other than cognitive impairment, such as low education level,","confidence":0.9578704833984375,"confidence_rate":0.9996087792292351},{"cnt":[[120,2411],[1888,2411],[1888,2460],[120,2460]],"region":{"top_left_x":120,"top_left_y":2410,"width":1769,"height":50},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"182ed61d0e9b470e93b9e8ddcea37ebb","type":"text","conversion_output":true,"text":"visual impairment, or lack of fluency in the English language.Of the STOP-PD participants who achieved","text_display":" visual impairment, or lack of fluency in the English language.Of the STOP-PD participants who achieved","confidence":0.6787109375,"confidence_rate":0.9963844960298609},{"cnt":[[120,2454],[1987,2454],[1987,2503],[120,2503]],"region":{"top_left_x":120,"top_left_y":2453,"width":1868,"height":50},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1c20f626e084393867bc2629e828c8a","type":"text","conversion_output":true,"text":"remission with combination treatment and participated in the stabilization phase, only \\(1 / 37\\) had a MMSE score","text_display":" remission with combination treatment and participated in the stabilization phase, only \\(1 / 37\\) had a MMSE score","confidence":1,"confidence_rate":1},{"cnt":[[1972,2578],[2009,2578],[2009,2628],[1972,2628]],"region":{"top_left_x":1972,"top_left_y":2578,"width":37,"height":50},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"904ea4addcc44218a56b3af612433f5d","type":"page_info","conversion_output":false,"text":"9","text_display":"","confidence":0.98046875,"confidence_rate":0.98046875}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-12","page":12,"lines":[{"cnt":[[120,125],[1966,125],[1966,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1846,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9773125861ad4672b61a8774cacce5f9","type":"text","conversion_output":true,"text":"\\(<24\\) at the end of stabilization. Thus, we expect that this exclusion will have minimal impact on subject flow in","text_display":"\n\\(<24\\) at the end of stabilization. Thus, we expect that this exclusion will have minimal impact on subject flow in","confidence":0.95263671875,"confidence_rate":0.9995817974233588},{"cnt":[[120,168],[324,168],[324,213],[120,213]],"region":{"top_left_x":120,"top_left_y":167,"width":205,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfdecfddaa07448e8973ff6ee837876a","type":"text","conversion_output":true,"text":"to the RCT.","text_display":" to the RCT.","confidence":0.99951171875,"confidence_rate":0.9999694754347522},{"cnt":[[116,208],[1904,208],[1904,264],[116,264]],"region":{"top_left_x":116,"top_left_y":208,"width":1788,"height":57},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cd5d2d36c77409d81ddb158187906fe","type":"section_header","conversion_output":false,"children_ids":["b15b424bfb9a406384a18a2ba32cd5b1"],"text":"","text_display":""},{"cnt":[[120,213],[1899,213],[1899,260],[120,260]],"region":{"top_left_x":120,"top_left_y":212,"width":1780,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b15b424bfb9a406384a18a2ba32cd5b1","type":"text","conversion_output":true,"parent_id":"1cd5d2d36c77409d81ddb158187906fe","text":"3.9.4 Inclusion and Exclusion Criteria for participants are described in Human Subjects (Section 4.2.1)","text_display":"\n\n\\subsection*{3.9.4 Inclusion and Exclusion Criteria for participants are described in Human Subjects (Section 4.2.1)}","confidence":0.9833984375,"confidence_rate":0.9998450035605886},{"cnt":[[116,254],[754,254],[754,305],[116,305]],"region":{"top_left_x":116,"top_left_y":253,"width":639,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"730b80241d854b96a989365f04af9026","type":"section_header","conversion_output":false,"children_ids":["6cf011fe3b6849f9987ea058a9d2c1a3"],"text":"","text_display":""},{"cnt":[[120,258],[750,258],[750,299],[120,299]],"region":{"top_left_x":120,"top_left_y":257,"width":630,"height":42},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cf011fe3b6849f9987ea058a9d2c1a3","type":"text","conversion_output":true,"parent_id":"730b80241d854b96a989365f04af9026","text":"3.9.5 Assessments and Measures:","text_display":"\n\n\\subsection*{3.9.5 Assessments and Measures:}","confidence":1,"confidence_rate":1},{"cnt":[[120,299],[1921,299],[1921,348],[120,348]],"region":{"top_left_x":120,"top_left_y":298,"width":1801,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba8248d2f9e540f7a71aeef5c21a5be8","type":"text","conversion_output":true,"text":"Primary Clinical Measures pertain to the study's aims and hypotheses and/or eligibility criteria. They are:","text_display":"\n\nPrimary Clinical Measures pertain to the study's aims and hypotheses and/or eligibility criteria. They are:","confidence":1,"confidence_rate":1},{"cnt":[[120,339],[1863,339],[1863,391],[120,391]],"region":{"top_left_x":120,"top_left_y":339,"width":1743,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb0b9e1ed8b04a71b5311e44110cf228","type":"text","conversion_output":true,"text":"Structured Clinical Interview for DSM-IV-TR (SCID-IV), \\({ }^{106}\\) the GRID version of the 17 -item HAM-D, \\({ }^{98,107}\\)","text_display":" Structured Clinical Interview for DSM-IV-TR (SCID-IV), \\({ }^{106}\\) the GRID version of the 17 -item HAM-D, \\({ }^{98,107}\\)","confidence":0.8971707097953185,"confidence_rate":0.9991591976794538},{"cnt":[[120,385],[1884,385],[1884,436],[120,436]],"region":{"top_left_x":120,"top_left_y":384,"width":1765,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67b0c904b7774c4f81fd57f86a8217f2","type":"text","conversion_output":true,"text":"Delusion Assessment Scale (DAS), \\({ }^{96}\\) delusion and hallucination items of the SADS, \\({ }^{101}\\) Scale for Suicidal","text_display":" Delusion Assessment Scale (DAS), \\({ }^{96}\\) delusion and hallucination items of the SADS, \\({ }^{101}\\) Scale for Suicidal","confidence":1,"confidence_rate":1},{"cnt":[[120,425],[1779,425],[1779,479],[120,479]],"region":{"top_left_x":120,"top_left_y":425,"width":1659,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aeb44768ea9248ea89bd27cffcc06950","type":"text","conversion_output":true,"text":"Ideation (SSI) \\({ }^{108}\\), CGI, \\({ }^{99}\\) and MMSE. \\({ }^{100}\\) The 26-item Informant Questionnaire for Cognitive Decline","text_display":" Ideation (SSI) \\({ }^{108}\\), CGI, \\({ }^{99}\\) and MMSE. \\({ }^{100}\\) The 26-item Informant Questionnaire for Cognitive Decline","confidence":0.9260965987632517,"confidence_rate":0.9994314451592745},{"cnt":[[120,473],[1949,473],[1949,526],[120,526]],"region":{"top_left_x":120,"top_left_y":472,"width":1829,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"587a1cff77f24f4883dc356f0239f906","type":"text","conversion_output":true,"text":"(IQCODE) \\({ }^{109,110}\\) will be used to screen out clinically significant cognitive decline that began prior to the index","text_display":" (IQCODE) \\({ }^{109,110}\\) will be used to screen out clinically significant cognitive decline that began prior to the index","confidence":0.9975595474243164,"confidence_rate":0.9999810588202088},{"cnt":[[120,520],[1540,520],[1540,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1421,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e5228a600f2404a97dbd8d16c752c75","type":"text","conversion_output":true,"text":"episode of PD, to help avoid the inclusion of persons in the early stage of dementia.","text_display":" episode of PD, to help avoid the inclusion of persons in the early stage of dementia.","confidence":1,"confidence_rate":1},{"cnt":[[116,563],[1914,563],[1914,612],[116,612]],"region":{"top_left_x":116,"top_left_y":562,"width":1799,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebb2bfb0293c4811bce62191269175e1","type":"text","conversion_output":true,"text":"Secondary Clinical Measures: Anxiety symptoms, medical burden, executive dysfunction, psychomotor","text_display":"\nSecondary Clinical Measures: Anxiety symptoms, medical burden, executive dysfunction, psychomotor","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[1936,610],[1936,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1816,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a80549866f58437ab58c6b889e87403d","type":"text","conversion_output":true,"text":"change, and 'treatment resistance' during the index episode of depression have each been associated with","text_display":" change, and 'treatment resistance' during the index episode of depression have each been associated with","confidence":1,"confidence_rate":1},{"cnt":[[120,649],[1949,649],[1949,700],[120,700]],"region":{"top_left_x":120,"top_left_y":648,"width":1829,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f6285a7588b4dcda735de85ff4e3464","type":"text","conversion_output":true,"text":"increased risk of relapse/recurrence of major depression. \\({ }^{111-115}\\) These variables will therefore be included as","text_display":" increased risk of relapse/recurrence of major depression. \\({ }^{111-115}\\) These variables will therefore be included as","confidence":0.9496192932128906,"confidence_rate":0.9995898133662691},{"cnt":[[116,696],[1949,696],[1949,746],[116,746]],"region":{"top_left_x":116,"top_left_y":696,"width":1833,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a558f0eb11b14deba631a0a2d7d7877e","type":"text","conversion_output":true,"text":"covariates in the Cox model examining risk of relapse (Section 3.10.3). The pertinent measures are: anxiety","text_display":" covariates in the Cox model examining risk of relapse (Section 3.10.3). The pertinent measures are: anxiety","confidence":1,"confidence_rate":1},{"cnt":[[116,735],[1893,735],[1893,788],[116,788]],"region":{"top_left_x":116,"top_left_y":734,"width":1777,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbc579a4a48244daa988e1a5bee77999","type":"text","conversion_output":true,"text":"subscale of the Hospital Anxiety and Depression Scale, \\({ }^{116,117}\\) Cumulative Illness Rating Scale, \\({ }^{118}\\) DKEFS","text_display":" subscale of the Hospital Anxiety and Depression Scale, \\({ }^{116,117}\\) Cumulative Illness Rating Scale, \\({ }^{118}\\) DKEFS","confidence":0.9302096366882324,"confidence_rate":0.999443652492212},{"cnt":[[116,778],[1635,778],[1635,831],[116,831]],"region":{"top_left_x":116,"top_left_y":777,"width":1519,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"056ee37fa70b4da5aef24129216a10a2","type":"text","conversion_output":true,"text":"Stroop Conditions \\(1-3,{ }^{119}\\) the CORE \\({ }^{97}\\), and the Antidepressant Treatment History Form. \\({ }^{120}\\)","text_display":" Stroop Conditions \\(1-3,{ }^{119}\\) the CORE \\({ }^{97}\\), and the Antidepressant Treatment History Form. \\({ }^{120}\\)","confidence":0.6700669275175528,"confidence_rate":0.996696561953424},{"cnt":[[116,829],[1944,829],[1944,879],[116,879]],"region":{"top_left_x":116,"top_left_y":829,"width":1829,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19cf583be5954f98be6833ed7003f768","type":"text","conversion_output":true,"text":"- Given the age range of study participants, there will be 3 additional cognitive tests to help characterize the","text_display":"\n- Given the age range of study participants, there will be 3 additional cognitive tests to help characterize the","confidence":1,"confidence_rate":1},{"cnt":[[116,868],[1992,868],[1992,922],[116,922]],"region":{"top_left_x":116,"top_left_y":867,"width":1876,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bda6a438d68c46c6802e8fc33dfa79f8","type":"text","conversion_output":true,"text":"sample at entry in to the RCT; these tests, which target previously described impairments in \\(PD ^{121}\\) and late-life","text_display":" sample at entry in to the RCT; these tests, which target previously described impairments in \\(PD ^{121}\\) and late-life","confidence":0.9829182624816895,"confidence_rate":0.9998674756022954},{"cnt":[[116,911],[1895,911],[1895,965],[116,965]],"region":{"top_left_x":116,"top_left_y":910,"width":1779,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d8fe6be26d54fca87e7aef20948f80d","type":"text","conversion_output":true,"text":"depression, \\({ }^{121,123}\\) will be: i) a test of delayed recall (RBANS Immediate and Delayed Recall, \\({ }^{124}\\) ii) a test of","text_display":" depression, \\({ }^{121,123}\\) will be: i) a test of delayed recall (RBANS Immediate and Delayed Recall, \\({ }^{124}\\) ii) a test of","confidence":1,"confidence_rate":1},{"cnt":[[116,956],[1929,956],[1929,1010],[116,1010]],"region":{"top_left_x":116,"top_left_y":956,"width":1814,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f554ab726e3a4d8193c79fa1e913bafc","type":"text","conversion_output":true,"text":"psychomotor speed (RBANS coding task \\({ }^{124}\\) ), and iii) a test of cognitive flexibility (DKEFS Trail Making Test","text_display":" psychomotor speed (RBANS coding task \\({ }^{124}\\) ), and iii) a test of cognitive flexibility (DKEFS Trail Making Test","confidence":0.9980475902557373,"confidence_rate":0.9999842394937093},{"cnt":[[116,1001],[1962,1001],[1962,1051],[116,1051]],"region":{"top_left_x":116,"top_left_y":1001,"width":1846,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96eaf584051d41cd956219b69a5d6f8a","type":"text","conversion_output":true,"text":"Conditions 4 \\& 5. \\({ }^{119}\\) The DKEFS and RBANS tests were selected as they have norms available for the entire","text_display":" Conditions 4 \\& 5. \\({ }^{119}\\) The DKEFS and RBANS tests were selected as they have norms available for the entire","confidence":0.9008120696526021,"confidence_rate":0.9991511034202281},{"cnt":[[116,1044],[1906,1044],[1906,1096],[116,1096]],"region":{"top_left_x":116,"top_left_y":1044,"width":1790,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98ee722e76c04b4d99459c0423cbbded","type":"text","conversion_output":true,"text":"age range of our proposed sample and the two DKEFS tasks and the two RBANS tasks were co-normed.","text_display":" age range of our proposed sample and the two DKEFS tasks and the two RBANS tasks were co-normed.","confidence":1,"confidence_rate":1},{"cnt":[[116,1087],[1888,1087],[1888,1141],[116,1141]],"region":{"top_left_x":116,"top_left_y":1087,"width":1773,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cfd915e396148228bff3a07122ac842","type":"text","conversion_output":true,"text":"- Measures of non-metabolic safety will be: UKU Side Effects Scale; \\({ }^{125}\\) Simpson Angus Scale; \\({ }^{126}\\) Barnes","text_display":" - Measures of non-metabolic safety will be: UKU Side Effects Scale; \\({ }^{125}\\) Simpson Angus Scale; \\({ }^{126}\\) Barnes","confidence":1,"confidence_rate":1},{"cnt":[[116,1130],[1987,1130],[1987,1184],[116,1184]],"region":{"top_left_x":116,"top_left_y":1130,"width":1872,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2e6893e8e3945fbacdd59bfb896ed9a","type":"text","conversion_output":true,"text":"Akathisia Scale; \\({ }^{127}\\) Abnormal Involuntary Movement Scale; \\({ }^{128}\\) Orthostatic hypotension assessed after standing","text_display":" Akathisia Scale; \\({ }^{127}\\) Abnormal Involuntary Movement Scale; \\({ }^{128}\\) Orthostatic hypotension assessed after standing","confidence":0.99951171875,"confidence_rate":0.9999963552268055},{"cnt":[[116,1177],[1809,1177],[1809,1227],[116,1227]],"region":{"top_left_x":116,"top_left_y":1177,"width":1693,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"444ef1a32dc54dd9990dd3ab4fb69ce1","type":"text","conversion_output":true,"text":"for 1 minute, following 5 minutes in a supine position; and Falls Log (incidence and number of falls).","text_display":" for 1 minute, following 5 minutes in a supine position; and Falls Log (incidence and number of falls).","confidence":0.9990236759185791,"confidence_rate":0.9999913557807578},{"cnt":[[116,1222],[2004,1222],[2004,1270],[116,1270]],"region":{"top_left_x":116,"top_left_y":1222,"width":1889,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc835ac7b07e44bf9e533a8e7e17027c","type":"text","conversion_output":true,"text":"Anthropometric Measures : The selection of anthropometric measures and metabolic parameters is based on","text_display":"\nAnthropometric Measures : The selection of anthropometric measures and metabolic parameters is based on","confidence":0.947265625,"confidence_rate":0.9994984986262615},{"cnt":[[116,1265],[1738,1265],[1738,1317],[116,1317]],"region":{"top_left_x":116,"top_left_y":1265,"width":1623,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61dc7d1c0d1446bc868144e6d0b214b5","type":"text","conversion_output":true,"text":"Consensus Recommendations regarding the clinical monitoring of patients treated with atypical","text_display":" Consensus Recommendations regarding the clinical monitoring of patients treated with atypical","confidence":1,"confidence_rate":1},{"cnt":[[116,1306],[1886,1306],[1886,1360],[116,1360]],"region":{"top_left_x":116,"top_left_y":1306,"width":1771,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea66be39dadc41bdab6e87b697f3f015","type":"text","conversion_output":true,"text":"antipsychotics. \\({ }^{129}\\) Subjects will be weighed, and their height measured, in light clothing without shoes. In","text_display":" antipsychotics. \\({ }^{129}\\) Subjects will be weighed, and their height measured, in light clothing without shoes. In","confidence":1,"confidence_rate":1},{"cnt":[[116,1354],[1966,1354],[1966,1405],[116,1405]],"region":{"top_left_x":116,"top_left_y":1353,"width":1850,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37e41715ce2140b1ad0de71441482579","type":"text","conversion_output":true,"text":"addition, pre-morbid weight (average weight in the year prior to the onset of the index episode of depression)","text_display":" addition, pre-morbid weight (average weight in the year prior to the onset of the index episode of depression)","confidence":1,"confidence_rate":1},{"cnt":[[116,1399],[1957,1399],[1957,1450],[116,1450]],"region":{"top_left_x":116,"top_left_y":1398,"width":1842,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4962791bb0824dbd81affcc6b5fc7adb","type":"text","conversion_output":true,"text":"will be obtained from the patient's primary care physician's records. When pre-morbid weight is not available","text_display":" will be obtained from the patient's primary care physician's records. When pre-morbid weight is not available","confidence":1,"confidence_rate":1},{"cnt":[[116,1444],[1962,1444],[1962,1491],[116,1491]],"region":{"top_left_x":116,"top_left_y":1443,"width":1846,"height":49},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ff0ebbb9e614b628f7b039a78d22ef4","type":"text","conversion_output":true,"text":"from primary care physicians, the patient will be asked for this information. Pre-morbid weight will be used to","text_display":" from primary care physicians, the patient will be asked for this information. Pre-morbid weight will be used to","confidence":1,"confidence_rate":1},{"cnt":[[116,1487],[1987,1487],[1987,1536],[116,1536]],"region":{"top_left_x":116,"top_left_y":1486,"width":1872,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a8cbca676e84b3f99c7087ee160a8e4","type":"text","conversion_output":true,"text":"calculate weight loss during the index episode of depression; depression-related weight loss will be taken in to","text_display":" calculate weight loss during the index episode of depression; depression-related weight loss will be taken in to","confidence":1,"confidence_rate":1},{"cnt":[[116,1530],[1964,1530],[1964,1579],[116,1579]],"region":{"top_left_x":116,"top_left_y":1529,"width":1848,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"892aa7642d4b46deb9be366405781aea","type":"text","conversion_output":true,"text":"account in a secondary statistical analysis of weight change during the proposed study. In addition to weight,","text_display":" account in a secondary statistical analysis of weight change during the proposed study. In addition to weight,","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[116,1571],[1953,1571],[1953,1622],[116,1622]],"region":{"top_left_x":116,"top_left_y":1570,"width":1837,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bae2f27ea2534ca2ab68900c39fe1c23","type":"text","conversion_output":true,"text":"body mass index (BMI) and waist circumference are key clinical measures of body fat. \\({ }^{129}\\) BMI, a measure of","text_display":" body mass index (BMI) and waist circumference are key clinical measures of body fat. \\({ }^{129}\\) BMI, a measure of","confidence":0.982421875,"confidence_rate":0.99985344499693},{"cnt":[[116,1618],[1927,1618],[1927,1669],[116,1669]],"region":{"top_left_x":116,"top_left_y":1617,"width":1812,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e281e5a030c14ef38d0a45f2ea2d1de6","type":"text","conversion_output":true,"text":"weight relative to height, is an index of total body fat. Waist circumference, measured at the umbilicus, is a","text_display":" weight relative to height, is an index of total body fat. Waist circumference, measured at the umbilicus, is a","confidence":0.9951171875,"confidence_rate":0.9999574376677433},{"cnt":[[116,1663],[1940,1663],[1940,1712],[116,1712]],"region":{"top_left_x":116,"top_left_y":1662,"width":1825,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e78b5f6157d4e098b29e63c747be23d","type":"text","conversion_output":true,"text":"measure of abdominal obesity, which is more specifically associated with cardiovascular risk and metabolic","text_display":" measure of abdominal obesity, which is more specifically associated with cardiovascular risk and metabolic","confidence":1,"confidence_rate":1},{"cnt":[[116,1702],[1996,1702],[1996,1755],[116,1755]],"region":{"top_left_x":116,"top_left_y":1701,"width":1880,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"882c6213b8da4738957d584201e1ab40","type":"text","conversion_output":true,"text":"syndrome than BMI. \\({ }^{130}\\) BMI and waist circumference will be assessed at each study visit. Separate secondary","text_display":" syndrome than BMI. \\({ }^{130}\\) BMI and waist circumference will be assessed at each study visit. Separate secondary","confidence":0.9751095771789551,"confidence_rate":0.9997934194763594},{"cnt":[[116,1749],[2000,1749],[2000,1800],[116,1800]],"region":{"top_left_x":116,"top_left_y":1748,"width":1885,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c24b9ececbb481e98b236745e1af5c4","type":"text","conversion_output":true,"text":"statistical analyses pertaining to Aims 2-5 will be conducted, using each of these measures as an alternative to","text_display":" statistical analyses pertaining to Aims 2-5 will be conducted, using each of these measures as an alternative to","confidence":0.93994140625,"confidence_rate":0.9994707577097788},{"cnt":[[116,1796],[251,1796],[251,1841],[116,1841]],"region":{"top_left_x":116,"top_left_y":1796,"width":136,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c25c068574b3430fb2595fd05fe8a743","type":"text","conversion_output":true,"text":"weight.","text_display":" weight.","confidence":1,"confidence_rate":1},{"cnt":[[116,1830],[1987,1830],[1987,1884],[116,1884]],"region":{"top_left_x":116,"top_left_y":1830,"width":1872,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e7a851ac7e142b780b8c8ad9d96fd6f","type":"text","conversion_output":true,"text":"Metabolic Measures: Homeostatic model assessment (HOMA), a measure of insulin resistance \\({ }^{131,132}\\) and the","text_display":"\nMetabolic Measures: Homeostatic model assessment (HOMA), a measure of insulin resistance \\({ }^{131,132}\\) and the","confidence":1,"confidence_rate":1},{"cnt":[[116,1878],[1996,1878],[1996,1931],[116,1931]],"region":{"top_left_x":116,"top_left_y":1877,"width":1880,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24bbf412e0014390ac750e3f967aba41","type":"text","conversion_output":true,"text":"primary measure of glycemic function in this study, will be calculated based on an established formula, \\({ }^{132}\\) each","text_display":" primary measure of glycemic function in this study, will be calculated based on an established formula, \\({ }^{132}\\) each","confidence":1,"confidence_rate":1},{"cnt":[[116,1927],[1940,1927],[1940,1979],[116,1979]],"region":{"top_left_x":116,"top_left_y":1927,"width":1825,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44fde1dfe1d5476e8ebaacfbca800221","type":"text","conversion_output":true,"text":"time fasting glucose and insulin are measured. HbA 1 c will be a secondary measure of glycemic function, to","text_display":" time fasting glucose and insulin are measured. HbA 1 c will be a secondary measure of glycemic function, to","confidence":0.9975595474243164,"confidence_rate":0.9999794671407691},{"cnt":[[116,1970],[1893,1970],[1893,2022],[116,2022]],"region":{"top_left_x":116,"top_left_y":1970,"width":1777,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c7454091e484d8ab2a52987a2207a33","type":"text","conversion_output":true,"text":"assess the longitudinal stability of serum glucose levels during the course of the study. Triglycerides and","text_display":" assess the longitudinal stability of serum glucose levels during the course of the study. 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and the MMSE, Immediate and Delayed Recall, Stroop, Trail Making, and","text_display":"\n\\({ }^{\\text {H }}\\) Cognitive evaluation will include: the IQCODE at baseline; and the MMSE, Immediate and Delayed Recall, Stroop, Trail Making, and","confidence":0.9960973262786865,"confidence_rate":0.9999732174201372},{"cnt":[[120,1388],[1910,1388],[1910,1429],[120,1429]],"region":{"top_left_x":120,"top_left_y":1387,"width":1790,"height":42},"line":164,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c438e49d0c146d7b1a8c6b0932cc310","type":"text","conversion_output":true,"text":"Coding task at the end of the Stabilization Phase, and Delayed Recall, Stroop, Trail Making, and Coding task at RCT termination.","text_display":" Coding task at the end of the Stabilization Phase, and Delayed Recall, Stroop, Trail Making, and Coding task at RCT termination.","confidence":1,"confidence_rate":1},{"cnt":[[120,1422],[1931,1422],[1931,1467],[120,1467]],"region":{"top_left_x":120,"top_left_y":1422,"width":1812,"height":46},"line":165,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d087562e85c74c9888dcdda0a5035df5","type":"text","conversion_output":true,"text":"\\({ }^{1}\\) The SF-36 will be administered to: i) examine the association of acute and remitted psychotic depression with participants' health-","text_display":"\n\\({ }^{1}\\) The SF-36 will be administered to: i) examine the association of acute and remitted psychotic depression with participants' health","confidence":0.9550299985567108,"confidence_rate":0.9996805196079722},{"cnt":[[120,1463],[1996,1463],[1996,1502],[120,1502]],"region":{"top_left_x":120,"top_left_y":1463,"width":1876,"height":39},"line":166,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2f4c4ff081e455ebd6c0a1469fbf3ab","type":"text","conversion_output":true,"text":"related quality of life, and ii) explore the effect of continuation versus discontinuation of antipsychotic medication on participants' health-","text_display":"related quality of life, and ii) explore the effect of continuation versus discontinuation of antipsychotic medication on participants' health","confidence":1,"confidence_rate":1},{"cnt":[[120,1500],[415,1500],[415,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1499,"width":295,"height":38},"line":167,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab35ac2a68d54f48b8ee1d8ba6c99793","type":"text","conversion_output":true,"text":"related quality of life.","text_display":"related quality of life.","confidence":1,"confidence_rate":1},{"cnt":[[120,1532],[1940,1532],[1940,1575],[120,1575]],"region":{"top_left_x":120,"top_left_y":1531,"width":1821,"height":44},"line":168,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77518c57a8bf4d48b84489a8cf20ee42","type":"text","conversion_output":true,"text":"\\({ }^{ J }\\) The Best Guess Form will be completed independently by participant and rater at RCT termination, to determine, once the study is","text_display":"\n\\({ }^{ J }\\) The Best Guess Form will be completed independently by participant and rater at RCT termination, to determine, once the study is","confidence":1,"confidence_rate":1},{"cnt":[[120,1573],[1979,1573],[1979,1609],[120,1609]],"region":{"top_left_x":120,"top_left_y":1572,"width":1859,"height":38},"line":169,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c80d721f99a4f03bee61cbcf915be4e","type":"text","conversion_output":true,"text":"completed, whether participants and/or raters could guess treatment assignment on a greater than chance basis. This will serve as an","text_display":" completed, whether participants and/or raters could guess treatment assignment on a greater than chance basis. This will serve as an","confidence":1,"confidence_rate":1},{"cnt":[[120,1607],[969,1607],[969,1644],[120,1644]],"region":{"top_left_x":120,"top_left_y":1607,"width":849,"height":37},"line":170,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94c28c031e1940efbb245c1149c1ee8f","type":"text","conversion_output":true,"text":"indicator of how well the study's double-blind was preserved.","text_display":" indicator of how well the study's double-blind was preserved.","confidence":1,"confidence_rate":1},{"cnt":[[120,1637],[1463,1637],[1463,1682],[120,1682]],"region":{"top_left_x":120,"top_left_y":1637,"width":1344,"height":46},"line":171,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1dece51b6822487297759828a9d96564","type":"text","conversion_output":true,"text":"\\({ }^{ K }\\) The purpose of the Intent-to-Attend form is described in Section 3.10.5 ('Strategies for Attrition')","text_display":"\n\\({ }^{ K }\\) The purpose of the Intent-to-Attend form is described in Section 3.10.5 ('Strategies for Attrition')","confidence":0.9518221172506856,"confidence_rate":0.9995744258127645},{"cnt":[[120,1678],[2002,1678],[2002,1725],[120,1725]],"region":{"top_left_x":120,"top_left_y":1677,"width":1883,"height":49},"line":172,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9e0b28bbe3241578fafe2e066a7d03f","type":"text","conversion_output":true,"text":"Rater Training and Rater Reliability: All raters will participate in standardized training before being allowed to","text_display":"\nRater Training and Rater Reliability: All raters will participate in standardized training before being allowed to","confidence":1,"confidence_rate":1},{"cnt":[[120,1723],[2000,1723],[2000,1770],[120,1770]],"region":{"top_left_x":120,"top_left_y":1723,"width":1881,"height":48},"line":173,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8da3088e6394e24b0a9ec3d8f762bda","type":"text","conversion_output":true,"text":"assess and rate study participants. In addition, inter-rater reliability of the HAM-D and DAS will be assessed on","text_display":" assess and rate study participants. In addition, inter-rater reliability of the HAM-D and DAS will be assessed on","confidence":1,"confidence_rate":1},{"cnt":[[120,1766],[1656,1766],[1656,1813],[120,1813]],"region":{"top_left_x":120,"top_left_y":1766,"width":1537,"height":48},"line":174,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93f0a2b41f2f498c8bbfbb67f76a0e5c","type":"text","conversion_output":true,"text":"an annual basis. Please see 'Reliability and Quality Control' in Section 4.1.6 for full details.","text_display":" an annual basis. Please see 'Reliability and Quality Control' in Section 4.1.6 for full details.","confidence":1,"confidence_rate":1},{"cnt":[[120,1809],[1992,1809],[1992,1858],[120,1858]],"region":{"top_left_x":120,"top_left_y":1808,"width":1872,"height":51},"line":175,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf07bd16143d4dc9b2b89d2da5458f95","type":"text","conversion_output":true,"text":"3.9.6 Pharmacogenetics: Processing of DNA: Whole blood on all consenting participants will be sent directly","text_display":"\n3.9.6 Pharmacogenetics: Processing of DNA: Whole blood on all consenting participants will be sent directly","confidence":1,"confidence_rate":1},{"cnt":[[120,1852],[1843,1852],[1843,1901],[120,1901]],"region":{"top_left_x":120,"top_left_y":1851,"width":1724,"height":51},"line":176,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c1aa13fdd4340d39d5686b09ffceea5","type":"text","conversion_output":true,"text":"to the NIMH Center for Collaborative Genetic Studies ('the Center') for the generation of cell lines and","text_display":" to the NIMH Center for Collaborative Genetic Studies ('the Center') for the generation of cell lines and","confidence":1,"confidence_rate":1},{"cnt":[[120,1899],[2004,1899],[2004,1944],[120,1944]],"region":{"top_left_x":120,"top_left_y":1899,"width":1885,"height":46},"line":177,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aeb0501ff58140808632416012c2f68e","type":"text","conversion_output":true,"text":"extraction of DNA. Blood samples will be sent as they are collected and shipped at room temperature using the","text_display":" extraction of DNA. Blood samples will be sent as they are collected and shipped at room temperature using the","confidence":1,"confidence_rate":1},{"cnt":[[120,1942],[1970,1942],[1970,1989],[120,1989]],"region":{"top_left_x":120,"top_left_y":1942,"width":1851,"height":48},"line":178,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69f249b164034a17a157a1623c7d4cc1","type":"text","conversion_output":true,"text":"Center's established protocols that are designed to minimize trauma. In the rare event that a sample is lost in","text_display":" Center's established protocols that are designed to minimize trauma. In the rare event that a sample is lost in","confidence":1,"confidence_rate":1},{"cnt":[[120,1985],[1989,1985],[1989,2035],[120,2035]],"region":{"top_left_x":120,"top_left_y":1985,"width":1870,"height":50},"line":179,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65b79cf0ee9e4ef8a04d20e93571cf47","type":"text","conversion_output":true,"text":"transit, or if the sample is unsuitable for DNA extraction, or if a cell line is not successfully made, we will obtain","text_display":" transit, or if the sample is unsuitable for DNA extraction, or if a cell line is not successfully made, we will obtain","confidence":1,"confidence_rate":1},{"cnt":[[120,2030],[1931,2030],[1931,2078],[120,2078]],"region":{"top_left_x":120,"top_left_y":2030,"width":1812,"height":48},"line":180,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17208eaab63b41e8af9c8a8a2ce224f8","type":"text","conversion_output":true,"text":"a repeat blood sample to send to the Center. DNA will be shipped from the Center to Dr. James Kennedy's","text_display":" a repeat blood sample to send to the Center. DNA will be shipped from the Center to Dr. James Kennedy's","confidence":1,"confidence_rate":1},{"cnt":[[120,2075],[1929,2075],[1929,2121],[120,2121]],"region":{"top_left_x":120,"top_left_y":2075,"width":1810,"height":46},"line":181,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45c89bbd0d484f399aaef85e7463d75f","type":"text","conversion_output":true,"text":"genetics laboratory at CAMH in Toronto within 4 months of the blood sample being received by the Center.","text_display":" genetics laboratory at CAMH in Toronto within 4 months of the blood sample being received by the Center.","confidence":1,"confidence_rate":1},{"cnt":[[120,2118],[1979,2118],[1979,2168],[120,2168]],"region":{"top_left_x":120,"top_left_y":2118,"width":1859,"height":50},"line":182,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09f11a6fc3e2472fbe17f5c0237d5007","type":"text","conversion_output":true,"text":"With the exception of data entry personnel at Cornell, the study's research staff will not be privy to the genetic","text_display":" With the exception of data entry personnel at Cornell, the study's research staff will not be privy to the genetic","confidence":1,"confidence_rate":1},{"cnt":[[120,2161],[1227,2161],[1227,2209],[120,2209]],"region":{"top_left_x":120,"top_left_y":2161,"width":1107,"height":48},"line":183,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e7abfd858124dbbb3e4f5834d213712","type":"text","conversion_output":true,"text":"data until after the study has finished, so as to maintain the blind.","text_display":" data until after the study has finished, so as to maintain the blind.","confidence":1,"confidence_rate":1},{"cnt":[[120,2204],[1893,2204],[1893,2254],[120,2254]],"region":{"top_left_x":120,"top_left_y":2204,"width":1773,"height":50},"line":184,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2daba19712d143e7b84ea16757b38c98","type":"text","conversion_output":true,"text":"Genotyping: We will use standard TaqMan methods on our ABI-7500 for SNP markers and ABI-3100 for","text_display":"\nGenotyping: We will use standard TaqMan methods on our ABI-7500 for SNP markers and ABI-3100 for","confidence":0.9521715641021729,"confidence_rate":0.9995148697332218},{"cnt":[[120,2249],[1828,2249],[1828,2297],[120,2297]],"region":{"top_left_x":120,"top_left_y":2249,"width":1709,"height":48},"line":185,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8294a25086334877ae5ab946ae8d6794","type":"text","conversion_output":true,"text":"repeat polymorphisms. To ensure a clear result, any ambiguous genotypes will be discarded and the","text_display":" repeat polymorphisms. To ensure a clear result, any ambiguous genotypes will be discarded and the","confidence":1,"confidence_rate":1},{"cnt":[[120,2295],[1936,2295],[1936,2340],[120,2340]],"region":{"top_left_x":120,"top_left_y":2294,"width":1816,"height":46},"line":186,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8482d7d6bd4c4371ba20c2cd462d77ff","type":"text","conversion_output":true,"text":"participant's DNA will be re-genotyped until the results are unambiguous. \\(10 \\%\\) of the participants will be re-","text_display":" participant's DNA will be re-genotyped until the results are unambiguous. \\(10 \\%\\) of the participants will be re","confidence":0.990234375,"confidence_rate":0.9999161264111902},{"cnt":[[120,2338],[1910,2338],[1910,2385],[120,2385]],"region":{"top_left_x":120,"top_left_y":2337,"width":1790,"height":48},"line":187,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"595048e1d8a048d596c215da8839ecef","type":"text","conversion_output":true,"text":"genotyped to check for error rates (the test error rate in Dr. Kennedy's lab is \\(0.5 \\%\\) ). We will type selected","text_display":"genotyped to check for error rates (the test error rate in Dr. Kennedy's lab is \\(0.5 \\%\\) ). We will type selected","confidence":0.99755859375,"confidence_rate":0.9999791079845508},{"cnt":[[120,2380],[1927,2380],[1927,2428],[120,2428]],"region":{"top_left_x":120,"top_left_y":2380,"width":1808,"height":48},"line":188,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e766c4578d4b424fb899d8abb77fb87a","type":"text","conversion_output":true,"text":"SNPs (functional and certain tagged SNPs) across the candidate genes described in Section 3.6, and also","text_display":" SNPs (functional and certain tagged SNPs) across the candidate genes described in Section 3.6, and also","confidence":1,"confidence_rate":1},{"cnt":[[120,2423],[1841,2423],[1841,2473],[120,2473]],"region":{"top_left_x":120,"top_left_y":2423,"width":1722,"height":50},"line":189,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2797bfc2829a416ba259d3ecd337477c","type":"text","conversion_output":true,"text":"explore any highly promising genes emerging from the literature. We will test both single markers and","text_display":" explore any highly promising genes emerging from the literature. We will test both single markers and","confidence":1,"confidence_rate":1},{"cnt":[[120,2471],[324,2471],[324,2516],[120,2516]],"region":{"top_left_x":120,"top_left_y":2470,"width":205,"height":46},"line":190,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34a1dac143e144309b992501123e8828","type":"text","conversion_output":true,"text":"haplotypes.","text_display":" haplotypes.","confidence":1,"confidence_rate":1},{"cnt":[[1959,2578],[2007,2578],[2007,2628],[1959,2628]],"region":{"top_left_x":1959,"top_left_y":2578,"width":48,"height":50},"line":191,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2f7d7b52bbc4c5d9ef99392924d9333","type":"page_info","conversion_output":false,"text":"\\(\\underline{11}\\)","text_display":"","confidence":0.822265625,"confidence_rate":0.961617652185685}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-14","page":14,"lines":[{"cnt":[[116,116],[1970,116],[1970,174],[116,174]],"region":{"top_left_x":116,"top_left_y":116,"width":1855,"height":59},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17cc70d4adeb4e3eb71340098dd9f2dc","type":"text","conversion_output":true,"text":"Population Stratification will be examined using the STRUCTURE program. \\({ }^{133}\\) We will select a set of unlinked","text_display":"\n\nPopulation Stratification will be examined using the STRUCTURE program. \\({ }^{133}\\) We will select a set of unlinked","confidence":0.99951171875,"confidence_rate":0.9999960292721264},{"cnt":[[116,168],[2000,168],[2000,219],[116,219]],"region":{"top_left_x":116,"top_left_y":167,"width":1885,"height":53},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a610f74bdc95439492bb8f7ad5450a34","type":"text","conversion_output":true,"text":"SNPs from our set of selected markers, augmented by an additional 96 markers that are known to be 'ancestry","text_display":" SNPs from our set of selected markers, augmented by an additional 96 markers that are known to be 'ancestry","confidence":1,"confidence_rate":1},{"cnt":[[116,211],[1966,211],[1966,264],[116,264]],"region":{"top_left_x":116,"top_left_y":210,"width":1850,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"240b41f868cb460982975343d8d9aba2","type":"text","conversion_output":true,"text":"informative' and run the STRUCTURE program under an admixture model, assuming correlated frequencies,","text_display":" informative' and run the STRUCTURE program under an admixture model, assuming correlated frequencies,","confidence":1,"confidence_rate":1},{"cnt":[[116,254],[1992,254],[1992,307],[116,307]],"region":{"top_left_x":116,"top_left_y":253,"width":1876,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f4080a046b44e78872cad9cc21597af","type":"text","conversion_output":true,"text":"with 20,000 burn-ins and 20,000 repetitions. The group membership probabilities thus obtained would be used","text_display":" with 20,000 burn-ins and 20,000 repetitions. The group membership probabilities thus obtained would be used","confidence":0.994145393371582,"confidence_rate":0.9999502401192117},{"cnt":[[116,301],[1115,301],[1115,350],[116,350]],"region":{"top_left_x":116,"top_left_y":300,"width":1000,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"958d89d01a0041d3b1f61d64fdeadc51","type":"text","conversion_output":true,"text":"as a covariate in the pharmacogenetic statistical analyses.","text_display":" as a covariate in the pharmacogenetic statistical analyses.","confidence":1,"confidence_rate":1},{"cnt":[[114,335],[1940,335],[1940,397],[114,397]],"region":{"top_left_x":113,"top_left_y":335,"width":1828,"height":63},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"239df419daf941bdaacbaf81bbb35f96","type":"text","conversion_output":true,"text":"3.9.7 Drug Exposure: Pharmacokinetic changes associated with aging and other factors \\({ }^{134,135}\\) can result in","text_display":"\n3.9.7 Drug Exposure: Pharmacokinetic changes associated with aging and other factors \\({ }^{134,135}\\) can result in","confidence":1,"confidence_rate":1},{"cnt":[[116,387],[1983,387],[1983,440],[116,440]],"region":{"top_left_x":116,"top_left_y":386,"width":1868,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57cac0b870bf4715b124e59543140bcc","type":"text","conversion_output":true,"text":"variability of drug concentrations, which in turn can result in differences in pharmacodynamics. Drug exposure","text_display":" variability of drug concentrations, which in turn can result in differences in pharmacodynamics. Drug exposure","confidence":1,"confidence_rate":1},{"cnt":[[116,430],[1936,430],[1936,483],[116,483]],"region":{"top_left_x":116,"top_left_y":429,"width":1820,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3178534ae0949b081bdd4d72dac95b5","type":"text","conversion_output":true,"text":"is therefore an important piece of information when interpreting variability in treatment efficacy and adverse","text_display":" is therefore an important piece of information when interpreting variability in treatment efficacy and adverse","confidence":1,"confidence_rate":1},{"cnt":[[116,468],[1910,468],[1910,526],[116,526]],"region":{"top_left_x":116,"top_left_y":468,"width":1794,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"825f8de51e1a4fedb695348fa70dd70d","type":"text","conversion_output":true,"text":"effects. \\({ }^{134,136}\\) Blood will be collected for determination of plasma sertraline and olanzapine concentrations.","text_display":" effects. \\({ }^{134,136}\\) Blood will be collected for determination of plasma sertraline and olanzapine concentrations.","confidence":1,"confidence_rate":1},{"cnt":[[116,518],[1983,518],[1983,571],[116,571]],"region":{"top_left_x":116,"top_left_y":517,"width":1868,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7a07b85b3b04fde8e080920e059e9a4","type":"text","conversion_output":true,"text":"Each site will send frozen batched plasma samples to Dr. Pollock's psychopharmacology lab in Toronto every","text_display":" Each site will send frozen batched plasma samples to Dr. Pollock's psychopharmacology lab in Toronto every","confidence":1,"confidence_rate":1},{"cnt":[[116,563],[1998,563],[1998,617],[116,617]],"region":{"top_left_x":116,"top_left_y":562,"width":1883,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38aebac5163e41dd950ca74ac8a65232","type":"text","conversion_output":true,"text":"6 months for pharmacokinetic analyses. The analytic strategy will use population pharmacokinetics which uses","text_display":" 6 months for pharmacokinetic analyses. The analytic strategy will use population pharmacokinetics which uses","confidence":1,"confidence_rate":1},{"cnt":[[116,602],[1936,602],[1936,660],[116,660]],"region":{"top_left_x":116,"top_left_y":601,"width":1820,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30e97d1bafa442348a83dcb5644eaa3c","type":"text","conversion_output":true,"text":"nonlinear mixed effect modeling \\({ }^{137}\\) to identify intra- and inter-individual sources of variability. The modeling","text_display":" nonlinear mixed effect modeling \\({ }^{137}\\) to identify intra- and inter-individual sources of variability. The modeling","confidence":1,"confidence_rate":1},{"cnt":[[116,649],[1981,649],[1981,703],[116,703]],"region":{"top_left_x":116,"top_left_y":648,"width":1865,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"154fd6866a02460da63b86c5f94bb4ed","type":"text","conversion_output":true,"text":"provides: (1) magnitude of exposure, expressed as average drug concentration or Area Under the Curve, and","text_display":" provides: (1) magnitude of exposure, expressed as average drug concentration or Area Under the Curve, and","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[116,694],[1996,694],[1996,748],[116,748]],"region":{"top_left_x":116,"top_left_y":693,"width":1880,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fb6cc872c124722ae5cc317892e5628","type":"text","conversion_output":true,"text":"(2) variability of exposure from what is expected, expressed as a ratio of the predicted drug concentration for a","text_display":" (2) variability of exposure from what is expected, expressed as a ratio of the predicted drug concentration for a","confidence":1,"confidence_rate":1},{"cnt":[[116,739],[1949,739],[1949,793],[116,793]],"region":{"top_left_x":116,"top_left_y":739,"width":1833,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e18df86f3eff4045bbb5302ea9548362","type":"text","conversion_output":true,"text":"given time point to the observed concentration (Cpred/obs). Variability from the norm in drug concentrations","text_display":" given time point to the observed concentration (Cpred/obs). Variability from the norm in drug concentrations","confidence":0.9980475902557373,"confidence_rate":0.9999827052983993},{"cnt":[[116,778],[1607,778],[1607,836],[116,836]],"region":{"top_left_x":116,"top_left_y":777,"width":1492,"height":59},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ead54dc3ee941d3b94c2641a2a56aa4","type":"text","conversion_output":true,"text":"can be determined using sparse (between two and four) plasma samples per patient. \\({ }^{138}\\)","text_display":" can be determined using sparse (between two and four) plasma samples per patient. \\({ }^{138}\\)","confidence":1,"confidence_rate":1},{"cnt":[[109,819],[423,815],[424,879],[110,883]],"region":{"top_left_x":109,"top_left_y":815,"width":315,"height":69},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb371ce0ccf645649b17d76a10417c49","type":"section_header","conversion_output":false,"children_ids":["353bc0288b1e4b01b5f3a052b4ecc392"],"text":"","text_display":""},{"cnt":[[116,827],[415,827],[415,872],[116,872]],"region":{"top_left_x":116,"top_left_y":827,"width":299,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"353bc0288b1e4b01b5f3a052b4ecc392","type":"text","conversion_output":true,"parent_id":"cb371ce0ccf645649b17d76a10417c49","text":"3.9.8 Outcomes","text_display":"\n\n\\subsection*{3.9.8 Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[116,868],[1972,868],[1972,922],[116,922]],"region":{"top_left_x":116,"top_left_y":867,"width":1857,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"121791efe1754dafbb44595e23f5b842","type":"text","conversion_output":true,"text":"Outcome Criteria: Relapse is the primary measure of outcome. Relapse criteria are broad, to reflect a range","text_display":"\n\nOutcome Criteria: Relapse is the primary measure of outcome. Relapse criteria are broad, to reflect a range","confidence":1,"confidence_rate":1},{"cnt":[[116,913],[1940,913],[1940,965],[116,965]],"region":{"top_left_x":116,"top_left_y":913,"width":1825,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07883ebaae8c4420b29ed340ca2e3047","type":"text","conversion_output":true,"text":"of clinically relevant outcomes of PD. The criterion for relapse will be at least one of the following: 1) SCID","text_display":" of clinically relevant outcomes of PD. The criterion for relapse will be at least one of the following: 1) SCID","confidence":0.9990236759185791,"confidence_rate":0.9999915793372107},{"cnt":[[116,958],[2000,958],[2000,1012],[116,1012]],"region":{"top_left_x":116,"top_left_y":958,"width":1885,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc8c16f264044ae49b9971ebf526939b","type":"text","conversion_output":true,"text":"symptoms of major depressive episode (preferably maintained for at least 1 week over two consecutive weekly","text_display":" symptoms of major depressive episode (preferably maintained for at least 1 week over two consecutive weekly","confidence":0.99853515625,"confidence_rate":0.9999872529709615},{"cnt":[[116,1001],[1987,1001],[1987,1055],[116,1055]],"region":{"top_left_x":116,"top_left_y":1001,"width":1872,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26058fe8e6b742168edd806d00ec9fdb","type":"text","conversion_output":true,"text":"visits); 2) 17-item HAM-D score of \\(\\geq 18\\) (preferably maintained for at least 1 week over two consecutive weekly","text_display":" visits); 2) 17-item HAM-D score of \\(\\geq 18\\) (preferably maintained for at least 1 week over two consecutive weekly","confidence":0.574253978626075,"confidence_rate":0.99538830410106},{"cnt":[[116,1044],[1886,1044],[1886,1098],[116,1098]],"region":{"top_left_x":116,"top_left_y":1044,"width":1771,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e280a144f50a4c82b1386908662de6cb","type":"text","conversion_output":true,"text":"visits) and a mean absolute increase of 5 points on at least one visit relative to entry into the RCT; 3) re-","text_display":" visits) and a mean absolute increase of 5 points on at least one visit relative to entry into the RCT; 3) re","confidence":0.9658203125,"confidence_rate":0.9997028008051103},{"cnt":[[116,1087],[1897,1087],[1897,1141],[116,1141]],"region":{"top_left_x":116,"top_left_y":1087,"width":1782,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc7e5a59ea674700970ac5f024f818f9","type":"text","conversion_output":true,"text":"emergence of SCID-rated psychosis (delusions or hallucinations) (preferably for at least 1 week over two","text_display":"emergence of SCID-rated psychosis (delusions or hallucinations) (preferably for at least 1 week over two","confidence":1,"confidence_rate":1},{"cnt":[[116,1130],[1772,1130],[1772,1188],[116,1188]],"region":{"top_left_x":116,"top_left_y":1130,"width":1657,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03cc2aa730824448a7c3b7a105066fe7","type":"text","conversion_output":true,"text":"consecutive weekly visits) and a score of \\(\\geq 3\\) on the SADS delusion or hallucination severity items","text_display":" consecutive weekly visits) and a score of \\(\\geq 3\\) on the SADS delusion or hallucination severity items","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[116,1177],[1968,1177],[1968,1231],[116,1231]],"region":{"top_left_x":116,"top_left_y":1177,"width":1852,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"258819bbf5244441a29dde27f28313ea","type":"text","conversion_output":true,"text":"(delusion/hallucination 'definitely present'); 4) significant clinical worsening, defined as either i) emergence of","text_display":" (delusion/hallucination 'definitely present'); 4) significant clinical worsening, defined as either i) emergence of","confidence":1,"confidence_rate":1},{"cnt":[[116,1220],[1983,1220],[1983,1274],[116,1274]],"region":{"top_left_x":116,"top_left_y":1220,"width":1868,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4f44d69fbce4cc4841534da8f354536","type":"text","conversion_output":true,"text":"'high risk' of suicide at any time (current suicide plan or suicide attempt), and/or ii) development of SCID-rated","text_display":" 'high risk' of suicide at any time (current suicide plan or suicide attempt), and/or ii) development of SCID-rated","confidence":1,"confidence_rate":1},{"cnt":[[116,1263],[1966,1263],[1966,1317],[116,1317]],"region":{"top_left_x":116,"top_left_y":1263,"width":1850,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09c053bae02e4e06b12d89e88bca6f13","type":"text","conversion_output":true,"text":"mania or hypomania (preferably for at least 1 week over two consecutive weekly visits), and/or iii) psychiatric","text_display":" mania or hypomania (preferably for at least 1 week over two consecutive weekly visits), and/or iii) psychiatric","confidence":1,"confidence_rate":1},{"cnt":[[116,1311],[1970,1311],[1970,1362],[116,1362]],"region":{"top_left_x":116,"top_left_y":1310,"width":1855,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec29447089ce409db29978c1b95d551d","type":"text","conversion_output":true,"text":"hospitalization for depression, psychosis, suicidality, or mania/hypomania, regardless of the duration of these","text_display":" hospitalization for depression, psychosis, suicidality, or mania/hypomania, regardless of the duration of these","confidence":1,"confidence_rate":1},{"cnt":[[116,1354],[2004,1354],[2004,1407],[116,1407]],"region":{"top_left_x":116,"top_left_y":1353,"width":1889,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20765301df49451ebbab7cde1d3ec1d9","type":"text","conversion_output":true,"text":"symptoms. Although a one-week time duration is preferable, the research psychiatrist is allowed to declare that","text_display":" symptoms. Although a one-week time duration is preferable, the research psychiatrist is allowed to declare that","confidence":1,"confidence_rate":1},{"cnt":[[116,1396],[1867,1396],[1867,1450],[116,1450]],"region":{"top_left_x":116,"top_left_y":1396,"width":1751,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e68779398a844420bcec1d564c181127","type":"text","conversion_output":true,"text":"a relapse has occurred if the clinical criterion is established at an in-person visit and postponing further","text_display":" a relapse has occurred if the clinical criterion is established at an in-person visit and postponing further","confidence":1,"confidence_rate":1},{"cnt":[[116,1439],[1936,1439],[1936,1493],[116,1493]],"region":{"top_left_x":116,"top_left_y":1439,"width":1820,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2b9e026da7c471cb23ffdff5e660f79","type":"text","conversion_output":true,"text":"intervention for another seven days is considered to place the subject at undue risk. Time to relapse will be","text_display":" intervention for another seven days is considered to place the subject at undue risk. Time to relapse will be","confidence":1,"confidence_rate":1},{"cnt":[[116,1485],[1938,1485],[1938,1538],[116,1538]],"region":{"top_left_x":116,"top_left_y":1484,"width":1822,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"409da7b3ede24919bfcca747a742563e","type":"text","conversion_output":true,"text":"defined as time from randomization to the first visit at which relapse is established or the start of psychiatric","text_display":" defined as time from randomization to the first visit at which relapse is established or the start of psychiatric","confidence":1,"confidence_rate":1},{"cnt":[[116,1525],[1979,1525],[1979,1583],[116,1583]],"region":{"top_left_x":116,"top_left_y":1525,"width":1863,"height":59},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"830dd761ebf548629682702b75343174","type":"text","conversion_output":true,"text":"hospitalization. These relapse criteria reflect a clinical deterioration for which most clinicians would consider a","text_display":" hospitalization. These relapse criteria reflect a clinical deterioration for which most clinicians would consider a","confidence":1,"confidence_rate":1},{"cnt":[[116,1573],[1927,1573],[1927,1626],[116,1626]],"region":{"top_left_x":116,"top_left_y":1572,"width":1812,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce141491fabb482ba61ff10e7a235068","type":"text","conversion_output":true,"text":"change of treatment. Even though patients with a history of bipolar affective disorder will not be allowed to","text_display":" change of treatment. Even though patients with a history of bipolar affective disorder will not be allowed to","confidence":1,"confidence_rate":1},{"cnt":[[116,1616],[1974,1616],[1974,1669],[116,1669]],"region":{"top_left_x":116,"top_left_y":1615,"width":1859,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5177754194843e18671cbece90cac63","type":"text","conversion_output":true,"text":"enter the study (Section 4.2.1), mania or hypomania is included as an outcome variable because onset of PD","text_display":" enter the study (Section 4.2.1), mania or hypomania is included as an outcome variable because onset of PD","confidence":1,"confidence_rate":1},{"cnt":[[116,1659],[1906,1659],[1906,1712],[116,1712]],"region":{"top_left_x":116,"top_left_y":1658,"width":1790,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73d30dde4e574bb0aade2b6952541787","type":"text","conversion_output":true,"text":"in younger adults may predict subsequent development of bipolar affective disorder. Participants who are","text_display":" in younger adults may predict subsequent development of bipolar affective disorder. Participants who are","confidence":1,"confidence_rate":1},{"cnt":[[116,1706],[1914,1706],[1914,1760],[116,1760]],"region":{"top_left_x":116,"top_left_y":1705,"width":1799,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9e205c81c7d4bf9acc4b4a87dc85caa","type":"text","conversion_output":true,"text":"suspected of having a relapse will be seen by one of the study's research psychiatrists who will determine","text_display":" suspected of having a relapse will be seen by one of the study's research psychiatrists who will determine","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[116,1749],[679,1749],[679,1798],[116,1798]],"region":{"top_left_x":116,"top_left_y":1748,"width":563,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8313bdb8198d4875a1aab78b30c2701c","type":"text","conversion_output":true,"text":"whether relapse criteria are met.","text_display":" whether relapse criteria are met.","confidence":1,"confidence_rate":1},{"cnt":[[116,1792],[1876,1792],[1876,1846],[116,1846]],"region":{"top_left_x":116,"top_left_y":1791,"width":1760,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23148188c5984377ab86a268419dd1eb","type":"text","conversion_output":true,"text":"Management of Relapse: Patients who meet relapse criteria will be seen for clinical management by a","text_display":"\nManagement of Relapse: Patients who meet relapse criteria will be seen for clinical management by a","confidence":1,"confidence_rate":1},{"cnt":[[116,1835],[1983,1835],[1983,1893],[116,1893]],"region":{"top_left_x":116,"top_left_y":1834,"width":1868,"height":59},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a45999ff2234741a8dedc491dd043fd","type":"text","conversion_output":true,"text":"psychiatrist at the research site who is not affiliated with the study within 48-72 hours of referral. Alternatively,","text_display":" psychiatrist at the research site who is not affiliated with the study within 48-72 hours of referral. Alternatively,","confidence":0.6180481910705566,"confidence_rate":0.9960635971611018},{"cnt":[[116,1882],[1962,1882],[1962,1934],[116,1934]],"region":{"top_left_x":116,"top_left_y":1882,"width":1846,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d90865ffc45a447981350296190b1e9d","type":"text","conversion_output":true,"text":"patients can be referred for acute psychiatric hospitalization, if deemed appropriate by the study psychiatrist.","text_display":" patients can be referred for acute psychiatric hospitalization, if deemed appropriate by the study psychiatrist.","confidence":1,"confidence_rate":1},{"cnt":[[116,1921],[1828,1921],[1828,1979],[116,1979]],"region":{"top_left_x":116,"top_left_y":1920,"width":1713,"height":59},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"193c2d8437ed4084a7822d422ad54059","type":"text","conversion_output":true,"text":"The non-study psychiatrist will be notified by the research pharmacist whether the patient was taking","text_display":" The non-study psychiatrist will be notified by the research pharmacist whether the patient was taking","confidence":1,"confidence_rate":1},{"cnt":[[116,1968],[1927,1968],[1927,2022],[116,2022]],"region":{"top_left_x":116,"top_left_y":1967,"width":1812,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b8a3ccc4d8a4c0a89c24a17acf50d2c","type":"text","conversion_output":true,"text":"olanzapine at the time of relapse. Other research personnel will not be aware of the treatment assignment.","text_display":" olanzapine at the time of relapse. Other research personnel will not be aware of the treatment assignment.","confidence":1,"confidence_rate":1},{"cnt":[[116,2013],[1914,2013],[1914,2065],[116,2065]],"region":{"top_left_x":116,"top_left_y":2013,"width":1799,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b76f37e8b2444f0d9f1a98a612238027","type":"text","conversion_output":true,"text":"Based on the frequency of relapse postulated for the study, we estimate that there will be an average of 3","text_display":" Based on the frequency of relapse postulated for the study, we estimate that there will be an average of 3","confidence":1,"confidence_rate":1},{"cnt":[[116,2054],[810,2054],[810,2108],[116,2108]],"region":{"top_left_x":116,"top_left_y":2053,"width":694,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44c05d37d9ec4158b34a8d9482429cf6","type":"text","conversion_output":true,"text":"cases of relapse per year per study site.","text_display":" cases of relapse per year per study site.","confidence":1,"confidence_rate":1},{"cnt":[[116,2099],[1923,2099],[1923,2155],[116,2155]],"region":{"top_left_x":116,"top_left_y":2099,"width":1807,"height":56},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"224aa7a62ccf4157ab6350d2e42358c9","type":"text","conversion_output":true,"text":"3.9.9 Pharmacotherapy: Please see the appended Pharmacotherapy Protocol (Appendix1) for full details","text_display":"\n3.9.9 Pharmacotherapy: Please see the appended Pharmacotherapy Protocol (Appendix1) for full details","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[116,2144],[1042,2144],[1042,2196],[116,2196]],"region":{"top_left_x":116,"top_left_y":2144,"width":926,"height":52},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fb9afe5283c4c2cb12f8d45792fbe62","type":"text","conversion_output":true,"text":"regarding pharmacotherapy in all phases of the study.","text_display":" regarding pharmacotherapy in all phases of the study.","confidence":1,"confidence_rate":1},{"cnt":[[116,2187],[1938,2187],[1938,2241],[116,2241]],"region":{"top_left_x":116,"top_left_y":2187,"width":1822,"height":54},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7036b65446b4257ae1111961dc357a7","type":"text","conversion_output":true,"text":"Acute phase: The only psychotropic medications allowed in the study will be i)olanzapine, ii)sertraline, and","text_display":"\nAcute phase: The only psychotropic medications allowed in the study will be i)olanzapine, ii)sertraline, and","confidence":1,"confidence_rate":1},{"cnt":[[116,2228],[1989,2228],[1989,2284],[116,2284]],"region":{"top_left_x":116,"top_left_y":2227,"width":1874,"height":57},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5021300013748019931f087dbabb74e","type":"text","conversion_output":true,"text":"iii)'as needed' lorazepam and benztropine (doses of lorazepam and benztropine will not be permitted in the 12","text_display":" iii)'as needed' lorazepam and benztropine (doses of lorazepam and benztropine will not be permitted in the 12","confidence":0.9439017641125247,"confidence_rate":0.9994892173815633},{"cnt":[[116,2277],[1777,2277],[1777,2327],[116,2327]],"region":{"top_left_x":116,"top_left_y":2277,"width":1661,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a445ad6346d94985ab655fcc4af95699","type":"text","conversion_output":true,"text":"hours prior to psychometric testing, so as to minimize the effect of these medications on cognitive","text_display":" hours prior to psychometric testing, so as to minimize the effect of these medications on cognitive","confidence":1,"confidence_rate":1},{"cnt":[[116,2320],[1962,2320],[1962,2374],[116,2374]],"region":{"top_left_x":116,"top_left_y":2320,"width":1846,"height":55},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eb2c5d86f534da99e9d721698707a37","type":"text","conversion_output":true,"text":"performance). Psychotropic medications that are not permitted in the study will be withdrawn prior to starting","text_display":" performance). Psychotropic medications that are not permitted in the study will be withdrawn prior to starting","confidence":1,"confidence_rate":1},{"cnt":[[116,2363],[1996,2363],[1996,2417],[116,2417]],"region":{"top_left_x":116,"top_left_y":2363,"width":1880,"height":54},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c97d03607fb34030ba486c97e81e8333","type":"text","conversion_output":true,"text":"study medications, but if this is not feasible, by the end of the first week of the study. Sertraline and olanzapine","text_display":" study medications, but if this is not feasible, by the end of the first week of the study. Sertraline and olanzapine","confidence":1,"confidence_rate":1},{"cnt":[[116,2406],[1996,2406],[1996,2460],[116,2460]],"region":{"top_left_x":116,"top_left_y":2406,"width":1880,"height":54},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d48f497561824ee78b3bea39d951c881","type":"text","conversion_output":true,"text":"will be dispensed in a non-blind, open-label fashion during the acute and stabilization phases of the study. The","text_display":" will be dispensed in a non-blind, open-label fashion during the acute and stabilization phases of the study. The","confidence":1,"confidence_rate":1},{"cnt":[[116,2451],[1970,2451],[1970,2503],[116,2503]],"region":{"top_left_x":116,"top_left_y":2451,"width":1855,"height":52},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54d96142abfb468d8f1bda490df6f857","type":"text","conversion_output":true,"text":"titration schedule of sertraline and olanzapine, and the target dosages of these medications, will be the same","text_display":" titration schedule of sertraline and olanzapine, and the target dosages of these medications, will be the same","confidence":1,"confidence_rate":1},{"cnt":[[116,2496],[1927,2496],[1927,2550],[116,2550]],"region":{"top_left_x":116,"top_left_y":2496,"width":1812,"height":55},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2cb3eba60fc461f81c75e61cd995a66","type":"text","conversion_output":true,"text":"as that successfully employed in STOP-PD. Sertraline will be started at \\(50 mg /\\) day and increased by 50 mg","text_display":" as that successfully employed in STOP-PD. Sertraline will be started at \\(50 mg /\\) day and increased by 50 mg","confidence":0.9741334915161133,"confidence_rate":0.9997741037099092},{"cnt":[[1955,2574],[2011,2574],[2011,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2573,"width":56,"height":55},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23a3c3803bc34166be3645fc40cba313","type":"page_info","conversion_output":false,"text":"12","text_display":"","confidence":0.640625,"confidence_rate":0.8003905296791061}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-15","page":15,"lines":[{"cnt":[[120,125],[1996,125],[1996,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1876,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a4836d974a944ebaaae062525e367e2","type":"text","conversion_output":true,"text":"increments to reach a target dose of \\(150 mg /\\) day by the end of the first week of treatment. Participants who did","text_display":"\nincrements to reach a target dose of \\(150 mg /\\) day by the end of the first week of treatment. Participants who did","confidence":0.9980475902557373,"confidence_rate":0.9999839811268232},{"cnt":[[120,172],[1970,172],[1970,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":1851,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6afa75f6d56d4999affc09a4af3ac142","type":"text","conversion_output":true,"text":"not experience at least partial improvement (based on operationalized criteria) in depressive symptoms, after","text_display":" not experience at least partial improvement (based on operationalized criteria) in depressive symptoms, after","confidence":1,"confidence_rate":1},{"cnt":[[120,215],[2000,215],[2000,260],[120,260]],"region":{"top_left_x":120,"top_left_y":214,"width":1881,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd14fbef49d443ac9b05331e533a9194","type":"text","conversion_output":true,"text":"taking sertraline at a dosage of \\(150 mg /\\) day for 4 weeks, will have the sertraline dose increased to \\(200 mg /\\) day,","text_display":" taking sertraline at a dosage of \\(150 mg /\\) day for 4 weeks, will have the sertraline dose increased to \\(200 mg /\\) day,","confidence":0.838613910600543,"confidence_rate":0.9986573536343566},{"cnt":[[120,260],[1974,258],[1974,303],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1855,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e67026f4da74a48ab1d14aaf331788b","type":"text","conversion_output":true,"text":"as tolerated. Olanzapine will be started at \\(5 mg /\\) day and increased by 5 mg increments to reach a target dose","text_display":" as tolerated. Olanzapine will be started at \\(5 mg /\\) day and increased by 5 mg increments to reach a target dose","confidence":1,"confidence_rate":1},{"cnt":[[120,348],[120,299],[1972,302],[1972,351]],"region":{"top_left_x":120,"top_left_y":298,"width":1853,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42329a3a6e864ba0ab3663ff09fff8df","type":"text","conversion_output":true,"text":"of \\(15 mg /\\) day by the end of the first week of treatment. If there is no improvement or inadequate improvement","text_display":" of \\(15 mg /\\) day by the end of the first week of treatment. If there is no improvement or inadequate improvement","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[120,348],[1998,348],[1998,393],[120,393]],"region":{"top_left_x":120,"top_left_y":348,"width":1879,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4beeca124fd9420c9999be6164490ac7","type":"text","conversion_output":true,"text":"in psychosis after 7 days of \\(15 mg /\\) day of olanzapine, the dosage of olanzapine will be increased to \\(20 mg /\\) day,","text_display":" in psychosis after 7 days of \\(15 mg /\\) day of olanzapine, the dosage of olanzapine will be increased to \\(20 mg /\\) day,","confidence":0.9726941585540771,"confidence_rate":0.9997870567178097},{"cnt":[[120,391],[1955,391],[1955,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1836,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf91f7727cf043eda2fecf5b1f5a9e09","type":"text","conversion_output":true,"text":"as tolerated. Slower titration or temporary dose reductions of one or both medications will be allowed if there","text_display":" as tolerated. Slower titration or temporary dose reductions of one or both medications will be allowed if there","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1901,434],[1901,479],[120,479]],"region":{"top_left_x":120,"top_left_y":433,"width":1782,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f967a1e1f8f847c4880e1c871fa0d721","type":"text","conversion_output":true,"text":"are clinically significant side effects, but a concerted effort will be made to achieve the target dosages, as","text_display":" are clinically significant side effects, but a concerted effort will be made to achieve the target dosages, as","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,477],[286,477],[286,518],[120,518]],"region":{"top_left_x":120,"top_left_y":476,"width":166,"height":42},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9807b8549f3542d7af4166ea4e3648e7","type":"text","conversion_output":true,"text":"tolerated.","text_display":" tolerated.","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[1949,520],[1949,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1829,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d70face515741cdaceb882830dbbb1a","type":"text","conversion_output":true,"text":"Stabilization Phase: When participants meet remission criteria, they will continue with open-label sertraline","text_display":"\nStabilization Phase: When participants meet remission criteria, they will continue with open-label sertraline","confidence":1,"confidence_rate":1},{"cnt":[[120,563],[1985,563],[1985,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1866,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59f1aa753573432994c8ce2f39c4a07e","type":"text","conversion_output":true,"text":"and olanzapine during the 8 -week stabilization phase. Since the goal of this phase is to consolidate stability of","text_display":" and olanzapine during the 8 -week stabilization phase. Since the goal of this phase is to consolidate stability of","confidence":0.98876953125,"confidence_rate":0.9999074304600803},{"cnt":[[120,610],[1962,610],[1962,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1842,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"853c304dc4fd40e9b5be57ebf04a7b83","type":"text","conversion_output":true,"text":"remission, adjustment of the doses of study medications will be allowed, if necessitated by clinical worsening","text_display":" remission, adjustment of the doses of study medications will be allowed, if necessitated by clinical worsening","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[2002,653],[2002,698],[120,698]],"region":{"top_left_x":120,"top_left_y":653,"width":1883,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe1832c37f6e4d01bc10e4998f7e697b","type":"text","conversion_output":true,"text":"or significant side effects. The maximum allowable daily dosages of sertraline and olanzapine, respectively, will","text_display":" or significant side effects. The maximum allowable daily dosages of sertraline and olanzapine, respectively, will","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1940,696],[1940,743],[120,743]],"region":{"top_left_x":120,"top_left_y":696,"width":1821,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d5f882efdba44369370a64d066cca63","type":"text","conversion_output":true,"text":"be 200 mg and 20 mg , and the minimum allowable daily dosages will be 50 mg and 5 mg . Because sustained","text_display":" be 200 mg and 20 mg , and the minimum allowable daily dosages will be 50 mg and 5 mg . Because sustained","confidence":1,"confidence_rate":1},{"cnt":[[120,741],[1985,741],[1985,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":1866,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c67976e03a644136b2ace6dd14cc742c","type":"text","conversion_output":true,"text":"remission of psychosis during the stabilization phase will be required for eligibility for the RCT, participants will","text_display":" remission of psychosis during the stabilization phase will be required for eligibility for the RCT, participants will","confidence":1,"confidence_rate":1},{"cnt":[[120,786],[1914,786],[1914,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1795,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9a407ba2c1249398625328c7d20bc6f","type":"text","conversion_output":true,"text":"leave the stabilization phase if they experience a relapse of delusions or hallucinations during that time as","text_display":" leave the stabilization phase if they experience a relapse of delusions or hallucinations during that time as","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[642,829],[642,874],[120,874]],"region":{"top_left_x":120,"top_left_y":829,"width":523,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cc453723260435c81058cabc522cc2e","type":"text","conversion_output":true,"text":"determined by SCID interview.","text_display":" determined by SCID interview.","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1987,872],[1987,917],[120,917]],"region":{"top_left_x":120,"top_left_y":872,"width":1868,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ec01b6412254697b098a8d4561090e6","type":"text","conversion_output":true,"text":"Randomized Phase: Participants who meet the study's remission criteria will be randomly allocated, following","text_display":"\nRandomized Phase: Participants who meet the study's remission criteria will be randomly allocated, following","confidence":1,"confidence_rate":1},{"cnt":[[120,917],[1953,917],[1953,965],[120,965]],"region":{"top_left_x":120,"top_left_y":917,"width":1833,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd9d78111c6d4eb6860ff6ba7acd1685","type":"text","conversion_output":true,"text":"completion of the stabilization phase, to either continue olanzapine or switch, over a period of 4 -weeks, from","text_display":" completion of the stabilization phase, to either continue olanzapine or switch, over a period of 4 -weeks, from","confidence":0.9287455081939697,"confidence_rate":0.9993790120579029},{"cnt":[[120,960],[1970,960],[1970,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":960,"width":1851,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1429a49f5004df686610ea4531a8fe2","type":"text","conversion_output":true,"text":"olanzapine to placebo. All participants will take open-label sertraline for the duration of the RCT. The goal will","text_display":" olanzapine to placebo. All participants will take open-label sertraline for the duration of the RCT. The goal will","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[1772,1005],[1772,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1005,"width":1653,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89b1ef49b5d04588bc25c8740d9b9ae1","type":"text","conversion_output":true,"text":"be to maintain sertraline at the same acute dose that the participant was prescribed at the time of","text_display":" be to maintain sertraline at the same acute dose that the participant was prescribed at the time of","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1955,1048],[1955,1094],[120,1094]],"region":{"top_left_x":120,"top_left_y":1048,"width":1836,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abb8d9f6615749bc80114eb4762fe651","type":"text","conversion_output":true,"text":"randomization to the RCT. Because participants will have taken sertraline for a minimum of 10 weeks before","text_display":" randomization to the RCT. Because participants will have taken sertraline for a minimum of 10 weeks before","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1970,1091],[1970,1139],[120,1139]],"region":{"top_left_x":120,"top_left_y":1091,"width":1851,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12240ba3d1e04c938b320e507ae18fbb","type":"text","conversion_output":true,"text":"entering the RCT, we anticipate that the dose of sertraline will rarely need to be adjusted in the RCT because","text_display":" entering the RCT, we anticipate that the dose of sertraline will rarely need to be adjusted in the RCT because","confidence":1,"confidence_rate":1},{"cnt":[[120,1137],[1863,1137],[1863,1182],[120,1182]],"region":{"top_left_x":120,"top_left_y":1136,"width":1743,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77d25f0c08c449bd897caee8e1af8a6a","type":"text","conversion_output":true,"text":"of side effects. However, a reduction of the dosage of sertraline will be allowed if the site PI agrees. An","text_display":" of side effects. However, a reduction of the dosage of sertraline will be allowed if the site PI agrees. An","confidence":0.9492433071136475,"confidence_rate":0.9995350176859689},{"cnt":[[120,1182],[1985,1182],[1985,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1181,"width":1866,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8d640ce002641e782c777dbddb27e74","type":"text","conversion_output":true,"text":"increase in dose of sertraline will not be permitted at any time during the RCT, because it will confound testing","text_display":" increase in dose of sertraline will not be permitted at any time during the RCT, because it will confound testing","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1854,1225],[1854,1270],[120,1270]],"region":{"top_left_x":120,"top_left_y":1224,"width":1735,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6b0fead8e374d3d957e0b37235e84dd","type":"text","conversion_output":true,"text":"of H 1 . The goal will be to maintain olanzapine/placebo at the same acute dose that the participant was","text_display":" of H 1 . The goal will be to maintain olanzapine/placebo at the same acute dose that the participant was","confidence":0.92626953125,"confidence_rate":0.9993283833878872},{"cnt":[[120,1268],[1979,1268],[1979,1315],[120,1315]],"region":{"top_left_x":120,"top_left_y":1267,"width":1859,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"642f67ebddb643aba84b97100b1fcd2b","type":"text","conversion_output":true,"text":"prescribed at the time of randomization to the RCT. However, a change in dose of olanzapine/placebo will be","text_display":" prescribed at the time of randomization to the RCT. However, a change in dose of olanzapine/placebo will be","confidence":1,"confidence_rate":1},{"cnt":[[120,1313],[2000,1313],[2000,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1312,"width":1881,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81561ada737149f3a5390d3df7b700d0","type":"text","conversion_output":true,"text":"permitted, if necessitated by adverse effects or clinical worsening during the RCT, following discussion with the","text_display":" permitted, if necessitated by adverse effects or clinical worsening during the RCT, following discussion with the","confidence":1,"confidence_rate":1},{"cnt":[[120,1358],[1968,1358],[1968,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1357,"width":1848,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc427ab7d1c947a0a310d5335ad748de","type":"text","conversion_output":true,"text":"site PI . The rationale for allowing a change in olanzapine/placebo dose, is that the primary aim of the study is","text_display":" site PI . The rationale for allowing a change in olanzapine/placebo dose, is that the primary aim of the study is","confidence":0.9535131454467773,"confidence_rate":0.9996161860341685},{"cnt":[[120,1401],[1893,1401],[1893,1446],[120,1446]],"region":{"top_left_x":120,"top_left_y":1400,"width":1773,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2c3aa5a5ced473ea3047fc04477e290","type":"text","conversion_output":true,"text":"to assess whether olanzapine, administered within a clinically relevant dose range, prevents relapse, not","text_display":" to assess whether olanzapine, administered within a clinically relevant dose range, prevents relapse, not","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[1949,1444],[1949,1489],[120,1489]],"region":{"top_left_x":120,"top_left_y":1443,"width":1829,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"896626380faf4db890bf5265a223d096","type":"text","conversion_output":true,"text":"whether a specific dose of olanzapine prevents relapse. Dose changes of sertraline and olanzapine/placebo","text_display":" whether a specific dose of olanzapine prevents relapse. Dose changes of sertraline and olanzapine/placebo","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1699,1487],[1699,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1580,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57cb513fce504dca878d2c2e750388a4","type":"text","conversion_output":true,"text":"will be carefully recorded and will be reported in a descriptive fashion for each treatment arm.","text_display":" will be carefully recorded and will be reported in a descriptive fashion for each treatment arm.","confidence":1,"confidence_rate":1},{"cnt":[[116,1573],[526,1573],[526,1618],[116,1618]],"region":{"top_left_x":116,"top_left_y":1572,"width":411,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51ca7cb2928f42dc8a7d3b80b02ab97f","type":"section_header","conversion_output":false,"children_ids":["3da46ddea82c4d798c196117cde1ac67"],"text":"","text_display":""},{"cnt":[[120,1577],[522,1577],[522,1618],[120,1618]],"region":{"top_left_x":120,"top_left_y":1576,"width":403,"height":42},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3da46ddea82c4d798c196117cde1ac67","type":"text","conversion_output":true,"parent_id":"51ca7cb2928f42dc8a7d3b80b02ab97f","text":"3.10 DATA ANALYSIS","text_display":"\n\n\\subsection*{3.10 DATA ANALYSIS}","confidence":1,"confidence_rate":1},{"cnt":[[116,1616],[1540,1616],[1540,1669],[116,1669]],"region":{"top_left_x":116,"top_left_y":1615,"width":1425,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18558ad66ee44e81a14b7a4f579f4916","type":"section_header","conversion_output":false,"children_ids":["9d965f688cc24269ba02235760f88191"],"text":"","text_display":""},{"cnt":[[120,1620],[1536,1620],[1536,1665],[120,1665]],"region":{"top_left_x":120,"top_left_y":1619,"width":1417,"height":47},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d965f688cc24269ba02235760f88191","type":"text","conversion_output":true,"parent_id":"18558ad66ee44e81a14b7a4f579f4916","text":"3.10.1 Data Management is described as a part of Quality Control in Section 4.1.6.","text_display":"\n\n\\subsection*{3.10.1 Data Management is described as a part of Quality Control in Section 4.1.6.}","confidence":1,"confidence_rate":1},{"cnt":[[120,1663],[1884,1663],[1884,1708],[120,1708]],"region":{"top_left_x":120,"top_left_y":1662,"width":1765,"height":47},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41bf7c533dcd4df8896edbcce1e36d9e","type":"text","conversion_output":true,"text":"3.10.2 Randomization: We will randomize 88 participants to each of the two treatment arms using a \\(1: 1\\)","text_display":"\n3.10.2 Randomization: We will randomize 88 participants to each of the two treatment arms using a \\(1: 1\\)","confidence":1,"confidence_rate":1},{"cnt":[[120,1708],[1979,1708],[1979,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1708,"width":1859,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e8ad29bdfc1458da2a851d43804fe5f","type":"text","conversion_output":true,"text":"allocation ratio, stratified by age, remission group at randomization, and site. In order to reduce the probability","text_display":" allocation ratio, stratified by age, remission group at randomization, and site. In order to reduce the probability","confidence":1,"confidence_rate":1},{"cnt":[[120,1753],[1957,1753],[1957,1798],[120,1798]],"region":{"top_left_x":120,"top_left_y":1753,"width":1838,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9c7a3c411db4f859276c011c89f5a68","type":"text","conversion_output":true,"text":"that a disproportionate number of subjects are randomized to any one level of the factors a blocking strategy","text_display":" that a disproportionate number of subjects are randomized to any one level of the factors a blocking strategy","confidence":1,"confidence_rate":1},{"cnt":[[120,1796],[1957,1796],[1957,1841],[120,1841]],"region":{"top_left_x":120,"top_left_y":1796,"width":1838,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ffc2cecf63642f399761d3d51921325","type":"text","conversion_output":true,"text":"will be used. Randomization will be conducted by Dr. Leon, the study's statistician, using the Dallal software.","text_display":" will be used. Randomization will be conducted by Dr. Leon, the study's statistician, using the Dallal software.","confidence":1,"confidence_rate":1},{"cnt":[[120,1839],[1824,1839],[1824,1884],[120,1884]],"region":{"top_left_x":120,"top_left_y":1839,"width":1705,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e50d79519e7f4288a93d7a33abc3e858","type":"text","conversion_output":true,"text":"3.10.3 Data Analytic Procedures: Initially, baseline demographic and clinical characteristics will be","text_display":"\n3.10.3 Data Analytic Procedures: Initially, baseline demographic and clinical characteristics will be","confidence":0.9462890625,"confidence_rate":0.9994793130223806},{"cnt":[[120,1882],[1893,1882],[1893,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1882,"width":1773,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc48c3b608bc489bad4164150ffec5f1","type":"text","conversion_output":true,"text":"examined. Frequency distributions will be produced. Descriptive and graphical displays will be produced.","text_display":" examined. Frequency distributions will be produced. Descriptive and graphical displays will be produced.","confidence":1,"confidence_rate":1},{"cnt":[[120,1927],[1946,1927],[1946,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1927,"width":1827,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f57ea74096cf4828b19c133e33bf9796","type":"text","conversion_output":true,"text":"Transformations will be used when distributional assumptions are not fulfilled for inferential tests. Treatment","text_display":" Transformations will be used when distributional assumptions are not fulfilled for inferential tests. Treatment","confidence":1,"confidence_rate":1},{"cnt":[[120,1972],[1983,1972],[1983,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1972,"width":1864,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf2b28ed2f1c45dd872c60bcc41cea81","type":"text","conversion_output":true,"text":"groups will be compared on baseline demographic and clinical variables using t-tests for continuous variables,","text_display":" groups will be compared on baseline demographic and clinical variables using t-tests for continuous variables,","confidence":0.99658203125,"confidence_rate":0.9999702280662401},{"cnt":[[120,2015],[1966,2015],[1966,2060],[120,2060]],"region":{"top_left_x":120,"top_left_y":2015,"width":1846,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"199f649f2c394cedaba056a08547e212","type":"text","conversion_output":true,"text":"Mann-Whitney tests for ordinal variables, and chi-square tests for categorical variables. If significant baseline","text_display":" Mann-Whitney tests for ordinal variables, and chi-square tests for categorical variables. If significant baseline","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[1897,2058],[1897,2103],[120,2103]],"region":{"top_left_x":120,"top_left_y":2058,"width":1778,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea135e94cc7d4d20aa5adb111be1c400","type":"text","conversion_output":true,"text":"group imbalance is detected on any particular variable, that variable will be included as a covariate in the","text_display":" group imbalance is detected on any particular variable, that variable will be included as a covariate in the","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[120,2103],[1906,2103],[1906,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2103,"width":1786,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8fc9ff993244a2db04f9bcb9e483705","type":"text","conversion_output":true,"text":"inferential analyses if its correlation with outcome is 0.30 or greater. Dropouts and completers will also be","text_display":" inferential analyses if its correlation with outcome is 0.30 or greater. Dropouts and completers will also be","confidence":1,"confidence_rate":1},{"cnt":[[120,2146],[1966,2146],[1966,2194],[120,2194]],"region":{"top_left_x":120,"top_left_y":2146,"width":1846,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cc831674c55469eab76a528ced40b28","type":"text","conversion_output":true,"text":"compared on baseline variables using t-tests, Mann-Whitney tests, or chi-square tests. The primary analyses","text_display":" compared on baseline variables using t-tests, Mann-Whitney tests, or chi-square tests. The primary analyses","confidence":1,"confidence_rate":1},{"cnt":[[120,2191],[1940,2191],[1940,2237],[120,2237]],"region":{"top_left_x":120,"top_left_y":2191,"width":1821,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c60d68bcdbdc472c9a15efe3a958dc4d","type":"text","conversion_output":true,"text":"will adhere to the Intent-to-Treat principle. Each statistical test for \\(H 1-3\\) will involve a two-tailed alpha of .05 .","text_display":" will adhere to the Intent-to-Treat principle. Each statistical test for \\(H 1-3\\) will involve a two-tailed alpha of .05 .","confidence":0.5783249019368668,"confidence_rate":0.9958284241198208},{"cnt":[[116,2230],[672,2230],[672,2284],[116,2284]],"region":{"top_left_x":116,"top_left_y":2230,"width":557,"height":54},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4cb6844da2e44ba973acb111c0d602d","type":"section_header","conversion_output":false,"children_ids":["3ea59e0ad5c74dc2b00d3ff55a6e716f"],"text":"","text_display":""},{"cnt":[[120,2234],[668,2234],[668,2279],[120,2279]],"region":{"top_left_x":120,"top_left_y":2234,"width":549,"height":46},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ea59e0ad5c74dc2b00d3ff55a6e716f","type":"text","conversion_output":true,"parent_id":"e4cb6844da2e44ba973acb111c0d602d","text":"Primary Hypothesis: Efficacy.","text_display":"\n\n\\section*{Primary Hypothesis: Efficacy.}","confidence":1,"confidence_rate":1},{"cnt":[[120,2277],[1962,2277],[1962,2325],[120,2325]],"region":{"top_left_x":120,"top_left_y":2277,"width":1842,"height":48},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ec9a47dc06e4eb1afb6725ecf985079","type":"text","conversion_output":true,"text":"H1: The combination of sertraline and olanzapine will be associated with less risk of relapse than the","text_display":"\n\nH1: The combination of sertraline and olanzapine will be associated with less risk of relapse than the","confidence":1,"confidence_rate":1},{"cnt":[[120,2322],[1861,2322],[1861,2368],[120,2368]],"region":{"top_left_x":120,"top_left_y":2322,"width":1741,"height":46},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db2c7db697314135b51c0daaacdd6504","type":"text","conversion_output":true,"text":"combination of sertraline and placebo. H1 will be tested with a Cox proportional hazards model that","text_display":" combination of sertraline and placebo. H1 will be tested with a Cox proportional hazards model that","confidence":1,"confidence_rate":1},{"cnt":[[120,2368],[1962,2368],[1962,2413],[120,2413]],"region":{"top_left_x":120,"top_left_y":2367,"width":1842,"height":46},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9244dcf73afa4f7bb1dcd240a1835919","type":"text","conversion_output":true,"text":"compares survival time across treatment groups. Survival time will be defined as time from randomization to","text_display":" compares survival time across treatment groups. Survival time will be defined as time from randomization to","confidence":1,"confidence_rate":1},{"cnt":[[120,2411],[1979,2411],[1979,2456],[120,2456]],"region":{"top_left_x":120,"top_left_y":2410,"width":1859,"height":46},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61c6c6f81a074a5d8f6d6a8ea3634f38","type":"text","conversion_output":true,"text":"relapse (Section 3.9.8) and will be measured in weeks. A subject's survival time will be classified as censored","text_display":" relapse (Section 3.9.8) and will be measured in weeks. A subject's survival time will be classified as censored","confidence":0.7216796875,"confidence_rate":0.9971921056969828},{"cnt":[[122,2454],[1998,2454],[1998,2501],[122,2501]],"region":{"top_left_x":122,"top_left_y":2453,"width":1877,"height":48},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31a99505fdc84460881713bd7d7dc6ca","type":"text","conversion_output":true,"text":"at the point of study discontinuation, (e.g., due to withdrawal of consent or a severe intervening non-psychiatric","text_display":" at the point of study discontinuation, (e.g., due to withdrawal of consent or a severe intervening non-psychiatric","confidence":1,"confidence_rate":1},{"cnt":[[120,2499],[2000,2499],[2000,2546],[120,2546]],"region":{"top_left_x":120,"top_left_y":2498,"width":1881,"height":48},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a9709d23a64446e907dc85caa3ef298","type":"text","conversion_output":true,"text":"medical event) or at end of follow-up, if relapse has not yet occurred. Kaplan Meier survival curves will be used","text_display":" medical event) or at end of follow-up, if relapse has not yet occurred. Kaplan Meier survival curves will be used","confidence":1,"confidence_rate":1},{"cnt":[[1959,2578],[2007,2578],[2007,2628],[1959,2628]],"region":{"top_left_x":1959,"top_left_y":2578,"width":48,"height":50},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"049a7f22d3ac45f58a7fdacf30528640","type":"page_info","conversion_output":false,"text":"\\(\\underline{13}\\)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-16","page":16,"lines":[{"cnt":[[116,122],[1962,122],[1962,174],[116,174]],"region":{"top_left_x":116,"top_left_y":122,"width":1846,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e01034f50c754728952ebd2c03e16438","type":"text","conversion_output":true,"text":"for descriptive analyses of time to relapse. The Cox models will include treatment group and the stratification","text_display":"\nfor descriptive analyses of time to relapse. The Cox models will include treatment group and the stratification","confidence":1,"confidence_rate":1},{"cnt":[[116,168],[1848,168],[1848,217],[116,217]],"region":{"top_left_x":116,"top_left_y":167,"width":1732,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f07072e181d940eeb0c5daf045853a8f","type":"text","conversion_output":true,"text":"variables: site, remission group at randomization (full-remission vs. near-remission), and age group at","text_display":" variables: site, remission group at randomization (full-remission vs. near-remission), and age group at","confidence":1,"confidence_rate":1},{"cnt":[[116,213],[1846,213],[1846,262],[116,262]],"region":{"top_left_x":116,"top_left_y":212,"width":1730,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"690579c4277f44978ee7b6605691005e","type":"text","conversion_output":true,"text":"randomization ( \\(18-59 vs . \\geq 60\\) years). Treatment groups will be compared on 5 variables at the time of","text_display":" randomization ( \\(18-59 vs . \\geq 60\\) years). Treatment groups will be compared on 5 variables at the time of","confidence":0.7529880887941115,"confidence_rate":0.9974924776867089},{"cnt":[[116,258],[1983,258],[1983,305],[116,305]],"region":{"top_left_x":116,"top_left_y":257,"width":1868,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1293a9c7fa2b4ae7aa4d48497f96d4be","type":"text","conversion_output":true,"text":"randomization that have the potential to be associated with risk of relapse (anxiety, medical burden, executive","text_display":" randomization that have the potential to be associated with risk of relapse (anxiety, medical burden, executive","confidence":1,"confidence_rate":1},{"cnt":[[116,301],[2004,301],[2004,350],[116,350]],"region":{"top_left_x":116,"top_left_y":300,"width":1889,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ada04f7b87c4ffc82651c6c44812dd1","type":"text","conversion_output":true,"text":"dysfunction, psychomotor change, and treatment resistance prior to study entry; Section 3.9.5); if the treatment","text_display":" dysfunction, psychomotor change, and treatment resistance prior to study entry; Section 3.9.5); if the treatment","confidence":1,"confidence_rate":1},{"cnt":[[116,346],[1962,346],[1962,393],[116,393]],"region":{"top_left_x":116,"top_left_y":345,"width":1846,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d25e99dac6744045ab35aa414bc19f3a","type":"text","conversion_output":true,"text":"groups differ significantly on one or more of these variables ( \\(p \\leqq .05\\) ) and the variable in question is correlated","text_display":" groups differ significantly on one or more of these variables ( \\(p \\leqq .05\\) ) and the variable in question is correlated","confidence":0.7519378291204952,"confidence_rate":0.9977217860177932},{"cnt":[[116,389],[1833,389],[1833,436],[116,436]],"region":{"top_left_x":116,"top_left_y":388,"width":1717,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4042143c85464372be47204a51222b34","type":"text","conversion_output":true,"text":"with relapse (r>.30), the variable will be included as a covariate in the Cox model. Based on our prior","text_display":" with relapse (r>.30), the variable will be included as a covariate in the Cox model. Based on our prior","confidence":0.8866060599684715,"confidence_rate":0.9988862269872948},{"cnt":[[116,430],[1895,430],[1895,483],[116,483]],"region":{"top_left_x":116,"top_left_y":429,"width":1779,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"915ff81e8e8848ce8494739e62d5ea55","type":"text","conversion_output":true,"text":"studies, \\({ }^{38,41,139}\\) we expect no more than \\(10 \\%\\) attrition during the RCT among these participants who have","text_display":" studies, \\({ }^{38,41,139}\\) we expect no more than \\(10 \\%\\) attrition during the RCT among these participants who have","confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[116,477],[2004,477],[2004,526],[116,526]],"region":{"top_left_x":116,"top_left_y":476,"width":1889,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60e8eace35f540479c40d2ef5df4b607","type":"text","conversion_output":true,"text":"already been enrolled for 12-20 weeks prior to randomization and who are in sustained remission at the time of","text_display":" already been enrolled for 12-20 weeks prior to randomization and who are in sustained remission at the time of","confidence":0.98828125,"confidence_rate":0.9998975012902904},{"cnt":[[116,520],[1992,520],[1992,569],[116,569]],"region":{"top_left_x":116,"top_left_y":519,"width":1876,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8576a71a71f348fcba84d5e956be833c","type":"text","conversion_output":true,"text":"randomization. This attrition rate might appear to be low, but this is because those subjects most vulnerable to","text_display":" randomization. This attrition rate might appear to be low, but this is because those subjects most vulnerable to","confidence":1,"confidence_rate":1},{"cnt":[[116,563],[2000,563],[2000,612],[116,612]],"region":{"top_left_x":116,"top_left_y":562,"width":1885,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5458a387b964506b06321856fe1d196","type":"text","conversion_output":true,"text":"attrition will likely drop out in the phases prior to randomization. Non-informative censoring will be examined by","text_display":" attrition will likely drop out in the phases prior to randomization. Non-informative censoring will be examined by","confidence":1,"confidence_rate":1},{"cnt":[[116,608],[2004,608],[2004,655],[116,655]],"region":{"top_left_x":116,"top_left_y":608,"width":1889,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ff7b0170ae24a0987d3a96425f37d19","type":"text","conversion_output":true,"text":"comparing those who do and do not dropout on their HAM-D ratings from the prior week. The constant hazards","text_display":" comparing those who do and do not dropout on their HAM-D ratings from the prior week. The constant hazards","confidence":1,"confidence_rate":1},{"cnt":[[116,653],[1962,653],[1962,700],[116,700]],"region":{"top_left_x":116,"top_left_y":653,"width":1846,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9797300cdadb4c82ba3d5b16df810e15","type":"text","conversion_output":true,"text":"assumption will be examined by examining the incremental contribution of a treatment x vulnerable period of","text_display":" assumption will be examined by examining the incremental contribution of a treatment x vulnerable period of","confidence":0.78515625,"confidence_rate":0.997842753988959},{"cnt":[[116,696],[1884,696],[1884,746],[116,746]],"region":{"top_left_x":116,"top_left_y":696,"width":1769,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f601d6a929e54932a5760e35459c9c9a","type":"text","conversion_output":true,"text":"relapse interaction (exploring the possibility of higher risk in the first 3 months following discontinuation).","text_display":" relapse interaction (exploring the possibility of higher risk in the first 3 months following discontinuation).","confidence":1,"confidence_rate":1},{"cnt":[[110,735],[1106,735],[1106,795],[110,795]],"region":{"top_left_x":109,"top_left_y":734,"width":998,"height":61},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cf39945dc644bf782cc130195ec38c4","type":"section_header","conversion_output":false,"children_ids":["d84a6f94c5c14468ad33e7f1ecae56d5"],"text":"","text_display":""},{"cnt":[[116,741],[1098,741],[1098,788],[116,788]],"region":{"top_left_x":116,"top_left_y":741,"width":982,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d84a6f94c5c14468ad33e7f1ecae56d5","type":"text","conversion_output":true,"parent_id":"2cf39945dc644bf782cc130195ec38c4","text":"Secondary Hypotheses: Weight and Metabolic Safety","text_display":"\n\n\\section*{Secondary Hypotheses: Weight and Metabolic Safety}","confidence":1,"confidence_rate":1},{"cnt":[[116,782],[1938,782],[1938,831],[116,831]],"region":{"top_left_x":116,"top_left_y":782,"width":1822,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aff263bde874e6780cac7ea6c5b64ae","type":"text","conversion_output":true,"text":"H2: The combination of sertraline and olanzapine will be associated with higher weight, higher total","text_display":"\n\nH2: The combination of sertraline and olanzapine will be associated with higher weight, higher total","confidence":1,"confidence_rate":1},{"cnt":[[116,827],[1953,827],[1953,879],[116,879]],"region":{"top_left_x":116,"top_left_y":827,"width":1837,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c94b507de0d4642814e3e972db7e5c7","type":"text","conversion_output":true,"text":"cholesterol, and higher triglycerides compared with the combination of sertraline and placebo in the","text_display":" cholesterol, and higher triglycerides compared with the combination of sertraline and placebo in the","confidence":1,"confidence_rate":1},{"cnt":[[116,872],[1946,872],[1946,922],[116,922]],"region":{"top_left_x":116,"top_left_y":872,"width":1831,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed41bacd76e048baaa54a832345388e6","type":"text","conversion_output":true,"text":"randomized phase. This will be tested using separate mixed-effects linear regression analyses for weight,","text_display":" randomized phase. This will be tested using separate mixed-effects linear regression analyses for weight,","confidence":1,"confidence_rate":1},{"cnt":[[116,915],[1783,915],[1783,965],[116,965]],"region":{"top_left_x":116,"top_left_y":915,"width":1668,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c4deb665459477dafb948942de35308","type":"text","conversion_output":true,"text":"cholesterol, and triglycerides during the randomized phase. Models will include up to 15 repeated","text_display":" cholesterol, and triglycerides during the randomized phase. Models will include up to 15 repeated","confidence":1,"confidence_rate":1},{"cnt":[[116,958],[1972,958],[1972,1008],[116,1008]],"region":{"top_left_x":116,"top_left_y":958,"width":1857,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5316ea49fbd84b7ea34f9aca2a7d3ba1","type":"text","conversion_output":true,"text":"assessments of weight and up to 5 repeated measures of total cholesterol and triglycerides over the 36-week","text_display":" assessments of weight and up to 5 repeated measures of total cholesterol and triglycerides over the 36-week","confidence":0.9853515625,"confidence_rate":0.9998716883609396},{"cnt":[[116,1003],[1974,1003],[1974,1053],[116,1053]],"region":{"top_left_x":116,"top_left_y":1003,"width":1859,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4729b5b7cdd446c8bce6adc3fbd90dd","type":"text","conversion_output":true,"text":"trial, as the respective dependent variables. Using a regulatory approach to safety analyses (H2, H3, E1 and","text_display":" trial, as the respective dependent variables. Using a regulatory approach to safety analyses (H2, H3, E1 and","confidence":0.9990236759185791,"confidence_rate":0.9999913557807578},{"cnt":[[116,1044],[1970,1044],[1970,1098],[116,1098]],"region":{"top_left_x":116,"top_left_y":1044,"width":1855,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c792e2f5f0af444bafca89e0b4d9964a","type":"text","conversion_output":true,"text":"E2), we will classify subjects based on medications taken during protocolized treatment. Likelihood ratio (LR)","text_display":" E2), we will classify subjects based on medications taken during protocolized treatment. Likelihood ratio (LR)","confidence":1,"confidence_rate":1},{"cnt":[[116,1091],[1972,1091],[1972,1139],[116,1139]],"region":{"top_left_x":116,"top_left_y":1091,"width":1857,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"456b414071164e9e8f72fb07c74c9bf9","type":"text","conversion_output":true,"text":"tests will successively examine the incremental contributions of a quadratic term for time and two interactions","text_display":" tests will successively examine the incremental contributions of a quadratic term for time and two interactions","confidence":1,"confidence_rate":1},{"cnt":[[116,1130],[1979,1130],[1979,1184],[116,1184]],"region":{"top_left_x":116,"top_left_y":1130,"width":1863,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d86b6002136d4a60b5eb73840ae5658a","type":"text","conversion_output":true,"text":"(treatment by site and treatment by time). \\({ }^{140}\\) The decision rule calls for rejection of \\(H _{0}\\) if the latter interaction is","text_display":" (treatment by site and treatment by time). \\({ }^{140}\\) The decision rule calls for rejection of \\(H _{0}\\) if the latter interaction is","confidence":1,"confidence_rate":1},{"cnt":[[116,1179],[2004,1179],[2004,1227],[116,1227]],"region":{"top_left_x":116,"top_left_y":1179,"width":1889,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"105bf7f874ff43dcaaa88ab116b814bd","type":"text","conversion_output":true,"text":"statistically significant. Interaction and quadratic terms will only be included in subsequent models if statistically","text_display":" statistically significant. Interaction and quadratic terms will only be included in subsequent models if statistically","confidence":1,"confidence_rate":1},{"cnt":[[116,1225],[1927,1225],[1927,1274],[116,1274]],"region":{"top_left_x":116,"top_left_y":1224,"width":1812,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"725ca9f923c84df4b38979aa29720b1d","type":"text","conversion_output":true,"text":"significant. LR tests will determine if the time better approximated with weekly time indicators that allow for","text_display":" significant. LR tests will determine if the time better approximated with weekly time indicators that allow for","confidence":1,"confidence_rate":1},{"cnt":[[116,1268],[1876,1268],[1876,1317],[116,1317]],"region":{"top_left_x":116,"top_left_y":1267,"width":1760,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"962f9d235cec4188aec9746c15223926","type":"text","conversion_output":true,"text":"other forms of non-linear change over time. In addition a spline-based approach will examine metabolic","text_display":" other forms of non-linear change over time. In addition a spline-based approach will examine metabolic","confidence":1,"confidence_rate":1},{"cnt":[[116,1311],[1964,1311],[1964,1360],[116,1360]],"region":{"top_left_x":116,"top_left_y":1310,"width":1848,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec872f820e5a480594193becdc108061","type":"text","conversion_output":true,"text":"changes. If a participant receives new treatment or a change of treatment for hyperlipidemia during the RCT,","text_display":" changes. If a participant receives new treatment or a change of treatment for hyperlipidemia during the RCT,","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[116,1354],[1966,1354],[1966,1403],[116,1403]],"region":{"top_left_x":116,"top_left_y":1353,"width":1850,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8133b4808e54ca19526697b161833a7","type":"text","conversion_output":true,"text":"his/her pertinent metabolic data from that point onwards will be excluded from the mixed model, although the","text_display":" his/her pertinent metabolic data from that point onwards will be excluded from the mixed model, although the","confidence":1,"confidence_rate":1},{"cnt":[[116,1401],[1949,1401],[1949,1446],[116,1446]],"region":{"top_left_x":116,"top_left_y":1400,"width":1833,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5137f7d171f5498685710013b9131ef4","type":"text","conversion_output":true,"text":"metabolic measures in question will continue to be collected for safety analyses and reporting to the DSMB.","text_display":" metabolic measures in question will continue to be collected for safety analyses and reporting to the DSMB.","confidence":1,"confidence_rate":1},{"cnt":[[116,1439],[1979,1439],[1979,1491],[116,1491]],"region":{"top_left_x":116,"top_left_y":1439,"width":1863,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7926e12541dd495ca116653079339f3c","type":"text","conversion_output":true,"text":"Based on data from STOP-PD, we expect that fewer than \\(5 \\%\\) of participants (i.e. \\(<10\\) participants in the RCT)","text_display":" Based on data from STOP-PD, we expect that fewer than \\(5 \\%\\) of participants (i.e. \\(<10\\) participants in the RCT)","confidence":0.9946372479898855,"confidence_rate":0.9999544316892699},{"cnt":[[116,1487],[2002,1487],[2002,1536],[116,1536]],"region":{"top_left_x":116,"top_left_y":1486,"width":1887,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7765b19f636e4b5390ea79216b2f1f00","type":"text","conversion_output":true,"text":"will have metabolic data censored for this reason. We chose not to include these post-randomization metabolic","text_display":" will have metabolic data censored for this reason. We chose not to include these post-randomization metabolic","confidence":1,"confidence_rate":1},{"cnt":[[116,1530],[1927,1530],[1927,1577],[116,1577]],"region":{"top_left_x":116,"top_left_y":1529,"width":1812,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7b0fb9fb22c42a3a1a23d6cb5c4e3ba","type":"text","conversion_output":true,"text":"data as covariates in the mixed model, because doing so could confound 'cause and effect' and result in a","text_display":" data as covariates in the mixed model, because doing so could confound 'cause and effect' and result in a","confidence":0.9975595474243164,"confidence_rate":0.9999777871982178},{"cnt":[[116,1568],[1768,1568],[1768,1622],[116,1622]],"region":{"top_left_x":116,"top_left_y":1568,"width":1653,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1588b39f68e84bc9bfae78bcfeb46038","type":"text","conversion_output":true,"text":"biased estimate of the treatment effect, thereby compromising the primary goal of the analysis. \\({ }^{141}\\)","text_display":" biased estimate of the treatment effect, thereby compromising the primary goal of the analysis. \\({ }^{141}\\)","confidence":1,"confidence_rate":1},{"cnt":[[116,1618],[1996,1618],[1996,1669],[116,1669]],"region":{"top_left_x":116,"top_left_y":1617,"width":1880,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"736e3ae0f25e4fbe9b9d81bac7dc1e1a","type":"text","conversion_output":true,"text":"H3: Older age will be associated with less weight gain during the open-label phase. Mixed-effects linear","text_display":"\nH3: Older age will be associated with less weight gain during the open-label phase. Mixed-effects linear","confidence":1,"confidence_rate":1},{"cnt":[[116,1663],[1929,1663],[1929,1712],[116,1712]],"region":{"top_left_x":116,"top_left_y":1662,"width":1814,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa46acc063ab414cae848b45a23bcb66","type":"text","conversion_output":true,"text":"regression analysis will examine weight change from Acute Phase baseline. The model will include up to 6","text_display":" regression analysis will examine weight change from Acute Phase baseline. The model will include up to 6","confidence":1,"confidence_rate":1},{"cnt":[[116,1706],[1989,1706],[1989,1755],[116,1755]],"region":{"top_left_x":116,"top_left_y":1705,"width":1874,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b379d152138496cbe48127d07553050","type":"text","conversion_output":true,"text":"weight assessments over the \\(12-20\\) week acute and stabilization phases. We will use the strategy above (H2)","text_display":" weight assessments over the \\(12-20\\) week acute and stabilization phases. We will use the strategy above (H2)","confidence":0.8884146413765848,"confidence_rate":0.9989626725501235},{"cnt":[[116,1749],[1940,1749],[1940,1798],[116,1798]],"region":{"top_left_x":116,"top_left_y":1748,"width":1825,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7e4463f979e43f2a8c1f1dc783c5c3c","type":"text","conversion_output":true,"text":"except that age will be the primary fixed effect because treatment is a constant in the open-label phase. LR","text_display":" except that age will be the primary fixed effect because treatment is a constant in the open-label phase. LR","confidence":0.9975595474243164,"confidence_rate":0.9999783769122432},{"cnt":[[116,1796],[1923,1796],[1923,1841],[116,1841]],"region":{"top_left_x":116,"top_left_y":1796,"width":1807,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df08d2e582a54995beb43ee8df278608","type":"text","conversion_output":true,"text":"tests will examine incremental contributions of a quadratic term for time and the age by time interaction. In","text_display":" tests will examine incremental contributions of a quadratic term for time and the age by time interaction. In","confidence":0.9990234375,"confidence_rate":0.9999914295135003},{"cnt":[[116,1839],[1983,1839],[1983,1888],[116,1888]],"region":{"top_left_x":116,"top_left_y":1839,"width":1868,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecf29eab856b4662bea6afce062dc67b","type":"text","conversion_output":true,"text":"addition a spline-based approach will be used to fit metabolic measures. \\(H _{0}\\) will be rejected if the interaction is","text_display":" addition a spline-based approach will be used to fit metabolic measures. \\(H _{0}\\) will be rejected if the interaction is","confidence":1,"confidence_rate":1},{"cnt":[[116,1882],[507,1882],[507,1931],[116,1931]],"region":{"top_left_x":116,"top_left_y":1882,"width":392,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b696f78ec722491a8d4cfd6fb1b5bbdd","type":"text","conversion_output":true,"text":"statistically significant.","text_display":" statistically significant.","confidence":1,"confidence_rate":1},{"cnt":[[112,1921],[529,1921],[529,1979],[112,1979]],"region":{"top_left_x":111,"top_left_y":1920,"width":418,"height":59},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c7d0c34885a4aa1b35fa60a8427b19c","type":"section_header","conversion_output":false,"children_ids":["f9226a55759c4791ab7108fb18c28302"],"text":"","text_display":""},{"cnt":[[116,1925],[522,1925],[522,1974],[116,1974]],"region":{"top_left_x":116,"top_left_y":1925,"width":407,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9226a55759c4791ab7108fb18c28302","type":"text","conversion_output":true,"parent_id":"1c7d0c34885a4aa1b35fa60a8427b19c","text":"Exploratory Analyses","text_display":"\n\n\\section*{Exploratory Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[116,1968],[1826,1968],[1826,2017],[116,2017]],"region":{"top_left_x":116,"top_left_y":1967,"width":1711,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2154e81a612e4b14a2106f8a63e6c9af","type":"text","conversion_output":true,"text":"E1. Explore older age as a moderator of change in weight and metabolic variables during the","text_display":"\n\nE1. Explore older age as a moderator of change in weight and metabolic variables during the","confidence":1,"confidence_rate":1},{"cnt":[[116,2007],[1966,2007],[1966,2065],[116,2065]],"region":{"top_left_x":116,"top_left_y":2006,"width":1850,"height":59},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2107d48d07914e569d7c8c0a8b293ed1","type":"text","conversion_output":true,"text":"randomized phase. Analyses of age as a moderator are exploratory and, as recommended \\({ }^{142}\\) will focus on","text_display":" randomized phase. Analyses of age as a moderator are exploratory and, as recommended \\({ }^{142}\\) will focus on","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[116,2058],[1904,2058],[1904,2108],[116,2108]],"region":{"top_left_x":116,"top_left_y":2058,"width":1788,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e2280c24ec048bdaa91f2a72d347f56","type":"text","conversion_output":true,"text":"the magnitude of the effect and not involve significance testing. Separate mixed-effects linear regression","text_display":" the magnitude of the effect and not involve significance testing. Separate mixed-effects linear regression","confidence":1,"confidence_rate":1},{"cnt":[[116,2101],[1695,2101],[1695,2151],[116,2151]],"region":{"top_left_x":116,"top_left_y":2101,"width":1580,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efc4021549344c59928da1ed2cf5079a","type":"text","conversion_output":true,"text":"models will examine change on weight, total cholesterol, triglycerides, and insulin resistance.","text_display":" models will examine change on weight, total cholesterol, triglycerides, and insulin resistance.","confidence":1,"confidence_rate":1},{"cnt":[[116,2144],[1949,2144],[1949,2194],[116,2194]],"region":{"top_left_x":116,"top_left_y":2144,"width":1833,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bc292f3e65a4883a4eacc4639e0944c","type":"text","conversion_output":true,"text":"E2. Explore the association of selected genetic polymorphisms with: i) remission, ii) relapse, and iii)","text_display":"\nE2. Explore the association of selected genetic polymorphisms with: i) remission, ii) relapse, and iii)","confidence":1,"confidence_rate":1},{"cnt":[[116,2189],[1912,2189],[1912,2239],[116,2239]],"region":{"top_left_x":116,"top_left_y":2189,"width":1797,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa1511b7123449408e93e003517ed8f0","type":"text","conversion_output":true,"text":"weight and metabolic variables during the open-label and randomized phases of the study. We will","text_display":" weight and metabolic variables during the open-label and randomized phases of the study. We will","confidence":1,"confidence_rate":1},{"cnt":[[116,2234],[1906,2234],[1906,2282],[116,2282]],"region":{"top_left_x":116,"top_left_y":2234,"width":1790,"height":48},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a26e6814031c471fb72c09114dd9e314","type":"text","conversion_output":true,"text":"apply quality control for the genotyped genetic markers: i) all tag SNPs with a call rate less than \\(95 \\%\\) and","text_display":" apply quality control for the genotyped genetic markers: i) all tag SNPs with a call rate less than \\(95 \\%\\) and","confidence":0.99658203125,"confidence_rate":0.9999702280662401},{"cnt":[[116,2277],[2004,2277],[2004,2327],[116,2327]],"region":{"top_left_x":116,"top_left_y":2277,"width":1889,"height":50},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d091243bc0e445688c4fec89147c89b","type":"text","conversion_output":true,"text":"minor allele frequency less than \\(10 \\%\\) will be excluded to provide sufficiently informative variation, and ii) we will","text_display":" minor allele frequency less than \\(10 \\%\\) will be excluded to provide sufficiently informative variation, and ii) we will","confidence":0.99951171875,"confidence_rate":0.9999960612940623},{"cnt":[[116,2320],[1957,2320],[1957,2374],[116,2374]],"region":{"top_left_x":116,"top_left_y":2320,"width":1842,"height":55},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d03f4b0e9aa4c2ca0e4332435752258","type":"text","conversion_output":true,"text":"test for Hardy-Weinberg equilibrium (HWE) for each marker; markers not in HWE will be discarded ( \\(p <.001\\) ).","text_display":" test for Hardy-Weinberg equilibrium (HWE) for each marker; markers not in HWE will be discarded ( \\(p <.001\\) ).","confidence":0.98291015625,"confidence_rate":0.9998539296479603},{"cnt":[[116,2368],[1987,2368],[1987,2415],[116,2415]],"region":{"top_left_x":116,"top_left_y":2367,"width":1872,"height":48},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b14e79f78ab4d92be419e4b717bc99a","type":"text","conversion_output":true,"text":"The analyses for remission and relapse will compare those with and without each candidate genotype on time","text_display":" The analyses for remission and relapse will compare those with and without each candidate genotype on time","confidence":1,"confidence_rate":1},{"cnt":[[116,2411],[1987,2411],[1987,2460],[116,2460]],"region":{"top_left_x":116,"top_left_y":2410,"width":1872,"height":50},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95ca891d506e4baf972ff397fab59410","type":"text","conversion_output":true,"text":"until remission/relapse in separate Cox proportional hazards models. Analyses will examine one genotype per","text_display":" until remission/relapse in separate Cox proportional hazards models. Analyses will examine one genotype per","confidence":1,"confidence_rate":1},{"cnt":[[116,2454],[1987,2454],[1987,2503],[116,2503]],"region":{"top_left_x":116,"top_left_y":2453,"width":1872,"height":50},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fc1a6c442854e7bb40bd8ffcf03135e","type":"text","conversion_output":true,"text":"model. Mixed-effects linear regression analyses will compare those with and without each candidate genotype","text_display":" model. Mixed-effects linear regression analyses will compare those with and without each candidate genotype","confidence":1,"confidence_rate":1},{"cnt":[[116,2496],[1929,2496],[1929,2546],[116,2546]],"region":{"top_left_x":116,"top_left_y":2496,"width":1814,"height":50},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acbb1c6c9e0a4f3eb2a0dcfc14ffb54f","type":"text","conversion_output":true,"text":"on weight and metabolic variables. There will be separate models for weight and each pertinent metabolic","text_display":" on weight and metabolic variables. There will be separate models for weight and each pertinent metabolic","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2009,2578],[2009,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":54,"height":50},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b2c07e4a52746c3899d09effd97aadd","type":"page_info","conversion_output":false,"text":"\\(\\underline{14}\\)","text_display":"","confidence":0.97607421875,"confidence_rate":0.9951683796797726}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-17","page":17,"lines":[{"cnt":[[120,125],[1944,125],[1944,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1825,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"178677d58d2241119618552418c8324b","type":"text","conversion_output":true,"text":"variable; these analyses will examine one genotype per model. Each open-label analysis will involve a main","text_display":"\nvariable; these analyses will examine one genotype per model. Each open-label analysis will involve a main","confidence":1,"confidence_rate":1},{"cnt":[[120,172],[1985,172],[1985,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":1866,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a2f7fc5f08742058f09fe01eb728e89","type":"text","conversion_output":true,"text":"effect of genotype, whereas each randomized phase analysis will involve both the main effects and interaction","text_display":" effect of genotype, whereas each randomized phase analysis will involve both the main effects and interaction","confidence":1,"confidence_rate":1},{"cnt":[[120,215],[1927,215],[1927,262],[120,262]],"region":{"top_left_x":120,"top_left_y":214,"width":1808,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3acdbf3bdb14455597febb71071ed15b","type":"text","conversion_output":true,"text":"of genotype and randomized treatment. Haplotype analyses will follow the same approach as for genotype","text_display":" of genotype and randomized treatment. Haplotype analyses will follow the same approach as for genotype","confidence":1,"confidence_rate":1},{"cnt":[[120,260],[1609,260],[1609,305],[120,305]],"region":{"top_left_x":120,"top_left_y":259,"width":1490,"height":47},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"977f73f276574cecaa6b6f5a3fa45ce4","type":"text","conversion_output":true,"text":"analyses. Haplotypes occurring at a frequency of \\(<10 \\%\\) will not be included in analyses.","text_display":" analyses. Haplotypes occurring at a frequency of \\(<10 \\%\\) will not be included in analyses.","confidence":0.99609375,"confidence_rate":0.9999588019084422},{"cnt":[[120,301],[1946,301],[1946,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1827,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c48145413de49b9a9a62ec9d3941753","type":"text","conversion_output":true,"text":"Analysis of Non-Metabolic Safety Data: Data on non-metabolic adverse events during each phase will be","text_display":"\nAnalysis of Non-Metabolic Safety Data: Data on non-metabolic adverse events during each phase will be","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[120,346],[1833,346],[1833,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1713,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"751aa23dfb87440da685c00bbfbdc72f","type":"text","conversion_output":true,"text":"collected for reporting to the DSMB. In addition, these data during the RCT will allow for a descriptive","text_display":" collected for reporting to the DSMB. In addition, these data during the RCT will allow for a descriptive","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1992,391],[1992,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1872,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a29bc06ba9f4f999bd219776a2cf810","type":"text","conversion_output":true,"text":"comparison between participants maintained on olanzapine and those switched to placebo. For each phase of","text_display":" comparison between participants maintained on olanzapine and those switched to placebo. For each phase of","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1957,434],[1957,483],[120,483]],"region":{"top_left_x":120,"top_left_y":433,"width":1838,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdc818f37c1747bfb5023930bc168cb4","type":"text","conversion_output":true,"text":"the study, we will report the number and \\% of participants who meet criteria for specific adverse events, who","text_display":" the study, we will report the number and \\% of participants who meet criteria for specific adverse events, who","confidence":0.99169921875,"confidence_rate":0.9999268849135732},{"cnt":[[120,477],[2000,477],[2000,524],[120,524]],"region":{"top_left_x":120,"top_left_y":476,"width":1881,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02602d9c9d1f48b4876180ca63c4fbbe","type":"text","conversion_output":true,"text":"did not meet these criteria at acute phase baseline. Adverse events will be defined as: an increase of \\(\\geq 2\\) points","text_display":" did not meet these criteria at acute phase baseline. Adverse events will be defined as: an increase of \\(\\geq 2\\) points","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[1899,520],[1899,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1780,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67d9fa6325d54189bc59429c2ff58b71","type":"text","conversion_output":true,"text":"from baseline or a score of 3 on individual items of the UKU; a global severity score of \\(\\geq 2\\) on the AIMS; a","text_display":" from baseline or a score of 3 on individual items of the UKU; a global severity score of \\(\\geq 2\\) on the AIMS; a","confidence":1,"confidence_rate":1},{"cnt":[[120,563],[1904,563],[1904,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1784,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcf3edffa8cf4e64b460fad532400f90","type":"text","conversion_output":true,"text":"global assessment score of \\(\\geq 2\\) on the Barnes Akathisia scale; a mean score of \\(\\geq 2\\) on the Simpson Angus","text_display":" global assessment score of \\(\\geq 2\\) on the Barnes Akathisia scale; a mean score of \\(\\geq 2\\) on the Simpson Angus","confidence":1,"confidence_rate":1},{"cnt":[[120,608],[1919,608],[1919,655],[120,655]],"region":{"top_left_x":120,"top_left_y":608,"width":1799,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8df769e842934daba06b8dc6627d3a21","type":"text","conversion_output":true,"text":"Scale; a score of \\(\\geq 1\\) on item \\#4 or \\#5 of the SSI; a reduction in systolic blood pressure of \\(\\geq 20 mmHg\\) or in","text_display":" Scale; a score of \\(\\geq 1\\) on item \\#4 or \\#5 of the SSI; a reduction in systolic blood pressure of \\(\\geq 20 mmHg\\) or in","confidence":0.62841796875,"confidence_rate":0.9961038301903897},{"cnt":[[120,653],[1979,653],[1979,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1859,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e90fe2f2ff4a424682a61637f35e9c49","type":"text","conversion_output":true,"text":"diastolic blood pressure of \\(\\geq 10 mm Hg\\) within 3 minutes of standing; one or more falls. We will also report the","text_display":" diastolic blood pressure of \\(\\geq 10 mm Hg\\) within 3 minutes of standing; one or more falls. We will also report the","confidence":0.35791015625,"confidence_rate":0.9916813517075713},{"cnt":[[120,696],[1949,696],[1949,741],[120,741]],"region":{"top_left_x":120,"top_left_y":696,"width":1829,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dad8b4f21bfd49248939f7748db95124","type":"text","conversion_output":true,"text":"N and \\% of individuals who meet criteria for an adverse event from week 8 onwards of the RCT, to allow for","text_display":" N and \\% of individuals who meet criteria for an adverse event from week 8 onwards of the RCT, to allow for","confidence":0.9663248062133789,"confidence_rate":0.9997047396068205},{"cnt":[[120,741],[1966,741],[1966,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":1846,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc98a03245264857a0645e4a4de194b6","type":"text","conversion_output":true,"text":"the possibility of improvement in adverse effects once open-label phase olanzapine is cleared from the body.","text_display":" the possibility of improvement in adverse effects once open-label phase olanzapine is cleared from the body.","confidence":1,"confidence_rate":1},{"cnt":[[120,784],[2004,784],[2004,831],[120,831]],"region":{"top_left_x":120,"top_left_y":784,"width":1885,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2081bad8bf42473eb90401d5e56519c4","type":"text","conversion_output":true,"text":"We will also report the N and \\% of individuals who are started on a lipid-lowering or glucose-lowering drug after","text_display":" We will also report the N and \\% of individuals who are started on a lipid-lowering or glucose-lowering drug after","confidence":0.9521715641021729,"confidence_rate":0.999604835791222},{"cnt":[[120,829],[1867,829],[1867,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1747,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fbe582b44444791a880e9cbccd99caf","type":"text","conversion_output":true,"text":"study enrollment. Because of the large number of variables, these data will be presented descriptively.","text_display":" study enrollment. Because of the large number of variables, these data will be presented descriptively.","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1996,872],[1996,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1876,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c3d7c91ab22428299b7282478b37c6c","type":"text","conversion_output":true,"text":"Analysis of Drug Exposure: The analyses of drug exposure are exploratory and will not directly influence the","text_display":"\nAnalysis of Drug Exposure: The analyses of drug exposure are exploratory and will not directly influence the","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[1867,915],[1867,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1747,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d12ae95e77b408da409826f53a55bcb","type":"text","conversion_output":true,"text":"findings of \\(H 1-3\\) and E1-2, but will instead provide supplementary information for interpretation of these","text_display":" findings of \\(H 1-3\\) and E1-2, but will instead provide supplementary information for interpretation of these","confidence":0.4144768714904785,"confidence_rate":0.9924361808818368},{"cnt":[[120,958],[1972,958],[1972,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":958,"width":1853,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb99438e68b7416cb9c0c3d17dd4ba74","type":"text","conversion_output":true,"text":"findings. Mixed effects linear regression analyses will compare treatment groups on magnitude and variability","text_display":" findings. Mixed effects linear regression analyses will compare treatment groups on magnitude and variability","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[1888,1005],[1888,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1005,"width":1769,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f117a8d2f68b49918814252b53a4971f","type":"text","conversion_output":true,"text":"of sertraline exposure in the randomized phase. Mixed effects linear models will compare age groups on","text_display":" of sertraline exposure in the randomized phase. Mixed effects linear models will compare age groups on","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1886,1048],[1886,1096],[120,1096]],"region":{"top_left_x":120,"top_left_y":1048,"width":1767,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01b4ac83cd5c4eb7868edc5b950d19dc","type":"text","conversion_output":true,"text":"magnitude and variability of i) sertraline exposure and ii) olanzapine exposure during the open-label and","text_display":" magnitude and variability of i) sertraline exposure and ii) olanzapine exposure during the open-label and","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1949,1091],[1949,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1829,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4f5357cc21a455eae436a3dcd40d07e","type":"text","conversion_output":true,"text":"randomized phases. There will be separate models for each phase and for each measure of drug exposure.","text_display":" randomized phases. There will be separate models for each phase and for each measure of drug exposure.","confidence":1,"confidence_rate":1},{"cnt":[[114,1130],[1330,1130],[1330,1188],[114,1188]],"region":{"top_left_x":113,"top_left_y":1130,"width":1217,"height":59},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00f776c1421341d1819a1edf70f40f54","type":"section_header","conversion_output":false,"children_ids":["0916126c1f1e455e89d5443abce0f182"],"text":"","text_display":""},{"cnt":[[120,1137],[1321,1137],[1321,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1136,"width":1202,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0916126c1f1e455e89d5443abce0f182","type":"text","conversion_output":true,"parent_id":"00f776c1421341d1819a1edf70f40f54","text":"3.10.4 Sample Size Determination and Statistical Power Analyses:","text_display":"\n\n\\subsection*{3.10.4 Sample Size Determination and Statistical Power Analyses:}","confidence":1,"confidence_rate":1},{"cnt":[[120,1179],[1843,1177],[1843,1227],[120,1229]],"region":{"top_left_x":120,"top_left_y":1176,"width":1724,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d19341c88583486dad3b7ed9ab7f96da","type":"text","conversion_output":true,"text":"Assumptions for Power Calculations for H1: We propose 20\\% as the minimal clinically meaningful","text_display":"\n\nAssumptions for Power Calculations for H1: We propose 20\\% as the minimal clinically meaningful","confidence":0.9297552108764648,"confidence_rate":0.9992645741784999},{"cnt":[[120,1225],[2002,1225],[2002,1274],[120,1274]],"region":{"top_left_x":120,"top_left_y":1224,"width":1883,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76bdcbb4e6314af1a266e607a6075884","type":"text","conversion_output":true,"text":"difference in relapse rates between olanzapine and placebo over 36 weeks. A \\(20 \\%\\) difference would mean that","text_display":" difference in relapse rates between olanzapine and placebo over 36 weeks. A \\(20 \\%\\) difference would mean that","confidence":1,"confidence_rate":1},{"cnt":[[120,1268],[1966,1268],[1966,1317],[120,1317]],"region":{"top_left_x":120,"top_left_y":1267,"width":1846,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9215098ab8fc4af483c1a8f5bcb95e23","type":"text","conversion_output":true,"text":"5 patients (NNT) would need to be treated with olanzapine to prevent 1 case of relapse. Based on the review","text_display":" 5 patients (NNT) would need to be treated with olanzapine to prevent 1 case of relapse. Based on the review","confidence":1,"confidence_rate":1},{"cnt":[[120,1311],[1962,1311],[1962,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1310,"width":1842,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faeed77e4efe43f1a37062d4504577ad","type":"text","conversion_output":true,"text":"of literature (Section 3.4) and STOP-PD stabilization data (Section 3.8), we estimate that \\(15 \\%\\) of participants","text_display":" of literature (Section 3.4) and STOP-PD stabilization data (Section 3.8), we estimate that \\(15 \\%\\) of participants","confidence":0.9912352319907412,"confidence_rate":0.9999253976598925},{"cnt":[[120,1354],[1904,1354],[1904,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1353,"width":1784,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"080ce4f45ae4432f9136974636445900","type":"text","conversion_output":true,"text":"who are maintained on sertraline+olanzapine will have a relapse in the RCT. A relapse rate of \\(35 \\%\\) in the","text_display":" who are maintained on sertraline+olanzapine will have a relapse in the RCT. A relapse rate of \\(35 \\%\\) in the","confidence":0.9970722198486328,"confidence_rate":0.9999738211062122},{"cnt":[[120,1401],[1861,1401],[1861,1448],[120,1448]],"region":{"top_left_x":120,"top_left_y":1400,"width":1741,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e473d7a60a74a2e9a550c90355ddd71","type":"text","conversion_output":true,"text":"sertraline+placebo group would therefore be consistent with the hypothesized \\(20 \\%\\) difference between","text_display":" sertraline+placebo group would therefore be consistent with the hypothesized \\(20 \\%\\) difference between","confidence":0.9604682922363281,"confidence_rate":0.9996231148797445},{"cnt":[[120,1444],[1921,1444],[1921,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1443,"width":1801,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80859ad89bf8473da033f7ab48a07aa3","type":"text","conversion_output":true,"text":"treatment groups. A \\(35 \\%\\) relapse following olanzapine discontinuation is the same as the rate reported by","text_display":" treatment groups. A \\(35 \\%\\) relapse following olanzapine discontinuation is the same as the rate reported by","confidence":0.99853515625,"confidence_rate":0.9999869115349181},{"cnt":[[120,1482],[1936,1482],[1936,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1482,"width":1816,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f1f664e2dcd4517985419857d8e5ede","type":"text","conversion_output":true,"text":"Aronson et al. \\({ }^{32}\\) in a naturalistic study of antipsychotic discontinuation in PD, but not as high as some of the","text_display":" Aronson et al. \\({ }^{32}\\) in a naturalistic study of antipsychotic discontinuation in PD, but not as high as some of the","confidence":1,"confidence_rate":1},{"cnt":[[120,1525],[1888,1525],[1888,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1525,"width":1769,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d4c142894c34cc9a9312db4c8dce049","type":"text","conversion_output":true,"text":"rates of relapse of PD following cessation of a course of ECT. \\({ }^{4,37-39}\\) Based on our previous experience of","text_display":" rates of relapse of PD following cessation of a course of ECT. \\({ }^{4,37-39}\\) Based on our previous experience of","confidence":0.9990234375,"confidence_rate":0.9999919253247671},{"cnt":[[120,1571],[1981,1571],[1981,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1570,"width":1861,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"927db38d5e9a46ac94c38ab8a2bd62ac","type":"text","conversion_output":true,"text":"conducting studies of the continuation and maintenance treatment of PD, \\({ }^{38,41,139}\\) we predict that attrition during","text_display":" conducting studies of the continuation and maintenance treatment of PD, \\({ }^{38,41,139}\\) we predict that attrition during","confidence":0.7269608974456787,"confidence_rate":0.997531094717491},{"cnt":[[120,1620],[629,1620],[629,1661],[120,1661]],"region":{"top_left_x":120,"top_left_y":1619,"width":510,"height":42},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"709b28117f42405b95459629c3e094e8","type":"text","conversion_output":true,"text":"the RCT will not exceed \\(10 \\%\\).","text_display":" the RCT will not exceed \\(10 \\%\\).","confidence":1,"confidence_rate":1},{"cnt":[[116,1697],[1033,1697],[1033,1747],[116,1747]],"region":{"top_left_x":116,"top_left_y":1697,"width":918,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cd58e50877c4e07ab0052a0d9fa7a8f","type":"figure_label","conversion_output":false,"text":"Table 2. Statistical Power for Survival Analyses for H1.","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999759688513347},{"cnt":[[116,1742],[900,1742],[900,2108],[116,2108]],"region":{"top_left_x":116,"top_left_y":1742,"width":785,"height":366},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b62a85478f934756b5dc48fb41bae792","type":"table","conversion_output":true,"selected_labels":["5cd58e50877c4e07ab0052a0d9fa7a8f"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline \\begin{tabular}{l} \nSert + Pla \\\\\nRelapse\n\\end{tabular} & \\begin{tabular}{l} \nSert +Olanz \\\\\nRelapse\n\\end{tabular} & Attrition & Power \\\\\n\\hline \\(40 \\%\\) & \\(15 \\%\\) & \\(10 \\%\\) & 0.95 \\\\\n\\hline \\(40 \\%\\) & \\(15 \\%\\) & \\(15 \\%\\) & 0.94 \\\\\n\\hline \\(35 \\%\\) & \\(15 \\%\\) & \\(10 \\%\\) & 0.84 \\\\\n\\hline \\(35 \\%\\) & \\(15 \\%\\) & \\(15 \\%\\) & 0.82 \\\\\n\\hline \\(35 \\%\\) & \\(10 \\%\\) & \\(10 \\%\\) & 0.98 \\\\\n\\hline \\(35 \\%\\) & \\(10 \\%\\) & \\(15 \\%\\) & 0.97 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 2. Statistical Power for Survival Analyses for H1.}\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\begin{tabular}{l} \nSert + Pla \\\\\nRelapse\n\\end{tabular} & \\begin{tabular}{l} \nSert +Olanz \\\\\nRelapse\n\\end{tabular} & Attrition & Power \\\\\n\\hline \\(40 \\%\\) & \\(15 \\%\\) & \\(10 \\%\\) & 0.95 \\\\\n\\hline \\(40 \\%\\) & \\(15 \\%\\) & \\(15 \\%\\) & 0.94 \\\\\n\\hline \\(35 \\%\\) & \\(15 \\%\\) & \\(10 \\%\\) & 0.84 \\\\\n\\hline \\(35 \\%\\) & \\(15 \\%\\) & \\(15 \\%\\) & 0.82 \\\\\n\\hline \\(35 \\%\\) & \\(10 \\%\\) & \\(10 \\%\\) & 0.98 \\\\\n\\hline \\(35 \\%\\) & \\(10 \\%\\) & \\(15 \\%\\) & 0.97 \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.9990234375,"confidence_rate":0.9999965597254676},{"cnt":[[920,1745],[1996,1745],[1996,1790],[920,1790]],"region":{"top_left_x":919,"top_left_y":1744,"width":1077,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3792b99666164ba8a3b02288a721edf2","type":"text","conversion_output":true,"text":"Power calculations for H1: The sample size proposed for this","text_display":"\n\nPower calculations for H1: The sample size proposed for this","confidence":1,"confidence_rate":1},{"cnt":[[920,1788],[1970,1788],[1970,1835],[920,1835]],"region":{"top_left_x":919,"top_left_y":1787,"width":1052,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5f0fb6224254de29ca0073bcd052115","type":"text","conversion_output":true,"text":"study was determined based on statistical power analyses for","text_display":" study was determined based on statistical power analyses for","confidence":1,"confidence_rate":1},{"cnt":[[920,1830],[1970,1830],[1970,1880],[920,1880]],"region":{"top_left_x":919,"top_left_y":1830,"width":1052,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1edce86ec6e4049925a90f2e1b4262f","type":"text","conversion_output":true,"text":"the primary hypothesis (H1), which will be tested with survival","text_display":" the primary hypothesis (H1), which will be tested with survival","confidence":0.9878273010253906,"confidence_rate":0.9998199074973377},{"cnt":[[920,1873],[1996,1873],[1996,1923],[920,1923]],"region":{"top_left_x":919,"top_left_y":1873,"width":1077,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec89a2f983ea450b8abea7ddcb3ff7ab","type":"text","conversion_output":true,"text":"analysis. The protocol specifies randomization of a total of 176","text_display":" analysis. The protocol specifies randomization of a total of 176","confidence":1,"confidence_rate":1},{"cnt":[[920,1919],[2000,1919],[2000,1966],[920,1966]],"region":{"top_left_x":919,"top_left_y":1918,"width":1082,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4529ef3cff2046e188ce423a2f658691","type":"text","conversion_output":true,"text":"participants (88/group), and specifies a two-tailed alpha level of","text_display":" participants (88/group), and specifies a two-tailed alpha level of","confidence":0.9873046875,"confidence_rate":0.9998200642667286},{"cnt":[[924,1964],[1884,1964],[1884,2013],[924,2013]],"region":{"top_left_x":923,"top_left_y":1963,"width":962,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"166353c06b6947d084a393b9c7e3f4e8","type":"text","conversion_output":true,"text":".05. Power was estimated in a simulation study using S+","text_display":" .05. Power was estimated in a simulation study using S+","confidence":0.94580078125,"confidence_rate":0.9990717090829693},{"cnt":[[920,2007],[1878,2007],[1878,2056],[920,2056]],"region":{"top_left_x":919,"top_left_y":2006,"width":959,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7d0d85767ec4af292b33f6ce1add3ce","type":"text","conversion_output":true,"text":"survfit. The proposed sample size will provide sufficient","text_display":" survfit. The proposed sample size will provide sufficient","confidence":1,"confidence_rate":1},{"cnt":[[922,2050],[1949,2050],[1949,2099],[922,2099]],"region":{"top_left_x":921,"top_left_y":2049,"width":1028,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"018a02a8b46844f5b328ed697d995678","type":"text","conversion_output":true,"text":"statistical power to detect clinically meaningful differences in","text_display":" statistical power to detect clinically meaningful differences in","confidence":1,"confidence_rate":1},{"cnt":[[922,2093],[1154,2093],[1154,2142],[922,2142]],"region":{"top_left_x":921,"top_left_y":2092,"width":233,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"505369473b274fc59adfdf3aef46918f","type":"text","conversion_output":true,"text":"H1 (Table 2).","text_display":" H1 (Table 2).","confidence":1,"confidence_rate":1},{"cnt":[[120,2138],[1931,2138],[1931,2185],[120,2185]],"region":{"top_left_x":120,"top_left_y":2137,"width":1812,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"340deaddf4804bf793d67c0730b2fdc7","type":"text","conversion_output":true,"text":"Assumptions for Power Calculations for H2: 1) Data from RCTs in schizophrenia show that olanzapine-","text_display":"\nAssumptions for Power Calculations for H2: 1) Data from RCTs in schizophrenia show that olanzapine","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[120,2179],[1972,2179],[1972,2230],[120,2230]],"region":{"top_left_x":120,"top_left_y":2178,"width":1853,"height":53},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b9b4bfa6a1c4ab0889196bbc690ed2b","type":"text","conversion_output":true,"text":"related weight gain slows after the first 12 weeks of treatment \\({ }^{143}\\) but can continue by an average of \\(1 lb /\\) month","text_display":"related weight gain slows after the first 12 weeks of treatment \\({ }^{143}\\) but can continue by an average of \\(1 lb /\\) month","confidence":0.9975595474243164,"confidence_rate":0.9999820337251166},{"cnt":[[120,2221],[1979,2221],[1979,2275],[120,2275]],"region":{"top_left_x":120,"top_left_y":2221,"width":1859,"height":55},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"092df88628cb4d39ad28af2f6fc749c7","type":"text","conversion_output":true,"text":"for up to 9 months of treatment. \\({ }^{144-146}\\) In the post-acute stabilization phase of STOP-PD, weight gain slowed to","text_display":" for up to 9 months of treatment. \\({ }^{144-146}\\) In the post-acute stabilization phase of STOP-PD, weight gain slowed to","confidence":0.99853515625,"confidence_rate":0.9999887237737117},{"cnt":[[120,2269],[1996,2269],[1996,2318],[120,2318]],"region":{"top_left_x":120,"top_left_y":2268,"width":1876,"height":51},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96d5b4e1b395408b87bc510f60b83459","type":"text","conversion_output":true,"text":"an average \\(1.5 lbs /\\) month; 2 ) We propose that participants assigned to placebo will lose most, but not all, of the","text_display":" an average \\(1.5 lbs /\\) month; 2 ) We propose that participants assigned to placebo will lose most, but not all, of the","confidence":0.9585261817301216,"confidence_rate":0.9996691297375034},{"cnt":[[120,2314],[1934,2314],[1934,2361],[120,2361]],"region":{"top_left_x":120,"top_left_y":2313,"width":1814,"height":49},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8e875c9520f4e19a954212d3bc92c4c","type":"text","conversion_output":true,"text":"weight gained during the open-label phase of the study, because some of the weight gained will have been","text_display":" weight gained during the open-label phase of the study, because some of the weight gained will have been","confidence":1,"confidence_rate":1},{"cnt":[[120,2359],[1914,2359],[1914,2408],[120,2408]],"region":{"top_left_x":120,"top_left_y":2358,"width":1795,"height":51},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0003b867b6a84ace941cf92770c859ec","type":"text","conversion_output":true,"text":"restoration of depression-related weight loss; 3) Ongoing increases in triglycerides, averaging \\(8-10 mg / dl /\\)","text_display":" restoration of depression-related weight loss; 3) Ongoing increases in triglycerides, averaging \\(8-10 mg / dl /\\)","confidence":0.99853515625,"confidence_rate":0.9999873628584485},{"cnt":[[120,2396],[1953,2396],[1953,2449],[120,2449]],"region":{"top_left_x":120,"top_left_y":2395,"width":1833,"height":55},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13f693cc714746359533a1c656205da4","type":"text","conversion_output":true,"text":"month over periods of 4-12 months, have been reported with olanzapine in studies of schizophrenia. \\({ }^{145-147}\\) In","text_display":" month over periods of 4-12 months, have been reported with olanzapine in studies of schizophrenia. \\({ }^{145-147}\\) In","confidence":0.7520740032196045,"confidence_rate":0.9977048914167468},{"cnt":[[120,2445],[1884,2445],[1884,2494],[120,2494]],"region":{"top_left_x":120,"top_left_y":2444,"width":1765,"height":51},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f9585f89d31485eb99441d4c77e273a","type":"text","conversion_output":true,"text":"STOP-PD, there was a similar mean increase of approximately \\(9 mg / dl / month\\). We therefore assume an","text_display":" STOP-PD, there was a similar mean increase of approximately \\(9 mg / dl / month\\). We therefore assume an","confidence":0.9907402927055955,"confidence_rate":0.9999183994270096},{"cnt":[[120,2488],[1880,2488],[1880,2537],[120,2537]],"region":{"top_left_x":120,"top_left_y":2487,"width":1760,"height":51},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da88dddf07b14ed9a729be6b12c91859","type":"text","conversion_output":true,"text":"increase in triglycerides in the olanzapine arm of the RCT; 4) RCTs of schizophrenia report only a slight","text_display":" increase in triglycerides in the olanzapine arm of the RCT; 4) RCTs of schizophrenia report only a slight","confidence":1,"confidence_rate":1},{"cnt":[[120,2529],[1876,2529],[1876,2580],[120,2580]],"region":{"top_left_x":120,"top_left_y":2528,"width":1756,"height":53},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b632b512c0c490498020b8bef6d32f6","type":"text","conversion_output":true,"text":"increase in total cholesterol with olanzapine after the first 12-16 weeks of treatment. \\({ }^{145,146}\\) We therefore","text_display":" increase in total cholesterol with olanzapine after the first 12-16 weeks of treatment. \\({ }^{145,146}\\) We therefore","confidence":0.71533203125,"confidence_rate":0.9972800597042215},{"cnt":[[1959,2578],[2009,2578],[2009,2628],[1959,2628]],"region":{"top_left_x":1959,"top_left_y":2578,"width":50,"height":50},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82909ba4cee1403ea64e0a6cae1f8d17","type":"page_info","conversion_output":false,"text":"\\(\\underline{15}\\)","text_display":"","confidence":0.990234375,"confidence_rate":0.998039200594109}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-18","page":18,"lines":[{"cnt":[[120,125],[1852,125],[1852,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1732,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88066b6e23044394a6e9582d8750bdab","type":"text","conversion_output":true,"text":"assume little or no change in total cholesterol from randomization values in the olanzapine arm; 5) We","text_display":"\nassume little or no change in total cholesterol from randomization values in the olanzapine arm; 5) We","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[120,172],[1972,172],[1972,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":1853,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55c0fa65960d4b02951ab7ec8177ec56","type":"text","conversion_output":true,"text":"hypothesize that triglycerides and total cholesterol in placebo-treated patients will return towards acute phase","text_display":" hypothesize that triglycerides and total cholesterol in placebo-treated patients will return towards acute phase","confidence":1,"confidence_rate":1},{"cnt":[[120,215],[402,215],[402,256],[120,256]],"region":{"top_left_x":120,"top_left_y":214,"width":282,"height":42},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"973862adc2d543efbcdb83eddd33f837","type":"text","conversion_output":true,"text":"baseline values.","text_display":" baseline values.","confidence":1,"confidence_rate":1},{"cnt":[[116,251],[840,251],[840,346],[116,346]],"region":{"top_left_x":116,"top_left_y":251,"width":725,"height":95},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a58512723274b0f9d0f37d4df6f0e6c","type":"figure_label","conversion_output":false,"children_ids":["fbac0089006a4a469b0494a5e4c83563","e122183d8ad648928494e486ebb87f71"],"text":"","text_display":""},{"cnt":[[120,258],[836,258],[836,296],[120,296]],"region":{"top_left_x":120,"top_left_y":257,"width":716,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fbac0089006a4a469b0494a5e4c83563","type":"text","conversion_output":false,"parent_id":"5a58512723274b0f9d0f37d4df6f0e6c","text":"Table 3: Statistical Power of Mixed-Effects","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999796501863057},{"cnt":[[120,296],[831,296],[831,342],[120,342]],"region":{"top_left_x":120,"top_left_y":296,"width":712,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e122183d8ad648928494e486ebb87f71","type":"text","conversion_output":false,"parent_id":"5a58512723274b0f9d0f37d4df6f0e6c","text":"Linear Regression Analyses for H2 and H3","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999782882435296},{"cnt":[[120,350],[984,350],[984,696],[120,696]],"region":{"top_left_x":120,"top_left_y":350,"width":864,"height":347},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75903235c1ce496cab74ef8a0ff211dc","type":"table","conversion_output":true,"selected_labels":["5a58512723274b0f9d0f37d4df6f0e6c"],"text":"\\begin{tabular}{|c|c|c|c|}\n\\hline \\begin{tabular}{c} \n\\# observations \\\\\n/subject\n\\end{tabular} & \\begin{tabular}{c} \nStandardized \\\\\nEffect\n\\end{tabular} & \\begin{tabular}{c}\n\\(ICC =.50\\) \\\\\nLipids\n\\end{tabular} & \\begin{tabular}{c}\n\\(ICC =.95\\) \\\\\nWeight\n\\end{tabular} \\\\\n\\hline 4 & .35 & .74 & .77 \\\\\n\\hline 4 & .40 & .84 & .85 \\\\\n\\hline 4 & .45 & .89 & .93 \\\\\n\\hline 8 & .35 & - & .80 \\\\\n\\hline 8 & .40 & - & .89 \\\\\n\\hline 8 & .45 & - & .95 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 3: Statistical Power of Mixed-Effects Linear Regression Analyses for H2 and H3}\n\\begin{tabular}{|c|c|c|c|}\n\\hline \\begin{tabular}{c} \n\\# observations \\\\\n/subject\n\\end{tabular} & \\begin{tabular}{c} \nStandardized \\\\\nEffect\n\\end{tabular} & \\begin{tabular}{c}\n\\(ICC =.50\\) \\\\\nLipids\n\\end{tabular} & \\begin{tabular}{c}\n\\(ICC =.95\\) \\\\\nWeight\n\\end{tabular} \\\\\n\\hline 4 & .35 & .74 & .77 \\\\\n\\hline 4 & .40 & .84 & .85 \\\\\n\\hline 4 & .45 & .89 & .93 \\\\\n\\hline 8 & .35 & - & .80 \\\\\n\\hline 8 & .40 & - & .89 \\\\\n\\hline 8 & .45 & - & .95 \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.7515654563903809,"confidence_rate":0.9990578798081674},{"cnt":[[1003,374],[1906,374],[1906,423],[1003,423]],"region":{"top_left_x":1003,"top_left_y":373,"width":903,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d121d5f75314c79afdb0b904f5c0dc5","type":"text","conversion_output":true,"text":"Power Calculations for H2 (Weight and Metabolic","text_display":"\n\nPower Calculations for H2 (Weight and Metabolic","confidence":0.958984375,"confidence_rate":0.999194930065049},{"cnt":[[1003,421],[1996,421],[1996,471],[1003,471]],"region":{"top_left_x":1003,"top_left_y":421,"width":993,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59f1d1aa25634eee8291e1b79cc2b511","type":"text","conversion_output":true,"text":"During RCT) : Power was estimated in a simulation study","text_display":" During RCT) : Power was estimated in a simulation study","confidence":0.9990234375,"confidence_rate":0.999983716138453},{"cnt":[[1005,468],[1968,468],[1968,513],[1005,513]],"region":{"top_left_x":1005,"top_left_y":468,"width":963,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81e0b4bb8e034b0db1900f4c8a527c60","type":"text","conversion_output":true,"text":"using SAS PROC MIXED. To account for attrition in H2,","text_display":" using SAS PROC MIXED. To account for attrition in H2,","confidence":0.99169921875,"confidence_rate":0.9998562961095139},{"cnt":[[1005,511],[1966,511],[1966,556],[1005,556]],"region":{"top_left_x":1005,"top_left_y":511,"width":961,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e12a3d0dde846c0824ef0b809c689e7","type":"text","conversion_output":true,"text":"the power analyses assumed we would collect at least 8","text_display":" the power analyses assumed we would collect at least 8","confidence":1,"confidence_rate":1},{"cnt":[[1005,554],[1841,554],[1841,599],[1005,599]],"region":{"top_left_x":1005,"top_left_y":554,"width":837,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f1a762737c44b61a2d8f5d037cab146","type":"text","conversion_output":true,"text":"of 15 repeated assessments of weight and 4 of 5","text_display":" of 15 repeated assessments of weight and 4 of 5","confidence":1,"confidence_rate":1},{"cnt":[[1005,597],[1972,597],[1972,642],[1005,642]],"region":{"top_left_x":1005,"top_left_y":597,"width":968,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30c7fb8184484a95b20e0192360fb66e","type":"text","conversion_output":true,"text":"measures of total cholesterol and triglycerides.during the","text_display":" measures of total cholesterol and triglycerides.during the","confidence":1,"confidence_rate":1},{"cnt":[[1005,640],[1987,640],[1987,690],[1005,690]],"region":{"top_left_x":1005,"top_left_y":640,"width":983,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"101acef879224612a245fa67036ff536","type":"text","conversion_output":true,"text":"RCT. The proposed design will have power \\(\\geq .80\\) to detect","text_display":" RCT. The proposed design will have power \\(\\geq .80\\) to detect","confidence":0.69873046875,"confidence_rate":0.9943258384704395},{"cnt":[[1005,683],[2000,683],[2000,733],[1005,733]],"region":{"top_left_x":1005,"top_left_y":683,"width":996,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32924d1132944e9eb952a1f5b47462bf","type":"text","conversion_output":true,"text":"differential slopes that result in standardized differences at","text_display":" differential slopes that result in standardized differences at","confidence":1,"confidence_rate":1},{"cnt":[[120,730],[1979,730],[1979,780],[120,780]],"region":{"top_left_x":120,"top_left_y":730,"width":1859,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3c2fb820e634f3690307393ed6a4c34","type":"text","conversion_output":true,"text":"endpoint \\(\\geq .35\\) for weight and \\(\\geq .40\\) for triglycerides and total cholesterol. To put these in perspective, based on","text_display":" endpoint \\(\\geq .35\\) for weight and \\(\\geq .40\\) for triglycerides and total cholesterol. To put these in perspective, based on","confidence":1,"confidence_rate":1},{"cnt":[[120,778],[1867,778],[1867,823],[120,823]],"region":{"top_left_x":120,"top_left_y":777,"width":1747,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7767d0d7101f447980d4279b49d889d9","type":"text","conversion_output":true,"text":"STOP-PD data, these effects correspond to group differences as small as 4.9 lbs in weight, \\(38 mg / dl\\) in","text_display":" STOP-PD data, these effects correspond to group differences as small as 4.9 lbs in weight, \\(38 mg / dl\\) in","confidence":0.958984375,"confidence_rate":0.9996510567511535},{"cnt":[[120,821],[904,821],[904,866],[120,866]],"region":{"top_left_x":120,"top_left_y":820,"width":785,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d2cc0a08dbe4157b5a0d3d7ad4ac1e0","type":"text","conversion_output":true,"text":"triglycerides, and \\(22 mg / dl\\) in total cholesterol.","text_display":" triglycerides, and \\(22 mg / dl\\) in total cholesterol.","confidence":0.93603515625,"confidence_rate":0.9989344029406844},{"cnt":[[120,864],[1938,864],[1938,913],[120,913]],"region":{"top_left_x":120,"top_left_y":863,"width":1818,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5485e51a721943b69fa6fc0996675219","type":"text","conversion_output":true,"text":"Assumptions and Statistical Power for H3 (Weight During Open-Label Phase): Power analyses for H3","text_display":"\nAssumptions and Statistical Power for H3 (Weight During Open-Label Phase): Power analyses for H3","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[120,907],[1983,907],[1983,956],[120,956]],"region":{"top_left_x":120,"top_left_y":906,"width":1864,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aa07585f29248ba82f22f7769b4c385","type":"text","conversion_output":true,"text":"assumed that we would collect at least 4 of the 6 planned assessments of weight during open-label treatment.","text_display":" assumed that we would collect at least 4 of the 6 planned assessments of weight during open-label treatment.","confidence":1,"confidence_rate":1},{"cnt":[[120,952],[1972,952],[1972,999],[120,999]],"region":{"top_left_x":120,"top_left_y":951,"width":1853,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e69b00fc6604623967a133a6fead44a","type":"text","conversion_output":true,"text":"The proposed design will have power >. 80 to detect differential slopes that result in a standardized difference","text_display":" The proposed design will have power >. 80 to detect differential slopes that result in a standardized difference","confidence":0.9248046875,"confidence_rate":0.9993487728703818},{"cnt":[[120,995],[1884,995],[1884,1042],[120,1042]],"region":{"top_left_x":120,"top_left_y":994,"width":1765,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d74a03ae17b4346b86383eb137d5d6f","type":"text","conversion_output":true,"text":"as small as . 40 by the end of the open-label phase (Table 3). To put this in context, of the participants in","text_display":" as small as . 40 by the end of the open-label phase (Table 3). To put this in context, of the participants in","confidence":0.7004010386299342,"confidence_rate":0.9969610185709191},{"cnt":[[120,1040],[1989,1040],[1989,1087],[120,1087]],"region":{"top_left_x":120,"top_left_y":1039,"width":1870,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c97f7354a30448aaf71add02f460cb3","type":"text","conversion_output":true,"text":"STOP-PD who completed 12 weeks of acute treatment, the younger group gained a mean \\(16.6 \\pm 16.5 lbs\\) and","text_display":" STOP-PD who completed 12 weeks of acute treatment, the younger group gained a mean \\(16.6 \\pm 16.5 lbs\\) and","confidence":0.990234375,"confidence_rate":0.9999131575635154},{"cnt":[[120,1083],[2000,1083],[2000,1130],[120,1130]],"region":{"top_left_x":120,"top_left_y":1082,"width":1881,"height":49},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dce785df56c495aab1910a19c9be905","type":"text","conversion_output":true,"text":"the older group gained a mean \\(10.7 \\pm 11.3 lbs\\); the standardized effect size for this weight difference was 0.42 .","text_display":" the older group gained a mean \\(10.7 \\pm 11.3 lbs\\); the standardized effect size for this weight difference was 0.42 .","confidence":1,"confidence_rate":1},{"cnt":[[120,1121],[2004,1121],[2004,1175],[120,1175]],"region":{"top_left_x":120,"top_left_y":1121,"width":1885,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd4c60cf43334049a19f62fc7c69e1a0","type":"text","conversion_output":true,"text":"3.10.5 Strategies for Attrition: Attrition can introduce bias and reduce power, precision and generalizability. \\({ }^{148}\\)","text_display":" 3.10.5 Strategies for Attrition: Attrition can introduce bias and reduce power, precision and generalizability. \\({ }^{148}\\)","confidence":0.99951171875,"confidence_rate":0.999996123813083},{"cnt":[[120,1171],[1944,1171],[1944,1218],[120,1218]],"region":{"top_left_x":120,"top_left_y":1170,"width":1825,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90547e7ed9d74f2e899dd4b6b793673d","type":"text","conversion_output":true,"text":"Based on our prior studies, we expect no more than \\(10 \\%\\) attrition during the RCT (see above). Cox models","text_display":" Based on our prior studies, we expect no more than \\(10 \\%\\) attrition during the RCT (see above). Cox models","confidence":0.99658203125,"confidence_rate":0.9999691552203086},{"cnt":[[120,1216],[1938,1216],[1938,1261],[120,1261]],"region":{"top_left_x":120,"top_left_y":1216,"width":1818,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf8b2bba48344537b4033eba2d9d8191","type":"text","conversion_output":true,"text":"assume non-informative censoring. The assessment frequency allows us to gauge survival status no more","text_display":" assume non-informative censoring. The assessment frequency allows us to gauge survival status no more","confidence":1,"confidence_rate":1},{"cnt":[[120,1259],[1876,1259],[1876,1308],[120,1308]],"region":{"top_left_x":120,"top_left_y":1258,"width":1756,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd863b131f81485fa7963b32e7108331","type":"text","conversion_output":true,"text":"than 2 weeks prior to dropout. Also, for the survival analysis of H1, we will adhere to the Intent-to-Treat","text_display":" than 2 weeks prior to dropout. Also, for the survival analysis of H1, we will adhere to the Intent-to-Treat","confidence":0.96875,"confidence_rate":0.999723962467854},{"cnt":[[120,1302],[1865,1302],[1865,1351],[120,1351]],"region":{"top_left_x":120,"top_left_y":1301,"width":1745,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed34274033b74f339e7c14ddad299222","type":"text","conversion_output":true,"text":"principle, in that we will make every effort to continue assessments for the entire course of randomized","text_display":" principle, in that we will make every effort to continue assessments for the entire course of randomized","confidence":1,"confidence_rate":1},{"cnt":[[120,1347],[1781,1347],[1781,1394],[120,1394]],"region":{"top_left_x":120,"top_left_y":1347,"width":1662,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65d2d225bf58446fab5d909c48d6410d","type":"text","conversion_output":true,"text":"treatment or until relapse (which ever comes first), even among those nonadherent to randomized","text_display":" treatment or until relapse (which ever comes first), even among those nonadherent to randomized","confidence":1,"confidence_rate":1},{"cnt":[[120,1386],[1888,1386],[1888,1437],[120,1437]],"region":{"top_left_x":120,"top_left_y":1385,"width":1769,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a7ea8c1ebff4ae8b1972a7987409ad2","type":"text","conversion_output":true,"text":"assignment. \\({ }^{149,150}\\) Mixed models (H2, H3, E1, E2) yield valid inferences assuming ignorable attrition (i.e.","text_display":" assignment. \\({ }^{149,150}\\) Mixed models (H2, H3, E1, E2) yield valid inferences assuming ignorable attrition (i.e.","confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[120,1431],[1871,1431],[1871,1480],[120,1480]],"region":{"top_left_x":120,"top_left_y":1430,"width":1752,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b57dfcdfdcaf4ff3982346b1c07c7ff5","type":"text","conversion_output":true,"text":"attrition is accounted for by covariates/dependent variable measured prior to drop-out). \\({ }^{151}\\) Following the","text_display":" attrition is accounted for by covariates/dependent variable measured prior to drop-out). \\({ }^{151}\\) Following the","confidence":1,"confidence_rate":1},{"cnt":[[120,1478],[1867,1478],[1867,1525],[120,1525]],"region":{"top_left_x":120,"top_left_y":1478,"width":1747,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d484f71d5d649fe9dcfec6217c7116e","type":"text","conversion_output":true,"text":"regulatory approach to safety, we will classify subjects based on medications taken during protocolized","text_display":" regulatory approach to safety, we will classify subjects based on medications taken during protocolized","confidence":1,"confidence_rate":1},{"cnt":[[120,1517],[1861,1517],[1861,1568],[120,1568]],"region":{"top_left_x":120,"top_left_y":1516,"width":1741,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36b1be0e123b48f5a280acf1ccc14de3","type":"text","conversion_output":true,"text":"treatment. We will examine the ignorable attrition assumption. First, using a pattern mixture model, \\({ }^{152}\\)","text_display":" treatment. We will examine the ignorable attrition assumption. First, using a pattern mixture model, \\({ }^{152}\\)","confidence":1,"confidence_rate":1},{"cnt":[[120,1560],[1919,1560],[1919,1613],[120,1613]],"region":{"top_left_x":120,"top_left_y":1559,"width":1799,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"657d840a76e84f95bbca1417f0833759","type":"text","conversion_output":true,"text":"implemented in a longitudinal framework. \\({ }^{153}\\) Second, Intent-to-Attend at entry to the RCT will be used as a","text_display":" implemented in a longitudinal framework. \\({ }^{153}\\) Second, Intent-to-Attend at entry to the RCT will be used as a","confidence":1,"confidence_rate":1},{"cnt":[[120,1607],[1904,1607],[1904,1656],[120,1656]],"region":{"top_left_x":120,"top_left_y":1607,"width":1784,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"063e93a4843f4a46ab651438fb5ec828","type":"text","conversion_output":true,"text":"covariate to account for attrition. \\({ }^{154}\\) Estimates of treatment effect from the models described above will be","text_display":" covariate to account for attrition. \\({ }^{154}\\) Estimates of treatment effect from the models described above will be","confidence":1,"confidence_rate":1},{"cnt":[[120,1654],[1826,1654],[1826,1704],[120,1704]],"region":{"top_left_x":120,"top_left_y":1654,"width":1707,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ad2eeb64ca241bdadf1cbd1af433c93","type":"text","conversion_output":true,"text":"compared with models that also include the main effects of either dropout pattern or Intent-to-Attend.","text_display":" compared with models that also include the main effects of either dropout pattern or Intent-to-Attend.","confidence":1,"confidence_rate":1},{"cnt":[[698,1736],[1429,1736],[1429,1790],[698,1790]],"region":{"top_left_x":698,"top_left_y":1735,"width":731,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f82ce4294ad4d33be4040702a4edc89","type":"section_header","conversion_output":false,"children_ids":["0b83b3b8fe0d4c7a87cb97bc94759cb6"],"text":"","text_display":""},{"cnt":[[700,1740],[1422,1740],[1422,1785],[700,1785]],"region":{"top_left_x":700,"top_left_y":1740,"width":723,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b83b3b8fe0d4c7a87cb97bc94759cb6","type":"text","conversion_output":true,"parent_id":"1f82ce4294ad4d33be4040702a4edc89","text":"4. PROTECTION OF HUMAN SUBJECTS","text_display":"\n\n\\section*{4. PROTECTION OF HUMAN SUBJECTS}","confidence":1,"confidence_rate":1},{"cnt":[[116,1824],[1895,1824],[1895,1923],[116,1923]],"region":{"top_left_x":116,"top_left_y":1824,"width":1779,"height":99},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2d31bf4f84f41eab34a941eace70d36","type":"section_header","conversion_output":false,"children_ids":["b59e7a15f09744348764e3ba8f52e6e6","4753fc1ced9c48b8a001dd69b9016f76"],"text":"","text_display":""},{"cnt":[[120,1828],[1893,1828],[1893,1876],[120,1876]],"region":{"top_left_x":120,"top_left_y":1828,"width":1773,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b59e7a15f09744348764e3ba8f52e6e6","type":"text","conversion_output":true,"parent_id":"f2d31bf4f84f41eab34a941eace70d36","text":"4.1. LEADERSHIP PLAN TO PROTECT THE INTEGRITY OF HUMAN SUBJECT DATA COLLECTED","text_display":"\n\n\\subsection*{4.1. LEADERSHIP PLAN TO PROTECT THE INTEGRITY OF HUMAN SUBJECT DATA COLLECTED","confidence":1,"confidence_rate":1},{"cnt":[[120,1873],[617,1873],[617,1919],[120,1919]],"region":{"top_left_x":120,"top_left_y":1873,"width":497,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4753fc1ced9c48b8a001dd69b9016f76","type":"text","conversion_output":true,"parent_id":"f2d31bf4f84f41eab34a941eace70d36","text":"ACROSS MULTIPLE SITES","text_display":" ACROSS MULTIPLE SITES}","confidence":1,"confidence_rate":1},{"cnt":[[120,1959],[1904,1959],[1904,2009],[120,2009]],"region":{"top_left_x":120,"top_left_y":1959,"width":1784,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ac61e1a0c9c494a8edea32022b41e4b","type":"text","conversion_output":true,"text":"4.1.1 Rationale: This grant proposal is a Renewal (formally known as Competing Continuation) of a NIH-","text_display":"\n4.1.1 Rationale: This grant proposal is a Renewal (formally known as Competing Continuation) of a NIH","confidence":1,"confidence_rate":1},{"cnt":[[120,2007],[1987,2007],[1987,2054],[120,2054]],"region":{"top_left_x":120,"top_left_y":2006,"width":1868,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"241ca166c6d746079499a46302bb3d5f","type":"text","conversion_output":true,"text":"funded U01 'Acute Pharmacotherapy of Unipolar Psychotic Depression' (MH62446, MH62518, MH62565, and","text_display":"funded U01 'Acute Pharmacotherapy of Unipolar Psychotic Depression' (MH62446, MH62518, MH62565, and","confidence":0.99560546875,"confidence_rate":0.9999576526698952},{"cnt":[[120,2050],[2000,2050],[2000,2097],[120,2097]],"region":{"top_left_x":120,"top_left_y":2049,"width":1881,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c54e88a4458541bbaa1b2e95f6f00ba3","type":"text","conversion_output":true,"text":"MH62624). This U01 is also known as the Study of the Pharmacotherapy of Psychotic Depression (STOP-PD)","text_display":" MH62624). This U01 is also known as the Study of the Pharmacotherapy of Psychotic Depression (STOP-PD)","confidence":1,"confidence_rate":1},{"cnt":[[120,2093],[1996,2093],[1996,2142],[120,2142]],"region":{"top_left_x":120,"top_left_y":2092,"width":1876,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"623874fa2830421983968663d969abb4","type":"text","conversion_output":true,"text":"for the purpose of communications, presentations of research findings, and publications. The change in title of","text_display":" for the purpose of communications, presentations of research findings, and publications. The change in title of","confidence":1,"confidence_rate":1},{"cnt":[[120,2138],[1884,2138],[1884,2185],[120,2185]],"region":{"top_left_x":120,"top_left_y":2137,"width":1765,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa6725efdc0a497c8ac1e57520025abb","type":"text","conversion_output":true,"text":"the renewal, 'Sustaining Remission of Psychotic Depression' reflects the focus of the proposed study on","text_display":" the renewal, 'Sustaining Remission of Psychotic Depression' reflects the focus of the proposed study on","confidence":0.9970703125,"confidence_rate":0.9999728338186853},{"cnt":[[120,2183],[827,2183],[827,2228],[120,2228]],"region":{"top_left_x":120,"top_left_y":2182,"width":708,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ad922edce9f415cb3fd2467da28eedd","type":"text","conversion_output":true,"text":"treatment of PD beyond the acute phase.","text_display":" treatment of PD beyond the acute phase.","confidence":1,"confidence_rate":1},{"cnt":[[120,2269],[1833,2269],[1833,2316],[120,2316]],"region":{"top_left_x":120,"top_left_y":2268,"width":1713,"height":49},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a18a8f7b90b4721bc939986ce42cc68","type":"text","conversion_output":true,"text":"STOP-PD was a multi-center study involving the following four sites: Weill Medical College of Cornell","text_display":"\n\nSTOP-PD was a multi-center study involving the following four sites: Weill Medical College of Cornell","confidence":1,"confidence_rate":1},{"cnt":[[122,2312],[1949,2312],[1949,2361],[122,2361]],"region":{"top_left_x":122,"top_left_y":2311,"width":1827,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69d511f5fa454c70ae431fabbc55cf0a","type":"text","conversion_output":true,"text":"University (PI: Dr. Barnett Meyers), University of Toronto (PI: Dr. Alastair Flint), University of Massachusetts","text_display":" University (PI: Dr. Barnett Meyers), University of Toronto (PI: Dr. Alastair Flint), University of Massachusetts","confidence":1,"confidence_rate":1},{"cnt":[[120,2357],[1949,2357],[1949,2404],[120,2404]],"region":{"top_left_x":120,"top_left_y":2356,"width":1829,"height":49},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54562ab94faa4ce483c0d7ec2524ed56","type":"text","conversion_output":true,"text":"Medical School (PI: Dr. Anthony Rothschild), and University of Pittsburgh School of Medicine (PI: Dr. Benoit","text_display":" Medical School (PI: Dr. Anthony Rothschild), and University of Pittsburgh School of Medicine (PI: Dr. Benoit","confidence":0.99853515625,"confidence_rate":0.9999870273612914},{"cnt":[[120,2402],[1936,2402],[1936,2447],[120,2447]],"region":{"top_left_x":120,"top_left_y":2401,"width":1816,"height":47},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5e651ec531e4739bc569e1dd9c604d9","type":"text","conversion_output":true,"text":"Mulsant). The coordinating centre for STOP-PD was based at Cornell, under the leadership of Dr. Meyers,","text_display":" Mulsant). The coordinating centre for STOP-PD was based at Cornell, under the leadership of Dr. Meyers,","confidence":0.9990234375,"confidence_rate":0.9999909533775151},{"cnt":[[120,2445],[2000,2445],[2000,2494],[120,2494]],"region":{"top_left_x":120,"top_left_y":2444,"width":1881,"height":51},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e58caf2dddfd4d16a258d1b13fb61fe8","type":"text","conversion_output":true,"text":"who was the overall principal of the study. The STOP-PD grant proposal was submitted as four identical R01s.","text_display":" who was the overall principal of the study. The STOP-PD grant proposal was submitted as four identical R01s.","confidence":0.99560546875,"confidence_rate":0.9999610254003707},{"cnt":[[120,2488],[1970,2488],[1970,2537],[120,2537]],"region":{"top_left_x":120,"top_left_y":2487,"width":1851,"height":51},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6616c7c9980440f585243086c527e0a5","type":"text","conversion_output":true,"text":"At the time of funding, the mechanism was changed to U01s by NIMH, consistent with the approach taken by","text_display":" At the time of funding, the mechanism was changed to U01s by NIMH, consistent with the approach taken by","confidence":0.9873161315917969,"confidence_rate":0.999882896807574},{"cnt":[[120,2533],[810,2533],[810,2576],[120,2576]],"region":{"top_left_x":120,"top_left_y":2533,"width":690,"height":43},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9a753005df84109af99d59934beed2a","type":"text","conversion_output":true,"text":"NIH with other multi-center clinical trials.","text_display":" NIH with other multi-center clinical trials.","confidence":1,"confidence_rate":1},{"cnt":[[1959,2578],[2007,2578],[2007,2619],[1959,2619]],"region":{"top_left_x":1959,"top_left_y":2578,"width":48,"height":41},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00054cd462074c7da572ed2da1742c54","type":"page_info","conversion_output":false,"text":"\\(\\underline{16}\\)","text_display":"","confidence":0.99365234375,"confidence_rate":0.9987272329993021}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-19","page":19,"lines":[{"cnt":[[120,168],[1762,168],[1762,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":1642,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"396028fb610b43a4a6352a7cd7cbf84b","type":"text","conversion_output":true,"text":"The proposed study will include the same sites as STOP-PD. At Cornell University, University of","text_display":"\n\nThe proposed study will include the same sites as STOP-PD. At Cornell University, University of","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[120,215],[1880,215],[1880,260],[120,260]],"region":{"top_left_x":120,"top_left_y":214,"width":1760,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a189fcad80f449dc83f29d27ef305718","type":"text","conversion_output":true,"text":"Massachusetts, and University of Toronto, the same principal investigators as in STOP-PD will serve as","text_display":" Massachusetts, and University of Toronto, the same principal investigators as in STOP-PD will serve as","confidence":1,"confidence_rate":1},{"cnt":[[120,260],[1869,260],[1869,305],[120,305]],"region":{"top_left_x":120,"top_left_y":259,"width":1750,"height":47},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dab3f261cc554fd5b864032a2b53c5f5","type":"text","conversion_output":true,"text":"principal investigators of the new study. At the Pittsburgh site, Ellen Whyte M.D. will serve as principal","text_display":" principal investigators of the new study. At the Pittsburgh site, Ellen Whyte M.D. will serve as principal","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[120,301],[1880,301],[1880,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1760,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7655a8c2ed7b4ca289d02a6ee1d8984f","type":"text","conversion_output":true,"text":"investigator for that site. Dr. Whyte joined the STOP-PD PI team in September 2005, when Dr. Mulsant","text_display":" investigator for that site. 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She assumed day-to-day operations of the Pittsburgh site and","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1983,391],[1983,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1864,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78422d66fdf344919a1d3264cca63ba1","type":"text","conversion_output":true,"text":"actively participated in the overall leadership of the previous study through participation in the study's Steering","text_display":" actively participated in the overall leadership of the previous study through participation in the study's Steering","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1974,434],[1974,479],[120,479]],"region":{"top_left_x":120,"top_left_y":433,"width":1855,"height":47},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc6a72b5ff0b4be5b053d5c36d59b268","type":"text","conversion_output":true,"text":"Committee and Publications Sub-Committee, participation in weekly conference calls and annual face-to-face","text_display":" Committee and Publications Sub-Committee, participation in weekly conference calls and annual face-to-face","confidence":0.9990234375,"confidence_rate":0.9999911978797494},{"cnt":[[120,477],[1893,477],[1893,524],[120,524]],"region":{"top_left_x":120,"top_left_y":476,"width":1773,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83810b28ed47423397d6cda4548e100d","type":"text","conversion_output":true,"text":"meetings with the principal investigators from the other sites, reviewing and approving the results of data","text_display":" meetings with the principal investigators from the other sites, reviewing and approving the results of data","confidence":1,"confidence_rate":1},{"cnt":[[120,522],[1966,522],[1966,569],[120,569]],"region":{"top_left_x":120,"top_left_y":522,"width":1846,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3ecf6bd5e274a339d8c0008ce518cf8","type":"text","conversion_output":true,"text":"analyses, presenting findings at scientific meetings, and writing and publishing manuscripts. In the proposed","text_display":" analyses, presenting findings at scientific meetings, and writing and publishing manuscripts. In the proposed","confidence":1,"confidence_rate":1},{"cnt":[[120,567],[1970,567],[1970,612],[120,612]],"region":{"top_left_x":120,"top_left_y":567,"width":1851,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e58c6afec4b4c95aed23cd177b3b309","type":"text","conversion_output":true,"text":"study, Dr. Mulsant will serve as a co-investigator at the Pittsburgh site (in addition to his leadership role at the","text_display":" study, Dr. Mulsant will serve as a co-investigator at the Pittsburgh site (in addition to his leadership role at the","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[1938,610],[1938,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1818,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"741153e57c2347c49548a61fe37da0eb","type":"text","conversion_output":true,"text":"Centre for Addiction and Mental Health [CAMH] consortium site in Toronto), and will continue to collaborate","text_display":" Centre for Addiction and Mental Health [CAMH] consortium site in Toronto), and will continue to collaborate","confidence":0.998046875,"confidence_rate":0.9999825444841725},{"cnt":[[120,653],[1033,653],[1033,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":914,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99889e313b6742438be6de780fd35bd8","type":"text","conversion_output":true,"text":"closely with Dr. Whyte in the management of this site.","text_display":" closely with Dr. Whyte in the management of this site.","confidence":1,"confidence_rate":1},{"cnt":[[120,741],[1996,741],[1996,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":1876,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34966447d625455799772e4e15092f3f","type":"text","conversion_output":true,"text":"Use of multiple sites (through the Collaborative Clinical Studies of Mental Disorders mechanism [PAR-09-153])","text_display":"\n\nUse of multiple sites (through the Collaborative Clinical Studies of Mental Disorders mechanism [PAR-09-153])","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[120,786],[1949,786],[1949,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1829,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b39935080bb6413081cbec100fa72763","type":"text","conversion_output":true,"text":"is justified by the fact that the majority of patients with PD need to be recruited from inpatient settings due to","text_display":" is justified by the fact that the majority of patients with PD need to be recruited from inpatient settings due to","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1970,829],[1970,874],[120,874]],"region":{"top_left_x":120,"top_left_y":829,"width":1851,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a3fb5e90b504cfba5b7da10f29f133f","type":"text","conversion_output":true,"text":"the severity of their illness. Recruiting and retaining patients in a treatment study of PD is labor intensive and","text_display":" the severity of their illness. 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Meyers, Flint, Mulsant, and Rothschild have many years of","text_display":"\n4.1.2 Experience And Background: Drs. Meyers, Flint, Mulsant, and Rothschild have many years of","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1979,1048],[1979,1096],[120,1096]],"region":{"top_left_x":120,"top_left_y":1048,"width":1859,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"846f1845262a48aab3d79dc2d71ba766","type":"text","conversion_output":true,"text":"experience in conducting research in PD. The principal investigators of the proposed study have worked as a","text_display":" experience in conducting research in PD. The principal investigators of the proposed study have worked as a","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1888,1091],[1888,1139],[120,1139]],"region":{"top_left_x":120,"top_left_y":1091,"width":1769,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7aef2451dd6c48c191099a21083289e0","type":"text","conversion_output":true,"text":"group on STOP-PD for the past 8 years. This collaboration has involved: conceptualization, formulation,","text_display":" group on STOP-PD for the past 8 years. This collaboration has involved: conceptualization, formulation,","confidence":1,"confidence_rate":1},{"cnt":[[120,1139],[1824,1139],[1824,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1138,"width":1705,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34e6e88e3f914fd899331aa39afb3609","type":"text","conversion_output":true,"text":"writing, and revision of the STOP-PD grant application; recruiting and training of research personnel;","text_display":" writing, and revision of the STOP-PD grant application; recruiting and training of research personnel;","confidence":1,"confidence_rate":1},{"cnt":[[120,1182],[1944,1182],[1944,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1181,"width":1825,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ade97988b0ac4204b538c92cf0e75224","type":"text","conversion_output":true,"text":"recruitment and treatment of participants in the study; data collection and oversight of the transfer of data to","text_display":" recruitment and treatment of participants in the study; data collection and oversight of the transfer of data to","confidence":0.99609375,"confidence_rate":0.9999665484285664},{"cnt":[[120,1225],[1979,1225],[1979,1270],[120,1270]],"region":{"top_left_x":120,"top_left_y":1224,"width":1859,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af88851134e3478db5decd0daf7718c3","type":"text","conversion_output":true,"text":"the coordinating center; membership of, and participation in, the study's Steering Committee and Publications","text_display":" the coordinating center; membership of, and participation in, the study's Steering Committee and Publications","confidence":0.9985356330871582,"confidence_rate":0.9999871453444995},{"cnt":[[120,1268],[1910,1268],[1910,1315],[120,1315]],"region":{"top_left_x":120,"top_left_y":1267,"width":1790,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f308684e54e40ec9a8410ea8943f826","type":"text","conversion_output":true,"text":"Sub-Committee; participation in weekly conference calls and annual face-to-face meetings; reviewing and","text_display":" Sub-Committee; participation in weekly conference calls and annual face-to-face meetings; reviewing and","confidence":0.99853515625,"confidence_rate":0.999986426780242},{"cnt":[[120,1313],[1944,1313],[1944,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1312,"width":1825,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45257c357f974163b0a1e9cce12c1267","type":"text","conversion_output":true,"text":"approving the results of data analyses, presenting findings at scientific meetings; and writing and publishing","text_display":" approving the results of data analyses, presenting findings at scientific meetings; and writing and publishing","confidence":1,"confidence_rate":1},{"cnt":[[120,1358],[1992,1358],[1992,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1357,"width":1872,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7da108f894b6449ba207d778a0fcd14e","type":"text","conversion_output":true,"text":"manuscripts. This partnership will continue in the proposed renewal. The successful completion of STOP-PD,","text_display":" manuscripts. This partnership will continue in the proposed renewal. The successful completion of STOP-PD,","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[120,1401],[1957,1401],[1957,1446],[120,1446]],"region":{"top_left_x":120,"top_left_y":1400,"width":1838,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f4fad070b05406bb7476f86f945ba0a","type":"text","conversion_output":true,"text":"including meeting the planned recruitment target, is testimony to the successful collaboration of this group of","text_display":" including meeting the planned recruitment target, is testimony to the successful collaboration of this group of","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[354,1444],[354,1489],[120,1489]],"region":{"top_left_x":120,"top_left_y":1443,"width":235,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52cc154ec8054112a905047c3bde5377","type":"text","conversion_output":true,"text":"investigators.","text_display":" investigators.","confidence":1,"confidence_rate":1},{"cnt":[[120,1532],[1916,1532],[1916,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1531,"width":1797,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c74ba66bd3469fa6b17049e6bfc495","type":"text","conversion_output":true,"text":"In addition to leading STOP-PD, Dr. Meyers has other experience in leading and coordinating multi-center","text_display":"\n\nIn addition to leading STOP-PD, Dr. Meyers has other experience in leading and coordinating multi-center","confidence":1,"confidence_rate":1},{"cnt":[[120,1577],[1951,1577],[1951,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1576,"width":1831,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae9994c04ab441ebbb4715064856ac6e","type":"text","conversion_output":true,"text":"studies. Dr. Meyers used support from a R24 award (MH53816) to develop a clinical mental health services","text_display":" studies. Dr. Meyers used support from a R24 award (MH53816) to develop a clinical mental health services","confidence":1,"confidence_rate":1},{"cnt":[[120,1620],[1906,1620],[1906,1665],[120,1665]],"region":{"top_left_x":120,"top_left_y":1619,"width":1786,"height":47},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7deb608915564e33953e09779c83886d","type":"text","conversion_output":true,"text":"research infrastructure that completed 10 pilot projects at 16 diverse sites. These studies recruited 2,500","text_display":" research infrastructure that completed 10 pilot projects at 16 diverse sites. These studies recruited 2,500","confidence":0.93896484375,"confidence_rate":0.9994618778262762},{"cnt":[[120,1663],[1833,1663],[1833,1710],[120,1710]],"region":{"top_left_x":120,"top_left_y":1662,"width":1713,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c211fb4aeb642f8a50cf71a79176409","type":"text","conversion_output":true,"text":"subjects, and managed systematically collected 6 -month longitudinal data on 250 patients with major","text_display":" subjects, and managed systematically collected 6 -month longitudinal data on 250 patients with major","confidence":0.91357421875,"confidence_rate":0.9991860012076733},{"cnt":[[120,1710],[1296,1710],[1296,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1710,"width":1176,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca4986e45fd942e683a5bb72bd31cb2a","type":"text","conversion_output":true,"text":"depression from multiple primary care and mental health sector sites.","text_display":" depression from multiple primary care and mental health sector sites.","confidence":1,"confidence_rate":1},{"cnt":[[120,1794],[1968,1794],[1968,1841],[120,1841]],"region":{"top_left_x":120,"top_left_y":1793,"width":1848,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6470a2922bd4a698484dbab40b5146f","type":"text","conversion_output":true,"text":"4.1.3 Site Functions: Dr. Meyers will be the overall principal investigator of the proposed study, with support","text_display":"\n4.1.3 Site Functions: Dr. Meyers will be the overall principal investigator of the proposed study, with support","confidence":1,"confidence_rate":1},{"cnt":[[120,1839],[1953,1839],[1953,1884],[120,1884]],"region":{"top_left_x":120,"top_left_y":1839,"width":1833,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eec60cf7cf6d4f94958ef4d1fefaddb8","type":"text","conversion_output":true,"text":"in this role from Dr. Flint. The coordinating center will be based at Cornell. The inter-site project coordinator,","text_display":" in this role from Dr. Flint. The coordinating center will be based at Cornell. The inter-site project coordinator,","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[120,1882],[1863,1882],[1863,1929],[120,1929]],"region":{"top_left_x":120,"top_left_y":1882,"width":1743,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d05af5f6a2014a8d9d1e2f2f227b4e8b","type":"text","conversion_output":true,"text":"data manager, and the project's statistician/methodologist will be based at Cornell. Other investigators","text_display":" data manager, and the project's statistician/methodologist will be based at Cornell. Other investigators","confidence":1,"confidence_rate":1},{"cnt":[[120,1927],[1992,1927],[1992,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1927,"width":1872,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07317aad112747728cda518e5c3f4df6","type":"text","conversion_output":true,"text":"associated with the Geriatric Psychiatry Institute at Cornell (Drs. Alexopoulos, Bruce, and Young) have several","text_display":" associated with the Geriatric Psychiatry Institute at Cornell (Drs. Alexopoulos, Bruce, and Young) have several","confidence":1,"confidence_rate":1},{"cnt":[[120,1972],[1944,1972],[1944,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1972,"width":1825,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a81adf8162c471ba19b30347b311a74","type":"text","conversion_output":true,"text":"R01s, R24 research infrastructure grants, as well as a U01, that allow for synergy in supporting and sharing","text_display":" R01s, R24 research infrastructure grants, as well as a U01, that allow for synergy in supporting and sharing","confidence":1,"confidence_rate":1},{"cnt":[[120,2015],[1953,2015],[1953,2062],[120,2062]],"region":{"top_left_x":120,"top_left_y":2015,"width":1833,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c250c7bab7eb44f1bf80d5413f48202b","type":"text","conversion_output":true,"text":"research staff between projects at Cornell. In addition, the Institute's Advanced Centre for Interventions and","text_display":" research staff between projects at Cornell. In addition, the Institute's Advanced Centre for Interventions and","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[1921,2058],[1921,2105],[120,2105]],"region":{"top_left_x":120,"top_left_y":2058,"width":1801,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d09eb3619ecf4aeea69a6d66490b7097","type":"text","conversion_output":true,"text":"Services Research (PI: Alexopoulos GS) will contribute to infrastructure support for research operations at","text_display":" Services Research (PI: Alexopoulos GS) will contribute to infrastructure support for research operations at","confidence":0.9975595474243164,"confidence_rate":0.9999781838510657},{"cnt":[[120,2101],[1734,2101],[1734,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2101,"width":1614,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c15b454cb17c4afca0d389ba4c6dfc97","type":"text","conversion_output":true,"text":"Cornell, as it did for STOP-PD. Each study site will contribute equally to recruitment of patients.","text_display":" Cornell, as it did for STOP-PD. Each study site will contribute equally to recruitment of patients.","confidence":1,"confidence_rate":1},{"cnt":[[120,2144],[1927,2144],[1927,2194],[120,2194]],"region":{"top_left_x":120,"top_left_y":2144,"width":1808,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"beada09212154b178c8f65031dde7fb6","type":"text","conversion_output":true,"text":"Pharmacogenetic and pharmacometric analyses of the proposed study will be conducted in Toronto, in the","text_display":" Pharmacogenetic and pharmacometric analyses of the proposed study will be conducted in Toronto, in the","confidence":1,"confidence_rate":1},{"cnt":[[120,2191],[1446,2191],[1446,2237],[120,2237]],"region":{"top_left_x":120,"top_left_y":2191,"width":1326,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3194d52819164154860528a24297c09c","type":"text","conversion_output":true,"text":"research laboratories of Drs. James Kennedy and Bruce Pollock, respectively.","text_display":" research laboratories of Drs. James Kennedy and Bruce Pollock, respectively.","confidence":1,"confidence_rate":1},{"cnt":[[116,2277],[1141,2277],[1141,2327],[116,2327]],"region":{"top_left_x":116,"top_left_y":2277,"width":1025,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1624fada65744413b42c538799a6bfe8","type":"figure_label","conversion_output":false,"text":"Table 4: Functions Performed by Each of the Four Sites","text_display":"","confidence":0.9858465194702148,"confidence_rate":0.9997584258572544},{"cnt":[[120,2316],[2007,2316],[2007,2557],[120,2557]],"region":{"top_left_x":120,"top_left_y":2316,"width":1887,"height":241},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"210e1b0b211948b2b4558b15119b64bd","type":"table","conversion_output":true,"selected_labels":["1624fada65744413b42c538799a6bfe8"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Function & Site & Areas of Primary Responsibility \\\\\n\\hline \\begin{tabular}{l} \nSubject recruitment \\\\\n\\& clinical \\\\\nmanagement\n\\end{tabular} & \\begin{tabular}{l} \nAll four \\\\\nsites\n\\end{tabular} & \\begin{tabular}{l}\n\\(\\bullet\\) Each site will recruit 98 acutely ill participants and randomize 44 \\\\\nremitted participants, with anticipated differences in race and \\\\\nethnicity as described in Section 7; \\\\\n- Recruitment and subject management are identical across sites\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4: Functions Performed by Each of the Four Sites}\n\\begin{tabular}{|l|l|l|}\n\\hline Function & Site & Areas of Primary Responsibility \\\\\n\\hline \\begin{tabular}{l} \nSubject recruitment \\\\\n\\& clinical \\\\\nmanagement\n\\end{tabular} & \\begin{tabular}{l} \nAll four \\\\\nsites\n\\end{tabular} & \\begin{tabular}{l}\n\\(\\bullet\\) Each site will recruit 98 acutely ill participants and randomize 44 \\\\\nremitted participants, with anticipated differences in race and \\\\\nethnicity as described in Section 7; \\\\\n- Recruitment and subject management are identical across sites\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.9873404107243542,"confidence_rate":0.9999721829094785},{"cnt":[[1959,2578],[2007,2578],[2007,2628],[1959,2628]],"region":{"top_left_x":1959,"top_left_y":2578,"width":48,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8e7f9ebaec2413d8c7c3d7fd60a2237","type":"page_info","conversion_output":false,"text":"\\(\\underline{17}\\)","text_display":"","confidence":0.9423828125,"confidence_rate":0.9882014148251297}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-20","page":20,"lines":[{"cnt":[[120,120],[2007,120],[2007,1283],[120,1283]],"region":{"top_left_x":120,"top_left_y":120,"width":1887,"height":1163},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c54b65f2cf14c8fae9a57fa000b66c6","type":"table","conversion_output":true,"children_ids":["8460665a369843c786c7abc82339ed6f","81b560012cb2458cae2c5e2b50f593dd","f09b24a2dc724de9a49f2e94a1182575","5d49ff9b69174a49b1e15b0092529ae7","2d836eed23f2438a84ac3f7794e670ab","a60e2fc29a2942a9b793f628beeca2c6","bf685724be6547929269ea1d1e539ff3","d864a10acd0c42ccaf53fad1855b06d7","a6284ad740764899ac9112050d66a0c2","b640764e5b674a44a464d1abddc9cda6","eaf7c656ae2a4ca0b4f759d9d16f7d32","c00e21b0787f4bf6b184e30918d6995b","491fc1117daf417d83667d3f70999a68","00e00869afcb459bb40d67ca50d329ab","c66a6c8a99954304af904a4c24809aab","3c16d68c9bfc44eab0e50065ce80f968","9182399999c74cdbaa30cf169565d089","8da5cedf28fe415f9fcee5120061df32","443bd3007d6d48bab9356b86d4f74014","05cea271b9774918866c4e85e780634d","300b61cbd7b741a78fb050f84361194b","edb93b51363149559e291f193423591c","52533bbc2ff44312b45c8f6762525e41"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Coordinating Center & Cornell & \\begin{tabular}{l}\n- Coordinates and oversees research activities across sites; \\\\\n- Inter-site Coordinator communicates with and monitors activities of site raters and reports to Principal Investigators; \\\\\n- Assures adherence to the Study Manual; \\\\\n- Assures completeness and quality of data; manages data base; \\\\\n- Chairs Steering Committee and Publication Committee; \\\\\n- Communicates with regulatory bodies and external agencies\n\\end{tabular} \\\\\n\\hline Recruitment, Assessment, and Adherence & University of Toronto; Cornell & \\begin{tabular}{l}\n- Develops the Study Manual; \\\\\n- Coordinates training on clinical assessments and reliability testing in collaboration with the Cornell Inter-site Project Coordinator; \\\\\n- Provides leadership for monitoring recruitment, retention, and medication adherence; coordinates strategies to overcome obstacles\n\\end{tabular} \\\\\n\\hline Neuropsychological Training & Pittsburgh & - Conducts training and annual re-training on neuropsychological assessments and coordinates analyses of test results \\\\\n\\hline Methodology, Data Management and Data Analysis & Cornell & \\begin{tabular}{l}\n- Provides centralized data management for all sites; \\\\\n- Provides methodological leadership and consultation (e.g., blinding, consistency across sites, reliability assessments); \\\\\n- Provides biostatistical leadership for analyses of project data\n\\end{tabular} \\\\\n\\hline Pharmacokinetics and Pharmacogenetics & Toronto & \\begin{tabular}{l}\n- Oversees quality assurance efforts regarding sample acquisition, pre-processing, and storage; \\\\\n- Carries out all pharmacokinetic and pharmacogenetic assays; \\\\\n- Applies population pharmacokinetic modeling to the drug concentration data\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Coordinating Center & Cornell & \\begin{tabular}{l}\n- Coordinates and oversees research activities across sites; \\\\\n- Inter-site Coordinator communicates with and monitors activities of site raters and reports to Principal Investigators; \\\\\n- Assures adherence to the Study Manual; \\\\\n- Assures completeness and quality of data; manages data base; \\\\\n- Chairs Steering Committee and Publication Committee; \\\\\n- Communicates with regulatory bodies and external agencies\n\\end{tabular} \\\\\n\\hline Recruitment, Assessment, and Adherence & University of Toronto; Cornell & \\begin{tabular}{l}\n- Develops the Study Manual; \\\\\n- Coordinates training on clinical assessments and reliability testing in collaboration with the Cornell Inter-site Project Coordinator; \\\\\n- Provides leadership for monitoring recruitment, retention, and medication adherence; coordinates strategies to overcome obstacles\n\\end{tabular} \\\\\n\\hline Neuropsychological Training & Pittsburgh & - Conducts training and annual re-training on neuropsychological assessments and coordinates analyses of test results \\\\\n\\hline Methodology, Data Management and Data Analysis & Cornell & \\begin{tabular}{l}\n- Provides centralized data management for all sites; \\\\\n- Provides methodological leadership and consultation (e.g., blinding, consistency across sites, reliability assessments); \\\\\n- Provides biostatistical leadership for analyses of project data\n\\end{tabular} \\\\\n\\hline Pharmacokinetics and Pharmacogenetics & Toronto & \\begin{tabular}{l}\n- Oversees quality assurance efforts regarding sample acquisition, pre-processing, and storage; \\\\\n- Carries out all pharmacokinetic and pharmacogenetic assays; \\\\\n- Applies population pharmacokinetic modeling to the drug concentration data\n\\end{tabular} 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The","text_display":" auditing procedures across the four sites in collaboration with the Cornell Inter-Site Project Coordinator. The","confidence":1,"confidence_rate":1},{"cnt":[[120,258],[1987,258],[1987,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1868,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bddfa8171684f0b9ccec5ddd658f1bd","type":"text","conversion_output":true,"text":"data management team has developed a set of standards and procedures for data entry and checking and for","text_display":" data management team has developed a set of standards and procedures for data entry and checking and for","confidence":1,"confidence_rate":1},{"cnt":[[120,301],[1987,301],[1987,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1868,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1d8c3fc0f744ef3b89ff58a1522b5d8","type":"text","conversion_output":true,"text":"the documentation of data sets generated for statistical analysis. These methods, which assure the integrity of","text_display":" the documentation of data sets generated for statistical analysis. These methods, which assure the integrity of","confidence":1,"confidence_rate":1},{"cnt":[[120,346],[2000,346],[2000,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1881,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7ef98e3f93942e2ab2444ba5ac7387f","type":"text","conversion_output":true,"text":"study data, are described below. In addition to preparing and then locking data sets that report results from this","text_display":" study data, are described below. In addition to preparing and then locking data sets that report results from this","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1927,391],[1927,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1808,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05d32a7a3144489ab1118e484e8f5164","type":"text","conversion_output":true,"text":"project, the data manager will analyze results of the annual rater inter-rater reliability assessments. He will","text_display":" project, the data manager will analyze results of the annual rater inter-rater reliability assessments. He will","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1985,434],[1985,481],[120,481]],"region":{"top_left_x":120,"top_left_y":433,"width":1866,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98b46d3f561c478fa646f2e163354e5b","type":"text","conversion_output":true,"text":"also oversee and execute procedures for data security and access, data quality control, storage, and back-up,","text_display":" also oversee and execute procedures for data security and access, data quality control, storage, and back-up,","confidence":1,"confidence_rate":1},{"cnt":[[120,477],[1955,477],[1955,526],[120,526]],"region":{"top_left_x":120,"top_left_y":476,"width":1836,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d6f2011716742a2b1e3812cf17d0b8f","type":"text","conversion_output":true,"text":"and will provide periodic reports of accrual, follow-up, and summary statistics as required by the Data Safety","text_display":" and will provide periodic reports of accrual, follow-up, and summary statistics as required by the Data Safety","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[578,520],[578,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":458,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b56b69ef3f2f44089e95007d648d8a1f","type":"text","conversion_output":true,"text":"Monitoring Board (DSMB).","text_display":" Monitoring Board (DSMB).","confidence":0.9990234375,"confidence_rate":0.9999663095451973},{"cnt":[[120,608],[2002,608],[2002,655],[120,655]],"region":{"top_left_x":120,"top_left_y":608,"width":1883,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2004314115c4c28b7130709e7550017","type":"text","conversion_output":true,"text":"Data Integrity: Sites will send original copies of de-identified hard data to the data management team at Cornell","text_display":"\n\nData Integrity: Sites will send original copies of de-identified hard data to the data management team at Cornell","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[2000,653],[2000,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1881,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce26cd0f76de4849a5f8c5ab4d845764","type":"text","conversion_output":true,"text":"by overnight shipping every second week. Sites will retain hard copies of these records. The de-identified hard","text_display":" by overnight shipping every second week. Sites will retain hard copies of these records. The de-identified hard","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1882,696],[1882,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1763,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d82ecdb447c4aca94ecea08764e767e","type":"text","conversion_output":true,"text":"data will be stored in a locked filing cabinet stored in a locked office to further protect subject anonymity.","text_display":" data will be stored in a locked filing cabinet stored in a locked office to further protect subject anonymity.","confidence":1,"confidence_rate":1},{"cnt":[[120,741],[2002,741],[2002,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":1883,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"548ae2536e0141929e79082f14f7a615","type":"text","conversion_output":true,"text":"Results will be published as group data without the use of characteristics that would identify individual subjects.","text_display":" Results will be published as group data without the use of characteristics that would identify individual subjects.","confidence":1,"confidence_rate":1},{"cnt":[[120,786],[1833,786],[1833,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1713,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"757c05ecc1d24560b76d87d2ed43ce11","type":"text","conversion_output":true,"text":"Data auditing, entry and quality control will be carried out at Cornell under the supervision of the data","text_display":" Data auditing, entry and quality control will be carried out at Cornell under the supervision of the data","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1962,829],[1962,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1842,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c82f32bb568249df9cc1dc5e7da1bf8c","type":"text","conversion_output":true,"text":"management team. The Cornell data management team has many years of experience in data management","text_display":" management team. The Cornell data management team has many years of experience in data management","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1953,872],[1953,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1833,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18b7628f1829450485929e7afffd159d","type":"text","conversion_output":true,"text":"and coordination of multi-study, multi-site research projects. The data management team has developed an","text_display":" and coordination of multi-study, multi-site research projects. The data management team has developed an","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[2004,915],[2004,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1885,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe95b946da25454c9298b72cd9585cd9","type":"text","conversion_output":true,"text":"infrastructure that supports the design of and standardization of databases, data entry, data quality control, and","text_display":" infrastructure that supports the design of and standardization of databases, data entry, data quality control, and","confidence":1,"confidence_rate":1},{"cnt":[[120,960],[1992,960],[1992,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":960,"width":1872,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8cac10cad314457878fd5bd741583f9","type":"text","conversion_output":true,"text":"preparation of data for statistical analysis. This expertise will be applied in implementing a system that assures","text_display":" preparation of data for statistical analysis. This expertise will be applied in implementing a system that assures","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[2000,1005],[2000,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1005,"width":1881,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bed5ffe53a34d748196bb5dc83cef6f","type":"text","conversion_output":true,"text":"the quality of data entry, storage, verification, and validation, and the reporting of data from this study. This will","text_display":" the quality of data entry, storage, verification, and validation, and the reporting of data from this study. This will","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1955,1048],[1955,1094],[120,1094]],"region":{"top_left_x":120,"top_left_y":1048,"width":1836,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c25a6035e1c4a97ad52a4bc310681d8","type":"text","conversion_output":true,"text":"involve consultation with the study's statistician on the design of study databases and other issues related to","text_display":" involve consultation with the study's statistician on the design of study databases and other issues related to","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1998,1091],[1998,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1879,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7a23e8f700f418b90bb89e6b8ebb641","type":"text","conversion_output":true,"text":"the study's data management infrastructure. 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Emphasis will be given to incorporate database components that","confidence":1,"confidence_rate":1},{"cnt":[[120,1137],[1979,1137],[1979,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1136,"width":1859,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1ddadc0e08b413c9c2a57cdb4b77588","type":"text","conversion_output":true,"text":"were used in STOP-PD because the proposed project is also a randomized controlled trial and uses variables","text_display":" were used in STOP-PD because the proposed project is also a randomized controlled trial and uses variables","confidence":1,"confidence_rate":1},{"cnt":[[120,1179],[1949,1179],[1949,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1179,"width":1829,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a3221d57fd24b3f8bce2df506f69055","type":"text","conversion_output":true,"text":"that overlap with those used in STOP-PD. This system will also support the tracking of subjects and data at","text_display":" that overlap with those used in STOP-PD. This system will also support the tracking of subjects and data at","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1940,1225],[1940,1272],[120,1272]],"region":{"top_left_x":120,"top_left_y":1224,"width":1821,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf7a639f997543d888db83fd8403717b","type":"text","conversion_output":true,"text":"the individual sites. The Cornell data management team will maintain regular communication with site study","text_display":" the individual sites. The Cornell data management team will maintain regular communication with site study","confidence":1,"confidence_rate":1},{"cnt":[[120,1268],[1927,1268],[1927,1317],[120,1317]],"region":{"top_left_x":120,"top_left_y":1267,"width":1808,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fe31ba313834e6cb002ddc036770e87","type":"text","conversion_output":true,"text":"coordinators to ensure that data collection is complete and accurate. Regularly scheduled, and as needed,","text_display":" coordinators to ensure that data collection is complete and accurate. Regularly scheduled, and as needed,","confidence":1,"confidence_rate":1},{"cnt":[[120,1313],[1871,1313],[1871,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1312,"width":1752,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a62cc09011ec4ff59de4d7d83f6f9ac7","type":"text","conversion_output":true,"text":"communications between the inter-site project coordinator at Cornell, the data manager, and raters and","text_display":" communications between the inter-site project coordinator at Cornell, the data manager, and raters and","confidence":1,"confidence_rate":1},{"cnt":[[120,1356],[1738,1356],[1738,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1355,"width":1619,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16e3336743ed403693e754cefd0b162d","type":"text","conversion_output":true,"text":"investigators will be used to clarify inconsistencies and ambiguities in data submitted to Cornell.","text_display":" investigators will be used to clarify inconsistencies and ambiguities in data submitted to Cornell.","confidence":1,"confidence_rate":1},{"cnt":[[120,1439],[1910,1439],[1910,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1439,"width":1790,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9758f7020995458eae5604cda0a7ad89","type":"text","conversion_output":true,"text":"A project team dedicated to the study led by the study's statistician will oversee all data management and","text_display":"\n\nA project team dedicated to the study led by the study's statistician will oversee all data management and","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1931,1487],[1931,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1812,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"430a21e682cc4110b3c77db93fd85b89","type":"text","conversion_output":true,"text":"quality assurance procedures, including coordination across sites. All data management resources used at","text_display":" quality assurance procedures, including coordination across sites. All data management resources used at","confidence":1,"confidence_rate":1},{"cnt":[[120,1530],[1979,1530],[1979,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1529,"width":1859,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf55a80d8aa34495849eb8fb1b62a50c","type":"text","conversion_output":true,"text":"Cornell in the multi-site and single site studies conducted through the Geriatric Institute will be made available","text_display":" Cornell in the multi-site and single site studies conducted through the Geriatric Institute will be made available","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[120,1575],[1931,1575],[1931,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1574,"width":1812,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62233725625d417da0b93de42ca8c268","type":"text","conversion_output":true,"text":"to the proposed study. Data management resources will be devoted to overall quality assurance including:","text_display":" to the proposed study. Data management resources will be devoted to overall quality assurance including:","confidence":1,"confidence_rate":1},{"cnt":[[120,1620],[1985,1620],[1985,1667],[120,1667]],"region":{"top_left_x":120,"top_left_y":1619,"width":1866,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a511750fc4654bbc8f3824639f1d74c2","type":"text","conversion_output":true,"text":"maintaining interview schedules and subject tracking, monitoring scale completion, monitoring the accuracy of","text_display":" maintaining interview schedules and subject tracking, monitoring scale completion, monitoring the accuracy of","confidence":1,"confidence_rate":1},{"cnt":[[120,1663],[1927,1663],[1927,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1662,"width":1808,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0315c10e97294505aec6f0f22995a964","type":"text","conversion_output":true,"text":"scale completion and data entry, analyzing results of inter-rater reliability assessments as instructed by the","text_display":" scale completion and data entry, analyzing results of inter-rater reliability assessments as instructed by the","confidence":1,"confidence_rate":1},{"cnt":[[120,1708],[1949,1708],[1949,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1708,"width":1829,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b429968236045468c1a5a9295de55bc","type":"text","conversion_output":true,"text":"investigators, and developing and maintaining a dataset for use in analyses that have been approved by the","text_display":" investigators, and developing and maintaining a dataset for use in analyses that have been approved by the","confidence":1,"confidence_rate":1},{"cnt":[[120,1749],[1897,1749],[1897,1798],[120,1798]],"region":{"top_left_x":120,"top_left_y":1748,"width":1778,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63650a745829400590a95da943cdf01a","type":"text","conversion_output":true,"text":"Publications Sub-Committee. The data management staff has automated many data management steps,","text_display":" Publications Sub-Committee. The data management staff has automated many data management steps,","confidence":1,"confidence_rate":1},{"cnt":[[120,1796],[1923,1796],[1923,1841],[120,1841]],"region":{"top_left_x":120,"top_left_y":1796,"width":1803,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21f7506336404c17a8c4b238bf20a49d","type":"text","conversion_output":true,"text":"which will facilitate the development of the database and the standardization of databases and procedures","text_display":" which will facilitate the development of the database and the standardization of databases and procedures","confidence":1,"confidence_rate":1},{"cnt":[[120,1839],[1996,1839],[1996,1886],[120,1886]],"region":{"top_left_x":120,"top_left_y":1839,"width":1876,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d2f9a7f8d3e4b0ca992a6aa6838c23e","type":"text","conversion_output":true,"text":"across sites. For example, several steps in database design have been automated previously so that when the","text_display":" across sites. For example, several steps in database design have been automated previously so that when the","confidence":0.99462890625,"confidence_rate":0.9999519157102598},{"cnt":[[120,1882],[1979,1882],[1979,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1882,"width":1859,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"000f46c942294d6c818cfb20c3e5b1f8","type":"text","conversion_output":true,"text":"database of the proposed study is set up, it will have a standard structure, with all tables set up the same way","text_display":" database of the proposed study is set up, it will have a standard structure, with all tables set up the same way","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[120,1927],[1987,1927],[1987,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1927,"width":1868,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b9a813d8d294f46bcccb7df901b5d6b","type":"text","conversion_output":true,"text":"and variables named following a standard convention. The data management team has also has developed a","text_display":" and variables named following a standard convention. The data management team has also has developed a","confidence":0.99853515625,"confidence_rate":0.9999862999285899},{"cnt":[[120,1972],[1751,1972],[1751,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1972,"width":1631,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3852f3286c1f47c0961054dc59005370","type":"text","conversion_output":true,"text":"set of standards and procedures for documentation of data sets produced for statistical analysis.","text_display":" set of standards and procedures for documentation of data sets produced for statistical analysis.","confidence":1,"confidence_rate":1},{"cnt":[[120,2075],[1888,2075],[1888,2125],[120,2125]],"region":{"top_left_x":120,"top_left_y":2075,"width":1769,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18be8ccee39a423685d60dd0a6a0ccea","type":"text","conversion_output":true,"text":"To assure that the entry of subject data is accurate, the data management team audits \\(100 \\%\\) of the data","text_display":"\n\nTo assure that the entry of subject data is accurate, the data management team audits \\(100 \\%\\) of the data","confidence":1,"confidence_rate":1},{"cnt":[[120,2123],[1798,2123],[1798,2170],[120,2170]],"region":{"top_left_x":120,"top_left_y":2122,"width":1679,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39924c65120c4cbeb47ebe4c6b102605","type":"text","conversion_output":true,"text":"turned in by research assistants and investigators for necessary identifiers, item completeness and","text_display":" turned in by research assistants and investigators for necessary identifiers, item completeness and","confidence":1,"confidence_rate":1},{"cnt":[[120,2166],[1992,2166],[1992,2215],[120,2215]],"region":{"top_left_x":120,"top_left_y":2165,"width":1872,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73ed54b152f447bc9dc48f1ec33ebb86","type":"text","conversion_output":true,"text":"consistency of major clinical indicators. Audits include such factors as diagnosis, depression severity (Ham-D)","text_display":" consistency of major clinical indicators. Audits include such factors as diagnosis, depression severity (Ham-D)","confidence":1,"confidence_rate":1},{"cnt":[[120,2211],[1927,2211],[1927,2258],[120,2258]],"region":{"top_left_x":120,"top_left_y":2210,"width":1808,"height":49},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"628693d5386d4b049e4b23bede7087e6","type":"text","conversion_output":true,"text":"and whether the severity score is consistent with the diagnosis. Data are audited and tracked by scale. To","text_display":" and whether the severity score is consistent with the diagnosis. Data are audited and tracked by scale. To","confidence":1,"confidence_rate":1},{"cnt":[[120,2256],[1863,2256],[1863,2301],[120,2301]],"region":{"top_left_x":120,"top_left_y":2255,"width":1743,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35c2e88af32844d79284e90b461b5dec","type":"text","conversion_output":true,"text":"date, the auditing system at Cornell has tracked over 170,000 individual scales representing all studies","text_display":" date, the auditing system at Cornell has tracked over 170,000 individual scales representing all studies","confidence":0.63720703125,"confidence_rate":0.995874033757707},{"cnt":[[120,2299],[1944,2299],[1944,2346],[120,2346]],"region":{"top_left_x":120,"top_left_y":2298,"width":1825,"height":49},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99d6aa037e4547748a485de08847067f","type":"text","conversion_output":true,"text":"conducted at Cornell. These data have been contributed by users of the Advanced Center for Services and","text_display":" conducted at Cornell. These data have been contributed by users of the Advanced Center for Services and","confidence":1,"confidence_rate":1},{"cnt":[[120,2342],[1979,2342],[1979,2391],[120,2391]],"region":{"top_left_x":120,"top_left_y":2341,"width":1859,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f3a7d35763145f0abceff5949b4186f","type":"text","conversion_output":true,"text":"Intervention Center (Dr. Alexopoulos); through various R24 research infrastructure grants (Dr. Meyers and Dr.","text_display":" Intervention Center (Dr. Alexopoulos); through various R24 research infrastructure grants (Dr. Meyers and Dr.","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[120,2385],[1811,2385],[1811,2434],[120,2434]],"region":{"top_left_x":120,"top_left_y":2384,"width":1692,"height":51},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84421bda00e04e94947ab20a6cc704fa","type":"text","conversion_output":true,"text":"Bruce); through the two U01 grants led by Cornell investigators (Dr. Meyers and Dr. Young); and by","text_display":" Bruce); through the two U01 grants led by Cornell investigators (Dr. Meyers and Dr. Young); and by","confidence":1,"confidence_rate":1},{"cnt":[[120,2432],[1863,2432],[1863,2477],[120,2477]],"region":{"top_left_x":120,"top_left_y":2432,"width":1743,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"056c4c6840f045d9a821511ec9a8eeda","type":"text","conversion_output":true,"text":"investigators conducting R01s at Cornell. When problems are found (approximately \\(6 \\%\\) of scales), the","text_display":" investigators conducting R01s at Cornell. When problems are found (approximately \\(6 \\%\\) of scales), the","confidence":0.9951171875,"confidence_rate":0.99995425551008},{"cnt":[[120,2475],[1893,2475],[1893,2520],[120,2520]],"region":{"top_left_x":120,"top_left_y":2475,"width":1773,"height":46},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25754b19bfd445f7a59f9d9637ad269a","type":"text","conversion_output":true,"text":"instrument is returned to the interviewer. Also, errors are entered into a report, which is then sent to the","text_display":" instrument is returned to the interviewer. Also, errors are entered into a report, which is then sent to the","confidence":1,"confidence_rate":1},{"cnt":[[120,2518],[1910,2518],[1910,2565],[120,2565]],"region":{"top_left_x":120,"top_left_y":2517,"width":1790,"height":49},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"801adc079bfb4a5db5febfcf895722e8","type":"text","conversion_output":true,"text":"relevant site's coordinator. The coordinator is responsible for ensuring the errors are corrected within two","text_display":" relevant site's coordinator. The coordinator is responsible for ensuring the errors are corrected within two","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2007,2578],[2007,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":52,"height":50},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22c282bd1c7548ce921205ba25fa7ac4","type":"page_info","conversion_output":false,"text":"\\(\\underline{20}\\)","text_display":"","confidence":0.9990234375,"confidence_rate":0.9998046111613206}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-23","page":23,"lines":[{"cnt":[[116,125],[1992,125],[1992,174],[116,174]],"region":{"top_left_x":116,"top_left_y":124,"width":1876,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cf8f7d6d554443e8dfb43bca1c658d7","type":"text","conversion_output":true,"text":"weeks. Also, reports on error rates are prepared at regularly scheduled intervals. The data management team","text_display":"\nweeks. Also, reports on error rates are prepared at regularly scheduled intervals. The data management team","confidence":1,"confidence_rate":1},{"cnt":[[116,168],[2002,168],[2002,217],[116,217]],"region":{"top_left_x":116,"top_left_y":167,"width":1887,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a585b824891149afbafd4535a8c5a9b8","type":"text","conversion_output":true,"text":"tracks this information over time to assure that all data errors are corrected and that the error rates of individual","text_display":" tracks this information over time to assure that all data errors are corrected and that the error rates of individual","confidence":1,"confidence_rate":1},{"cnt":[[116,211],[1974,211],[1974,260],[116,260]],"region":{"top_left_x":116,"top_left_y":210,"width":1859,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b865a3cc8324d3f9ac56c5196868319","type":"text","conversion_output":true,"text":"interviewers and individual sites are consistently low over time. If error rates are not acceptable, the inter-site","text_display":" interviewers and individual sites are consistently low over time. If error rates are not acceptable, the inter-site","confidence":1,"confidence_rate":1},{"cnt":[[116,258],[1983,258],[1983,305],[116,305]],"region":{"top_left_x":116,"top_left_y":257,"width":1868,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89b27326b53846d3ae6193ce1ef91a38","type":"text","conversion_output":true,"text":"project coordinator intervenes and additional training is provided to problematic raters with interventions made","text_display":" project coordinator intervenes and additional training is provided to problematic raters with interventions made","confidence":1,"confidence_rate":1},{"cnt":[[116,301],[1934,301],[1934,350],[116,350]],"region":{"top_left_x":116,"top_left_y":300,"width":1818,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee02d2e770c84054b020238d2b46da5c","type":"text","conversion_output":true,"text":"by site principal investigators and the overall principal investigator as needed. The audit system also keeps","text_display":" by site principal investigators and the overall principal investigator as needed. The audit system also keeps","confidence":1,"confidence_rate":1},{"cnt":[[116,346],[1934,346],[1934,393],[116,393]],"region":{"top_left_x":116,"top_left_y":345,"width":1818,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6c71ab5d64b426494fff9eb23ca4072","type":"text","conversion_output":true,"text":"track of the physical location of all data. As scales are entered, a proportion ( \\(10 \\%\\) ) will be randomly chosen","text_display":" track of the physical location of all data. As scales are entered, a proportion ( \\(10 \\%\\) ) will be randomly chosen","confidence":0.981037518940866,"confidence_rate":0.9998391341626436},{"cnt":[[116,391],[1949,391],[1949,436],[116,436]],"region":{"top_left_x":116,"top_left_y":391,"width":1833,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0437b1f066a34ee5b1d4c29dc4cbfbf7","type":"text","conversion_output":true,"text":"and flagged for double entry. When the data entry person finishes entering such a scale, he or will receive a","text_display":" and flagged for double entry. When the data entry person finishes entering such a scale, he or will receive a","confidence":1,"confidence_rate":1},{"cnt":[[116,434],[1966,434],[1966,483],[116,483]],"region":{"top_left_x":116,"top_left_y":433,"width":1850,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93eb438aa59d4215b33b26b2e66bd734","type":"text","conversion_output":true,"text":"message that the scale must be entered a second time, and this second entry must be completed before any","text_display":" message that the scale must be entered a second time, and this second entry must be completed before any","confidence":1,"confidence_rate":1},{"cnt":[[116,477],[1953,477],[1953,524],[116,524]],"region":{"top_left_x":116,"top_left_y":476,"width":1837,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc35cd7f7581472b8dd4b0d95f08dc01","type":"text","conversion_output":true,"text":"further tasks are allowed. The system automatically checks each item and tabulates and records error rates.","text_display":" further tasks are allowed. The system automatically checks each item and tabulates and records error rates.","confidence":1,"confidence_rate":1},{"cnt":[[116,520],[1646,520],[1646,569],[116,569]],"region":{"top_left_x":116,"top_left_y":519,"width":1530,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a333a55fb61842e8b2acb1279817f1e9","type":"text","conversion_output":true,"text":"This system is completely automatic and the current overall data entry error rate is \\(0.27 \\%\\).","text_display":" This system is completely automatic and the current overall data entry error rate is \\(0.27 \\%\\).","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[114,602],[746,602],[746,655],[114,655]],"region":{"top_left_x":113,"top_left_y":601,"width":633,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"322c0e0393134790b91afd80881d1104","type":"section_header","conversion_output":false,"children_ids":["c2029b42f5e34158af31996803dcc401"],"text":"","text_display":""},{"cnt":[[116,606],[741,606],[741,651],[116,651]],"region":{"top_left_x":116,"top_left_y":605,"width":626,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2029b42f5e34158af31996803dcc401","type":"text","conversion_output":true,"parent_id":"322c0e0393134790b91afd80881d1104","text":"4.2 RISKS TO HUMAN SUBJECTS","text_display":"\n\n\\subsection*{4.2 RISKS TO HUMAN SUBJECTS}","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[116,692],[1946,692],[1946,746],[116,746]],"region":{"top_left_x":116,"top_left_y":691,"width":1831,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a7bd95b689c475c869cc18cec1c3197","type":"text","conversion_output":true,"text":"4.2.1 Human Subjects' Involvement and Characteristics: This proposed multi-centered study will involve","text_display":"\n4.2.1 Human Subjects' Involvement and Characteristics: This proposed multi-centered study will involve","confidence":0.99658203125,"confidence_rate":0.9999680021628804},{"cnt":[[116,741],[1944,741],[1944,788],[116,788]],"region":{"top_left_x":116,"top_left_y":741,"width":1829,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75198c34d03048bd9bab837e948e2b65","type":"text","conversion_output":true,"text":"four research sites, with each site recruiting 82 patients 18 years or older with non-bipolar major depression","text_display":" four research sites, with each site recruiting 82 patients 18 years or older with non-bipolar major depression","confidence":1,"confidence_rate":1},{"cnt":[[116,784],[1944,784],[1944,834],[116,834]],"region":{"top_left_x":116,"top_left_y":784,"width":1829,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cb6774082b74368ae0ca13c6e6ed2d4","type":"text","conversion_output":true,"text":"with psychotic features (PD). 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broad approach that was employed in STOP-PD and","text_display":" Potential participants will be identified using the same broad approach that was employed in STOP-PD and","confidence":1,"confidence_rate":1},{"cnt":[[116,958],[1916,958],[1916,1010],[116,1010]],"region":{"top_left_x":116,"top_left_y":958,"width":1801,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a75242b649a84cf897949659de20d173","type":"text","conversion_output":true,"text":"that adhered to local IRB requirements and privacy legislation: daily screening (on week days) of inpatient","text_display":" that adhered to local IRB requirements and privacy legislation: daily screening (on week days) of 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established through both a clinical","confidence":1,"confidence_rate":1},{"cnt":[[116,1311],[1992,1311],[1992,1360],[116,1360]],"region":{"top_left_x":116,"top_left_y":1310,"width":1876,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4b35f1ac40a4287826b9c1ece693494","type":"text","conversion_output":true,"text":"interview by a research psychiatrist and the subsequent administration of the SCID-IV by a research associate","text_display":" interview by a research psychiatrist and the subsequent administration of the SCID-IV by a research associate","confidence":1,"confidence_rate":1},{"cnt":[[116,1401],[1850,1401],[1850,1452],[116,1452]],"region":{"top_left_x":116,"top_left_y":1400,"width":1734,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9eefb3f974f448768d37cd4241a45146","type":"text","conversion_output":true,"text":"3) Score of \\(\\geq 3\\) on the delusion severity item of the SADS 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reality testing by the interviewer);","text_display":" does not change the belief in response to reality testing by the interviewer);","confidence":1,"confidence_rate":1},{"cnt":[[116,1667],[666,1667],[666,1721],[116,1721]],"region":{"top_left_x":116,"top_left_y":1667,"width":551,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c3109da7e3741a59d212e2dc86516b3","type":"text","conversion_output":true,"text":"5) 17 -item Ham-D score of \\(\\geq 21\\).","text_display":"\n5) 17 -item Ham-D score of \\(\\geq 21\\).","confidence":0.68603515625,"confidence_rate":0.9912748819558724},{"cnt":[[116,1794],[453,1794],[453,1852],[116,1852]],"region":{"top_left_x":116,"top_left_y":1793,"width":338,"height":59},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61e72763c32d475f8d537df97d9aaa26","type":"section_header","conversion_output":false,"children_ids":["93c23da9b91c4ab5a28bd8aede81b5b0"],"text":"","text_display":""},{"cnt":[[120,1799],[451,1796],[452,1849],[120,1852]],"region":{"top_left_x":119,"top_left_y":1796,"width":333,"height":56},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93c23da9b91c4ab5a28bd8aede81b5b0","type":"text","conversion_output":true,"parent_id":"61e72763c32d475f8d537df97d9aaa26","text":"Exclusion criteria","text_display":"\n\n\\section*{Exclusion criteria}","confidence":1,"confidence_rate":1},{"cnt":[[120,1852],[1858,1852],[1858,1904],[120,1904]],"region":{"top_left_x":120,"top_left_y":1851,"width":1739,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bea29db8513c44a58c8fcb883fa20a12","type":"text","conversion_output":true,"text":"1) Current or lifetime DSM-IV criteria for schizophrenia, other psychotic disorders (e.g., schizoaffective","text_display":"\n1) Current or lifetime DSM-IV criteria for schizophrenia, other psychotic disorders (e.g., schizoaffective","confidence":1,"confidence_rate":1},{"cnt":[[116,1899],[1953,1899],[1953,1949],[116,1949]],"region":{"top_left_x":116,"top_left_y":1899,"width":1837,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96f4be298d2040f8b04b09e05283340f","type":"text","conversion_output":true,"text":"disorder, delusional disorder, brief psychotic disorder, and shared psychotic disorder), or mental retardation,","text_display":" disorder, delusional disorder, brief psychotic disorder, and shared psychotic disorder), or mental retardation,","confidence":1,"confidence_rate":1},{"cnt":[[116,1942],[1876,1942],[1876,1992],[116,1992]],"region":{"top_left_x":116,"top_left_y":1942,"width":1760,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ba595c0c7084adca5a2df603244c795","type":"text","conversion_output":true,"text":"or meeting DSM-IV criteria for current brief psychotic disorder, body dysmorphic disorder, or obsessive-","text_display":" or meeting DSM-IV criteria for current brief psychotic disorder, body dysmorphic disorder, or obsessive","confidence":1,"confidence_rate":1},{"cnt":[[116,1987],[483,1987],[483,2035],[116,2035]],"region":{"top_left_x":116,"top_left_y":1987,"width":368,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e35d7d9a9d034a35848da6471a3fd009","type":"text","conversion_output":true,"text":"compulsive disorder;","text_display":"compulsive disorder;","confidence":1,"confidence_rate":1},{"cnt":[[116,2075],[1244,2075],[1244,2127],[116,2127]],"region":{"top_left_x":116,"top_left_y":2075,"width":1128,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f49f2dfea4f48a49fe444b69ef0c0a4","type":"text","conversion_output":true,"text":"2) Current or lifetime DSM-IV criteria for bipolar affective disorder;","text_display":"\n2) Current or lifetime DSM-IV criteria for bipolar affective disorder;","confidence":1,"confidence_rate":1},{"cnt":[[116,2161],[1983,2161],[1983,2215],[116,2215]],"region":{"top_left_x":116,"top_left_y":2161,"width":1868,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e96184e88175402f8c73579b81255b9f","type":"text","conversion_output":true,"text":"3) History of DSM-IV defined substance abuse or dependence, including alcohol, within the last three months;","text_display":"\n3) History of DSM-IV defined substance abuse or dependence, including alcohol, within the last three months;","confidence":1,"confidence_rate":1},{"cnt":[[116,2252],[2004,2252],[2004,2301],[116,2301]],"region":{"top_left_x":116,"top_left_y":2251,"width":1889,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ce1891ae265492cb6c240845bb32e88","type":"text","conversion_output":true,"text":"4) DSM-IV defined Alzheimer's dementia, vascular dementia, or dementia due to other medical conditions, or a","text_display":"\n4) DSM-IV defined Alzheimer's dementia, vascular dementia, or dementia due to other medical conditions, or a","confidence":1,"confidence_rate":1},{"cnt":[[116,2299],[1927,2299],[1927,2346],[116,2346]],"region":{"top_left_x":116,"top_left_y":2298,"width":1812,"height":49},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2b7cc74c2e34e6da3e8090ea1c49de0","type":"text","conversion_output":true,"text":"history of clinically significant cognitive impairment prior to the index episode of depression, and/or a mean","text_display":" history of clinically significant cognitive impairment prior to the index episode of depression, and/or a mean","confidence":0.9985356330871582,"confidence_rate":0.9999872571234004},{"cnt":[[116,2342],[1914,2342],[1914,2391],[116,2391]],"region":{"top_left_x":116,"top_left_y":2341,"width":1799,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3259c06b1c6d4695b864714b0131606b","type":"text","conversion_output":true,"text":"score of \\(\\geq 4\\) on the 26 -item IQCODE. The IQCODE will be used to screen for clinically significant cognitive","text_display":" score of \\(\\geq 4\\) on the 26 -item IQCODE. The IQCODE will be used to screen for clinically significant cognitive","confidence":0.9951171875,"confidence_rate":0.9999581652137595},{"cnt":[[116,2385],[1893,2385],[1893,2434],[116,2434]],"region":{"top_left_x":116,"top_left_y":2384,"width":1777,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f9d2c40770b4d0fa3c9d61b036af400","type":"text","conversion_output":true,"text":"decline that began prior to the index episode of PD. The IQCODE is not significantly confounded by age,","text_display":" decline that began prior to the index episode of PD. The IQCODE is not significantly confounded by age,","confidence":1,"confidence_rate":1},{"cnt":[[116,2426],[1820,2426],[1820,2477],[116,2477]],"region":{"top_left_x":116,"top_left_y":2425,"width":1704,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f128ba41db645c18099550708e8a641","type":"text","conversion_output":true,"text":"education, or premorbid intelligence. \\({ }^{110}\\) Persons with a mean total IQCODE \\(\\geq 4\\) will be excluded from","text_display":" education, or premorbid intelligence. \\({ }^{110}\\) Persons with a mean total IQCODE \\(\\geq 4\\) will be excluded from","confidence":0.9965834617614746,"confidence_rate":0.999970749248898},{"cnt":[[116,2475],[1949,2475],[1949,2520],[116,2520]],"region":{"top_left_x":116,"top_left_y":2475,"width":1833,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39430b0fb5d345198e49ba308c9bbbad","type":"text","conversion_output":true,"text":"participation in the study; this cut score has been found to have a sensitivity of \\(84-93 \\%\\) and specificity of 88 -","text_display":" participation in the study; this cut score has been found to have a sensitivity of \\(84-93 \\%\\) and specificity of 88 ","confidence":0.9527901329579436,"confidence_rate":0.9996100710676005},{"cnt":[[116,2514],[1904,2514],[1904,2567],[116,2567]],"region":{"top_left_x":116,"top_left_y":2513,"width":1788,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abc92790b91c4c019cc65ec025aac73e","type":"text","conversion_output":true,"text":"\\(94 \\%\\) in screening for dementia in general, psychiatric, and medical populations of older adults. \\({ }^{109,110,155,156}\\)","text_display":"\\(94 \\%\\) in screening for dementia in general, psychiatric, and medical populations of older adults. \\({ }^{109,110,155,156}\\)","confidence":0.9912249993067235,"confidence_rate":0.9999271619277675},{"cnt":[[1955,2578],[2007,2578],[2007,2621],[1955,2621]],"region":{"top_left_x":1955,"top_left_y":2578,"width":52,"height":44},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3320a97533a40639b73f813131e8696","type":"page_info","conversion_output":false,"text":"\\(\\underline{21}\\)","text_display":"","confidence":0.9033203125,"confidence_rate":0.9798697604811296}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-24","page":24,"lines":[{"cnt":[[116,165],[2004,165],[2004,217],[116,217]],"region":{"top_left_x":116,"top_left_y":165,"width":1889,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed5ada76a0784a2f9e56b20b2d3478ec","type":"text","conversion_output":true,"text":"5) Type 1 diabetes mellitus (defined as insulin-dependent diabetes mellitus with onset < 35 years of age and/or","text_display":"\n5) Type 1 diabetes mellitus (defined as insulin-dependent diabetes mellitus with onset < 35 years of age and/or","confidence":0.9053194522857666,"confidence_rate":0.9991850256195716},{"cnt":[[116,208],[1723,208],[1723,264],[116,264]],"region":{"top_left_x":116,"top_left_y":208,"width":1608,"height":57},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e05a5e21afa04f97b6a6ccda475bbb41","type":"text","conversion_output":true,"text":"diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis \\({ }^{157}\\) )","text_display":" diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis \\({ }^{157}\\) )","confidence":0.998046875,"confidence_rate":0.9999822271139778},{"cnt":[[116,296],[1951,296],[1951,350],[116,350]],"region":{"top_left_x":116,"top_left_y":296,"width":1835,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62128eb61a584cd8bd5ff256ad23a71a","type":"text","conversion_output":true,"text":"6) Acute or unstable medical illnesses (e.g., delirium; metastatic cancer; unstable diabetes; decompensated","text_display":"\n6) Acute or unstable medical illnesses (e.g., delirium; metastatic cancer; unstable diabetes; decompensated","confidence":0.9970703125,"confidence_rate":0.9999738040267384},{"cnt":[[116,344],[1921,344],[1921,393],[116,393]],"region":{"top_left_x":116,"top_left_y":343,"width":1805,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a132ffa8ee645df85c5a0d72a597f2f","type":"text","conversion_output":true,"text":"cardiac, hepatic, renal or pulmonary disease; stroke; or myocardial infarction) within the last three months;","text_display":" cardiac, hepatic, renal or pulmonary disease; stroke; or myocardial infarction) within the last three months;","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[116,387],[1848,387],[1848,436],[116,436]],"region":{"top_left_x":116,"top_left_y":386,"width":1732,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"187a2bce4ae446c99b4d7a45553bf540","type":"text","conversion_output":true,"text":"current abnormal serum free T4; current abnormally low serum vitamin B12 or folic acid level; medical","text_display":" current abnormal serum free T4; current abnormally low serum vitamin B12 or folic acid level; medical","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[116,430],[1987,430],[1987,483],[116,483]],"region":{"top_left_x":116,"top_left_y":429,"width":1872,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ccb695aebe949379fce84ce9c614064","type":"text","conversion_output":true,"text":"conditions and/or medications for which psychotic or depressive symptoms can be a direct manifestation (e.g.","text_display":" conditions and/or medications for which psychotic or depressive symptoms can be a direct manifestation (e.g.","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[116,473],[1841,473],[1841,526],[116,526]],"region":{"top_left_x":116,"top_left_y":472,"width":1726,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe53428073db47b1b0611a7843781221","type":"text","conversion_output":true,"text":"Cushing's disease, high-dose systemic corticosteroids, L-dopa); neurological disease associated with","text_display":" Cushing's disease, high-dose systemic corticosteroids, L-dopa); neurological disease associated with","confidence":1,"confidence_rate":1},{"cnt":[[116,518],[1946,518],[1946,569],[116,569]],"region":{"top_left_x":116,"top_left_y":517,"width":1831,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2617458396a545ebace0b8c5c5bfd448","type":"text","conversion_output":true,"text":"extrapyramidal signs and symptoms (e.g. Parkinson's disease); epilepsy, if the person has had one or more","text_display":" extrapyramidal signs and symptoms (e.g. Parkinson's disease); epilepsy, if the person has had one or more","confidence":1,"confidence_rate":1},{"cnt":[[116,563],[840,563],[840,614],[116,614]],"region":{"top_left_x":116,"top_left_y":562,"width":725,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cd5aad2c955439e9d8d668dafc9198a","type":"text","conversion_output":true,"text":"grand mal seizures in the past 12 months;","text_display":" grand mal seizures in the past 12 months;","confidence":1,"confidence_rate":1},{"cnt":[[116,692],[1966,692],[1966,746],[116,746]],"region":{"top_left_x":116,"top_left_y":691,"width":1850,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffe1ee4e652840f9946d8481352a6e45","type":"text","conversion_output":true,"text":"7) The need for treatment with any psychotropic medications other than sertraline, olanzapine, or lorazepam;","text_display":"\n7) The need for treatment with any psychotropic medications other than sertraline, olanzapine, or lorazepam;","confidence":0.99755859375,"confidence_rate":0.9999783684521797},{"cnt":[[116,739],[1938,739],[1938,793],[116,793]],"region":{"top_left_x":116,"top_left_y":739,"width":1822,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84bee104e1f24a58a5b26cbae3db4218","type":"text","conversion_output":true,"text":"or with an anticonvulsant medication with mood-stabilizing properties (carbamazepine, lamotrigine, valproic","text_display":" or with an anticonvulsant medication with mood-stabilizing properties (carbamazepine, lamotrigine, valproic","confidence":1,"confidence_rate":1},{"cnt":[[116,784],[226,784],[226,834],[116,834]],"region":{"top_left_x":116,"top_left_y":784,"width":110,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d2b87d5af394816ac674e10661f99bd","type":"text","conversion_output":true,"text":"acid);","text_display":" acid);","confidence":1,"confidence_rate":1},{"cnt":[[122,868],[1983,868],[1983,922],[122,922]],"region":{"top_left_x":122,"top_left_y":867,"width":1862,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"776c34cdea514bbc9c12f1e16946b366","type":"text","conversion_output":true,"text":"8) Current pregnancy or a plan to become pregnant during the duration of the study in woman of childbearing","text_display":"\n8) Current pregnancy or a plan to become pregnant during the duration of the study in woman of childbearing","confidence":1,"confidence_rate":1},{"cnt":[[116,915],[846,915],[846,965],[116,965]],"region":{"top_left_x":116,"top_left_y":915,"width":731,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88da9d93cd1c4d0b8626499fcf93506d","type":"text","conversion_output":true,"text":"age; breast-feeding in woman with infants;","text_display":" age; breast-feeding in woman with infants;","confidence":1,"confidence_rate":1},{"cnt":[[116,999],[1970,999],[1970,1053],[116,1053]],"region":{"top_left_x":116,"top_left_y":999,"width":1855,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39b95ad412164950b68f55e3d3c151a8","type":"text","conversion_output":true,"text":"9) A clearly documented history of being unable to tolerate sertraline and/or olanzapine, including having had","text_display":"\n9) A clearly documented history of being unable to tolerate sertraline and/or olanzapine, including having had","confidence":0.9990234375,"confidence_rate":0.9999915040391533},{"cnt":[[116,1044],[1835,1044],[1835,1096],[116,1096]],"region":{"top_left_x":116,"top_left_y":1044,"width":1719,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"717a9a01e71442ff83eba48c7b0e9f72","type":"text","conversion_output":true,"text":"an untoward previous reaction to sertraline such as significant bradycardia (heart rate of <50 bpm) or","text_display":" an untoward previous reaction to sertraline such as significant bradycardia (heart rate of <50 bpm) or","confidence":0.9931640625,"confidence_rate":0.9999358954234694},{"cnt":[[116,1087],[1910,1087],[1910,1141],[116,1141]],"region":{"top_left_x":116,"top_left_y":1087,"width":1794,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc76a39aacd546d0b7d4b6bee1a036a3","type":"text","conversion_output":true,"text":"development of the syndrome of inappropriate antidiuretic hormone secretion with a serum sodium of 129","text_display":" development of the syndrome of inappropriate antidiuretic hormone secretion with a serum sodium of 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day sertraline","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[116,1242],[793,1242],[793,1296],[116,1296]],"region":{"top_left_x":116,"top_left_y":1241,"width":677,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40ad0b632f7943e6a106e01d7d0da83e","type":"text","conversion_output":true,"text":"combined with \\(\\geq 15 mg /\\) day olanzapine;","text_display":" combined with \\(\\geq 15 mg /\\) day olanzapine;","confidence":1,"confidence_rate":1},{"cnt":[[116,1306],[2004,1306],[2004,1360],[116,1360]],"region":{"top_left_x":116,"top_left_y":1306,"width":1889,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26b63f2ec2614794bbb84d3313a4fa8f","type":"text","conversion_output":true,"text":"11) Patients showing ongoing improvement in the index episode of PD with treatment, other than sertraline and","text_display":"\n11) Patients showing ongoing improvement in the index episode of PD with treatment, other than sertraline and","confidence":0.9990234375,"confidence_rate":0.9999914295135003},{"cnt":[[116,1351],[776,1351],[776,1403],[116,1403]],"region":{"top_left_x":116,"top_left_y":1351,"width":660,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c52b3c4b781b416e96508146db9d68ad","type":"text","conversion_output":true,"text":"olanzapine, initiated prior to the study;","text_display":" olanzapine, initiated prior to the study;","confidence":1,"confidence_rate":1},{"cnt":[[116,1414],[1800,1414],[1800,1467],[116,1467]],"region":{"top_left_x":116,"top_left_y":1413,"width":1685,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a338623ad5c84fd8a78b0f44c1c67fed","type":"text","conversion_output":true,"text":"12) Sufficiently ill to require immediate ECT (e.g., imminent risk of suicide, refusing to eat or severe","text_display":"\n12) Sufficiently ill to require immediate ECT (e.g., imminent risk of suicide, refusing to eat or severe","confidence":1,"confidence_rate":1},{"cnt":[[116,1461],[518,1461],[518,1510],[116,1510]],"region":{"top_left_x":116,"top_left_y":1460,"width":402,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20a2ae8d80354904a2b7446d10ddf695","type":"text","conversion_output":true,"text":"malnutrition, catatonic)","text_display":" malnutrition, catatonic)","confidence":0.99951171875,"confidence_rate":0.999983158745329},{"cnt":[[112,1603],[112,1538],[954,1541],[954,1605]],"region":{"top_left_x":111,"top_left_y":1538,"width":844,"height":67},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6881291bef9249cc8ab792b3da0be2a2","type":"section_header","conversion_output":false,"children_ids":["606e1261b83a4eb09ec4b2e1ee06e1f3"],"text":"","text_display":""},{"cnt":[[116,1547],[947,1547],[947,1596],[116,1596]],"region":{"top_left_x":116,"top_left_y":1546,"width":832,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"606e1261b83a4eb09ec4b2e1ee06e1f3","type":"text","conversion_output":true,"parent_id":"6881291bef9249cc8ab792b3da0be2a2","text":"Rationale for inclusion and exclusion criteria","text_display":"\n\n\\section*{Rationale for inclusion and exclusion criteria}","confidence":0.99951171875,"confidence_rate":0.9999904235654993},{"cnt":[[122,1590],[1983,1590],[1983,1644],[122,1644]],"region":{"top_left_x":122,"top_left_y":1589,"width":1862,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"313f8de8213f465db14035cd0a821150","type":"text","conversion_output":true,"text":"1) Age criterion: Excluding children below the age of 18 years from this study of PD is justified on ethical and","text_display":"\n1) Age criterion: Excluding children below the age of 18 years from this study of PD is justified on ethical and","confidence":0.99951171875,"confidence_rate":0.9999959300041316},{"cnt":[[116,1687],[116,1634],[1893,1637],[1893,1690]],"region":{"top_left_x":115,"top_left_y":1634,"width":1778,"height":57},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a11d235f1394b41ad3513bdb3b6e80b","type":"text","conversion_output":true,"text":"scientific grounds. We do not know enough about the efficacy of these medications or their tolerability in","text_display":" scientific grounds. We do not know enough about the efficacy of these medications or their tolerability in","confidence":1,"confidence_rate":1},{"cnt":[[116,1680],[995,1680],[995,1732],[116,1732]],"region":{"top_left_x":116,"top_left_y":1680,"width":879,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9864c920b7c2467d97f4f024c759275a","type":"text","conversion_output":true,"text":"children at target doses to justify including children.","text_display":" children at target doses to justify including children.","confidence":1,"confidence_rate":1},{"cnt":[[116,1766],[1798,1766],[1798,1818],[116,1818]],"region":{"top_left_x":116,"top_left_y":1766,"width":1683,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77eaf68358984888bbd552bace257e38","type":"text","conversion_output":true,"text":"2) Excluding patients with bipolar affective disorder: Persons with bipolar affective disorder require","text_display":"\n2) Excluding patients with bipolar affective disorder: Persons with bipolar affective disorder require","confidence":1,"confidence_rate":1},{"cnt":[[116,1811],[1927,1811],[1927,1863],[116,1863]],"region":{"top_left_x":116,"top_left_y":1811,"width":1812,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7589f54e883d4b12b48ab482bba5da36","type":"text","conversion_output":true,"text":"continuation and maintenance treatment with a mood-stabilizing medication to lessen the risk of relapse or","text_display":" continuation and maintenance treatment with a mood-stabilizing medication to lessen the risk of relapse or","confidence":1,"confidence_rate":1},{"cnt":[[116,1856],[1970,1856],[1970,1906],[116,1906]],"region":{"top_left_x":116,"top_left_y":1856,"width":1855,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d957e7e4957c4a8db167b544d609511b","type":"text","conversion_output":true,"text":"recurrence of mania, hypomania, or depression. Antidepressant medication alone is not recommended in the","text_display":" recurrence of mania, hypomania, or depression. Antidepressant medication alone is not recommended in the","confidence":1,"confidence_rate":1},{"cnt":[[116,1899],[1888,1899],[1888,1949],[116,1949]],"region":{"top_left_x":116,"top_left_y":1899,"width":1773,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3141b2a33aa443cda4ca346868b6f2e6","type":"text","conversion_output":true,"text":"continuation or maintenance treatment of bipolar disorder. As a result, we exclude patients with a known","text_display":" continuation or maintenance treatment of bipolar disorder. As a result, we exclude patients with a known","confidence":1,"confidence_rate":1},{"cnt":[[116,1942],[1962,1942],[1962,1996],[116,1996]],"region":{"top_left_x":116,"top_left_y":1942,"width":1846,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b579a0537a74b379c4f79d2f06108fc","type":"text","conversion_output":true,"text":"history of bipolar disorder, because it would not be ethical to discontinue olanzapine, which has efficacy as a","text_display":" history of bipolar disorder, because it would not be ethical to discontinue olanzapine, which has efficacy as a","confidence":1,"confidence_rate":1},{"cnt":[[116,1987],[1059,1987],[1059,2039],[116,2039]],"region":{"top_left_x":116,"top_left_y":1987,"width":944,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc5b5cb2ef774cdbaae60457759e6de4","type":"text","conversion_output":true,"text":"mood-stabilizer in bipolar disorder, in these individuals.","text_display":" mood-stabilizer in bipolar disorder, in these individuals.","confidence":1,"confidence_rate":1},{"cnt":[[116,2071],[1968,2071],[1968,2125],[116,2125]],"region":{"top_left_x":116,"top_left_y":2071,"width":1852,"height":54},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbf9a3e8b93e4a34890e1ee1f3c0a0cf","type":"text","conversion_output":true,"text":"3) Depression severity criteria: Only subjects with moderately severe to severe depression will be included to","text_display":"\n3) Depression severity criteria: Only subjects with moderately severe to severe depression will be included to","confidence":0.99658203125,"confidence_rate":0.9999702280662401},{"cnt":[[116,2118],[1974,2118],[1974,2172],[116,2172]],"region":{"top_left_x":116,"top_left_y":2118,"width":1859,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfb8361b3e78494e9254f0b3af422533","type":"text","conversion_output":true,"text":"increase the likelihood that delusions are a symptom of PD, rather than of schizophrenia or another psychotic","text_display":" increase the likelihood that delusions are a symptom of PD, rather than of schizophrenia or another psychotic","confidence":1,"confidence_rate":1},{"cnt":[[116,2161],[741,2161],[741,2215],[116,2215]],"region":{"top_left_x":116,"top_left_y":2161,"width":626,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2f6b951853f4a57addfe2f2c15ec2bc","type":"text","conversion_output":true,"text":"disorder with secondary depression.","text_display":" disorder with secondary depression.","confidence":1,"confidence_rate":1},{"cnt":[[116,2247],[1919,2247],[1919,2301],[116,2301]],"region":{"top_left_x":116,"top_left_y":2247,"width":1803,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca7309a836b24ce0bff2b0d13ea7568e","type":"text","conversion_output":true,"text":"4) Requiring delusions, with or without hallucinations: The rationale for requiring delusions, whether or not","text_display":"\n4) Requiring delusions, with or without hallucinations: The rationale for requiring delusions, whether or not","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[116,2295],[1936,2295],[1936,2346],[116,2346]],"region":{"top_left_x":116,"top_left_y":2294,"width":1820,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f97180738c740adb9f84e619f14a8a5","type":"text","conversion_output":true,"text":"hallucinations are present, is based on the infrequency of hallucinations alone (that is, without delusions) in","text_display":" hallucinations are present, is based on the infrequency of hallucinations alone (that is, without delusions) in","confidence":1,"confidence_rate":1},{"cnt":[[116,2333],[2000,2333],[2000,2391],[116,2391]],"region":{"top_left_x":116,"top_left_y":2333,"width":1885,"height":59},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"633247b117c94f57a83685a56939156e","type":"text","conversion_output":true,"text":"PD. \\({ }^{158,159}\\) Psychotic patients with hallucinations only, who do not have delusions, are more likely to be suffering","text_display":" PD. \\({ }^{158,159}\\) Psychotic patients with hallucinations only, who do not have delusions, are more likely to be suffering","confidence":1,"confidence_rate":1},{"cnt":[[116,2383],[1921,2383],[1921,2434],[116,2434]],"region":{"top_left_x":116,"top_left_y":2382,"width":1805,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acaa7f24b98c451abe65d387073913c7","type":"text","conversion_output":true,"text":"from another disorder, such as schizophrenia, schizoaffective disorder, brief psychotic disorder, or a toxic-","text_display":" from another disorder, such as schizophrenia, schizoaffective disorder, brief psychotic disorder, or a toxic","confidence":1,"confidence_rate":1},{"cnt":[[116,2428],[1936,2428],[1936,2477],[116,2477]],"region":{"top_left_x":116,"top_left_y":2427,"width":1820,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67bca306440a48a2bbcf5df76b00fe13","type":"text","conversion_output":true,"text":"metabolic encephalopathy, as a cause of their psychotic symptoms. Thus, the requirement of delusions will","text_display":"metabolic encephalopathy, as a cause of their psychotic symptoms. Thus, the requirement of delusions will","confidence":1,"confidence_rate":1},{"cnt":[[116,2471],[627,2471],[627,2520],[116,2520]],"region":{"top_left_x":116,"top_left_y":2470,"width":512,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccb8a87364454c6d98a157fa69d507f9","type":"text","conversion_output":true,"text":"facilitate diagnostic precision.","text_display":" facilitate diagnostic precision.","confidence":1,"confidence_rate":1},{"cnt":[[1955,2574],[2011,2574],[2011,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2573,"width":56,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05cee72b7a2342968147f64b09782543","type":"page_info","conversion_output":false,"text":"22","text_display":"","confidence":0.93994140625,"confidence_rate":0.9695057535930357}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-25","page":25,"lines":[{"cnt":[[120,125],[1820,125],[1820,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1700,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9be1c02bd6454c4fb83e8adc9b3e02ba","type":"text","conversion_output":true,"text":"5) Exclusion of recent substance abuse or dependence: The DSM-IV criteria for substance abuse or","text_display":"\n5) Exclusion of recent substance abuse or dependence: The DSM-IV criteria for substance abuse or","confidence":1,"confidence_rate":1},{"cnt":[[120,172],[1953,172],[1953,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":1833,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"312391b698e54ab4a37216c3cb292e50","type":"text","conversion_output":true,"text":"dependence defines these disorders as a maladaptive pattern of substance use occurring within a 12 -month","text_display":" dependence defines these disorders as a maladaptive pattern of substance use occurring within a 12 -month","confidence":0.9926791191101074,"confidence_rate":0.9999349772463806},{"cnt":[[120,215],[1970,215],[1970,260],[120,260]],"region":{"top_left_x":120,"top_left_y":214,"width":1851,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d7e231ced934be980f344f736230ca8","type":"text","conversion_output":true,"text":"period. We elected to use a narrower exclusion criterion of abuse (within the past 3 months) in order to allow","text_display":" period. We elected to use a narrower exclusion criterion of abuse (within the past 3 months) in order to allow","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[120,260],[2002,258],[2002,305],[120,307]],"region":{"top_left_x":120,"top_left_y":257,"width":1883,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"417b1ab38a0a436e91ae7657f36fda01","type":"text","conversion_output":true,"text":"participation by subjects with histories of substance abuse or dependence problems that could be secondary to","text_display":" participation by subjects with histories of substance abuse or dependence problems that could be secondary to","confidence":1,"confidence_rate":1},{"cnt":[[120,348],[120,300],[1947,302],[1946,350]],"region":{"top_left_x":120,"top_left_y":299,"width":1827,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e9b8cec3f734e5685fd5aaad5654f87","type":"text","conversion_output":true,"text":"their mood disorders. However, we decided to exclude individuals in whom very recent substance abuse or","text_display":" their mood disorders. However, we decided to exclude individuals in whom very recent substance abuse or","confidence":1,"confidence_rate":1},{"cnt":[[120,348],[1854,348],[1854,393],[120,393]],"region":{"top_left_x":120,"top_left_y":348,"width":1735,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ac1aceddd0847ea9be6d930c3c71779","type":"text","conversion_output":true,"text":"dependence might be contributing to the mood or psychotic symptoms. A valid and reliable diagnostic","text_display":" dependence might be contributing to the mood or psychotic symptoms. A valid and reliable diagnostic","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1944,391],[1944,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1825,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"032764188cc244b794ebc66906435b9c","type":"text","conversion_output":true,"text":"distinction between unipolar PD and a substance-induced mood disorder with psychotic features can not be","text_display":" distinction between unipolar PD and a substance-induced mood disorder with psychotic features can not be","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1938,434],[1938,479],[120,479]],"region":{"top_left_x":120,"top_left_y":433,"width":1818,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aee339199d1c4a8f83fa65669382e343","type":"text","conversion_output":true,"text":"made in the presence of current substance abuse. Participants with a secondary psychotic depression may","text_display":" made in the presence of current substance abuse. Participants with a secondary psychotic depression may","confidence":1,"confidence_rate":1},{"cnt":[[120,477],[1979,477],[1979,524],[120,524]],"region":{"top_left_x":120,"top_left_y":476,"width":1859,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c283e957c78f496d91af0fe69c9d0aae","type":"text","conversion_output":true,"text":"have a different treatment response and longer term outcome than those with primary PD. However, allowing","text_display":" have a different treatment response and longer term outcome than those with primary PD. However, allowing","confidence":1,"confidence_rate":1},{"cnt":[[120,522],[1904,522],[1904,569],[120,569]],"region":{"top_left_x":120,"top_left_y":522,"width":1784,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f68fc8c3be48ee8f4e22f12427d90c","type":"text","conversion_output":true,"text":"participation by patients with histories of substance abuse or dependence more than three months earlier","text_display":" participation by patients with histories of substance abuse or dependence more than three months earlier","confidence":1,"confidence_rate":1},{"cnt":[[120,567],[1747,567],[1747,612],[120,612]],"region":{"top_left_x":120,"top_left_y":567,"width":1627,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f7cd95f42b048f7b87b2632bbb4861f","type":"text","conversion_output":true,"text":"broadens the inclusion criteria to more closely approximate patients seen in 'real world' settings.","text_display":" broadens the inclusion criteria to more closely approximate patients seen in 'real world' settings.","confidence":1,"confidence_rate":1},{"cnt":[[120,657],[1972,657],[1972,705],[120,705]],"region":{"top_left_x":120,"top_left_y":657,"width":1853,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27c63ad21e3945dabee0b6d8bb319155","type":"text","conversion_output":true,"text":"6) Patients with schizophrenia, schizoaffective disorder, and other psychotic disorders are excluded, because","text_display":"\n6) Patients with schizophrenia, schizoaffective disorder, and other psychotic disorders are excluded, because","confidence":0.99560546875,"confidence_rate":0.9999613672762195},{"cnt":[[120,700],[2004,700],[2004,750],[120,750]],"region":{"top_left_x":120,"top_left_y":700,"width":1885,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdd4d430ed394e25b3d390f5824799bb","type":"text","conversion_output":true,"text":"the focus of this study is on major depressive disorder with psychotic features, not 'primary' psychotic disorders","text_display":" the focus of this study is on major depressive disorder with psychotic features, not 'primary' psychotic disorders","confidence":1,"confidence_rate":1},{"cnt":[[120,746],[1858,746],[1858,793],[120,793]],"region":{"top_left_x":120,"top_left_y":745,"width":1739,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1561cc62d974779ac50424a100f1724","type":"text","conversion_output":true,"text":"with associated depression. Current body dysmorphic disorder and obsessive-compulsive disorder are","text_display":" with associated depression. Current body dysmorphic disorder and obsessive-compulsive disorder are","confidence":1,"confidence_rate":1},{"cnt":[[120,791],[1987,791],[1987,836],[120,836]],"region":{"top_left_x":120,"top_left_y":790,"width":1868,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31d7f793762a4d62bc0a8c73e4077f57","type":"text","conversion_output":true,"text":"excluded because the ideation and phenomenology associated with these disorders may be difficult to reliably","text_display":" excluded because the ideation and phenomenology associated with these disorders may be difficult to reliably","confidence":1,"confidence_rate":1},{"cnt":[[120,834],[471,834],[471,879],[120,879]],"region":{"top_left_x":120,"top_left_y":833,"width":351,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22b45997998a4bde96328b84cdab4130","type":"text","conversion_output":true,"text":"distinguish from PD.","text_display":" distinguish from PD.","confidence":1,"confidence_rate":1},{"cnt":[[120,898],[1227,898],[1227,947],[120,947]],"region":{"top_left_x":120,"top_left_y":898,"width":1107,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"702bbc2ab38d4335b2403d765c2cb1f0","type":"text","conversion_output":true,"text":"7) Persons with dementia are excluded for the following reasons:","text_display":"\n7) Persons with dementia are excluded for the following reasons:","confidence":1,"confidence_rate":1},{"cnt":[[183,941],[1871,941],[1871,988],[183,988]],"region":{"top_left_x":182,"top_left_y":941,"width":1690,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2acc791b9e54634804fba41f9b43b52","type":"text","conversion_output":true,"text":"a)delusions and depression may be symptomatic manifestations of dementia. The pathophysiology,","text_display":"\na)delusions and depression may be symptomatic manifestations of dementia. The pathophysiology,","confidence":0.977175235748291,"confidence_rate":0.9997668021244472},{"cnt":[[183,982],[1981,982],[1981,1033],[183,1033]],"region":{"top_left_x":182,"top_left_y":981,"width":1799,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b60bc9476f0499aa8f092be17e6dc26","type":"text","conversion_output":true,"text":"treatment response, and course of these symptoms of dementia may differ from those of PD. \\({ }^{160}\\) Moreover,","text_display":" treatment response, and course of these symptoms of dementia may differ from those of PD. \\({ }^{160}\\) Moreover,","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[183,1027],[1837,1027],[1837,1076],[183,1076]],"region":{"top_left_x":182,"top_left_y":1026,"width":1655,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"693b26f778ab435d97519fdfcf36ff46","type":"text","conversion_output":true,"text":"non-delusional confabulations are a frequent symptom of dementia and may be difficult to reliably","text_display":" non-delusional confabulations are a frequent symptom of dementia and may be difficult to reliably","confidence":1,"confidence_rate":1},{"cnt":[[183,1074],[642,1074],[642,1119],[183,1119]],"region":{"top_left_x":182,"top_left_y":1074,"width":461,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e91ac5cf71224426b4c17d16ec56fea7","type":"text","conversion_output":true,"text":"distinguish from delusions;","text_display":" distinguish from delusions;","confidence":1,"confidence_rate":1},{"cnt":[[183,1117],[1895,1117],[1895,1164],[183,1164]],"region":{"top_left_x":182,"top_left_y":1117,"width":1713,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1a81b8f29f44b4aa99d0e1c4f28ea17","type":"text","conversion_output":true,"text":"b) dementia may affect a person's ability to reliably and accurately report the presence and course of","text_display":"\nb) dementia may affect a person's ability to reliably and accurately report the presence and course of","confidence":1,"confidence_rate":1},{"cnt":[[183,1162],[1257,1162],[1257,1210],[183,1210]],"region":{"top_left_x":182,"top_left_y":1162,"width":1075,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ed0f3f8019249feb9a4f4736be3d32a","type":"text","conversion_output":true,"text":"symptoms, which could affect the validity of ratings of outcome.","text_display":" symptoms, which could affect the validity of ratings of outcome.","confidence":1,"confidence_rate":1},{"cnt":[[120,1248],[1957,1248],[1957,1296],[120,1296]],"region":{"top_left_x":120,"top_left_y":1248,"width":1838,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b62d1ae5fdc4e30a1d58a5f1669e1de","type":"text","conversion_output":true,"text":"8) Persons with Type 1 diabetes mellitus are at risk of ketoacidosis if they become hyperglycaemic, whereas","text_display":"\n8) Persons with Type 1 diabetes mellitus are at risk of ketoacidosis if they become hyperglycaemic, whereas","confidence":1,"confidence_rate":1},{"cnt":[[120,1289],[1966,1289],[1966,1343],[120,1343]],"region":{"top_left_x":120,"top_left_y":1289,"width":1846,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cf328bd76ef468da049e8172760f629","type":"text","conversion_output":true,"text":"ketoacidosis is a very rare event in persons with Type 2 diabetes mellitus. \\({ }^{157}\\) Therefore, to avoid the potential","text_display":" ketoacidosis is a very rare event in persons with Type 2 diabetes mellitus. \\({ }^{157}\\) Therefore, to avoid the potential","confidence":1,"confidence_rate":1},{"cnt":[[120,1336],[1983,1336],[1983,1386],[120,1386]],"region":{"top_left_x":120,"top_left_y":1336,"width":1864,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"389b871a333a438ab9a3c0fb48bb4f91","type":"text","conversion_output":true,"text":"risk of ketoacidosis precipitated by olanzapine-associated hyperglycemia, persons with Type I diabetes will be","text_display":" risk of ketoacidosis precipitated by olanzapine-associated hyperglycemia, persons with Type I diabetes will be","confidence":1,"confidence_rate":1},{"cnt":[[120,1381],[1974,1381],[1974,1429],[120,1429]],"region":{"top_left_x":120,"top_left_y":1381,"width":1855,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2aa3ff97298a4850a92ec675d86cfc50","type":"text","conversion_output":true,"text":"excluded from the study. In STOP-PD, no more than 7 of the 259 participants had Type 1 diabetes; therefore,","text_display":" excluded from the study. In STOP-PD, no more than 7 of the 259 participants had Type 1 diabetes; therefore,","confidence":1,"confidence_rate":1},{"cnt":[[116,1427],[1919,1427],[1919,1472],[116,1472]],"region":{"top_left_x":116,"top_left_y":1426,"width":1803,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08618be126e041ae99b61363c5debd55","type":"text","conversion_output":true,"text":"we do not anticipate that this exclusion will have a significant impact on recruitment, the aims pertaining to","text_display":" we do not anticipate that this exclusion will have a significant impact on recruitment, the aims pertaining to","confidence":1,"confidence_rate":1},{"cnt":[[120,1470],[1154,1470],[1154,1515],[120,1515]],"region":{"top_left_x":120,"top_left_y":1469,"width":1034,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b48ce4c0b1ab481185ba3222124a2ea0","type":"text","conversion_output":true,"text":"metabolic changes, or generalizability of the study's findings.","text_display":" metabolic changes, or generalizability of the study's findings.","confidence":1,"confidence_rate":1},{"cnt":[[120,1555],[1957,1555],[1957,1605],[120,1605]],"region":{"top_left_x":120,"top_left_y":1555,"width":1838,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"894e81a48ba842c5b4cadfc1e8da3d33","type":"text","conversion_output":true,"text":"9) Acute or unstable medical illnesses may prevent participants from tolerating the acute trial target doses of","text_display":"\n9) Acute or unstable medical illnesses may prevent participants from tolerating the acute trial target doses of","confidence":1,"confidence_rate":1},{"cnt":[[120,1601],[1858,1601],[1858,1648],[120,1648]],"region":{"top_left_x":120,"top_left_y":1600,"width":1739,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22870ba42ef04c00af65f55d9f69d2f9","type":"text","conversion_output":true,"text":"study medications, interfere with subjects' ability to complete the study, and/or contribute to psychiatric","text_display":" study medications, interfere with subjects' ability to complete the study, and/or contribute to psychiatric","confidence":1,"confidence_rate":1},{"cnt":[[120,1646],[1882,1646],[1882,1691],[120,1691]],"region":{"top_left_x":120,"top_left_y":1645,"width":1763,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"404bd1ce63104fcabd173762730eecd6","type":"text","conversion_output":true,"text":"symptomatology. We will, however, include subjects with stable chronic physical illness, to examine the","text_display":" symptomatology. We will, however, include subjects with stable chronic physical illness, to examine the","confidence":1,"confidence_rate":1},{"cnt":[[120,1689],[1714,1689],[1714,1734],[120,1734]],"region":{"top_left_x":120,"top_left_y":1688,"width":1595,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53c4d423931c402f9ffd2e0e3f59e8de","type":"text","conversion_output":true,"text":"interaction between chronic medical burden, duration of treatment with olanzapine, and risk of","text_display":" interaction between chronic medical burden, duration of treatment with olanzapine, and risk of","confidence":1,"confidence_rate":1},{"cnt":[[120,1732],[458,1732],[458,1781],[120,1781]],"region":{"top_left_x":120,"top_left_y":1731,"width":338,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c1c49262c62479a80b8e2bc9c781c1b","type":"text","conversion_output":true,"text":"relapse/recurrence.","text_display":" relapse/recurrence.","confidence":0.9970703125,"confidence_rate":0.9998777579957132},{"cnt":[[122,1818],[1912,1818],[1912,1867],[122,1867]],"region":{"top_left_x":122,"top_left_y":1817,"width":1791,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68fd2da5f2ed40f79418e3cb42802bdb","type":"text","conversion_output":true,"text":"10) Exclusion of women who are pregnant, plan to become pregnant or are breast-feeding. Sertraline and","text_display":"\n10) Exclusion of women who are pregnant, plan to become pregnant or are breast-feeding. Sertraline and","confidence":1,"confidence_rate":1},{"cnt":[[120,1865],[1979,1865],[1979,1910],[120,1910]],"region":{"top_left_x":120,"top_left_y":1864,"width":1859,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bf012ab90f34027827ec9e275f5d3c6","type":"text","conversion_output":true,"text":"olanzapine are not specifically known to harm the fetus, but the data are limited. As a result, to err on the side","text_display":" olanzapine are not specifically known to harm the fetus, but the data are limited. As a result, to err on the side","confidence":1,"confidence_rate":1},{"cnt":[[120,1908],[1893,1908],[1893,1955],[120,1955]],"region":{"top_left_x":120,"top_left_y":1907,"width":1773,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74b79449a2de43f3851b1e8592b9d4e4","type":"text","conversion_output":true,"text":"of caution, pregnancy is an exclusion criterion. Sertraline is present in breast milk and, therefore, may be","text_display":" of caution, pregnancy is an exclusion criterion. Sertraline is present in breast milk and, therefore, may be","confidence":1,"confidence_rate":1},{"cnt":[[120,1951],[750,1951],[750,2000],[120,2000]],"region":{"top_left_x":120,"top_left_y":1950,"width":630,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b5da6a90a2c41919577bc8adfdb33e7","type":"text","conversion_output":true,"text":"transmitted to breast-feeding infants.","text_display":" transmitted to breast-feeding infants.","confidence":1,"confidence_rate":1},{"cnt":[[122,2039],[1979,2039],[1979,2086],[122,2086]],"region":{"top_left_x":122,"top_left_y":2038,"width":1857,"height":49},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"708729f4316c4ab48393d11953b87083","type":"text","conversion_output":true,"text":"11) Exclusion of patients with a history of treatment resistance to an adequate trial of combined sertraline and","text_display":"\n11) Exclusion of patients with a history of treatment resistance to an adequate trial of combined sertraline and","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[120,2084],[1910,2084],[1910,2129],[120,2129]],"region":{"top_left_x":120,"top_left_y":2083,"width":1790,"height":47},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f024bc15edb4632aa460a52b4f9c8d6","type":"text","conversion_output":true,"text":"olanzapine during the index episode is justified on ethical and scientific grounds. It would not be ethical to","text_display":" olanzapine during the index episode is justified on ethical and scientific grounds. It would not be ethical to","confidence":1,"confidence_rate":1},{"cnt":[[120,2127],[1964,2127],[1964,2174],[120,2174]],"region":{"top_left_x":120,"top_left_y":2126,"width":1844,"height":49},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93624d08d5604cbc942b08abc21313e1","type":"text","conversion_output":true,"text":"include patients whose current episode of depression had previously failed to respond to an adequate trial of","text_display":" include patients whose current episode of depression had previously failed to respond to an adequate trial of","confidence":1,"confidence_rate":1},{"cnt":[[120,2172],[1966,2172],[1966,2219],[120,2219]],"region":{"top_left_x":120,"top_left_y":2172,"width":1846,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c05bb7c4930942c687f3abcdc6231d4b","type":"text","conversion_output":true,"text":"the same treatment used during the acute phase of the study. Moreover, the inclusion of such patients would","text_display":" the same treatment used during the acute phase of the study. Moreover, the inclusion of such patients would","confidence":1,"confidence_rate":1},{"cnt":[[120,2215],[1912,2215],[1912,2262],[120,2262]],"region":{"top_left_x":120,"top_left_y":2215,"width":1793,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab463e1f6a3140399d571ade637ebaa4","type":"text","conversion_output":true,"text":"likely reduce the overall frequency of remission and near remission of the acute phase of the trial, thereby","text_display":" likely reduce the overall frequency of remission and near remission of the acute phase of the trial, thereby","confidence":1,"confidence_rate":1},{"cnt":[[120,2260],[1944,2260],[1944,2305],[120,2305]],"region":{"top_left_x":120,"top_left_y":2260,"width":1825,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d2ec4e78f3c4ba6afee6870a339f6b1","type":"text","conversion_output":true,"text":"reducing the potential pool of patients available to enter the RCT. We expect that this exclusion criterion will","text_display":" reducing the potential pool of patients available to enter the RCT. We expect that this exclusion criterion will","confidence":1,"confidence_rate":1},{"cnt":[[120,2303],[1884,2303],[1884,2350],[120,2350]],"region":{"top_left_x":120,"top_left_y":2303,"width":1765,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e17f44be837478cb994734b3d952cc6","type":"text","conversion_output":true,"text":"have little impact on recruitment of participants to the acute phase of the study: in STOP-PD, only \\(5 \\%\\) of","text_display":" have little impact on recruitment of participants to the acute phase of the study: in STOP-PD, only \\(5 \\%\\) of","confidence":0.9570722579956055,"confidence_rate":0.9996117887745306},{"cnt":[[120,2346],[1858,2346],[1858,2396],[120,2396]],"region":{"top_left_x":120,"top_left_y":2346,"width":1739,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2528208a565485481d977f44fb9c052","type":"text","conversion_output":true,"text":"participants had received at least a three-week trial of adequate doses of combined treatment with any","text_display":" participants had received at least a three-week trial of adequate doses of combined treatment with any","confidence":1,"confidence_rate":1},{"cnt":[[120,2385],[1674,2385],[1674,2438],[120,2438]],"region":{"top_left_x":120,"top_left_y":2384,"width":1554,"height":55},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"984841579b5e42f0acc1572cd0c8bce1","type":"text","conversion_output":true,"text":"antidepressant and antipsychotic medications during the index episode prior to the study. \\({ }^{161}\\)","text_display":" antidepressant and antipsychotic medications during the index episode prior to the study. \\({ }^{161}\\)","confidence":1,"confidence_rate":1},{"cnt":[[122,2477],[2004,2477],[2004,2527],[122,2527]],"region":{"top_left_x":122,"top_left_y":2477,"width":1883,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c3f2c57437c4073bc18db9c9b986c74","type":"text","conversion_output":true,"text":"12) Exclusion of patients considered at imminent risk for suicide and/or whose symptoms are severe enough to","text_display":"\n12) Exclusion of patients considered at imminent risk for suicide and/or whose symptoms are severe enough to","confidence":1,"confidence_rate":1},{"cnt":[[120,2522],[1356,2522],[1356,2572],[120,2572]],"region":{"top_left_x":120,"top_left_y":2522,"width":1236,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c465af490e294c1da1e8eff16400674f","type":"text","conversion_output":true,"text":"warrant immediate treatment with ECT is appropriate on ethical grounds.","text_display":" warrant immediate treatment with ECT is appropriate on ethical grounds.","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2007,2578],[2007,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":52,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc5d1d97a70c448489d6d72445713639","type":"page_info","conversion_output":false,"text":"\\(\\underline{23}\\)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-26","page":26,"lines":[{"cnt":[[116,163],[1901,163],[1901,217],[116,217]],"region":{"top_left_x":116,"top_left_y":163,"width":1786,"height":54},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a681a0466abe4b61b6e18a03d01d96e6","type":"text","conversion_output":true,"text":"4.2.2 Sources of Materials: Following written informed consent, the research materials will come from 3","text_display":"\n4.2.2 Sources of Materials: Following written informed consent, the research materials will come from 3","confidence":0.99462890625,"confidence_rate":0.9999496688373789},{"cnt":[[116,215],[277,215],[277,260],[116,260]],"region":{"top_left_x":116,"top_left_y":214,"width":162,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e4813c103594eedb1495ec6881a86ef","type":"text","conversion_output":true,"text":"sources:","text_display":" sources:","confidence":1,"confidence_rate":1},{"cnt":[[116,254],[1998,254],[1998,305],[116,305]],"region":{"top_left_x":116,"top_left_y":253,"width":1883,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93aafefd52f64f92af1ec263b2e9ae80","type":"text","conversion_output":true,"text":"1) Interviews of patients, and when indicated, other reliable informants. Interviews and rating scales described","text_display":"\n1) Interviews of patients, and when indicated, other reliable informants. Interviews and rating scales described","confidence":0.99560546875,"confidence_rate":0.9999623578402365},{"cnt":[[116,301],[1919,301],[1919,350],[116,350]],"region":{"top_left_x":116,"top_left_y":300,"width":1803,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03adb1d82e9b415c9205db91693c5b04","type":"text","conversion_output":true,"text":"in Section 5.4 will be administered by trained research associates to patients. In the case of some scales,","text_display":" in Section 5.4 will be administered by trained research associates to patients. In the case of some scales,","confidence":1,"confidence_rate":1},{"cnt":[[116,344],[1852,344],[1852,397],[116,397]],"region":{"top_left_x":116,"top_left_y":343,"width":1736,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82566acf0e73426ca93b824f9dfb30cb","type":"text","conversion_output":true,"text":"collateral information will also be obtained from a reliable informant who is familiar with the participant.","text_display":" collateral information will also be obtained from a reliable informant who is familiar with the participant.","confidence":1,"confidence_rate":1},{"cnt":[[116,387],[1970,387],[1970,440],[116,440]],"region":{"top_left_x":116,"top_left_y":386,"width":1855,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a67fa9efa2d4ac186000bdb783a55b4","type":"text","conversion_output":true,"text":"2) Medical and pharmacy records: information from inpatient and outpatient medical records will, at times, be","text_display":"\n2) Medical and pharmacy records: information from inpatient and outpatient medical records will, at times, be","confidence":0.9990236759185791,"confidence_rate":0.9999914316069175},{"cnt":[[116,432],[1998,432],[1998,483],[116,483]],"region":{"top_left_x":116,"top_left_y":431,"width":1883,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"230430c6402a47ee9465657eb404b956","type":"text","conversion_output":true,"text":"used to supplement information obtained from patients and reliable informants, to facilitate completion of rating","text_display":" used to supplement information obtained from patients and reliable informants, to facilitate completion of rating","confidence":1,"confidence_rate":1},{"cnt":[[116,477],[1970,477],[1970,526],[116,526]],"region":{"top_left_x":116,"top_left_y":476,"width":1855,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7620fd5a951042f18d8c26f09f424107","type":"text","conversion_output":true,"text":"scales. In addition, information from pharmacy records may at times be required for completion of the ATHF,","text_display":" scales. In addition, information from pharmacy records may at times be required for completion of the ATHF,","confidence":1,"confidence_rate":1},{"cnt":[[114,520],[1916,520],[1916,571],[114,571]],"region":{"top_left_x":113,"top_left_y":519,"width":1804,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fab635f864c84bd8b9a35efb302d054e","type":"text","conversion_output":true,"text":"which rates the type and adequacy of antidepressant and antipsychotic treatment received by participants","text_display":" which rates the type and adequacy of antidepressant and antipsychotic treatment received by participants","confidence":1,"confidence_rate":1},{"cnt":[[116,563],[797,563],[797,612],[116,612]],"region":{"top_left_x":116,"top_left_y":562,"width":682,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d14b7c4ffa9346a98f983ace2ec000de","type":"text","conversion_output":true,"text":"during the index episode of depression.","text_display":" during the index episode of depression.","confidence":1,"confidence_rate":1},{"cnt":[[114,606],[2004,606],[2004,660],[114,660]],"region":{"top_left_x":113,"top_left_y":605,"width":1892,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"484e3e132a0e41458fbac1d4fd709531","type":"text","conversion_output":true,"text":"3) Blood tests: tests for genetic analyses, metabolic analyses, and sertraline and olanzapine plasma levels, will","text_display":"\n3) Blood tests: tests for genetic analyses, metabolic analyses, and sertraline and olanzapine plasma levels, will","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[116,649],[1059,649],[1059,703],[116,703]],"region":{"top_left_x":116,"top_left_y":648,"width":944,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20911e32ee9545a592c84f1a0dd141f0","type":"text","conversion_output":true,"text":"be based on blood samples obtained from participants.","text_display":" be based on blood samples obtained from participants.","confidence":1,"confidence_rate":1},{"cnt":[[114,735],[1931,735],[1931,793],[114,793]],"region":{"top_left_x":113,"top_left_y":734,"width":1819,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b74baf2eede4455af181a3a027cca3e","type":"text","conversion_output":true,"text":"4.2.3 Potential Risks: The most common side effects associated with the use of sertraline and olanzapine in","text_display":"\n4.2.3 Potential Risks: The most common side effects associated with the use of sertraline and olanzapine in","confidence":1,"confidence_rate":1},{"cnt":[[116,782],[1966,782],[1966,836],[116,836]],"region":{"top_left_x":116,"top_left_y":782,"width":1850,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b7598f8539940c9a03363b27c42946a","type":"text","conversion_output":true,"text":"STOP-PD (occurring in more than \\(10 \\%\\) of participants) were: weight gain, somnolence/sedation, gastrointestinal","text_display":" STOP-PD (occurring in more than \\(10 \\%\\) of participants) were: weight gain, somnolence/sedation, gastrointestinal","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[116,827],[1962,827],[1962,879],[116,879]],"region":{"top_left_x":116,"top_left_y":827,"width":1846,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4138f7d61c98424689e1bb7172b9e69e","type":"text","conversion_output":true,"text":"symptoms, experiencing at least one fall, and orthostatic dizziness. In addition, elevated levels of blood glucose,","text_display":" symptoms, experiencing at least one fall, and orthostatic dizziness. In addition, elevated levels of blood glucose,","confidence":1,"confidence_rate":1},{"cnt":[[116,870],[1871,870],[1871,922],[116,922]],"region":{"top_left_x":116,"top_left_y":870,"width":1756,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36081dbcc97c458191faf7bd92cb6fbe","type":"text","conversion_output":true,"text":"cholesterol and triglycerides have been associated with olanzapine. Olanzapine, along with other atypical","text_display":" cholesterol and triglycerides have been associated with olanzapine. Olanzapine, along with other atypical","confidence":1,"confidence_rate":1},{"cnt":[[116,915],[1938,915],[1938,967],[116,967]],"region":{"top_left_x":116,"top_left_y":915,"width":1822,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb3e2f623bba461794eed64a8ae03c43","type":"text","conversion_output":true,"text":"antipsychotics, has been associated with a slight increased absolute risk of cerebrovascular events (mainly","text_display":" antipsychotics, has been associated with a slight increased absolute risk of cerebrovascular events (mainly","confidence":1,"confidence_rate":1},{"cnt":[[116,958],[1979,958],[1979,1012],[116,1012]],"region":{"top_left_x":116,"top_left_y":958,"width":1863,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1ac1149cc144d048c43d40b4ff2c0e5","type":"text","conversion_output":true,"text":"TIAs) in persons with severe dementia. However, we will not be including persons with dementia in this study.","text_display":" TIAs) in persons with severe dementia. However, we will not be including persons with dementia in this study.","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[116,1001],[1897,1001],[1897,1055],[116,1055]],"region":{"top_left_x":116,"top_left_y":1001,"width":1782,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e151aaf02774fd9bd97c036c20d89a2","type":"text","conversion_output":true,"text":"Users of antipsychotic drugs have an increased risk of mortality compared with non-users of this class of","text_display":" Users of antipsychotic drugs have an increased risk of mortality compared with non-users of this class of","confidence":1,"confidence_rate":1},{"cnt":[[116,1044],[1897,1044],[1897,1098],[116,1098]],"region":{"top_left_x":116,"top_left_y":1044,"width":1782,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2aa11e22497463cac3e11a445795b42","type":"text","conversion_output":true,"text":"drugs: in the case of users of olanzapine, the increased absolute risk across diagnostic groups has been","text_display":" drugs: in the case of users of olanzapine, the increased absolute risk across diagnostic groups has been","confidence":1,"confidence_rate":1},{"cnt":[[116,1085],[1957,1085],[1957,1143],[116,1143]],"region":{"top_left_x":116,"top_left_y":1084,"width":1842,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27cf9b48cef847afb3e27bc5ad169c29","type":"text","conversion_output":true,"text":"estimated at \\(0.9 \\%\\) over \\(2-3\\) years of current use. \\({ }^{162}\\) We will explicitly discuss the potential mortality risk in the","text_display":" estimated at \\(0.9 \\%\\) over \\(2-3\\) years of current use. \\({ }^{162}\\) We will explicitly discuss the potential mortality risk in the","confidence":0.99951171875,"confidence_rate":0.9999964088263151},{"cnt":[[116,1130],[1394,1130],[1394,1188],[116,1188]],"region":{"top_left_x":116,"top_left_y":1130,"width":1279,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f331971f53c54a99adb263ec5af4da45","type":"text","conversion_output":true,"text":"consent process. Blood tests may cause some minor discomfort or bruising.","text_display":" consent process. Blood tests may cause some minor discomfort or bruising.","confidence":1,"confidence_rate":1},{"cnt":[[116,1220],[1979,1220],[1979,1274],[116,1274]],"region":{"top_left_x":116,"top_left_y":1220,"width":1863,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce034f2a0ca1419d91941ca7c43a629b","type":"text","conversion_output":true,"text":"Severe depression increases the risk of suicidal ideation and behavior. Participation in the study will likely reduce","text_display":"\n\nSevere depression increases the risk of suicidal ideation and behavior. Participation in the study will likely reduce","confidence":1,"confidence_rate":1},{"cnt":[[116,1263],[1914,1263],[1914,1319],[116,1319]],"region":{"top_left_x":116,"top_left_y":1263,"width":1799,"height":57},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"947a8094c5a7481a9c35e7474958acbf","type":"text","conversion_output":true,"text":"this risk, but this is not guaranteed. The FDA recommends close observation of people taking antidepressant","text_display":" this risk, but this is not guaranteed. The FDA recommends close observation of people taking antidepressant","confidence":1,"confidence_rate":1},{"cnt":[[116,1311],[1910,1311],[1910,1364],[116,1364]],"region":{"top_left_x":116,"top_left_y":1310,"width":1794,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65fe61fdb0854a83860ec73992ec5331","type":"text","conversion_output":true,"text":"medication, including sertraline, for worsening depression or the emergence of suicidal thoughts or plans. As","text_display":" medication, including sertraline, for worsening depression or the emergence of suicidal thoughts or plans. As","confidence":1,"confidence_rate":1},{"cnt":[[116,1354],[1729,1354],[1729,1407],[116,1407]],"region":{"top_left_x":116,"top_left_y":1353,"width":1614,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"172486693b504eeabddb795b4a5e7ff7","type":"text","conversion_output":true,"text":"described in Section 3.9.5 participants will be closely monitored for suicidal ideation and behavior.","text_display":" described in Section 3.9.5 participants will be closely monitored for suicidal ideation and behavior.","confidence":1,"confidence_rate":1},{"cnt":[[116,1439],[1944,1439],[1944,1493],[116,1493]],"region":{"top_left_x":116,"top_left_y":1439,"width":1829,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccdce0553a5f44c684ed098dbc6f185a","type":"text","conversion_output":true,"text":"Discontinuation of antipsychotic medication in PD may possibly be associated with an increased risk of relapse","text_display":"\n\nDiscontinuation of antipsychotic medication in PD may possibly be associated with an increased risk of relapse","confidence":1,"confidence_rate":1},{"cnt":[[116,1485],[1794,1485],[1794,1538],[116,1538]],"region":{"top_left_x":116,"top_left_y":1484,"width":1678,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0557739a221c421ea5abce846b00be18","type":"text","conversion_output":true,"text":"and recurrence of PD, although this is not known. We have estimated the overall risk of relapse to be","text_display":" and recurrence of PD, although this is not known. We have estimated the overall risk of relapse to be","confidence":1,"confidence_rate":1},{"cnt":[[116,1530],[1635,1530],[1635,1583],[116,1583]],"region":{"top_left_x":116,"top_left_y":1529,"width":1519,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68b93fdf5e3247f597a34922f8a48384","type":"text","conversion_output":true,"text":"approximately \\(25 \\%\\) during the course of the RCT. Cases of relapse will be treated promptly.","text_display":" approximately \\(25 \\%\\) during the course of the RCT. Cases of relapse will be treated promptly.","confidence":0.998046875,"confidence_rate":0.9999800508639274},{"cnt":[[116,1616],[1996,1616],[1996,1669],[116,1669]],"region":{"top_left_x":116,"top_left_y":1615,"width":1880,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1a2c645d2e645b78d990d93349cee1b","type":"text","conversion_output":true,"text":"Alternative Treatments: ECT can be used to successfully treat PD. However, ECT is associated with its own risks,","text_display":"\n\nAlternative Treatments: ECT can be used to successfully treat PD. However, ECT is associated with its own risks,","confidence":1,"confidence_rate":1},{"cnt":[[116,1659],[1996,1659],[1996,1712],[116,1712]],"region":{"top_left_x":116,"top_left_y":1658,"width":1880,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e3e90293cf24558959bae9965934463","type":"text","conversion_output":true,"text":"including cognitive impairment, cardiac arrythmias, musculoskeletal injury, damage to teeth, and very small risk of","text_display":" including cognitive impairment, cardiac arrythmias, musculoskeletal injury, damage to teeth, and very small risk of","confidence":1,"confidence_rate":1},{"cnt":[[116,1706],[2000,1706],[2000,1760],[116,1760]],"region":{"top_left_x":116,"top_left_y":1705,"width":1885,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"569c8a17caa14343840e6077f7d44470","type":"text","conversion_output":true,"text":"death. Although ECT is a successful acute treatment for PD, it is associated with up to a \\(50 \\%\\) risk of relapse of PD","text_display":" death. Although ECT is a successful acute treatment for PD, it is associated with up to a \\(50 \\%\\) risk of relapse of PD","confidence":0.99853515625,"confidence_rate":0.9999880820410805},{"cnt":[[116,1749],[1813,1749],[1813,1800],[116,1800]],"region":{"top_left_x":116,"top_left_y":1748,"width":1698,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"359d2e7caa2c42f4b7e69b5f8db36169","type":"text","conversion_output":true,"text":"in the 6 months following discontinuation of ECT. Antidepressant medications other than sertraline and","text_display":" in the 6 months following discontinuation of ECT. Antidepressant medications other than sertraline and","confidence":1,"confidence_rate":1},{"cnt":[[114,1792],[2004,1792],[2004,1846],[114,1846]],"region":{"top_left_x":113,"top_left_y":1791,"width":1892,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"005a453a2f0b4f6d8aec1f39eabd1438","type":"text","conversion_output":true,"text":"antipsychotic medications other than olanzapine are used in clinical practice to treat PD. However, as discussed in","text_display":" antipsychotic medications other than olanzapine are used in clinical practice to treat PD. However, as discussed in","confidence":1,"confidence_rate":1},{"cnt":[[116,1835],[1846,1835],[1846,1893],[116,1893]],"region":{"top_left_x":116,"top_left_y":1834,"width":1730,"height":59},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"099ce8592fd946a98b0fec83772494f0","type":"text","conversion_output":true,"text":"Section 3.5, olanzapine is the only atypical antipsychotic with evidence of efficacy in the treatment of PD.","text_display":" Section 3.5, olanzapine is the only atypical antipsychotic with evidence of efficacy in the treatment of PD.","confidence":0.9951171875,"confidence_rate":0.9999566843684435},{"cnt":[[110,1916],[1038,1916],[1038,1979],[110,1979]],"region":{"top_left_x":109,"top_left_y":1916,"width":929,"height":63},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2358bfd05cb94f2f97ae4b2efb8bbaef","type":"section_header","conversion_output":false,"children_ids":["78cdb4ad3e1e45938a44d0d5b267aa88"],"text":"","text_display":""},{"cnt":[[116,1921],[1029,1921],[1029,1970],[116,1970]],"region":{"top_left_x":116,"top_left_y":1920,"width":914,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78cdb4ad3e1e45938a44d0d5b267aa88","type":"text","conversion_output":true,"parent_id":"2358bfd05cb94f2f97ae4b2efb8bbaef","text":"4.3 ADEQUACY OF PROTECTION AGAINST RISKS","text_display":"\n\n\\subsection*{4.3 ADEQUACY OF PROTECTION AGAINST RISKS}","confidence":1,"confidence_rate":1},{"cnt":[[107,2002],[879,2002],[879,2067],[107,2067]],"region":{"top_left_x":107,"top_left_y":2002,"width":772,"height":65},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65e5cb7e99834aefbc55bc6286f591a9","type":"section_header","conversion_output":false,"children_ids":["6cf514aecb2e4215b6ec80025c35e5c5"],"text":"","text_display":""},{"cnt":[[116,2007],[870,2007],[870,2060],[116,2060]],"region":{"top_left_x":116,"top_left_y":2006,"width":755,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cf514aecb2e4215b6ec80025c35e5c5","type":"text","conversion_output":true,"parent_id":"65e5cb7e99834aefbc55bc6286f591a9","text":"4.3.1 Recruitment and Informed Consent","text_display":"\n\n\\subsection*{4.3.1 Recruitment and Informed Consent}","confidence":1,"confidence_rate":1},{"cnt":[[116,2054],[1912,2054],[1912,2108],[116,2108]],"region":{"top_left_x":116,"top_left_y":2053,"width":1797,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"740f7e969aff4ab1b735ad3ece8bd148","type":"text","conversion_output":true,"text":"Recruitment: It is imperative to screen, recruit and treat study participants as quickly as possible. This is","text_display":"\n\nRecruitment: It is imperative to screen, recruit and treat study participants as quickly as possible. This is","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[116,2101],[1914,2101],[1914,2153],[116,2153]],"region":{"top_left_x":116,"top_left_y":2101,"width":1799,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ccba59844b944179f43148a93b37262","type":"text","conversion_output":true,"text":"emphasized because patients with PD are frequently recruited from inpatient services and these units are","text_display":" emphasized because patients with PD are frequently recruited from inpatient services and these units are","confidence":1,"confidence_rate":1},{"cnt":[[116,2144],[1979,2144],[1979,2196],[116,2196]],"region":{"top_left_x":116,"top_left_y":2144,"width":1863,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1011a0077e5342f0879b596c244b9c6e","type":"text","conversion_output":true,"text":"under pressure to begin treatment rapidly. The study coordinator and principal investigator, both of whom will","text_display":" under pressure to begin treatment rapidly. The study coordinator and principal investigator, both of whom will","confidence":1,"confidence_rate":1},{"cnt":[[116,2187],[1966,2187],[1966,2239],[116,2239]],"region":{"top_left_x":116,"top_left_y":2187,"width":1850,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22a351d797ed41ec9d9bd2ff1c970aff","type":"text","conversion_output":true,"text":"be on beeper call, will aim to ensure that potential subjects are screened by the research associate within 24","text_display":" be on beeper call, will aim to ensure that potential subjects are screened by the research associate within 24","confidence":1,"confidence_rate":1},{"cnt":[[116,2230],[1910,2230],[1910,2284],[116,2284]],"region":{"top_left_x":116,"top_left_y":2230,"width":1794,"height":54},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30179d44a2624738a32f29e2350509e0","type":"text","conversion_output":true,"text":"hours of admission to a clinical service, or as close to that time frame as possible for patients admitted on","text_display":" hours of admission to a clinical service, or as close to that time frame as possible for patients admitted on","confidence":1,"confidence_rate":1},{"cnt":[[116,2275],[2000,2275],[2000,2327],[116,2327]],"region":{"top_left_x":116,"top_left_y":2275,"width":1885,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"683911c1c15f48c29818b5b81d2ebc24","type":"text","conversion_output":true,"text":"weekends. Each principal investigator has considerable experience in recruiting and studying patients with PD.","text_display":" weekends. Each principal investigator has considerable experience in recruiting and studying patients with PD.","confidence":1,"confidence_rate":1},{"cnt":[[116,2320],[1944,2320],[1944,2374],[116,2374]],"region":{"top_left_x":116,"top_left_y":2320,"width":1829,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3b340aca1d24bb9a91a849f40292daa","type":"text","conversion_output":true,"text":"In addition, by maintaining close communications with the admitting personnel of participating hospitals, the","text_display":" In addition, by maintaining close communications with the admitting personnel of participating hospitals, the","confidence":1,"confidence_rate":1},{"cnt":[[116,2365],[1934,2365],[1934,2417],[116,2417]],"region":{"top_left_x":116,"top_left_y":2365,"width":1818,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c515912262a94924bc2234631c0b660d","type":"text","conversion_output":true,"text":"principal investigator and study coordinator will be aware of scheduled admissions that may meet inclusion","text_display":" principal investigator and study coordinator will be aware of scheduled admissions that may meet inclusion","confidence":1,"confidence_rate":1},{"cnt":[[116,2408],[1871,2408],[1871,2460],[116,2460]],"region":{"top_left_x":116,"top_left_y":2408,"width":1756,"height":52},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d320c8e23c1c4477839a2ca86ab06cef","type":"text","conversion_output":true,"text":"criteria before they arrive at the hospital. The research associate will discuss potential subjects with the","text_display":" criteria before they arrive at the hospital. The research associate will discuss potential subjects with the","confidence":1,"confidence_rate":1},{"cnt":[[116,2451],[2004,2451],[2004,2503],[116,2503]],"region":{"top_left_x":116,"top_left_y":2451,"width":1889,"height":52},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11be075a04d542b48081b5ed0b821e62","type":"text","conversion_output":true,"text":"treating physician about potential suitability. The study coordinator and principal investigator will be contacted if","text_display":" treating physician about potential suitability. The study coordinator and principal investigator will be contacted if","confidence":1,"confidence_rate":1},{"cnt":[[116,2496],[1927,2496],[1927,2548],[116,2548]],"region":{"top_left_x":116,"top_left_y":2496,"width":1812,"height":53},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38dd304b697e4f9888f367e250067724","type":"text","conversion_output":true,"text":"the treating physician agrees that the patient is suffering from a unipolar delusional PD and the patient has","text_display":" the treating physician agrees that the patient is suffering from a unipolar delusional PD and the patient has","confidence":1,"confidence_rate":1},{"cnt":[[1955,2574],[2009,2574],[2009,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2573,"width":54,"height":55},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7685075d14240068da980cd2614a4c6","type":"page_info","conversion_output":false,"text":"\\(\\underline{24}\\)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-27","page":27,"lines":[{"cnt":[[120,125],[1897,125],[1897,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1778,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0df70dc68944468ab9a7cba9631003c0","type":"text","conversion_output":true,"text":"agreed to meet with the research team. This will facilitate rapid screening and scheduling of a meeting to","text_display":"\nagreed to meet with the research team. This will facilitate rapid screening and scheduling of a meeting to","confidence":1,"confidence_rate":1},{"cnt":[[120,172],[1957,172],[1957,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":1838,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"029f2b4de1aa436e9f0d342f1075aa65","type":"text","conversion_output":true,"text":"assess eligibility and of capacity assessment soon after admission. For scheduled admissions, the research","text_display":" assess eligibility and of capacity assessment soon after admission. For scheduled admissions, the research","confidence":1,"confidence_rate":1},{"cnt":[[120,215],[1985,215],[1985,262],[120,262]],"region":{"top_left_x":120,"top_left_y":214,"width":1866,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"872ca6e4cbb74a209215260a4854bb1b","type":"text","conversion_output":true,"text":"team will attempt to schedule a preliminary meeting with the patient and accompanying family members at the","text_display":" team will attempt to schedule a preliminary meeting with the patient and accompanying family members at the","confidence":1,"confidence_rate":1},{"cnt":[[120,260],[1472,260],[1472,307],[120,307]],"region":{"top_left_x":120,"top_left_y":259,"width":1352,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0abd92f77dde45728aaec536e99813b3","type":"text","conversion_output":true,"text":"time of admission, if the treating physician and the patient agree to the meeting.","text_display":" time of admission, if the treating physician and the patient agree to the meeting.","confidence":1,"confidence_rate":1},{"cnt":[[120,344],[2002,344],[2002,393],[120,393]],"region":{"top_left_x":120,"top_left_y":343,"width":1883,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02fcb842af5c4269828b1992f524be75","type":"text","conversion_output":true,"text":"Informed Consent: PD may impair a person's capacity to consent to participate in a research study. To recruit","text_display":"\n\nInformed Consent: PD may impair a person's capacity to consent to participate in a research study. To recruit","confidence":1,"confidence_rate":1},{"cnt":[[120,389],[1996,389],[1996,436],[120,436]],"region":{"top_left_x":120,"top_left_y":388,"width":1876,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47166c582eec48c49cdc96573e63f132","type":"text","conversion_output":true,"text":"people who are representative of the population being studied, the study will allow people who do not have the","text_display":" people who are representative of the population being studied, the study will allow people who do not have the","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1966,434],[1966,483],[120,483]],"region":{"top_left_x":120,"top_left_y":433,"width":1846,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adbb9a1b8baf400b841eeeda88fe8a44","type":"text","conversion_output":true,"text":"capacity to give informed consent to participate in the open-label phase of the study (acute and stabilization),","text_display":" capacity to give informed consent to participate in the open-label phase of the study (acute and stabilization),","confidence":1,"confidence_rate":1},{"cnt":[[120,477],[1880,477],[1880,524],[120,524]],"region":{"top_left_x":120,"top_left_y":476,"width":1760,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0de33fa26318458e982732bcaa3731ee","type":"text","conversion_output":true,"text":"as long as they assent to participate and informed consent is obtained from a surrogate decision maker.","text_display":" as long as they assent to participate and informed consent is obtained from a surrogate decision maker.","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[2000,520],[2000,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1881,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c29c20462a7e4e628f4b7bf47053520b","type":"text","conversion_output":true,"text":"Subjects who are eligible for the randomized phase must have achieved sustained remission or near remission","text_display":" Subjects who are eligible for the randomized phase must have achieved sustained remission or near remission","confidence":1,"confidence_rate":1},{"cnt":[[120,563],[1841,563],[1841,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1722,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33b4311b6eb84a548db07f9e4217fa4d","type":"text","conversion_output":true,"text":"by the end of stabilization and will therefore need to be capable of giving informed consent in order to","text_display":" by the end of stabilization and will therefore need to be capable of giving informed consent in order to","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[120,610],[879,610],[879,657],[120,657]],"region":{"top_left_x":120,"top_left_y":610,"width":759,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad73c25955a0415fb8672b063869d8af","type":"text","conversion_output":true,"text":"participate in the randomized controlled trial.","text_display":" participate in the randomized controlled trial.","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1996,696],[1996,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1876,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30499475864444ba9e9ad28f3c8272fe","type":"text","conversion_output":true,"text":"We are not able to provide uniform criteria for appointment of a surrogate, because sites in the proposed study","text_display":"\n\nWe are not able to provide uniform criteria for appointment of a surrogate, because sites in the proposed study","confidence":1,"confidence_rate":1},{"cnt":[[120,741],[1927,741],[1927,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":1808,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b4e1e3372004b31bf44bc28263d1e1d","type":"text","conversion_output":true,"text":"differ in their local requirements for how surrogates are selected. The Cornell IRB, in accordance with New","text_display":" differ in their local requirements for how surrogates are selected. The Cornell IRB, in accordance with New","confidence":1,"confidence_rate":1},{"cnt":[[120,784],[2004,784],[2004,831],[120,831]],"region":{"top_left_x":120,"top_left_y":784,"width":1885,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48f61d4ac5d6404cb40af721802c4c02","type":"text","conversion_output":true,"text":"York State regulations, stipulates that incapable research participants must have the capacity to know that they","text_display":" York State regulations, stipulates that incapable research participants must have the capacity to know that they","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1996,829],[1996,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1876,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd1a6088197546f6901f24f5a6910461","type":"text","conversion_output":true,"text":"are appointing a surrogate and must be aware of their relationship to the surrogate they are appointing. On the","text_display":" are appointing a surrogate and must be aware of their relationship to the surrogate they are appointing. On the","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1996,872],[1996,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1876,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcfbb91a442e440eab8cce4a264a4ae5","type":"text","conversion_output":true,"text":"other hand, IRBs of the other sites of the proposed study stipulate a priority order in which potential surrogates","text_display":" other hand, IRBs of the other sites of the proposed study stipulate a priority order in which potential surrogates","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[1938,915],[1938,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1818,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42d8c7a727954a96a5d1c86b48b96cdd","type":"text","conversion_output":true,"text":"may be approached, although the details of the assigned order differ between sites. We will ensure that the","text_display":" may be approached, although the details of the assigned order differ between sites. We will ensure that the","confidence":1,"confidence_rate":1},{"cnt":[[120,958],[1936,958],[1936,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":958,"width":1816,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a02ae1849b724843919273889a2da710","type":"text","conversion_output":true,"text":"surrogate appointment process meets all local requirements and that the process to be used at each site is","text_display":" surrogate appointment process meets all local requirements and that the process to be used at each site is","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[578,1005],[578,1053],[120,1053]],"region":{"top_left_x":120,"top_left_y":1005,"width":458,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20aca470cb0a4528ac129535ecf9fcc4","type":"text","conversion_output":true,"text":"approved by the local IRB.","text_display":" approved by the local IRB.","confidence":0.9990234375,"confidence_rate":0.9999684830886739},{"cnt":[[120,1091],[1897,1091],[1897,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1778,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"632c4ccf03924cdfbcd9217b78f175b0","type":"text","conversion_output":true,"text":"To protect the rights of people whose decision making capacity may be impaired, those who are deemed","text_display":"\n\nTo protect the rights of people whose decision making capacity may be impaired, those who are deemed","confidence":1,"confidence_rate":1},{"cnt":[[120,1134],[1968,1134],[1968,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1134,"width":1848,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"481ff2645aaf414a94c398d33e60c7aa","type":"text","conversion_output":true,"text":"capable of consenting to treatment by the research psychiatrist will have a second capacity assessment. The","text_display":" capable of consenting to treatment by the research psychiatrist will have a second capacity assessment. The","confidence":0.99755859375,"confidence_rate":0.9999781753154674},{"cnt":[[120,1179],[1867,1179],[1867,1229],[120,1229]],"region":{"top_left_x":120,"top_left_y":1179,"width":1747,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"769683d06c8249c39374194a8b6a658e","type":"text","conversion_output":true,"text":"second assessment will be completed by either a licensed mental healthcare professional (psychiatrist,","text_display":" second assessment will be completed by either a licensed mental healthcare professional (psychiatrist,","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1919,1225],[1919,1270],[120,1270]],"region":{"top_left_x":120,"top_left_y":1224,"width":1799,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c12b17279b954c3d9b2bd1951be2e025","type":"text","conversion_output":true,"text":"psychologist, or mental health social worker) who is independent of the study or by a research associate's","text_display":" psychologist, or mental health social worker) who is independent of the study or by a research associate's","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[120,1263],[1936,1263],[1936,1317],[120,1317]],"region":{"top_left_x":120,"top_left_y":1263,"width":1816,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc2dc6d786a84deeb30837ac492fbff7","type":"text","conversion_output":true,"text":"administration of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). \\({ }^{163}\\) The","text_display":" administration of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). \\({ }^{163}\\) The","confidence":1,"confidence_rate":1},{"cnt":[[120,1311],[1979,1311],[1979,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1310,"width":1859,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1404a4c76744f63a86b317a87f5c544","type":"text","conversion_output":true,"text":"MacCAT-CR is a semi-structured interview for assessment of capacities related to consent to research. It has","text_display":" MacCAT-CR is a semi-structured interview for assessment of capacities related to consent to research. It has","confidence":1,"confidence_rate":1},{"cnt":[[120,1354],[1987,1354],[1987,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1353,"width":1868,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adc9c07674e14c4b910e54903d20fa8e","type":"text","conversion_output":true,"text":"been found to be a valid measure of capacity to consent in persons with psychosis. The principal investigators","text_display":" been found to be a valid measure of capacity to consent in persons with psychosis. The principal investigators","confidence":1,"confidence_rate":1},{"cnt":[[120,1401],[1944,1401],[1944,1448],[120,1448]],"region":{"top_left_x":120,"top_left_y":1400,"width":1825,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef31500384de4bd68710abf84ce497eb","type":"text","conversion_output":true,"text":"of this study were trained in the use of the MacCAT by Dr. Paul Applebaum, who developed the instrument;","text_display":" of this study were trained in the use of the MacCAT by Dr. Paul Applebaum, who developed the instrument;","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[1871,1444],[1871,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1443,"width":1752,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90a52fdea0e042d4b3ce780a19969f5d","type":"text","conversion_output":true,"text":"they have several years of experience in the use of this instrument in STOP-PD. Because time is of the","text_display":" they have several years of experience in the use of this instrument in STOP-PD. Because time is of the","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1876,1487],[1876,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1756,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99c4d339303744379b45917f2700cf37","type":"text","conversion_output":true,"text":"essence in starting treatment in a study of PD, use of the MacCAT-CR will allow for situations where an","text_display":" essence in starting treatment in a study of PD, use of the MacCAT-CR will allow for situations where an","confidence":1,"confidence_rate":1},{"cnt":[[120,1532],[1910,1532],[1910,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1531,"width":1790,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcc22d1c6f034cbfa487b754f9c31753","type":"text","conversion_output":true,"text":"independent healthcare professional cannot provide a timely capacity assessment. If the second capacity","text_display":" independent healthcare professional cannot provide a timely capacity assessment. If the second capacity","confidence":1,"confidence_rate":1},{"cnt":[[120,1575],[1923,1575],[1923,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1574,"width":1803,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ee7258ad8f64a5e96dc63188f5c2dc4","type":"text","conversion_output":true,"text":"assessment suggests that the person lacks capacity to consent, surrogate consent must then be obtained.","text_display":" assessment suggests that the person lacks capacity to consent, surrogate consent must then be obtained.","confidence":1,"confidence_rate":1},{"cnt":[[120,1663],[1893,1663],[1893,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1662,"width":1773,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cae5b01787a42d3a0839aea64d7e5bc","type":"text","conversion_output":true,"text":"All participants for whom surrogate consent is obtained at the start of the study will have their capacity to","text_display":"\n\nAll participants for whom surrogate consent is obtained at the start of the study will have their capacity to","confidence":1,"confidence_rate":1},{"cnt":[[120,1706],[2004,1706],[2004,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1705,"width":1885,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26e8b92c1abe4ae9a84798a6154db3fe","type":"text","conversion_output":true,"text":"consent to participate in the study re-assessed at the start of the stabilization phase. Given that participants will","text_display":" consent to participate in the study re-assessed at the start of the stabilization phase. Given that participants will","confidence":1,"confidence_rate":1},{"cnt":[[120,1749],[2004,1749],[2004,1798],[120,1798]],"region":{"top_left_x":120,"top_left_y":1748,"width":1885,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bdd32fdd13e4a3f80e330657f77350a","type":"text","conversion_output":true,"text":"have experienced remission of psychosis and remission or near remission of depressive symptoms by the start","text_display":" have experienced remission of psychosis and remission or near remission of depressive symptoms by the start","confidence":1,"confidence_rate":1},{"cnt":[[120,1796],[1979,1796],[1979,1843],[120,1843]],"region":{"top_left_x":120,"top_left_y":1796,"width":1859,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ed02997010f4681aaa5d5099be95256","type":"text","conversion_output":true,"text":"of stabilization, we expect that incapable participants will have gained capacity to consent to the study by that","text_display":" of stabilization, we expect that incapable participants will have gained capacity to consent to the study by that","confidence":1,"confidence_rate":1},{"cnt":[[120,1839],[1974,1839],[1974,1886],[120,1886]],"region":{"top_left_x":120,"top_left_y":1839,"width":1855,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a1184f403a94982806492f06fa62b51","type":"text","conversion_output":true,"text":"stage. Once a participant is deemed capable of consenting to treatment by the research psychiatrist, s/he will","text_display":" stage. Once a participant is deemed capable of consenting to treatment by the research psychiatrist, s/he will","confidence":0.9931640625,"confidence_rate":0.9999403547392763},{"cnt":[[120,1882],[1983,1882],[1983,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1882,"width":1864,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5088d6875764410b91a6cea1891d746","type":"text","conversion_output":true,"text":"have a second capacity assessment as described in the paragraph immediately above. If the second capacity","text_display":" have a second capacity assessment as described in the paragraph immediately above. If the second capacity","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[120,1927],[2007,1927],[2007,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1927,"width":1887,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d0fcaff54a649ca88ba89c6999ee0f7","type":"text","conversion_output":true,"text":"assessment finds that the participant has capacity to consent to participate in the study, the participant will then","text_display":" assessment finds that the participant has capacity to consent to participate in the study, the participant will then","confidence":1,"confidence_rate":1},{"cnt":[[120,1972],[900,1972],[900,2020],[120,2020]],"region":{"top_left_x":120,"top_left_y":1972,"width":781,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fd50c4e07394356b06dc623f28cea08","type":"text","conversion_output":true,"text":"be asked to provide written informed consent.","text_display":" be asked to provide written informed consent.","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[1996,2058],[1996,2108],[120,2108]],"region":{"top_left_x":120,"top_left_y":2058,"width":1876,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"593166fce1e34e2c972cce7b6946a152","type":"text","conversion_output":true,"text":"Participants will have their capacity assessed by the research psychiatrist at the end of 8 weeks of stabilization","text_display":"\n\nParticipants will have their capacity assessed by the research psychiatrist at the end of 8 weeks of stabilization","confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[120,2103],[1966,2103],[1966,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2103,"width":1846,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a57c7d08cb544a58cac0ffef723510b","type":"text","conversion_output":true,"text":"to determine whether they have capacity to give informed consent to participate in the randomized controlled","text_display":" to determine whether they have capacity to give informed consent to participate in the randomized controlled","confidence":1,"confidence_rate":1},{"cnt":[[120,2144],[1974,2144],[1974,2194],[120,2194]],"region":{"top_left_x":120,"top_left_y":2144,"width":1855,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47ba699ae3194a73a1d311a5182737c6","type":"text","conversion_output":true,"text":"trial. If the participant has capacity to consent to participate in the randomized trial, the participant will then be","text_display":" trial. If the participant has capacity to consent to participate in the randomized trial, the participant will then be","confidence":1,"confidence_rate":1},{"cnt":[[120,2189],[1919,2189],[1919,2237],[120,2237]],"region":{"top_left_x":120,"top_left_y":2189,"width":1799,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1e9edbd8a0e483cb978f9cb4a42a15d","type":"text","conversion_output":true,"text":"asked to provide written informed consent. Capacity to consent to the randomized trial will be required for","text_display":" asked to provide written informed consent. Capacity to consent to the randomized trial will be required for","confidence":1,"confidence_rate":1},{"cnt":[[120,2234],[947,2234],[947,2284],[120,2284]],"region":{"top_left_x":120,"top_left_y":2234,"width":828,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"929a0b728c2643f98f7697b53faf94b7","type":"text","conversion_output":true,"text":"subjects to participate in that phase of the study.","text_display":" subjects to participate in that phase of the study.","confidence":1,"confidence_rate":1},{"cnt":[[114,2316],[707,2316],[707,2374],[114,2374]],"region":{"top_left_x":113,"top_left_y":2316,"width":594,"height":59},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4963c63660af44d8a3a33248f608cb93","type":"section_header","conversion_output":false,"children_ids":["203c8faea6e442619edd1c4bf5e2be9a"],"text":"","text_display":""},{"cnt":[[120,2320],[698,2320],[698,2370],[120,2370]],"region":{"top_left_x":120,"top_left_y":2320,"width":579,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"203c8faea6e442619edd1c4bf5e2be9a","type":"text","conversion_output":true,"parent_id":"4963c63660af44d8a3a33248f608cb93","text":"4.3.2 Protections Against Risks","text_display":"\n\n\\subsection*{4.3.2 Protections Against Risks}","confidence":1,"confidence_rate":1},{"cnt":[[120,2408],[1970,2408],[1970,2456],[120,2456]],"region":{"top_left_x":120,"top_left_y":2408,"width":1851,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f57064a39ff4d598e1f7e6e9ecd7d2e","type":"text","conversion_output":true,"text":"Non-Response or Worsening of Depression: Patients who do not meet the study's remission criteria after","text_display":"\n\nNon-Response or Worsening of Depression: Patients who do not meet the study's remission criteria after","confidence":0.99853515625,"confidence_rate":0.9999862999285899},{"cnt":[[120,2454],[1979,2454],[1979,2503],[120,2503]],"region":{"top_left_x":120,"top_left_y":2453,"width":1859,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14cdacb9bcc64a9f8c1aabd51b2efc6e","type":"text","conversion_output":true,"text":"12 weeks of acute treatment with sertraline and olanzapine will not be eligible to participate in the stabilization","text_display":" 12 weeks of acute treatment with sertraline and olanzapine will not be eligible to participate in the stabilization","confidence":1,"confidence_rate":1},{"cnt":[[120,2496],[1919,2496],[1919,2546],[120,2546]],"region":{"top_left_x":120,"top_left_y":2496,"width":1799,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fefa720d8ef740a09dedfb946120b4dc","type":"text","conversion_output":true,"text":"phase and the RCT. These patients will leave the study at the end of 12 weeks of acute treatment and be","text_display":" phase and the RCT. These patients will leave the study at the end of 12 weeks of acute treatment and be","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2009,2578],[2009,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":54,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4384a3073b70481d80d71a2db8c197b3","type":"page_info","conversion_output":false,"text":"\\(\\underline{25}\\)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999023246709238}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-28","page":28,"lines":[{"cnt":[[116,122],[1983,122],[1983,174],[116,174]],"region":{"top_left_x":116,"top_left_y":122,"width":1868,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa4b3709d4064ec3858639deb2af5c60","type":"text","conversion_output":true,"text":"treated on a 'doctor's choice' basis by an attending physician. Participants who are judged to have significant","text_display":"\ntreated on a 'doctor's choice' basis by an attending physician. Participants who are judged to have significant","confidence":1,"confidence_rate":1},{"cnt":[[116,168],[2002,168],[2002,217],[116,217]],"region":{"top_left_x":116,"top_left_y":167,"width":1887,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb65a3f7220f4d058965c894a1ae1a97","type":"text","conversion_output":true,"text":"clinical worsening during the acute or stabilization phases of the study will be withdrawn from the study, so that","text_display":" clinical worsening during the acute or stabilization phases of the study will be withdrawn from the study, so that","confidence":1,"confidence_rate":1},{"cnt":[[116,213],[1966,213],[1966,262],[116,262]],"region":{"top_left_x":116,"top_left_y":212,"width":1850,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fad828fc6bb54195b7dfd492f63588f0","type":"text","conversion_output":true,"text":"treatment can be administered under routine clinical conditions by an attending physician. Significant clinical","text_display":" treatment can be administered under routine clinical conditions by an attending physician. Significant clinical","confidence":1,"confidence_rate":1},{"cnt":[[116,258],[1871,258],[1871,307],[116,307]],"region":{"top_left_x":116,"top_left_y":257,"width":1756,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21fbd66212c6479a9268fe195847d11f","type":"text","conversion_output":true,"text":"worsening will be operationalized as a CGI change score of 6 or 7 ('much worse' or 'very much worse').","text_display":" worsening will be operationalized as a CGI change score of 6 or 7 ('much worse' or 'very much worse').","confidence":0.9990236759185791,"confidence_rate":0.9999913557807578},{"cnt":[[116,344],[1944,344],[1944,393],[116,393]],"region":{"top_left_x":116,"top_left_y":343,"width":1829,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceb2940156444f3689677babda433d87","type":"text","conversion_output":true,"text":"Monitoring During and Following Antipsychotic Discontinuation: Study participants will have in-person","text_display":"\n\nMonitoring During and Following Antipsychotic Discontinuation: Study participants will have in-person","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[116,389],[1974,389],[1974,436],[116,436]],"region":{"top_left_x":116,"top_left_y":388,"width":1859,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24e040408ad74297a7d71e8d85a605e6","type":"text","conversion_output":true,"text":"research assessments on a weekly basis during the first 8 weeks of the RCT. These weekly assessments will","text_display":" research assessments on a weekly basis during the first 8 weeks of the RCT. These weekly assessments will","confidence":1,"confidence_rate":1},{"cnt":[[116,432],[1906,432],[1906,479],[116,479]],"region":{"top_left_x":116,"top_left_y":431,"width":1790,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f17f0a1a5444d479ed2ab44fcb4e974","type":"text","conversion_output":true,"text":"cover the period of olanzapine taper and its immediate aftermath, thereby providing intensive follow-up of","text_display":" cover the period of olanzapine taper and its immediate aftermath, thereby providing intensive follow-up of","confidence":1,"confidence_rate":1},{"cnt":[[116,477],[1914,477],[1914,526],[116,526]],"region":{"top_left_x":116,"top_left_y":476,"width":1799,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8b5ee58561f4767bd186343be79e6be","type":"text","conversion_output":true,"text":"patients during this period. In addition, for the remainder of the RCT, participants will be assessed every 2","text_display":" patients during this period. In addition, for the remainder of the RCT, participants will be assessed every 2","confidence":1,"confidence_rate":1},{"cnt":[[116,520],[1951,520],[1951,569],[116,569]],"region":{"top_left_x":116,"top_left_y":519,"width":1835,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c60602cd87574ebd95ba0764ddb6776d","type":"text","conversion_output":true,"text":"weeks (alternating research and clinical assessments) to monitor for the possibility of clinical worsening. If a","text_display":" weeks (alternating research and clinical assessments) to monitor for the possibility of clinical worsening. If a","confidence":0.998046875,"confidence_rate":0.9999832904401549},{"cnt":[[116,563],[1962,563],[1962,612],[116,612]],"region":{"top_left_x":116,"top_left_y":562,"width":1846,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"137a69f2429046d69553cec7befe7ebd","type":"text","conversion_output":true,"text":"participant experiences clinical worsening, he/ she will be seen on an urgent basis by a research psychiatrist","text_display":" participant experiences clinical worsening, he/ she will be seen on an urgent basis by a research psychiatrist","confidence":0.9990234375,"confidence_rate":0.9999915040391533},{"cnt":[[116,610],[1901,610],[1901,657],[116,657]],"region":{"top_left_x":116,"top_left_y":610,"width":1786,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6e830aa22b9436cab404ae4dedf4944","type":"text","conversion_output":true,"text":"associated with the study, to determine if the participant meets criteria for relapse or whether a change in","text_display":" associated with the study, to determine if the participant meets criteria for relapse or whether a change in","confidence":1,"confidence_rate":1},{"cnt":[[116,653],[1175,653],[1175,700],[116,700]],"region":{"top_left_x":116,"top_left_y":653,"width":1060,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39d89d4069d3469696609b1ba4a2bacc","type":"text","conversion_output":true,"text":"olanzapine/placebo dose or the use of lorazapam is indicated.","text_display":" olanzapine/placebo dose or the use of lorazapam is indicated.","confidence":0.99853515625,"confidence_rate":0.9999777893726824},{"cnt":[[116,739],[1888,739],[1888,788],[116,788]],"region":{"top_left_x":116,"top_left_y":739,"width":1773,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15af5a3ec45940db87b34039012ffa44","type":"text","conversion_output":true,"text":"Management of Relapse: Patients who meet relapse criteria will be referred to a psychiatrist who is not","text_display":"\n\nManagement of Relapse: Patients who meet relapse criteria will be referred to a psychiatrist who is not","confidence":1,"confidence_rate":1},{"cnt":[[116,784],[1962,784],[1962,831],[116,831]],"region":{"top_left_x":116,"top_left_y":784,"width":1846,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"750584e91fa342d48648b68b94ae37f4","type":"text","conversion_output":true,"text":"affiliated with the study, who has agreed to see patients within \\(48-72\\) hours of referral. Alternatively, patients","text_display":" affiliated with the study, who has agreed to see patients within \\(48-72\\) hours of referral. Alternatively, patients","confidence":0.9951171875,"confidence_rate":0.9999595481539275},{"cnt":[[116,829],[1998,829],[1998,879],[116,879]],"region":{"top_left_x":116,"top_left_y":829,"width":1883,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f05ac666782b4ffd8ec08ae517a37f07","type":"text","conversion_output":true,"text":"can be referred for acute psychiatric hospitalization, if deemed appropriate by the study psychiatrist. Based on","text_display":" can be referred for acute psychiatric hospitalization, if deemed appropriate by the study psychiatrist. Based on","confidence":1,"confidence_rate":1},{"cnt":[[116,872],[1893,872],[1893,922],[116,922]],"region":{"top_left_x":116,"top_left_y":872,"width":1777,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c24a639c34824c908b44472ce5f69521","type":"text","conversion_output":true,"text":"the frequency of relapse postulated for the study, we estimate that there will be an average of 3 cases of","text_display":" the frequency of relapse postulated for the study, we estimate that there will be an average of 3 cases of","confidence":1,"confidence_rate":1},{"cnt":[[116,915],[655,915],[655,965],[116,965]],"region":{"top_left_x":116,"top_left_y":915,"width":540,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7ef2e761e524d6da0887ae978dea17f","type":"text","conversion_output":true,"text":"relapse per year per study site.","text_display":" relapse per year per study site.","confidence":1,"confidence_rate":1},{"cnt":[[116,1001],[1876,1001],[1876,1051],[116,1051]],"region":{"top_left_x":116,"top_left_y":1001,"width":1760,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af553b57d7a245f5918914ad92a37ec4","type":"text","conversion_output":true,"text":"Management of Suicide Risk: Lifetime suicidal ideation and behavior will be assessed with the SCID.","text_display":"\n\nManagement of Suicide Risk: Lifetime suicidal ideation and behavior will be assessed with the SCID.","confidence":1,"confidence_rate":1},{"cnt":[[116,1044],[2000,1044],[2000,1096],[116,1096]],"region":{"top_left_x":116,"top_left_y":1044,"width":1885,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dc2b1c2aeb449cb8a532cf95706487d","type":"text","conversion_output":true,"text":"Suicidal thoughts, plans, and attempts during the study will be rated with the SSI. Patients at 'imminent risk' of","text_display":" Suicidal thoughts, plans, and attempts during the study will be rated with the SSI. Patients at 'imminent risk' of","confidence":1,"confidence_rate":1},{"cnt":[[116,1091],[1951,1091],[1951,1141],[116,1141]],"region":{"top_left_x":116,"top_left_y":1091,"width":1835,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4973f204dc094eeab2b59a456d5dbbb4","type":"text","conversion_output":true,"text":"suicide will not be enrolled in the study. Patients at 'high risk' of suicide must start the study as an inpatient.","text_display":" suicide will not be enrolled in the study. Patients at 'high risk' of suicide must start the study as an inpatient.","confidence":1,"confidence_rate":1},{"cnt":[[116,1134],[2009,1134],[2009,1184],[116,1184]],"region":{"top_left_x":116,"top_left_y":1134,"width":1893,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7064d1f53cf64f5e82b3b47c36f8d86b","type":"text","conversion_output":true,"text":"High risk of suicide is operationalized as any one of the following: 1) a current suicide plan; 2) a suicide attempt","text_display":" High risk of suicide is operationalized as any one of the following: 1) a current suicide plan; 2) a suicide attempt","confidence":0.994636058807373,"confidence_rate":0.9999555515764839},{"cnt":[[116,1179],[1884,1179],[1884,1227],[116,1227]],"region":{"top_left_x":116,"top_left_y":1179,"width":1769,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d657674c82d4b29b1d2a6f3b598aa36","type":"text","conversion_output":true,"text":"during the index episode; 3) one or more lifetime serious suicide attempts, defined as attempts requiring","text_display":" during the index episode; 3) one or more lifetime serious suicide attempts, defined as attempts requiring","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[116,1222],[1944,1222],[1944,1274],[116,1274]],"region":{"top_left_x":116,"top_left_y":1222,"width":1829,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88d36f83cc3a416eb9c8bbb8fc5f8b8c","type":"text","conversion_output":true,"text":"inpatient medical treatment. Suicidal ideation and behavior will be rated with the SSI at each study visit. As","text_display":" inpatient medical treatment. Suicidal ideation and behavior will be rated with the SSI at each study visit. As","confidence":1,"confidence_rate":1},{"cnt":[[116,1268],[1987,1268],[1987,1317],[116,1317]],"region":{"top_left_x":116,"top_left_y":1267,"width":1872,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00823974182c4a4b9b496c79b453118e","type":"text","conversion_output":true,"text":"outlined in Section 3.9.5, participants will be seen weekly by a research psychiatrist for the first 6 weeks of the","text_display":" outlined in Section 3.9.5, participants will be seen weekly by a research psychiatrist for the first 6 weeks of the","confidence":0.9956097602844238,"confidence_rate":0.9999642290534762},{"cnt":[[116,1311],[1794,1311],[1794,1360],[116,1360]],"region":{"top_left_x":116,"top_left_y":1310,"width":1678,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb2e4553c63148329ff342125e77a1b7","type":"text","conversion_output":true,"text":"Acute Phase of the study, and then every two weeks for the remainder of the Acute Phase and the","text_display":" Acute Phase of the study, and then every two weeks for the remainder of the Acute Phase and the","confidence":1,"confidence_rate":1},{"cnt":[[116,1354],[1983,1354],[1983,1403],[116,1403]],"region":{"top_left_x":116,"top_left_y":1353,"width":1868,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"136b61f3f1624a62ba2d7e1cb7690acf","type":"text","conversion_output":true,"text":"Stabilization Phase. If a participant has a current suicide plan or has had a current suicide attempt, he/she will","text_display":" Stabilization Phase. If a participant has a current suicide plan or has had a current suicide attempt, he/she will","confidence":1,"confidence_rate":1},{"cnt":[[116,1401],[1826,1401],[1826,1446],[116,1446]],"region":{"top_left_x":116,"top_left_y":1400,"width":1711,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2aa236b73d674ff19346328e2b5f69d0","type":"text","conversion_output":true,"text":"be removed from the study and the research psychiatrist will make a clinical decision about the most","text_display":" be removed from the study and the research psychiatrist will make a clinical decision about the most","confidence":1,"confidence_rate":1},{"cnt":[[116,1444],[1955,1444],[1955,1491],[116,1491]],"region":{"top_left_x":116,"top_left_y":1443,"width":1840,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"350d00a6daa14479a6d30c273a2fa6dd","type":"text","conversion_output":true,"text":"appropriate course of action, including whether the patient requires immediate hospitalization. In the case of","text_display":" appropriate course of action, including whether the patient requires immediate hospitalization. In the case of","confidence":1,"confidence_rate":1},{"cnt":[[116,1487],[1869,1487],[1869,1536],[116,1536]],"region":{"top_left_x":116,"top_left_y":1486,"width":1754,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5723fb13cf3240abb63cfc5f498d55cc","type":"text","conversion_output":true,"text":"participants who are found to have a current suicide plan or had a current suicide attempt based on the","text_display":" participants who are found to have a current suicide plan or had a current suicide attempt based on the","confidence":1,"confidence_rate":1},{"cnt":[[116,1532],[1974,1532],[1974,1579],[116,1579]],"region":{"top_left_x":116,"top_left_y":1531,"width":1859,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5118b1afd5f8473490175c71cd69838f","type":"text","conversion_output":true,"text":"research associate's clinical phone assessment, the research psychiatrist, who will be available by pager, will","text_display":" research associate's clinical phone assessment, the research psychiatrist, who will be available by pager, will","confidence":0.9985356330871582,"confidence_rate":0.9999873669750909},{"cnt":[[116,1575],[1927,1575],[1927,1622],[116,1622]],"region":{"top_left_x":116,"top_left_y":1574,"width":1812,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"893b122e31cc4da9be5c658bd383abbc","type":"text","conversion_output":true,"text":"be immediately informed by the research associate and the psychiatrist will then talk on the phone with the","text_display":" be immediately informed by the research associate and the psychiatrist will then talk on the phone with the","confidence":1,"confidence_rate":1},{"cnt":[[116,1620],[1852,1620],[1852,1669],[116,1669]],"region":{"top_left_x":116,"top_left_y":1619,"width":1736,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ff3e42ac7db40f58ac63b2be5f5c2cd","type":"text","conversion_output":true,"text":"participant. The psychiatrist will then make a decision about whether the patient should be referred for","text_display":" participant. The psychiatrist will then make a decision about whether the patient should be referred for","confidence":1,"confidence_rate":1},{"cnt":[[116,1663],[1835,1663],[1835,1712],[116,1712]],"region":{"top_left_x":116,"top_left_y":1662,"width":1719,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b8a9b58cec44975b855907a60f735cc","type":"text","conversion_output":true,"text":"immediate psychiatric hospitalization or whether it is safe for the participant to be seen for a research","text_display":" immediate psychiatric hospitalization or whether it is safe for the participant to be seen for a research","confidence":0.99462890625,"confidence_rate":0.9999510414718479},{"cnt":[[116,1706],[1525,1706],[1525,1755],[116,1755]],"region":{"top_left_x":116,"top_left_y":1705,"width":1410,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a8d330519f54e00a8ff8acda0240064","type":"text","conversion_output":true,"text":"termination visit, and subsequent clinical management, the following business day.","text_display":" termination visit, and subsequent clinical management, the following business day.","confidence":1,"confidence_rate":1},{"cnt":[[116,1792],[1996,1792],[1996,1843],[116,1843]],"region":{"top_left_x":116,"top_left_y":1791,"width":1880,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b71b769f00f4e1da30abfeca792e2b7","type":"text","conversion_output":true,"text":"If a participant has current suicide ideation (as indicated by a score of 1 or 2 on items \\#4 or 5 of the SSI) but no","text_display":"\n\nIf a participant has current suicide ideation (as indicated by a score of 1 or 2 on items \\#4 or 5 of the SSI) but no","confidence":0.6756609700406128,"confidence_rate":0.9969886673976786},{"cnt":[[116,1839],[1955,1839],[1955,1888],[116,1888]],"region":{"top_left_x":116,"top_left_y":1839,"width":1840,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9edc6572eb6542699ca6f1437c61683f","type":"text","conversion_output":true,"text":"current suicide plan or attempt, he/she may remain in the study at the discretion of the research psychiatrist,","text_display":" current suicide plan or attempt, he/she may remain in the study at the discretion of the research psychiatrist,","confidence":1,"confidence_rate":1},{"cnt":[[116,1882],[1987,1882],[1987,1931],[116,1931]],"region":{"top_left_x":116,"top_left_y":1882,"width":1872,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"417acdfeb8984fb48a583fcf6f135404","type":"text","conversion_output":true,"text":"based on the psychiatrist's clinical assessment of the participant's suicide risk. If the participant remains in the","text_display":" based on the psychiatrist's clinical assessment of the participant's suicide risk. If the participant remains in the","confidence":1,"confidence_rate":1},{"cnt":[[116,1927],[1828,1927],[1828,1974],[116,1974]],"region":{"top_left_x":116,"top_left_y":1927,"width":1713,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e371cbb14b4a4ab7b8049cab1cc0a8db","type":"text","conversion_output":true,"text":"study, he/she will be followed in-person by the research psychiatrist on a weekly basis to monitor the","text_display":" study, he/she will be followed in-person by the research psychiatrist on a weekly basis to monitor the","confidence":1,"confidence_rate":1},{"cnt":[[116,1972],[1927,1972],[1927,2020],[116,2020]],"region":{"top_left_x":116,"top_left_y":1972,"width":1812,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d954355f5b2c4d83beb6fc3d99660c0c","type":"text","conversion_output":true,"text":"participant's safety, to decide whether ongoing participation in the study is appropriate, and, if indicated, to","text_display":" participant's safety, to decide whether ongoing participation in the study is appropriate, and, if indicated, to","confidence":1,"confidence_rate":1},{"cnt":[[116,2015],[1921,2015],[1921,2065],[116,2065]],"region":{"top_left_x":116,"top_left_y":2015,"width":1805,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d93a4fc9311844a7a96b08615a74cd36","type":"text","conversion_output":true,"text":"adjust the dosages of study medications as allowed by the treatment protocol. These weekly clinical visits,","text_display":" adjust the dosages of study medications as allowed by the treatment protocol. These weekly clinical visits,","confidence":1,"confidence_rate":1},{"cnt":[[116,2058],[1906,2058],[1906,2108],[116,2108]],"region":{"top_left_x":116,"top_left_y":2058,"width":1790,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5a5b74f102a417e87732757d4b69239","type":"text","conversion_output":true,"text":"which will be in addition to the scheduled research assessment visits, will continue until the participant no","text_display":" which will be in addition to the scheduled research assessment visits, will continue until the participant no","confidence":1,"confidence_rate":1},{"cnt":[[116,2101],[1510,2101],[1510,2151],[116,2151]],"region":{"top_left_x":116,"top_left_y":2101,"width":1395,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a6c43b6dcb5450592fe5650bf5c719c","type":"text","conversion_output":true,"text":"longer has suicidal ideation or is removed form the study and managed 'clinically'.","text_display":" longer has suicidal ideation or is removed form the study and managed 'clinically'.","confidence":1,"confidence_rate":1},{"cnt":[[116,2187],[1962,2187],[1962,2237],[116,2237]],"region":{"top_left_x":116,"top_left_y":2187,"width":1846,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d02694e1d53742b2a113d40091a94387","type":"text","conversion_output":true,"text":"Adverse Effects: Side effects will be systematically monitored at each assessment and visit (Section 3.9.5).","text_display":"\n\nAdverse Effects: Side effects will be systematically monitored at each assessment and visit (Section 3.9.5).","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[116,2230],[1962,2230],[1962,2282],[116,2282]],"region":{"top_left_x":116,"top_left_y":2230,"width":1846,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63b5782776b54b1691d88fd60ca12395","type":"text","conversion_output":true,"text":"As described in Section 3.9.9 and the appended Pharmacotherapy Protocol, reduction in dosing of sertraline","text_display":" As described in Section 3.9.9 and the appended Pharmacotherapy Protocol, reduction in dosing of sertraline","confidence":1,"confidence_rate":1},{"cnt":[[116,2277],[1972,2277],[1972,2327],[116,2327]],"region":{"top_left_x":116,"top_left_y":2277,"width":1857,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d993d5284f74cf1976505bcb061d2bc","type":"text","conversion_output":true,"text":"and olanzapine, to specified minimum dosages, will be allowed during the acute and stabilization phases and","text_display":" and olanzapine, to specified minimum dosages, will be allowed during the acute and stabilization phases and","confidence":1,"confidence_rate":1},{"cnt":[[116,2320],[1989,2320],[1989,2370],[116,2370]],"region":{"top_left_x":116,"top_left_y":2320,"width":1874,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a0a02aa3d81435f91cdd0034389d0a5","type":"text","conversion_output":true,"text":"RCT, if necessitated by clinically significant side effects. In addition, benztropine can be prescribed if clinically","text_display":" RCT, if necessitated by clinically significant side effects. In addition, benztropine can be prescribed if clinically","confidence":0.9990234375,"confidence_rate":0.9999919915103647},{"cnt":[[116,2368],[1962,2368],[1962,2413],[116,2413]],"region":{"top_left_x":116,"top_left_y":2367,"width":1846,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb2ea9cdf0d44cb9bfef3632add4df9c","type":"text","conversion_output":true,"text":"significant extrapyramidal side effects do not adequately improve with a reduction in dose of olanzapine (see","text_display":" significant extrapyramidal side effects do not adequately improve with a reduction in dose of olanzapine (see","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[116,2411],[1962,2411],[1962,2460],[116,2460]],"region":{"top_left_x":116,"top_left_y":2410,"width":1846,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abd95fd5bf1347698453a357a1b40ad5","type":"text","conversion_output":true,"text":"Section 3.9.8 and appended Pharmacotherapy Protocol). Participants who are withdrawn from the study will","text_display":" Section 3.9.8 and appended Pharmacotherapy Protocol). Participants who are withdrawn from the study will","confidence":1,"confidence_rate":1},{"cnt":[[116,2454],[1261,2454],[1261,2503],[116,2503]],"region":{"top_left_x":116,"top_left_y":2453,"width":1146,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"431706edf54e4e95a973748dc4df089a","type":"text","conversion_output":true,"text":"be treated on a physician choice basis by their attending physician.","text_display":" be treated on a physician choice basis by their attending physician.","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2009,2578],[2009,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":54,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4360852c09e5445898fec416f57edd0f","type":"page_info","conversion_output":false,"text":"\\(\\underline{26}\\)","text_display":"","confidence":0.9990234375,"confidence_rate":0.9998046111613206}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-29","page":29,"lines":[{"cnt":[[120,125],[1981,125],[1981,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1861,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08dc49e3710e4241bd06b9d001068810","type":"text","conversion_output":true,"text":"Monitoring of metabolic effects: As described in the Schedule of Events (Section 3.9.5), metabolic parameters","text_display":"\n\nMonitoring of metabolic effects: As described in the Schedule of Events (Section 3.9.5), metabolic parameters","confidence":1,"confidence_rate":1},{"cnt":[[120,168],[1899,168],[1899,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":1780,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c717bb3b8994b13800a9bb8e2a5be39","type":"text","conversion_output":true,"text":"will be measured at week 4 of the Acute Phase and thereafter every 8 weeks of the study. If a participant","text_display":" will be measured at week 4 of the Acute Phase and thereafter every 8 weeks of the study. If a participant","confidence":1,"confidence_rate":1},{"cnt":[[120,215],[1979,215],[1979,260],[120,260]],"region":{"top_left_x":120,"top_left_y":214,"width":1859,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be6c534e2cdb442488bf903f4e70ab70","type":"text","conversion_output":true,"text":"develops clinically significant elevations of fasting serum glucose ( \\(>100 mg / dL\\) ), triglycerides ( \\(>150 mg / dL\\) ), total","text_display":" develops clinically significant elevations of fasting serum glucose ( \\(>100 mg / dL\\) ), triglycerides ( \\(>150 mg / dL\\) ), total","confidence":0.42518272528414736,"confidence_rate":0.9939097905349523},{"cnt":[[120,258],[1901,258],[1901,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1782,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf4ba84384c44bc2b5903d0f51ff3ef6","type":"text","conversion_output":true,"text":"cholesterol( \\(>200 mg / dL\\) ), and/or LDL cholesterol \\((>130 mg / dL )\\), s/he will be referred to his/her primary care","text_display":" cholesterol( \\(>200 mg / dL\\) ), and/or LDL cholesterol \\((>130 mg / dL )\\), s/he will be referred to his/her primary care","confidence":0.39696922023644543,"confidence_rate":0.9929721662555874},{"cnt":[[120,301],[1944,301],[1944,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1825,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9ff075f16054ecfaa92d074beab79c3","type":"text","conversion_output":true,"text":"physician (PCP) for further assessment and management of the metabolic finding(s), including a discussion","text_display":" physician (PCP) for further assessment and management of the metabolic finding(s), including a discussion","confidence":1,"confidence_rate":1},{"cnt":[[120,346],[1916,346],[1916,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1797,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0bac893bf9e413692a6e0dc27e68972","type":"text","conversion_output":true,"text":"about the risks and benefits of ongoing participation in the study. If a participant does not have a PCP, the","text_display":" about the risks and benefits of ongoing participation in the study. If a participant does not have a PCP, the","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1888,391],[1888,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1769,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10cea5ae0dee4ddaa11f58cf71205829","type":"text","conversion_output":true,"text":"research psychiatrist will refer the patient to a PCP who has agreed to see patients enrolled in the study.","text_display":" research psychiatrist will refer the patient to a PCP who has agreed to see patients enrolled in the study.","confidence":0.9990234375,"confidence_rate":0.999991276469766},{"cnt":[[120,477],[1888,477],[1888,524],[120,524]],"region":{"top_left_x":120,"top_left_y":476,"width":1769,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35a14a81ebe046098acb96ad0fc9d65e","type":"text","conversion_output":true,"text":"Confidentiality of Information: The consent form will stipulate that participants' information will remain","text_display":"\n\nConfidentiality of Information: The consent form will stipulate that participants' information will remain","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[2004,520],[2004,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1885,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0328c273c8f4418f819a73b48a9edb42","type":"text","conversion_output":true,"text":"strictly confidential, with access limited to research staff, and, if indicated, local IRBs, the NIMH-run DSMB, and","text_display":" strictly confidential, with access limited to research staff, and, if indicated, local IRBs, the NIMH-run DSMB, and","confidence":0.98974609375,"confidence_rate":0.9999141133575739},{"cnt":[[120,563],[1830,563],[1830,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1711,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"168781a5c2c543bbac253ed7888b93df","type":"text","conversion_output":true,"text":"state or federal regulatory personnel. No one but study personnel will have access to the lists linking","text_display":" state or federal regulatory personnel. No one but study personnel will have access to the lists linking","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[1858,610],[1858,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1739,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d49c4859010a441383ab7e1ec91318d4","type":"text","conversion_output":true,"text":"participant's names to code numbers. All information pertaining to participants will be coded to protect","text_display":" participant's names to code numbers. All information pertaining to participants will be coded to protect","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[1968,653],[1968,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1848,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc592c65543e4dd99c42f33789b2cef9","type":"text","conversion_output":true,"text":"participants' identities and will be stored in locked cabinets in locked offices of the investigators. Publications","text_display":" participants' identities and will be stored in locked cabinets in locked offices of the investigators. Publications","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1497,696],[1497,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1378,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c1c615c4d4d4a97abf88420f23a8762","type":"text","conversion_output":true,"text":"or presentations of findings will not include information that identifies participants.","text_display":" or presentations of findings will not include information that identifies participants.","confidence":1,"confidence_rate":1},{"cnt":[[120,782],[1998,782],[1998,831],[120,831]],"region":{"top_left_x":120,"top_left_y":782,"width":1879,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eda7cbb6d50a4f509c7010e699a1a8b5","type":"text","conversion_output":true,"text":"Sharing of Genetic Data: We plan to collaborate with the NIMH Center for Genetic Studies, a facility operated","text_display":"\n\nSharing of Genetic Data: We plan to collaborate with the NIMH Center for Genetic Studies, a facility operated","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1843,829],[1843,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1724,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ec2e14793f5410ca8263fbb599c4ace","type":"text","conversion_output":true,"text":"under federal contact to manage data and establish high-quality cell lines for human genetics projects","text_display":" under federal contact to manage data and establish high-quality cell lines for human genetics projects","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1996,872],[1996,920],[120,920]],"region":{"top_left_x":120,"top_left_y":872,"width":1876,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01f5b106b63449848299a6513697a3c9","type":"text","conversion_output":true,"text":"supported by NIMH. Our biomaterials and the associated clinical data will be incorporated with other such data","text_display":" supported by NIMH. Our biomaterials and the associated clinical data will be incorporated with other such data","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[1992,915],[1992,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1872,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a507947db98a44e9812dec691cc9f5aa","type":"text","conversion_output":true,"text":"and biomaterials as part of the NIMH Human Genetics Initiative. NIMH will then follow existing procedures and","text_display":" and biomaterials as part of the NIMH Human Genetics Initiative. NIMH will then follow existing procedures and","confidence":1,"confidence_rate":1},{"cnt":[[120,958],[1981,958],[1981,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":958,"width":1861,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ae6fbde0f11492383cc63aae262146e","type":"text","conversion_output":true,"text":"protocols and distribute these data and biomaterials to qualified researchers in the wider scientific community.","text_display":" protocols and distribute these data and biomaterials to qualified researchers in the wider scientific community.","confidence":0.9990234375,"confidence_rate":0.9999916492686468},{"cnt":[[120,1003],[1949,1003],[1949,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1003,"width":1829,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbea4216b70e43cebe8db503791fe7e6","type":"text","conversion_output":true,"text":"Please see Section 15 (Resource Sharing), for the detailed plan of sharing of biomaterials and data with the","text_display":" Please see Section 15 (Resource Sharing), for the detailed plan of sharing of biomaterials and data with the","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[698,1048],[698,1089],[120,1089]],"region":{"top_left_x":120,"top_left_y":1048,"width":579,"height":42},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f808f3ff28294bd58f2a9354ee492b12","type":"text","conversion_output":true,"text":"NIMH Center for Genetic Studies.","text_display":" NIMH Center for Genetic Studies.","confidence":0.99658203125,"confidence_rate":0.9999074685150978},{"cnt":[[120,1134],[1927,1134],[1927,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1134,"width":1808,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74b4141c9ea64b5ca4376083037af69e","type":"text","conversion_output":true,"text":"We are in receipt of the NIMH-written model consent form pertaining to the sharing of genetic data. We will","text_display":"\n\nWe are in receipt of the NIMH-written model consent form pertaining to the sharing of genetic data. We will","confidence":1,"confidence_rate":1},{"cnt":[[120,1179],[1992,1179],[1992,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1179,"width":1872,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4d6ffcbb03342cbb7280c45e24ae71f","type":"text","conversion_output":true,"text":"utilize this consent form, which will clearly stipulate: (1) disclosure that biological materials (DNA and cell lines)","text_display":" utilize this consent form, which will clearly stipulate: (1) disclosure that biological materials (DNA and cell lines)","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1970,1225],[1970,1270],[120,1270]],"region":{"top_left_x":120,"top_left_y":1224,"width":1851,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce01e584815e4ebf95c5c719cb60b4ea","type":"text","conversion_output":true,"text":"and clinical data will be stored at a central data management/laboratory facility, as part of a national resource","text_display":" and clinical data will be stored at a central data management/laboratory facility, as part of a national resource","confidence":1,"confidence_rate":1},{"cnt":[[120,1268],[1880,1268],[1880,1315],[120,1315]],"region":{"top_left_x":120,"top_left_y":1267,"width":1760,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35cabc1b61164a6b9e160ad79b0febdb","type":"text","conversion_output":true,"text":"of data and materials distributed by NIMH for the genetic analysis of the disease under investigation; (2)","text_display":" of data and materials distributed by NIMH for the genetic analysis of the disease under investigation; (2)","confidence":0.9892628192901611,"confidence_rate":0.9999027503127916},{"cnt":[[120,1313],[1936,1313],[1936,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1312,"width":1816,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fbf99b8bcf74f708ce7f4fc89db5a46","type":"text","conversion_output":true,"text":"assurance that such data will be provided to a central facility without personal identifiers; (3) disclosure that","text_display":" assurance that such data will be provided to a central facility without personal identifiers; (3) disclosure that","confidence":0.99072265625,"confidence_rate":0.9999210145912609},{"cnt":[[120,1358],[1966,1358],[1966,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1357,"width":1846,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a42122c4c4d34e73b24c715045208733","type":"text","conversion_output":true,"text":"analyses of these data will be conducted by other scientists currently not included within the current research","text_display":" analyses of these data will be conducted by other scientists currently not included within the current research","confidence":1,"confidence_rate":1},{"cnt":[[120,1401],[1953,1401],[1953,1446],[120,1446]],"region":{"top_left_x":120,"top_left_y":1400,"width":1833,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3b2b27a60064efd9eb19977cebd56b3","type":"text","conversion_output":true,"text":"team; and (4) disclosure that there is no plan to provide subjects with any financial benefits from commercial","text_display":" team; and (4) disclosure that there is no plan to provide subjects with any financial benefits from commercial","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,1444],[1962,1444],[1962,1489],[120,1489]],"region":{"top_left_x":120,"top_left_y":1443,"width":1842,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a0d445159844094bd25bcb3a4b4d820","type":"text","conversion_output":true,"text":"products derived from the data. We will provide NIMH with our approved consent form prior to the start of the","text_display":" products derived from the data. We will provide NIMH with our approved consent form prior to the start of the","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1798,1487],[1798,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1679,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f283c590c4144a9a05f4d5bf762783b","type":"text","conversion_output":true,"text":"proposed study. Any data-sharing with investigators outside of Cornell University, the University of","text_display":" proposed study. Any data-sharing with investigators outside of Cornell University, the University of","confidence":1,"confidence_rate":1},{"cnt":[[120,1532],[1944,1532],[1944,1577],[120,1577]],"region":{"top_left_x":120,"top_left_y":1531,"width":1825,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35ff03fc72064fbfabe7ec1a52f4b3be","type":"text","conversion_output":true,"text":"Massachusetts, the University of Pittsburgh, and University of Toronto will involve making all of shared data","text_display":" Massachusetts, the University of Pittsburgh, and University of Toronto will involve making all of shared data","confidence":1,"confidence_rate":1},{"cnt":[[120,1575],[1510,1575],[1510,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1574,"width":1391,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8693cfe07a941c1b59332bb33f50ef5","type":"text","conversion_output":true,"text":"anonymous (so that no identifiers could link data back to subjects), per IRB policy.","text_display":" anonymous (so that no identifiers could link data back to subjects), per IRB policy.","confidence":1,"confidence_rate":1},{"cnt":[[116,1659],[612,1659],[612,1708],[116,1708]],"region":{"top_left_x":116,"top_left_y":1658,"width":497,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d84610f6efa444c2b4d05a5ecc9c79f1","type":"section_header","conversion_output":false,"children_ids":["17f26c55e94e49b98f48f3b7049caeda"],"text":"","text_display":""},{"cnt":[[120,1663],[608,1663],[608,1704],[120,1704]],"region":{"top_left_x":120,"top_left_y":1662,"width":489,"height":42},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17f26c55e94e49b98f48f3b7049caeda","type":"text","conversion_output":true,"parent_id":"d84610f6efa444c2b4d05a5ecc9c79f1","text":"4.4 POTENTIAL BENEFITS","text_display":"\n\n\\subsection*{4.4 POTENTIAL BENEFITS}","confidence":1,"confidence_rate":1},{"cnt":[[129,1749],[801,1749],[801,1798],[129,1798]],"region":{"top_left_x":128,"top_left_y":1748,"width":674,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be6a9a04f4a843249aa50d5aa6a69019","type":"text","conversion_output":true,"text":"The benefits to participants will include:","text_display":"\n\nThe benefits to participants will include:","confidence":1,"confidence_rate":1},{"cnt":[[125,1796],[971,1796],[971,1841],[125,1841]],"region":{"top_left_x":124,"top_left_y":1796,"width":848,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49d62271eb164af9a086241c4e310c3c","type":"text","conversion_output":true,"text":"1. Evaluation of their mental and physical health;","text_display":"\n1. Evaluation of their mental and physical health;","confidence":1,"confidence_rate":1},{"cnt":[[120,1839],[952,1839],[952,1884],[120,1884]],"region":{"top_left_x":120,"top_left_y":1839,"width":832,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cce37ae901794a0c991cb452708c2257","type":"text","conversion_output":true,"text":"2. Ongoing monitoring of their clinical condition;","text_display":"\n2. Ongoing monitoring of their clinical condition;","confidence":1,"confidence_rate":1},{"cnt":[[120,1882],[1968,1882],[1968,1929],[120,1929]],"region":{"top_left_x":120,"top_left_y":1882,"width":1848,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9fc42b311bc4a198440802693523b55","type":"text","conversion_output":true,"text":"3. Treatment with a medication regimen that has been shown to be efficacious in the acute treatment of PD;","text_display":"\n3. Treatment with a medication regimen that has been shown to be efficacious in the acute treatment of PD;","confidence":1,"confidence_rate":1},{"cnt":[[120,1927],[1270,1927],[1270,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1927,"width":1150,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c692a393d84b4356af379a876cbdf783","type":"text","conversion_output":true,"text":"4. The possibility that symptoms of PD will improve with treatment.","text_display":"\n4. The possibility that symptoms of PD will improve with treatment.","confidence":0.99462890625,"confidence_rate":0.9999252032150219},{"cnt":[[120,2015],[1983,2015],[1983,2062],[120,2062]],"region":{"top_left_x":120,"top_left_y":2015,"width":1864,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d4515ea7a03472ea476b81424df9624","type":"text","conversion_output":true,"text":"The potential benefit to society is determining whether continued antipsychotic medication prevents relapse of","text_display":"\n\nThe potential benefit to society is determining whether continued antipsychotic medication prevents relapse of","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[191,2058],[191,2108],[120,2108]],"region":{"top_left_x":120,"top_left_y":2058,"width":72,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fd1c47522db4f7e9b28c813f64150a8","type":"text","conversion_output":true,"text":"PD.","text_display":" PD.","confidence":0.467041015625,"confidence_rate":0.9092208321416955},{"cnt":[[116,2140],[1068,2140],[1068,2194],[116,2194]],"region":{"top_left_x":116,"top_left_y":2139,"width":952,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7204c4bd873b4ad4bcf0e4d9f705def1","type":"section_header","conversion_output":false,"children_ids":["972c4c868fcb4310817b94fbe8042c3c"],"text":"","text_display":""},{"cnt":[[120,2144],[1063,2144],[1063,2189],[120,2189]],"region":{"top_left_x":120,"top_left_y":2144,"width":944,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"972c4c868fcb4310817b94fbe8042c3c","type":"text","conversion_output":true,"parent_id":"7204c4bd873b4ad4bcf0e4d9f705def1","text":"4.5 IMPORTANCE OF KNOWLEDGE TO BE GAINED","text_display":"\n\n\\subsection*{4.5 IMPORTANCE OF KNOWLEDGE TO BE GAINED}","confidence":1,"confidence_rate":1},{"cnt":[[120,2234],[1996,2234],[1996,2279],[120,2279]],"region":{"top_left_x":120,"top_left_y":2234,"width":1876,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1f4879df0744d0386383275c16c0d79","type":"text","conversion_output":true,"text":"It is not known whether antipsychotic medication needs to be continued once an episode of PD has responded","text_display":"\n\nIt is not known whether antipsychotic medication needs to be continued once an episode of PD has responded","confidence":1,"confidence_rate":1},{"cnt":[[120,2277],[1962,2277],[1962,2325],[120,2325]],"region":{"top_left_x":120,"top_left_y":2277,"width":1842,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fb81c88bf6f4429a7a1ac08f673a7b7","type":"text","conversion_output":true,"text":"to combined antidepressant-antipsychotic treatment. This issue is of tremendous clinical importance. On the","text_display":" to combined antidepressant-antipsychotic treatment. This issue is of tremendous clinical importance. On the","confidence":1,"confidence_rate":1},{"cnt":[[120,2322],[1910,2322],[1910,2370],[120,2370]],"region":{"top_left_x":120,"top_left_y":2322,"width":1790,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ea805adc46a4d8a910e16f27dc30e21","type":"text","conversion_output":true,"text":"one hand, the unnecessary continuation of antipsychotic medication exposes a patient to adverse effects,","text_display":" one hand, the unnecessary continuation of antipsychotic medication exposes a patient to adverse effects,","confidence":1,"confidence_rate":1},{"cnt":[[120,2368],[1974,2368],[1974,2413],[120,2413]],"region":{"top_left_x":120,"top_left_y":2367,"width":1855,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1406a6e24dd845fe84e17a60342dafcc","type":"text","conversion_output":true,"text":"some of which have considerable public health significance. On the other hand, premature discontinuation of","text_display":" some of which have considerable public health significance. On the other hand, premature discontinuation of","confidence":1,"confidence_rate":1},{"cnt":[[120,2411],[1910,2411],[1910,2460],[120,2460]],"region":{"top_left_x":120,"top_left_y":2410,"width":1790,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45b5712abe4b485eabf2b26bfce805d2","type":"text","conversion_output":true,"text":"antipsychotic medication has the potential risk of early relapse of a severe, disabling disorder. Addressing","text_display":" antipsychotic medication has the potential risk of early relapse of a severe, disabling disorder. Addressing","confidence":1,"confidence_rate":1},{"cnt":[[120,2454],[1968,2454],[1968,2501],[120,2501]],"region":{"top_left_x":120,"top_left_y":2453,"width":1848,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a20e3ea9208b428681a28485fd085472","type":"text","conversion_output":true,"text":"these issues will be of major public health importance. In our view, given the precautions that will be taken in","text_display":" these issues will be of major public health importance. In our view, given the precautions that will be taken in","confidence":0.9990234375,"confidence_rate":0.9999916492686468},{"cnt":[[120,2496],[1549,2496],[1549,2546],[120,2546]],"region":{"top_left_x":120,"top_left_y":2496,"width":1430,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5afde49433134d38a19d6dd1ace2ce4c","type":"text","conversion_output":true,"text":"this study, the likely benefits to participants and society outweight the potential risks.","text_display":" this study, the likely benefits to participants and society outweight the potential risks.","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2009,2578],[2009,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":54,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34a9a913a4854657bce3a9d0abf88a16","type":"page_info","conversion_output":false,"text":"\\(\\underline{27}\\)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999023246709238}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-30","page":30,"lines":[{"cnt":[[114,163],[1119,163],[1119,221],[114,221]],"region":{"top_left_x":113,"top_left_y":163,"width":1007,"height":59},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ec47d34c47f4bc7bfb399d97e23ec01","type":"section_header","conversion_output":false,"children_ids":["2cd4977d665b42b1b348d76e6190d6bd"],"text":"","text_display":""},{"cnt":[[120,168],[1111,168],[1111,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":991,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cd4977d665b42b1b348d76e6190d6bd","type":"text","conversion_output":true,"parent_id":"4ec47d34c47f4bc7bfb399d97e23ec01","text":"4.6 DATA AND SAFETY MONITORING BOARD (DSMB)","text_display":"\n\n\\subsection*{4.6 DATA AND SAFETY MONITORING BOARD (DSMB)}","confidence":1,"confidence_rate":1},{"cnt":[[120,258],[1865,258],[1865,303],[120,303]],"region":{"top_left_x":120,"top_left_y":257,"width":1745,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ffd431307204e46a6bcf073a8ca1105","type":"text","conversion_output":true,"text":"A NIMH-run DSMB oversaw the STOP-PD U01 to ensure the safety of participants and the validity and","text_display":"\n\nA NIMH-run DSMB oversaw the STOP-PD U01 to ensure the safety of participants and the validity and","confidence":1,"confidence_rate":1},{"cnt":[[120,303],[2004,303],[2004,348],[120,348]],"region":{"top_left_x":120,"top_left_y":302,"width":1885,"height":47},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d1b243a35bf4e18bdea7ecbae238c2a","type":"text","conversion_output":true,"text":"integrity of the data. Our understanding is that this grant, submitted as a Collaborative R01, will be converted to","text_display":" integrity of the data. Our understanding is that this grant, submitted as a Collaborative R01, will be converted to","confidence":0.99951171875,"confidence_rate":0.9999959300041316},{"cnt":[[120,348],[1946,348],[1946,393],[120,393]],"region":{"top_left_x":120,"top_left_y":348,"width":1827,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"889fb9d4f95e4939b95bfffcb3b07466","type":"text","conversion_output":true,"text":"a U01 upon funding. As a result, members of the DSMB will be chosen by NIMH. The responsibilities of the","text_display":" a U01 upon funding. As a result, members of the DSMB will be chosen by NIMH. The responsibilities of the","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[122,391],[982,391],[982,436],[122,436]],"region":{"top_left_x":122,"top_left_y":391,"width":860,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5821cf158c5f4ccfa3c811e362de9feb","type":"text","conversion_output":true,"text":"DSMB will include, but not limited to, the following:","text_display":" DSMB will include, but not limited to, the following:","confidence":1,"confidence_rate":1},{"cnt":[[122,434],[1944,434],[1944,479],[122,479]],"region":{"top_left_x":122,"top_left_y":433,"width":1823,"height":47},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"570f54fb8ee54c3eb9b0e3a2e49a5e34","type":"text","conversion_output":true,"text":"1. Review of protocols, consent procedures, consent forms, and safety plans prior to initiation of the study;","text_display":"\n1. 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Make recommendations about the continuation, modification, or termination of the study, based on the","text_display":"\n3. Make recommendations about the continuation, modification, or termination of the study, based on the","confidence":1,"confidence_rate":1},{"cnt":[[183,653],[1072,653],[1072,698],[183,698]],"region":{"top_left_x":182,"top_left_y":653,"width":891,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15b4f986e731467cb36732b2f13ef02b","type":"text","conversion_output":true,"text":"balance of adverse events and beneficial outcomes;","text_display":" balance of adverse events and beneficial outcomes;","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[776,696],[776,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":656,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8e689bc892942208249199c84c3a646","type":"text","conversion_output":true,"text":"4. Request addition data, as needed.","text_display":"\n4. Request addition data, as needed.","confidence":1,"confidence_rate":1},{"cnt":[[120,786],[2000,786],[2000,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1881,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08e3640533b2447fb076aa0bc371891a","type":"text","conversion_output":true,"text":"The responsibilities of the overall principal investigator of the study (Dr. Meyers), in collaboration with the study","text_display":"\n\nThe responsibilities of the overall principal investigator of the study (Dr. Meyers), in collaboration with the study","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1777,829],[1777,874],[120,874]],"region":{"top_left_x":120,"top_left_y":829,"width":1657,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6040e9d7aae439587e1777701d56282","type":"text","conversion_output":true,"text":"statistician/methodologist, in relation to the DSMB, will include, but not be limited to, the following:","text_display":" statistician/methodologist, in relation to the DSMB, will include, but not be limited to, the following:","confidence":1,"confidence_rate":1},{"cnt":[[122,872],[1886,872],[1886,920],[122,920]],"region":{"top_left_x":122,"top_left_y":872,"width":1765,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d31b0ee0e22943c9a629217a408b97c6","type":"text","conversion_output":true,"text":"1. Preparation of quarterly reports of all adverse events, SAEs, participant recruitment, and reasons for","text_display":"\n1. Preparation of quarterly reports of all adverse events, SAEs, participant recruitment, and reasons for","confidence":1,"confidence_rate":1},{"cnt":[[183,920],[569,920],[569,965],[183,965]],"region":{"top_left_x":182,"top_left_y":919,"width":388,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39062f3c29ea42d7bf146a0e96fdb91c","type":"text","conversion_output":true,"text":"participant withdrawal;","text_display":" participant withdrawal;","confidence":1,"confidence_rate":1},{"cnt":[[120,962],[1871,962],[1871,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":962,"width":1752,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"377514a245ef45318cf6c25e4c6306a3","type":"text","conversion_output":true,"text":"2. Respond to questions and recommendations from the DSMB, based on their review of the quarterly","text_display":"\n2. Respond to questions and recommendations from the DSMB, based on their review of the quarterly","confidence":1,"confidence_rate":1},{"cnt":[[185,1005],[862,1005],[862,1051],[185,1051]],"region":{"top_left_x":184,"top_left_y":1005,"width":678,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abf49503233a44ce942bacdd0da701c3","type":"text","conversion_output":true,"text":"reports, or at any other time as needed;","text_display":" reports, or at any other time as needed;","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1532,1048],[1532,1096],[120,1096]],"region":{"top_left_x":120,"top_left_y":1048,"width":1412,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8323ce26d0146bd972e7bd9b622d2c0","type":"text","conversion_output":true,"text":"3. Inform the DSMB and the Coordinating Center IRB within 48 hours of any SAE;","text_display":"\n3. Inform the DSMB and the Coordinating Center IRB within 48 hours of any SAE;","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[120,1091],[1846,1091],[1846,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1726,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"828aaf6052ae466d905fce0b5bf5398c","type":"text","conversion_output":true,"text":"4. Send blinded data to the DSMB for DSMB-performed interim analyses, if requested by the DSMB;","text_display":"\n4. Send blinded data to the DSMB for DSMB-performed interim analyses, if requested by the DSMB;","confidence":1,"confidence_rate":1},{"cnt":[[120,1139],[1079,1139],[1079,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1138,"width":959,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94d20accef834db2a67a82764ce46dea","type":"text","conversion_output":true,"text":"5. Send the DSMB a final report of the study's findings;","text_display":"\n5. Send the DSMB a final report of the study's findings;","confidence":1,"confidence_rate":1},{"cnt":[[120,1182],[1934,1182],[1934,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1181,"width":1814,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97ae1cecce8740038d5519e12e01fb58","type":"text","conversion_output":true,"text":"6. In addition, the principal investigators of each study site will be responsible for reporting any SAE to the","text_display":"\n6. In addition, the principal investigators of each study site will be responsible for reporting any SAE to the","confidence":1,"confidence_rate":1},{"cnt":[[185,1225],[1901,1225],[1901,1274],[185,1274]],"region":{"top_left_x":184,"top_left_y":1224,"width":1718,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcf06d8206784c8bad246359bd4052df","type":"text","conversion_output":true,"text":"Cornel IRB within 48 hours, as well as reporting the SAE to their specific site IRB, based on local IRB","text_display":" Cornel IRB within 48 hours, as well as reporting the SAE to their specific site IRB, based on local IRB","confidence":1,"confidence_rate":1},{"cnt":[[185,1268],[423,1268],[423,1317],[185,1317]],"region":{"top_left_x":184,"top_left_y":1267,"width":240,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ea50cad756f4143bbd057f72354b4aa","type":"text","conversion_output":true,"text":"requirements.","text_display":" requirements.","confidence":1,"confidence_rate":1},{"cnt":[[116,1349],[621,1349],[621,1401],[116,1401]],"region":{"top_left_x":116,"top_left_y":1349,"width":505,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42e0113307234c3cbab08c3a5e05fd97","type":"section_header","conversion_output":false,"children_ids":["fe3c178073c2483f8aa3ca002618a02f"],"text":"","text_display":""},{"cnt":[[120,1354],[617,1354],[617,1396],[120,1396]],"region":{"top_left_x":120,"top_left_y":1353,"width":497,"height":44},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe3c178073c2483f8aa3ca002618a02f","type":"text","conversion_output":true,"parent_id":"42e0113307234c3cbab08c3a5e05fd97","text":"a. CLINICAL TRIALS.GOV","text_display":"\n\n\\section*{a. CLINICAL TRIALS.GOV}","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[1970,1444],[1970,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1443,"width":1851,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65e4305180a24d79939b1ed9c0452983","type":"text","conversion_output":true,"text":"This is a renewal of the NIMH-funded U01 'Acute Pharmacotherapy of Unipolar Psychotic Depression', which","text_display":"\n\nThis is a renewal of the NIMH-funded U01 'Acute Pharmacotherapy of Unipolar Psychotic Depression', which","confidence":0.98876953125,"confidence_rate":0.9998963906282001},{"cnt":[[120,1491],[937,1491],[937,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1491,"width":817,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37944bef405a42129a54b30e4fd80e69","type":"text","conversion_output":true,"text":"has a clinical trials.gov identifier NCT00056472.","text_display":" has a clinical trials.gov identifier NCT00056472.","confidence":1,"confidence_rate":1},{"cnt":[[649,1577],[1474,1577],[1474,1629],[649,1629]],"region":{"top_left_x":648,"top_left_y":1576,"width":826,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0167ac150d4c46fabdf4f9beaaa1795f","type":"section_header","conversion_output":false,"children_ids":["68133cac8bff412e9a88f2d8e4f7fcbc"],"text":"","text_display":""},{"cnt":[[655,1581],[1470,1581],[1470,1626],[655,1626]],"region":{"top_left_x":655,"top_left_y":1581,"width":815,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68133cac8bff412e9a88f2d8e4f7fcbc","type":"text","conversion_output":true,"parent_id":"0167ac150d4c46fabdf4f9beaaa1795f","text":"5. INCLUSION OF WOMEN AND MINORITIES","text_display":"\n\n\\section*{5. INCLUSION OF WOMEN AND MINORITIES}","confidence":1,"confidence_rate":1},{"cnt":[[116,1708],[1027,1708],[1027,1755],[116,1755]],"region":{"top_left_x":116,"top_left_y":1708,"width":911,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4174906d226b4d4ba663beb77557702e","type":"section_header","conversion_output":false,"children_ids":["213fffaadb61449eb703f170c89be8d9"],"text":"","text_display":""},{"cnt":[[120,1710],[1023,1710],[1023,1751],[120,1751]],"region":{"top_left_x":120,"top_left_y":1710,"width":903,"height":41},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"213fffaadb61449eb703f170c89be8d9","type":"text","conversion_output":true,"parent_id":"4174906d226b4d4ba663beb77557702e","text":"5.1 RECRUITMENT OF WOMEN AND MINORITIES","text_display":"\n\n\\subsection*{5.1 RECRUITMENT OF WOMEN AND MINORITIES}","confidence":1,"confidence_rate":1},{"cnt":[[120,1757],[1807,1757],[1807,1803],[120,1803]],"region":{"top_left_x":120,"top_left_y":1757,"width":1687,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cd22507b09740a6ae26744a57951367","type":"text","conversion_output":true,"text":"Eligible patients will be offered the opportunity to participate regardless of gender or minority status.","text_display":"\n\nEligible patients will be offered the opportunity to participate regardless of gender or minority status.","confidence":1,"confidence_rate":1},{"cnt":[[120,1800],[1934,1800],[1934,1846],[120,1846]],"region":{"top_left_x":120,"top_left_y":1800,"width":1814,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61c7ec1a49f243f5ae1f6a9c3998eb74","type":"text","conversion_output":true,"text":"Considering that \\(50 \\%\\) of subjects will be elderly patients, and considering the gender distribution of PD, the","text_display":" Considering that \\(50 \\%\\) of subjects will be elderly patients, and considering the gender distribution of PD, the","confidence":0.990243194391951,"confidence_rate":0.9999162025272746},{"cnt":[[120,1843],[1996,1843],[1996,1893],[120,1893]],"region":{"top_left_x":120,"top_left_y":1843,"width":1876,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73a162536fb847a28ae68fca3ae81d1f","type":"text","conversion_output":true,"text":"proportion of females to males will approximate \\(2: 1\\) at all sites. The composition of the study sample will reflect","text_display":" proportion of females to males will approximate \\(2: 1\\) at all sites. The composition of the study sample will reflect","confidence":0.9868226051330566,"confidence_rate":0.999891276508556},{"cnt":[[120,1886],[1828,1886],[1828,1936],[120,1936]],"region":{"top_left_x":120,"top_left_y":1886,"width":1709,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a18afba3a9040b39f559c82bf4c2e82","type":"text","conversion_output":true,"text":"the racial diversity of patients seen at the four research sites. Although sites vary somewhat by racial","text_display":" the racial diversity of patients seen at the four research sites. Although sites vary somewhat by racial","confidence":1,"confidence_rate":1},{"cnt":[[120,1934],[1987,1934],[1987,1979],[120,1979]],"region":{"top_left_x":120,"top_left_y":1933,"width":1868,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70bf6489122845ac8daf63add9774db4","type":"text","conversion_output":true,"text":"composition, the overall distribution of major ethnic and racial groups will assure all groups are represented as","text_display":" composition, the overall distribution of major ethnic and racial groups will assure all groups are represented as","confidence":1,"confidence_rate":1},{"cnt":[[120,1977],[990,1977],[990,2022],[120,2022]],"region":{"top_left_x":120,"top_left_y":1976,"width":871,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9abfb80672f444d4862be35f33b94248","type":"text","conversion_output":true,"text":"outlined in the Targeted/Planned Enrollment Table.","text_display":" outlined in the Targeted/Planned Enrollment Table.","confidence":1,"confidence_rate":1},{"cnt":[[120,2062],[1970,2062],[1970,2110],[120,2110]],"region":{"top_left_x":120,"top_left_y":2062,"width":1851,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dddca1f617d34d0a93835c0c06d9a8cd","type":"text","conversion_output":true,"text":"Cornell Westchester serves a large county that reflects the socioeconomic diversity of the United States. For","text_display":"\n\nCornell Westchester serves a large county that reflects the socioeconomic diversity of the United States. For","confidence":0.98291015625,"confidence_rate":0.9998488047599279},{"cnt":[[120,2105],[1914,2105],[1914,2155],[120,2155]],"region":{"top_left_x":120,"top_left_y":2105,"width":1795,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"476f4c3fa698438086b89029fd6c30d9","type":"text","conversion_output":true,"text":"example, Yonkers, the third largest city in New York State, has a more indigent population and has higher","text_display":" example, Yonkers, the third largest city in New York State, has a more indigent population and has higher","confidence":1,"confidence_rate":1},{"cnt":[[120,2151],[1899,2151],[1899,2198],[120,2198]],"region":{"top_left_x":120,"top_left_y":2150,"width":1780,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7b087cf82654cc9b8692d844e47fe8f","type":"text","conversion_output":true,"text":"proportions of Hispanic and African American persons, while northern Westchester is comprised of semi-","text_display":" proportions of Hispanic and African American persons, while northern Westchester is comprised of semi","confidence":1,"confidence_rate":1},{"cnt":[[120,2196],[1931,2196],[1931,2241],[120,2241]],"region":{"top_left_x":120,"top_left_y":2195,"width":1812,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bdc03a48c254593be45d1da8bd4904f","type":"text","conversion_output":true,"text":"urban, suburban, and rural communities that tend to be over-represented by Caucasians and more affluent","text_display":"urban, suburban, and rural communities that tend to be over-represented by Caucasians and more affluent","confidence":1,"confidence_rate":1},{"cnt":[[120,2239],[1987,2239],[1987,2286],[120,2286]],"region":{"top_left_x":120,"top_left_y":2238,"width":1868,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"932920d8d1084fdb8ef6112ac3dae53e","type":"text","conversion_output":true,"text":"individuals. Among subjects recruited from Westchester, \\(13 \\%\\) are anticipated to be African American and \\(13 \\%\\)","text_display":" individuals. Among subjects recruited from Westchester, \\(13 \\%\\) are anticipated to be African American and \\(13 \\%\\)","confidence":0.5348949432373047,"confidence_rate":0.9944782664398247},{"cnt":[[120,2282],[1869,2282],[1869,2331],[120,2331]],"region":{"top_left_x":120,"top_left_y":2281,"width":1750,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64d48ff3cf9e4619951847841df14326","type":"text","conversion_output":true,"text":"Hispanic; these percentages may, however, turn out to be higher, because of the greater prevalence of","text_display":" Hispanic; these percentages may, however, turn out to be higher, because of the greater prevalence of","confidence":1,"confidence_rate":1},{"cnt":[[120,2327],[1525,2327],[1525,2374],[120,2374]],"region":{"top_left_x":120,"top_left_y":2326,"width":1406,"height":49},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d8f10b4774641a4b20f9808ddd44cbf","type":"text","conversion_output":true,"text":"minorities among New York City residents recruited via Payne Whitney Manhatten.","text_display":" minorities among New York City residents recruited via Payne Whitney Manhatten.","confidence":1,"confidence_rate":1},{"cnt":[[120,2415],[1884,2415],[1884,2460],[120,2460]],"region":{"top_left_x":120,"top_left_y":2414,"width":1765,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dbe039b7bd341dc91a231d85c862ddb","type":"text","conversion_output":true,"text":"The University of Pittsburgh Medical Center serves the City of Pittsburgh and the surrounding Allegheny","text_display":"\n\nThe University of Pittsburgh Medical Center serves the City of Pittsburgh and the surrounding Allegheny","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[120,2458],[1974,2458],[1974,2505],[120,2505]],"region":{"top_left_x":120,"top_left_y":2457,"width":1855,"height":49},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24a476aa8ad34d52a266f7601aa871d0","type":"text","conversion_output":true,"text":"County. We anticipate that recruitment in the proposed study will reflect the demographic diversity of the City","text_display":" County. We anticipate that recruitment in the proposed study will reflect the demographic diversity of the City","confidence":0.93603515625,"confidence_rate":0.9994303154085273},{"cnt":[[120,2501],[1992,2501],[1992,2550],[120,2550]],"region":{"top_left_x":120,"top_left_y":2500,"width":1872,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f7090eda01b4578becb71289d32cccb","type":"text","conversion_output":true,"text":"of Pittsburgh [67\\% white, 27.1\\% African American, 2.8\\% Asian, 1.3\\% Hispanics with minimal representation of","text_display":" of Pittsburgh [67\\% white, 27.1\\% African American, 2.8\\% Asian, 1.3\\% Hispanics with minimal representation of","confidence":0.5015272304609978,"confidence_rate":0.9938573599237329},{"cnt":[[1955,2578],[2007,2578],[2007,2621],[1955,2621]],"region":{"top_left_x":1955,"top_left_y":2578,"width":52,"height":44},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f6f5c842c92422a8f33da77c4dc00d7","type":"page_info","conversion_output":false,"text":"\\(\\underline{28}\\)","text_display":"","confidence":0.98583984375,"confidence_rate":0.9971517902982727}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-31","page":31,"lines":[{"cnt":[[120,125],[1876,125],[1876,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1756,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e635dce1e9c042969cc1db99016340ca","type":"text","conversion_output":true,"text":"other ethnic minorities] and the City of McKeesport [72\\% white, \\(25 \\%\\) African American, \\(0 \\%\\) Asian, \\(1.5 \\%\\)","text_display":"\nother ethnic minorities] and the City of McKeesport [72\\% white, \\(25 \\%\\) African American, \\(0 \\%\\) Asian, \\(1.5 \\%\\)","confidence":0.25895349448925786,"confidence_rate":0.9877923365422301},{"cnt":[[120,172],[1201,172],[1201,219],[120,219]],"region":{"top_left_x":120,"top_left_y":171,"width":1081,"height":49},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2549e083d7d54b9ab9a54d7310ae6ab5","type":"text","conversion_output":true,"text":"Hispanic with minimal representation of other ethnic minorities.]","text_display":" Hispanic with minimal representation of other ethnic minorities.]","confidence":1,"confidence_rate":1},{"cnt":[[120,258],[1927,258],[1927,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1808,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73a831fb7a6c4ee69736237b2b77568f","type":"text","conversion_output":true,"text":"The University Health Network serves patients from the greater Toronto area. Toronto is one of the world's","text_display":"\n\nThe University Health Network serves patients from the greater Toronto area. Toronto is one of the world's","confidence":1,"confidence_rate":1},{"cnt":[[120,301],[1981,301],[1981,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1861,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cd819f192064b02bad14f1813d25335","type":"text","conversion_output":true,"text":"most ethnically diverse cities, with approximately \\(40 \\%\\) of its population classified as of visible minority. \\(34 \\%\\) of","text_display":" most ethnically diverse cities, with approximately \\(40 \\%\\) of its population classified as of visible minority. \\(34 \\%\\) of","confidence":1,"confidence_rate":1},{"cnt":[[120,348],[1820,348],[1820,393],[120,393]],"region":{"top_left_x":120,"top_left_y":348,"width":1700,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a0fdd40619048809b978188badfb28b","type":"text","conversion_output":true,"text":"patients recruited at the Toronto site of STOP-PD were Asian, Black, or Hispanic. We anticipate that","text_display":" patients recruited at the Toronto site of STOP-PD were Asian, Black, or Hispanic. We anticipate that","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1691,391],[1691,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1571,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"567485fe0184426b8919844c8c35a46c","type":"text","conversion_output":true,"text":"recruitment in the proposed study will continue to reflect Toronto's racial and ethnic diversity.","text_display":" recruitment in the proposed study will continue to reflect Toronto's racial and ethnic diversity.","confidence":1,"confidence_rate":1},{"cnt":[[120,477],[1998,477],[1998,524],[120,524]],"region":{"top_left_x":120,"top_left_y":476,"width":1879,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"890eff75dc8f4efbb43a42ad9aa8b90c","type":"text","conversion_output":true,"text":"At the University of Massachusetts Medical School, we expect 15-20\\% of the subjects recruited to be Hispanic.","text_display":"\n\nAt the University of Massachusetts Medical School, we expect 15-20\\% of the subjects recruited to be Hispanic.","confidence":0.900390625,"confidence_rate":0.9990800148316733},{"cnt":[[120,522],[1944,522],[1944,569],[120,569]],"region":{"top_left_x":120,"top_left_y":522,"width":1825,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bba8539087a84561a1af2d5645fa0248","type":"text","conversion_output":true,"text":"The 2000 United States Census indicated the Hispanic population of Worcester County to be \\(15.2 \\%\\), a \\(52 \\%\\)","text_display":" The 2000 United States Census indicated the Hispanic population of Worcester County to be \\(15.2 \\%\\), a \\(52 \\%\\)","confidence":0.9426634311676025,"confidence_rate":0.9994776057615768},{"cnt":[[120,567],[604,567],[604,608],[120,608]],"region":{"top_left_x":120,"top_left_y":567,"width":484,"height":42},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c73e85d0818c4cd38dedfbff45a30ee8","type":"text","conversion_output":true,"text":"increase from 1990 to 2000.","text_display":" increase from 1990 to 2000.","confidence":1,"confidence_rate":1},{"cnt":[[116,649],[1137,649],[1137,698],[116,698]],"region":{"top_left_x":116,"top_left_y":648,"width":1021,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"001d4930e7454868a75b67791d3e2907","type":"section_header","conversion_output":false,"children_ids":["f37a855c98f440a6bbf0c365ec84dd0f"],"text":"","text_display":""},{"cnt":[[120,653],[1132,653],[1132,694],[120,694]],"region":{"top_left_x":120,"top_left_y":653,"width":1013,"height":41},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f37a855c98f440a6bbf0c365ec84dd0f","type":"text","conversion_output":true,"parent_id":"001d4930e7454868a75b67791d3e2907","text":"5.2 CULTURAL COMPETENCE OF STUDY PERSONNEL","text_display":"\n\n\\subsection*{5.2 CULTURAL COMPETENCE OF STUDY PERSONNEL}","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[2000,696],[2000,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1881,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce270a2354fc489f848d8e9f42d70509","type":"text","conversion_output":true,"text":"Investigators, research coordinators, and research associates will participate in training in cultural competence,","text_display":"\n\nInvestigators, research coordinators, and research associates will participate in training in cultural competence,","confidence":0.99951171875,"confidence_rate":0.9999958958025558},{"cnt":[[120,743],[1996,743],[1996,788],[120,788]],"region":{"top_left_x":120,"top_left_y":743,"width":1876,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f065c64ceac4249b10373f7f2a82b10","type":"text","conversion_output":true,"text":"as part of the study's personnel training. These personnel will be required to complete the five core modules of","text_display":" as part of the study's personnel training. These personnel will be required to complete the five core modules of","confidence":1,"confidence_rate":1},{"cnt":[[120,786],[1996,786],[1996,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1876,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"960edd8c8cff44ccb16195b1d51c88c4","type":"text","conversion_output":true,"text":"the Curriculum in Ethnogeriatrics, an internet-based resource for education and training in cultural competence","text_display":" the Curriculum in Ethnogeriatrics, an internet-based resource for education and training in cultural competence","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1949,829],[1949,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1829,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9c2ff30811a40809cafc3475e84c877","type":"text","conversion_output":true,"text":"[http://www.stanford.edu/group/ethnoger] supported by the Bureau of Health Professions, Health Resources","text_display":" [http://www.stanford.edu/group/ethnoger] supported by the Bureau of Health Professions, Health Resources","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1927,872],[1927,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1808,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b56659044804011835a6f86fae4e244","type":"text","conversion_output":true,"text":"and Services Administration, U.S. Department of Health and Human Services. The five modules cover the","text_display":" and Services Administration, U.S. Department of Health and Human Services. The five modules cover the","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[1987,915],[1987,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1868,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ef3d024ff4c4cc5909144ec09eeaea0","type":"text","conversion_output":true,"text":"following topics: i) an introduction to, and overview of, culturally-competent care of elders, ii) patterns of health","text_display":" following topics: i) an introduction to, and overview of, culturally-competent care of elders, ii) patterns of health","confidence":1,"confidence_rate":1},{"cnt":[[120,958],[2000,958],[2000,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":958,"width":1881,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56c167e6dae1442aaf34aeca33fea05e","type":"text","conversion_output":true,"text":"risk among people from diverse ethnic backgrounds, iii) culturally-based health beliefs, iv) knowledge and skills","text_display":" risk among people from diverse ethnic backgrounds, iii) culturally-based health beliefs, iv) knowledge and skills","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[1992,1005],[1992,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1005,"width":1872,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffd6cb241bce499195988faea9a8ab1b","type":"text","conversion_output":true,"text":"needed to provide a culturally competent assessment, and v) cultural issues in the delivery of health care after","text_display":" needed to provide a culturally competent assessment, and v) cultural issues in the delivery of health care after","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[1876,1048],[1876,1096],[120,1096]],"region":{"top_left_x":120,"top_left_y":1048,"width":1756,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"785acbad89964f8fbea810543852f15d","type":"text","conversion_output":true,"text":"assessments are completed, including health promotion, informed consent, treatment, and working with","text_display":" assessments are completed, including health promotion, informed consent, treatment, and working with","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1858,1091],[1858,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1739,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e673f57ca7b94901ad4d174b5822dd4f","type":"text","conversion_output":true,"text":"families. The Curriculum in Ethnogeriatrics also has 12 ethnic-specific modules that can be used as an","text_display":" families. The Curriculum in Ethnogeriatrics also has 12 ethnic-specific modules that can be used as an","confidence":1,"confidence_rate":1},{"cnt":[[120,1134],[1974,1134],[1974,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1134,"width":1855,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3f481b192634840a06ca06d6c823701","type":"text","conversion_output":true,"text":"additional resource when needed. Although this educational tool has a focus on the older population, which is","text_display":" additional resource when needed. Although this educational tool has a focus on the older population, which is","confidence":1,"confidence_rate":1},{"cnt":[[120,1182],[1996,1182],[1996,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1181,"width":1876,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aae1ab75f2314fdaa15c03f8f54d5368","type":"text","conversion_output":true,"text":"very pertinent to the proposed study, its principles and themes are also applicable to younger and middle-aged","text_display":" very pertinent to the proposed study, its principles and themes are also applicable to younger and middle-aged","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[243,1225],[243,1265],[120,1265]],"region":{"top_left_x":120,"top_left_y":1224,"width":123,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"370f61b12fb440bab02cd12624ecc939","type":"text","conversion_output":true,"text":"adults.","text_display":" adults.","confidence":1,"confidence_rate":1},{"cnt":[[120,1311],[1987,1311],[1987,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1310,"width":1868,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b5dba247a714cb9969759aa41bcf119","type":"text","conversion_output":true,"text":"Data from STOP-PD are consistent with our research group having culturally competent attitudes and skills. In","text_display":"\n\nData from STOP-PD are consistent with our research group having culturally competent attitudes and skills. In","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[120,1354],[1923,1354],[1923,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1353,"width":1803,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0de9a6e129c48c2bdda9991484dd797","type":"text","conversion_output":true,"text":"STOP-PD, \\(84.2 \\%\\) of participants were white, \\(11.2 \\%\\) were African American or black, and \\(4.6 \\%\\) were Asian;","text_display":" STOP-PD, \\(84.2 \\%\\) of participants were white, \\(11.2 \\%\\) were African American or black, and \\(4.6 \\%\\) were Asian;","confidence":0.9985356330871582,"confidence_rate":0.9999872571234004},{"cnt":[[120,1401],[1970,1401],[1970,1448],[120,1448]],"region":{"top_left_x":120,"top_left_y":1400,"width":1851,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"942d5dc2067d46a6a2c4fac30014b6b3","type":"text","conversion_output":true,"text":"\\(11.6 \\%\\) of participants described themselves as Hispanic or Latino. Based on census data, these percentages","text_display":" \\(11.6 \\%\\) of participants described themselves as Hispanic or Latino. Based on census data, these percentages","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[1863,1444],[1863,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1443,"width":1743,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3678bc0dae5b48309d1411861c437a0b","type":"text","conversion_output":true,"text":"were comparable to the racial and ethnic make-up of the U.S. population at the time that the study was","text_display":" were comparable to the racial and ethnic make-up of the U.S. population at the time that the study was","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1927,1487],[1927,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1808,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb6fcf00a9d340f38ce7c192b394923b","type":"text","conversion_output":true,"text":"conducted. Rates of completion at Weeks 6 and 12 of the 12 -week study were highly comparable between","text_display":" conducted. Rates of completion at Weeks 6 and 12 of the 12 -week study were highly comparable between","confidence":0.99755859375,"confidence_rate":0.9999787446490132},{"cnt":[[120,1532],[1962,1532],[1962,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1531,"width":1842,"height":49},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b9891cd5d154849af53990936b01e78","type":"text","conversion_output":true,"text":"racial and ethnic groups (see Table 5). Thus, these data show that we were successful in both recruiting and","text_display":" racial and ethnic groups (see Table 5). Thus, these data show that we were successful in both recruiting and","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[120,1575],[681,1575],[681,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1574,"width":562,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c23eb718422c42dc9ee74828df3b40e4","type":"text","conversion_output":true,"text":"retaining minorities in STOP-PD.","text_display":" retaining minorities in STOP-PD.","confidence":1,"confidence_rate":1},{"cnt":[[116,1659],[1927,1659],[1927,1712],[116,1712]],"region":{"top_left_x":116,"top_left_y":1658,"width":1812,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3f0eab5dd994d27a3aec1096fd86976","type":"figure_label","conversion_output":false,"text":"Table 5: Percentage of Participants Completing the 12-Week STOP-PD Study by Ethnicity and Race","text_display":"","confidence":0.5258117276098346,"confidence_rate":0.9935279831687486},{"cnt":[[120,1745],[2007,1745],[2007,2209],[120,2209]],"region":{"top_left_x":120,"top_left_y":1744,"width":1887,"height":465},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f584eb741124e498a13d31312500ac6","type":"table","conversion_output":true,"children_ids":["ea26113a11b94602bf51fbd3c43d4e9d","4799c30a0d884506bcea464ea90a41a0","4eb452c0ece04744a6c25f7fcfd87ba6","effa89014b744012971c73ed2fd42c91","dfb760b58deb438793a47554a8209bfd","84e25f786cc1498fb7d6bf74a77dd443","e65fb866e7964e77a104a3dd854fc139","fb38a978f28a411aab896f4b33baeb1a","23058aab29c941948506737daa79158c","f0617ea9c41b4abd95d44c30d4bb84f5","77347d8a55d243c697924f07d73cb454","5093f4b4886a4e6087a5925735d6ff14","fde22e0a4a4c4ebba92b44b8331a3184","54e8169e9a794408b4fdebc9e0123594","c57fd3c2b72d42e0bb075c5e61a65830","a0d51e5627b44413a915ad0c40ac77c2","bc86bd48512548268536102d4629fc06","4d9a9ac623444ed4a1943800d1dc0281","8a682616b5884a48ae89baeb165425c2","7ed90270db0246e09d119e56a2012db8","f54451870a3149fb8f78b85fcadee969","ce363daa3ce54f7587d84f41294d1997","e24248b477a44a29abf8a9ac061072ca","cfb6beee6c02477bb6392896b8d8fedf","19511b9bdf1b44629fa1403d84ad0437","5f8957cd6683416da08d4c12c77d2551","59358e73848945df8c89c138db903cab","0d654c9a799649cbbbecdc00b9e482d8","d8dc68f47094461aa1ad52bb5b274036","5b912b395bb54111801544d20f2f32d3","01b8b65b46fd47f899fea1bf36e9a5a6","3b9cd279810e4d539a7478420b3c9f31","1452b77f3abd4c66b7ab21af9eb9baa2","cdc9c528e65240d1affe6ea1a0a8172c","54a355a3596c4b06b32339bd794f0322"],"selected_labels":["d3f0eab5dd994d27a3aec1096fd86976"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline 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Our biomaterials, and the associated clinical data, will be incorporated with other","text_display":" projects supported by NIMH. Our biomaterials, and the associated clinical data, will be incorporated with other","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[1893,915],[1893,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1773,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc17aa1775ff40f89e270d6d3a0941ae","type":"text","conversion_output":true,"text":"such data and biomaterials as part of the NIMH Human Genetics Initiative. NIMH will then follow existing","text_display":" such data and biomaterials as part of the NIMH Human Genetics Initiative. 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Yin Yao Ph.D., Director of the Genetics and Genomic Research Resources Program at","text_display":" scientific community. 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Blood samples sent to the Center will be identified by code","text_display":" the blood sample being received by the Center. Blood samples sent to the Center will be identified by code","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[1826,1444],[1826,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1443,"width":1707,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"406e8c1c143942b88ecd44dce4ff3f71","type":"text","conversion_output":true,"text":"number only. We anticipate that approximately 10 blood samples per month during the 38 months of","text_display":" number only. We anticipate that approximately 10 blood samples per month during the 38 months of","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1893,1487],[1893,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1773,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e300fb222d4d408aadfcd4b32fcfe340","type":"text","conversion_output":true,"text":"recruitment will be sent by our study personnel to the Center. Verified genotypic data will be provided for","text_display":" recruitment will be sent by our study personnel to the Center. Verified genotypic data will be provided for","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[120,1532],[1433,1532],[1433,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1531,"width":1314,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d34d2e05249940fc85fb082b94051d70","type":"text","conversion_output":true,"text":"release as stated below under \"Data and Biological Materials Dissemination\".","text_display":" release as stated below under \"Data and Biological Materials Dissemination\".","confidence":1,"confidence_rate":1},{"cnt":[[120,1618],[2004,1618],[2004,1669],[120,1669]],"region":{"top_left_x":120,"top_left_y":1617,"width":1885,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"966c9b31f5fd47d78b4ea239bb129df1","type":"text","conversion_output":true,"text":"6.2.2 Clinical Data: Verified clinical data will be electronically submitted from the study's coordinating center at","text_display":"\n6.2.2 Clinical Data: Verified clinical data will be electronically submitted from the study's coordinating center at","confidence":0.9975595474243164,"confidence_rate":0.9999798065234454},{"cnt":[[120,1663],[1910,1663],[1910,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1662,"width":1790,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b67258017ef94690ae32bfa7d9cf4c76","type":"text","conversion_output":true,"text":"Weill Cornell Medical College to the Center every 6 months. As described in detail in other sections of the","text_display":" Weill Cornell Medical College to the Center every 6 months. As described in detail in other sections of the","confidence":0.9892899582857761,"confidence_rate":0.9999063712788584},{"cnt":[[120,1708],[1747,1708],[1747,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1708,"width":1627,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"394e8993d16a4b7f8c6ead5ed541d228","type":"text","conversion_output":true,"text":"grant application, the following issues will be addressed to ensure and check the quality of data:","text_display":" grant application, the following issues will be addressed to ensure and check the quality of data:","confidence":1,"confidence_rate":1},{"cnt":[[120,1749],[1968,1749],[1968,1798],[120,1798]],"region":{"top_left_x":120,"top_left_y":1748,"width":1848,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75b6df4b8f774ef787114c02e666602d","type":"text","conversion_output":true,"text":"Structured Diagnostic Criteria. The diagnosis of non-bipolar major depression with psychotic features (PD)","text_display":"\nStructured Diagnostic Criteria. The diagnosis of non-bipolar major depression with psychotic features (PD)","confidence":1,"confidence_rate":1},{"cnt":[[120,1796],[939,1796],[939,1841],[120,1841]],"region":{"top_left_x":120,"top_left_y":1796,"width":819,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab1bc1d632f14ee7a64cfc1a5c61e8f8","type":"text","conversion_output":true,"text":"will be established according to DSM-IV criteria.","text_display":" will be established according to DSM-IV criteria.","confidence":1,"confidence_rate":1},{"cnt":[[120,1835],[1921,1835],[1921,1886],[120,1886]],"region":{"top_left_x":120,"top_left_y":1834,"width":1801,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"313e634f0e9e48c186776f4b19229ea0","type":"text","conversion_output":true,"text":"Comprehensive Phenotypic Assessment. The diagnosis of PD will be based on a clinical interview by a","text_display":"\nComprehensive Phenotypic Assessment. The diagnosis of PD will be based on a clinical interview by a","confidence":1,"confidence_rate":1},{"cnt":[[120,1882],[1897,1882],[1897,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1882,"width":1778,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2df6f1d8666e4c4cb56e5f71a7a809ed","type":"text","conversion_output":true,"text":"research psychiatrist associated with the study, followed by an research associate's administration of the","text_display":" research psychiatrist associated with the study, followed by an research associate's administration of the","confidence":0.9990234375,"confidence_rate":0.9999911978797494},{"cnt":[[120,1921],[1992,1921],[1992,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1920,"width":1872,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e67b2a892a9f4f3d9f97d5d0fa6d2bd9","type":"text","conversion_output":true,"text":"Structured Clinical Interview for DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, \\(4{ }^{\\text {th }}\\) edition,","text_display":" Structured Clinical Interview for DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, \\(4{ }^{\\text {th }}\\) edition,","confidence":0.95849609375,"confidence_rate":0.9996789167712645},{"cnt":[[120,1968],[1934,1968],[1934,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1967,"width":1814,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e81c3104d284599831060242c87d953","type":"text","conversion_output":true,"text":"text revision; SCID-IV-TR). \\({ }^{103}\\) As a third line of assessment, diagnostically unclear or complex cases will be","text_display":" text revision; SCID-IV-TR). \\({ }^{103}\\) As a third line of assessment, diagnostically unclear or complex cases will be","confidence":0.99951171875,"confidence_rate":0.9999960928036482},{"cnt":[[120,2015],[1921,2015],[1921,2065],[120,2065]],"region":{"top_left_x":120,"top_left_y":2015,"width":1801,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81f3450e60af4a34b51a6ccdaa1d06ae","type":"text","conversion_output":true,"text":"discussed by the principal investigators to reach a consensus about the patient's eligibility for the study. In","text_display":" discussed by the principal investigators to reach a consensus about the patient's eligibility for the study. In","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[1813,2058],[1813,2108],[120,2108]],"region":{"top_left_x":120,"top_left_y":2058,"width":1694,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec8889695f9d4f9c84d5719df07dd61a","type":"text","conversion_output":true,"text":"addition, as described in Section 3.9.5, participants will be well characterized at baseline in terms of","text_display":" addition, as described in Section 3.9.5, participants will be well characterized at baseline in terms of","confidence":1,"confidence_rate":1},{"cnt":[[120,2101],[1897,2101],[1897,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2101,"width":1778,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c62d2853a624cbb8165a10ad7405be7","type":"text","conversion_output":true,"text":"demographic characteristics, severity of depression, type and severity of psychosis, suicidal ideation and","text_display":" demographic characteristics, severity of depression, type and severity of psychosis, suicidal ideation and","confidence":1,"confidence_rate":1},{"cnt":[[120,2144],[1846,2144],[1846,2194],[120,2194]],"region":{"top_left_x":120,"top_left_y":2144,"width":1726,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34f708487a5e45238412defcb976cfb2","type":"text","conversion_output":true,"text":"behavior, severity of concomitant anxiety, cognitive function, medical burden, and history of treatment","text_display":" behavior, severity of concomitant anxiety, cognitive function, medical burden, and history of treatment","confidence":1,"confidence_rate":1},{"cnt":[[120,2191],[316,2191],[316,2237],[120,2237]],"region":{"top_left_x":120,"top_left_y":2191,"width":196,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55bdbbb21ad54c3d9a7a24782e465911","type":"text","conversion_output":true,"text":"resistance.","text_display":" resistance.","confidence":1,"confidence_rate":1},{"cnt":[[120,2230],[1979,2230],[1979,2282],[120,2282]],"region":{"top_left_x":120,"top_left_y":2230,"width":1859,"height":52},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"056587cf47a44c6dabb204042085e494","type":"text","conversion_output":true,"text":"Rater Training and Reliability. As described in Section 4.1.6, all raters will participate in formal training prior","text_display":"\nRater Training and Reliability. As described in Section 4.1.6, all raters will participate in formal training prior","confidence":1,"confidence_rate":1},{"cnt":[[120,2277],[2004,2277],[2004,2327],[120,2327]],"region":{"top_left_x":120,"top_left_y":2277,"width":1885,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"761679ff906e47a99de1f7f93dc2bdb5","type":"text","conversion_output":true,"text":"to assessing participants for the study and collecting data, receive ongoing supervision from study coordinators","text_display":" to assessing participants for the study and collecting data, receive ongoing supervision from study coordinators","confidence":1,"confidence_rate":1},{"cnt":[[120,2322],[1972,2322],[1972,2370],[120,2370]],"region":{"top_left_x":120,"top_left_y":2322,"width":1853,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba757edc6f2d4851900e1c3c3272cf8a","type":"text","conversion_output":true,"text":"and research psychiatrists at each site, and participate in weekly conference calls led by the inter-site Project","text_display":" and research psychiatrists at each site, and participate in weekly conference calls led by the inter-site Project","confidence":1,"confidence_rate":1},{"cnt":[[120,2368],[1940,2368],[1940,2415],[120,2415]],"region":{"top_left_x":120,"top_left_y":2367,"width":1821,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"311f1128edb84cfc8030e581eb72579b","type":"text","conversion_output":true,"text":"Coordinator to address quality assurance issues. Inter-rater reliability on primary outcome measures will be","text_display":" Coordinator to address quality assurance issues. Inter-rater reliability on primary outcome measures will be","confidence":1,"confidence_rate":1},{"cnt":[[120,2411],[1998,2411],[1998,2460],[120,2460]],"region":{"top_left_x":120,"top_left_y":2410,"width":1879,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8196415a3888442e90a8f7c79c2b944b","type":"text","conversion_output":true,"text":"evaluated and addressed on an annual basis. Inter-rater reliability assessments performed during each year of","text_display":" evaluated and addressed on an annual basis. Inter-rater reliability assessments performed during each year of","confidence":1,"confidence_rate":1},{"cnt":[[120,2454],[1841,2454],[1841,2503],[120,2503]],"region":{"top_left_x":120,"top_left_y":2453,"width":1722,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3ee4f9e7f0449a59a80e0e2e11a1b40","type":"text","conversion_output":true,"text":"the 5-year STOP-PD yielded ICCs of 0.93-0.98 for the GRID HAM-D total score and 0.69-0.84 for the","text_display":" the 5-year STOP-PD yielded ICCs of 0.93-0.98 for the GRID HAM-D total score and 0.69-0.84 for the","confidence":0.5016136169433594,"confidence_rate":0.9932588521785206},{"cnt":[[120,2496],[1687,2496],[1687,2546],[120,2546]],"region":{"top_left_x":120,"top_left_y":2496,"width":1567,"height":50},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13a2cb9b487b4d02bea600fff517bf77","type":"text","conversion_output":true,"text":"conviction dimension of the DAS, demonstrating good reliability for these primary measures.","text_display":" conviction dimension of the DAS, demonstrating good reliability for these primary measures.","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2009,2578],[2009,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":54,"height":50},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63953642447f434db96ec026f2c082d8","type":"page_info","conversion_output":false,"text":"\\(\\underline{30}\\)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-33","page":33,"lines":[{"cnt":[[120,125],[1983,125],[1983,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1864,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"089d57eaac9747d4a5c128d789434bce","type":"text","conversion_output":true,"text":"Computerized Database and Data Management. The data management center at Cornell has an extensive,","text_display":"\n\nComputerized Database and Data Management. The data management center at Cornell has an extensive,","confidence":1,"confidence_rate":1},{"cnt":[[120,168],[1962,168],[1962,217],[120,217]],"region":{"top_left_x":120,"top_left_y":167,"width":1842,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f27caaacfef04e579406c2c2ddb190c2","type":"text","conversion_output":true,"text":"fully-functioning computerized database to manage all data derived form the proposed study. Procedures for","text_display":" fully-functioning computerized database to manage all data derived form the proposed study. Procedures for","confidence":1,"confidence_rate":1},{"cnt":[[120,215],[1996,215],[1996,262],[120,262]],"region":{"top_left_x":120,"top_left_y":214,"width":1876,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b0c39fc52c49d392dc85b267c852ac","type":"text","conversion_output":true,"text":"ensuring data integrity are described in detail in Section 4.1.6. To date, the data auditing system at Cornell has","text_display":" ensuring data integrity are described in detail in Section 4.1.6. To date, the data auditing system at Cornell has","confidence":1,"confidence_rate":1},{"cnt":[[120,258],[1508,258],[1508,305],[120,305]],"region":{"top_left_x":120,"top_left_y":257,"width":1389,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1410c0edb1434100acbe4616eb0ebd1f","type":"text","conversion_output":true,"text":"tracked over 170,000 individual rating scales over a period of more than 20 years.","text_display":" tracked over 170,000 individual rating scales over a period of more than 20 years.","confidence":0.8222220579627901,"confidence_rate":0.9978274215069267},{"cnt":[[120,344],[1927,344],[1927,393],[120,393]],"region":{"top_left_x":120,"top_left_y":343,"width":1808,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e48eb2c1ecf745bf971a98a6516b27c0","type":"text","conversion_output":true,"text":"6.2.3 Data and Biological Materials Dissemination: Dissemination of phenotypic and genotypic data will","text_display":"\n6.2.3 Data and Biological Materials Dissemination: Dissemination of phenotypic and genotypic data will","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[120,391],[862,391],[862,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":742,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6208bdab6c14661aea74369a904db24","type":"text","conversion_output":true,"text":"occur at the points in time stipulated below:","text_display":" occur at the points in time stipulated below:","confidence":0.99951171875,"confidence_rate":0.9999902320377446},{"cnt":[[120,434],[1783,434],[1783,479],[120,479]],"region":{"top_left_x":120,"top_left_y":433,"width":1664,"height":47},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb58946f427c47718f2692d69f7689a7","type":"text","conversion_output":true,"text":"- Verified diagnostic data: Will be submitted to the Center no later than 6 months after generation.","text_display":"\n- Verified diagnostic data: Will be submitted to the Center no later than 6 months after generation.","confidence":0.9990234375,"confidence_rate":0.9999909533775151},{"cnt":[[120,477],[1901,477],[1901,522],[120,522]],"region":{"top_left_x":120,"top_left_y":476,"width":1782,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b01b9b5723374d95ba62dd3ce60dc17a","type":"text","conversion_output":true,"text":"- Remaining verified clinical data: Will be submitted to the Center no later than 6 months after generation.","text_display":"\n- Remaining verified clinical data: Will be submitted to the Center no later than 6 months after generation.","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[1987,520],[1987,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1868,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8164300d31114034b4b8cd17bf343c36","type":"text","conversion_output":true,"text":"- Genotype data: Will be submitted to the database of Genotypes and Phenotypes (dbGaP) when manuscripts","text_display":"\n- Genotype data: Will be submitted to the database of Genotypes and Phenotypes (dbGaP) when manuscripts","confidence":0.5304718017578125,"confidence_rate":0.9941469326617142},{"cnt":[[120,563],[1983,563],[1983,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1864,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f62908a8c0154572bfdec8550926c639","type":"text","conversion_output":true,"text":"reporting the results based on these data are accepted for publication or no later than at the end of the award,","text_display":" reporting the results based on these data are accepted for publication or no later than at the end of the award,","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[672,610],[672,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":553,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad4349b6bc1c49d79726e14f888ad9af","type":"text","conversion_output":true,"text":"depending on which occurs first.","text_display":" depending on which occurs first.","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[1467,653],[1467,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1348,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b88e957fac71408db87fa7c576dd7bfc","type":"text","conversion_output":true,"text":"- Cell lines and DNA samples: To be negotiated with Center's' Program Official.","text_display":"\n- Cell lines and DNA samples: To be negotiated with Center's' Program Official.","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1934,696],[1934,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1814,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"742404aefa99465d83f564078596b934","type":"text","conversion_output":true,"text":"- Diagnostic and clinical data will be eligible for release by the Center, and genotype data will be eligible for","text_display":"\n- Diagnostic and clinical data will be eligible for release by the Center, and genotype data will be eligible for","confidence":1,"confidence_rate":1},{"cnt":[[120,741],[857,741],[857,788],[120,788]],"region":{"top_left_x":120,"top_left_y":741,"width":738,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07ebe537de424144be663f8d30d360d1","type":"text","conversion_output":true,"text":"release by \\(dbGaP , 12\\) months after receipt.","text_display":" release by \\(dbGaP , 12\\) months after receipt.","confidence":0.9555878639221191,"confidence_rate":0.9991267552778407},{"cnt":[[120,827],[1936,827],[1936,874],[120,874]],"region":{"top_left_x":120,"top_left_y":827,"width":1816,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5852e1514ab4e6e85264f2c04a307fb","type":"text","conversion_output":true,"text":"6.2.4 Human Subjects Issues: We are in receipt of the NIMH-written model consent form pertaining to the","text_display":"\n6.2.4 Human Subjects Issues: We are in receipt of the NIMH-written model consent form pertaining to the","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1850,872],[1850,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1730,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"881f564d0aed4984ab104a5f8c23ff07","type":"text","conversion_output":true,"text":"sharing of genetic 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Andreescu C, Mulsant BH, Peasley-Miklus C, et al. Persisting low use of antipsychotics in the treatment","text_display":"\n161. Andreescu C, Mulsant BH, Peasley-Miklus C, et al. Persisting low use of antipsychotics in the treatment","confidence":1,"confidence_rate":1},{"cnt":[[243,258],[1871,258],[1871,305],[243,305]],"region":{"top_left_x":242,"top_left_y":257,"width":1630,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ca64cc53f494dacb3ef65d48f1ed005","type":"text","conversion_output":true,"text":"of major depressive disorder with psychotic features. J Clin Psychiatry. Feb 2007;68(2):194-200","text_display":" of major depressive disorder with psychotic features. J Clin Psychiatry. 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Sarasota, Fl, Professional Resource Press; 2001","text_display":"CR). Sarasota, Fl, Professional Resource Press; 2001","confidence":0.9302096366882324,"confidence_rate":0.9987089537174784},{"cnt":[[610,559],[1515,559],[1515,617],[610,617]],"region":{"top_left_x":610,"top_left_y":558,"width":905,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f0ee81cbd09444880abae36f1262f2c","type":"section_header","conversion_output":false,"children_ids":["a8d8956a498049bb926a3b08d3d13cac"],"text":"","text_display":""},{"cnt":[[614,563],[1510,563],[1510,612],[614,612]],"region":{"top_left_x":614,"top_left_y":562,"width":897,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8d8956a498049bb926a3b08d3d13cac","type":"text","conversion_output":true,"parent_id":"0f0ee81cbd09444880abae36f1262f2c","text":"APPENDIX 1. PHARMACOTHERAPY PROTOCOL","text_display":"\n\n\\section*{APPENDIX 1. 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ACUTE PHASE}","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1962,696],[1962,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1842,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37a078c239c94cc0967d2dd473e29e06","type":"text","conversion_output":true,"text":"After written consent is obtained, psychotropic medications that are not permitted in the study (Section 4.2.1)","text_display":"\n\nAfter written consent is obtained, psychotropic medications that are not permitted in the study (Section 4.2.1)","confidence":1,"confidence_rate":1},{"cnt":[[120,743],[1944,743],[1944,788],[120,788]],"region":{"top_left_x":120,"top_left_y":743,"width":1825,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c3dc6d9a2e94af082472d1d756cb49e","type":"text","conversion_output":true,"text":"will be withdrawn over a period of up to 4 days, when feasible, prior to starting study medications. However,","text_display":" will be withdrawn over a period of up to 4 days, when feasible, prior to starting study medications. However,","confidence":1,"confidence_rate":1},{"cnt":[[120,786],[1949,786],[1949,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1829,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d61568a1598e48178d3cb32adf5a4276","type":"text","conversion_output":true,"text":"withdrawal of anticonvulsant medications with mood-stabilizing properties that are not permitted in the study","text_display":" withdrawal of anticonvulsant medications with mood-stabilizing properties that are not permitted in the study","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[120,829],[2002,829],[2002,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1883,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85dc2d4f779042a6a99ddc63472e6048","type":"text","conversion_output":true,"text":"will be extended to 10 days, and may therefore include the first week of the acute treatment phase. In addition,","text_display":" will be extended to 10 days, and may therefore include the first week of the acute treatment phase. In addition,","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1972,872],[1972,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1853,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20192082321947358e2df9ebd4f48297","type":"text","conversion_output":true,"text":"if a participant experiences withdrawal symptoms associated with the taper of psychotropic medication during","text_display":" if a participant experiences withdrawal symptoms associated with the taper of psychotropic medication during","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[2000,915],[2000,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1881,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"439831ed16fd4a74b2112b618569b786","type":"text","conversion_output":true,"text":"the 4-day period, the taper may be slowed and continued over 10 days, which will overlap with the first week of","text_display":" the 4-day period, the taper may be slowed and continued over 10 days, which will overlap with the first week of","confidence":0.588292121887207,"confidence_rate":0.9955516740932651},{"cnt":[[120,958],[1871,958],[1871,1008],[120,1008]],"region":{"top_left_x":120,"top_left_y":958,"width":1752,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"814aa9bf6ac74ef48b32233dcf73a19f","type":"text","conversion_output":true,"text":"the acute phase treatment. Since one of the goals of the acute phase is to maximize the recruitment of","text_display":" the acute phase treatment. 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Persons who are taking sertraline,","text_display":" medications, to maximize the chance of recruiting and retaining participants. Persons who are taking sertraline,","confidence":1,"confidence_rate":1},{"cnt":[[120,1091],[1927,1091],[1927,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1808,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15ef4572cd5a40daa0bb12e5b728141e","type":"text","conversion_output":true,"text":"olanzapine, or both medications at the time of signing consent for the acute phase of treatment, where this","text_display":" olanzapine, or both medications at the time of signing consent for the acute phase of treatment, where this","confidence":1,"confidence_rate":1},{"cnt":[[120,1137],[1972,1137],[1972,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1136,"width":1853,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7505d3426f4470481029686f4edac19","type":"text","conversion_output":true,"text":"does not affect eligibility for the study (Section 4.2.1), will remain on these medications, and upon entry to the","text_display":" does not affect eligibility for the study (Section 4.2.1), will remain on these medications, and upon entry to the","confidence":1,"confidence_rate":1},{"cnt":[[120,1182],[1985,1182],[1985,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1181,"width":1866,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceace1850c03460f887ae577a2324430","type":"text","conversion_output":true,"text":"study will have the existing dosages adjusted, when necessary, to reach target doses, based on the protocol's","text_display":" study will have the existing dosages adjusted, when necessary, to reach target doses, based on the protocol's","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1949,1225],[1949,1272],[120,1272]],"region":{"top_left_x":120,"top_left_y":1224,"width":1829,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22dc5b2574284d599be8a8aa97f35c7f","type":"text","conversion_output":true,"text":"titration schedule. The only psychotropic medications allowed in the study will be olanzapine, sertraline, and","text_display":" titration schedule. The only psychotropic medications allowed in the study will be olanzapine, sertraline, and","confidence":1,"confidence_rate":1},{"cnt":[[122,1268],[1656,1268],[1656,1317],[122,1317]],"region":{"top_left_x":122,"top_left_y":1267,"width":1535,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f37ed463f3b4208afe585fa817c21c6","type":"text","conversion_output":true,"text":"'as needed' lorazepam; 'as needed' benztropine will be allowed to treat EPSE (see below).","text_display":" 'as needed' lorazepam; 'as needed' benztropine will be allowed to treat EPSE (see below).","confidence":0.97412109375,"confidence_rate":0.9997211063785326},{"cnt":[[120,1354],[1798,1354],[1798,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1353,"width":1679,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae21631f48ef4eebb51a06f898cb9da3","type":"text","conversion_output":true,"text":"Sertraline and olanzapine will be dispensed in a non-blind, open-label fashion during the acute and","text_display":"\n\nSertraline and olanzapine will be dispensed in a non-blind, open-label fashion during the acute and","confidence":1,"confidence_rate":1},{"cnt":[[120,1401],[1989,1401],[1989,1446],[120,1446]],"region":{"top_left_x":120,"top_left_y":1400,"width":1870,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3412a75f6ad4a7c8ffc3be5611fa0ee","type":"text","conversion_output":true,"text":"stabilization phases of the study. Sertraline will be dispensed in the morning as 50 mg tablets. Olanzapine will","text_display":" stabilization phases of the study. Sertraline will be dispensed in the morning as 50 mg tablets. Olanzapine will","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[2000,1444],[2000,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1443,"width":1881,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c20e50394c754c348281ce9b7faf28e1","type":"text","conversion_output":true,"text":"be dispensed in the evening as 5 mg tablets. The titration schedule of sertraline and olanzapine, and the target","text_display":" be dispensed in the evening as 5 mg tablets. The titration schedule of sertraline and olanzapine, and the target","confidence":1,"confidence_rate":1},{"cnt":[[120,1487],[1955,1487],[1955,1536],[120,1536]],"region":{"top_left_x":120,"top_left_y":1486,"width":1836,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a5c444dbc564f3d9fb3fdd06be75176","type":"text","conversion_output":true,"text":"dosages of these medications, will be the same as that successfully employed in STOP-PD. Thus, sertraline","text_display":" dosages of these medications, will be the same as that successfully employed in STOP-PD. Thus, sertraline","confidence":1,"confidence_rate":1},{"cnt":[[120,1532],[2000,1532],[2000,1579],[120,1579]],"region":{"top_left_x":120,"top_left_y":1531,"width":1881,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06dd5d3454474a70a4e4aa8759eba070","type":"text","conversion_output":true,"text":"will be started at a dosage of \\(50 mg /\\) day and olanzapine will be started at a dosage of \\(5 mg /\\) day. On day 4 , the","text_display":" will be started at a dosage of \\(50 mg /\\) day and olanzapine will be started at a dosage of \\(5 mg /\\) day. On day 4 , the","confidence":0.9544055303558707,"confidence_rate":0.9996438297518856},{"cnt":[[120,1575],[1850,1575],[1850,1622],[120,1622]],"region":{"top_left_x":120,"top_left_y":1574,"width":1730,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dca96f7c4714ad182cfc0de5f1efd7c","type":"text","conversion_output":true,"text":"dosages of sertraline and olanzapine will be increased to \\(100 mg /\\) day and \\(10 mg /\\) day, respectively, as","text_display":" dosages of sertraline and olanzapine will be increased to \\(100 mg /\\) day and \\(10 mg /\\) day, respectively, as","confidence":0.9702563285827637,"confidence_rate":0.9997419564944807},{"cnt":[[120,1620],[1901,1620],[1901,1665],[120,1665]],"region":{"top_left_x":120,"top_left_y":1619,"width":1782,"height":47},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e9c622df6bc42b889cc494ca247c7ad","type":"text","conversion_output":true,"text":"tolerated. On day 7, the dosages of sertraline and olanzapine will be increased to the target doses of 150","text_display":" tolerated. On day 7, the dosages of sertraline and olanzapine will be increased to the target doses of 150","confidence":0.984375,"confidence_rate":0.9998568433663604},{"cnt":[[120,1663],[1970,1663],[1970,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1662,"width":1851,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a314bf95face45ca93fdd2a413b0a7f2","type":"text","conversion_output":true,"text":"\\(mg /\\) day and \\(15 mg /\\) day, respectively, as tolerated. If a participant experiences side effects during the titration","text_display":" \\(mg /\\) day and \\(15 mg /\\) day, respectively, as tolerated. If a participant experiences side effects during the titration","confidence":0.9922039445955306,"confidence_rate":0.9999378860282174},{"cnt":[[120,1708],[1826,1708],[1826,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1708,"width":1707,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65b8011b8def495fb4eba7b613b8a189","type":"text","conversion_output":true,"text":"phase, downward titration of one or both medications will be allowed as indicated, and the titration of","text_display":" phase, downward titration of one or both medications will be allowed as indicated, and the titration of","confidence":1,"confidence_rate":1},{"cnt":[[120,1749],[1923,1749],[1923,1798],[120,1798]],"region":{"top_left_x":120,"top_left_y":1748,"width":1803,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc62a628c59842789314dc4db1d7f101","type":"text","conversion_output":true,"text":"medications can proceed more slowly. In these cases, however, the goal of titration will be to reach target","text_display":" medications can proceed more slowly. In these cases, however, the goal of titration will be to reach target","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[120,1796],[952,1796],[952,1841],[120,1841]],"region":{"top_left_x":120,"top_left_y":1796,"width":832,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cba29d42185d40068498548c0059b170","type":"text","conversion_output":true,"text":"doses within 14 days of starting the medications.","text_display":" doses within 14 days of starting the medications.","confidence":1,"confidence_rate":1},{"cnt":[[120,1882],[1904,1882],[1904,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1882,"width":1784,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70f01ec3c32e455fbbd15d6cf95154dc","type":"text","conversion_output":true,"text":"A1.1 Dosage Adjustments Due to Inadequate Improvement: If there is no improvement or inadequate","text_display":"\n\nA1.1 Dosage Adjustments Due to Inadequate Improvement: If there is no improvement or inadequate","confidence":1,"confidence_rate":1},{"cnt":[[120,1925],[1989,1925],[1989,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1925,"width":1870,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8195ac2d5074c538b63caf04697643f","type":"text","conversion_output":true,"text":"improvement in psychosis, based on the research psychiatrist's clinical judgment, after 7 days of \\(15 mg /\\) day of","text_display":" improvement in psychosis, based on the research psychiatrist's clinical judgment, after 7 days of \\(15 mg /\\) day of","confidence":0.9858934047486956,"confidence_rate":0.9998854336680798},{"cnt":[[120,1972],[1996,1972],[1996,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1972,"width":1876,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f01bd08084804669bf587ffa7a44b3b8","type":"text","conversion_output":true,"text":"olanzapine, the dosage of olanzapine will be increased to \\(20 mg /\\) day , as tolerated. This flexibility in dosing will","text_display":" olanzapine, the dosage of olanzapine will be increased to \\(20 mg /\\) day , as tolerated. This flexibility in dosing will","confidence":0.90966796875,"confidence_rate":0.9992719911612897},{"cnt":[[120,2015],[1940,2015],[1940,2060],[120,2060]],"region":{"top_left_x":120,"top_left_y":2015,"width":1821,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9e885c92c5047d2ac2cfe36115f7749","type":"text","conversion_output":true,"text":"allow for dosages to be used at the maximum dose recommended in the product monograph by 2 weeks of","text_display":" allow for dosages to be used at the maximum dose recommended in the product monograph by 2 weeks of","confidence":0.99853515625,"confidence_rate":0.9999862999285899},{"cnt":[[120,2058],[1964,2058],[1964,2105],[120,2105]],"region":{"top_left_x":120,"top_left_y":2058,"width":1844,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f930dbb6911143879dc08244f16d854b","type":"text","conversion_output":true,"text":"starting treatment. Participants who did not experience at least partial improvement in depressive symptoms","text_display":" starting treatment. Participants who did not experience at least partial improvement in depressive symptoms","confidence":1,"confidence_rate":1},{"cnt":[[120,2101],[1987,2101],[1987,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2101,"width":1868,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4a5e3c1e2594ff780f0902bd21334b4","type":"text","conversion_output":true,"text":"(partial improvement defined as a 17-item HAM-D score of below 16) after taking sertraline at a dosage of 150","text_display":" (partial improvement defined as a 17-item HAM-D score of below 16) after taking sertraline at a dosage of 150","confidence":0.63330078125,"confidence_rate":0.9959655955465655},{"cnt":[[120,2144],[1613,2144],[1613,2194],[120,2194]],"region":{"top_left_x":120,"top_left_y":2144,"width":1494,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c704f1dc7524cce9aba148fa45c443a","type":"text","conversion_output":true,"text":"\\(mg /\\) day for 4 weeks, will have the sertraline dose increased to \\(200 mg /\\) day , as tolerated.","text_display":" \\(mg /\\) day for 4 weeks, will have the sertraline dose increased to \\(200 mg /\\) day , as tolerated.","confidence":0.9839081764221191,"confidence_rate":0.9998525317569801},{"cnt":[[120,2230],[2000,2230],[2000,2282],[120,2282]],"region":{"top_left_x":120,"top_left_y":2230,"width":1881,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20d3950c16734a0297750e6195f29da9","type":"text","conversion_output":true,"text":"A1.2 Dosage Adjustments Due to Side Effects: The treating psychiatrist will be allowed to adjust the titration","text_display":"\n\nA1.2 Dosage Adjustments Due to Side Effects: The treating psychiatrist will be allowed to adjust the titration","confidence":1,"confidence_rate":1},{"cnt":[[120,2277],[1957,2277],[1957,2325],[120,2325]],"region":{"top_left_x":120,"top_left_y":2277,"width":1838,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf0fa18c2e744754bfff042bf35610c1","type":"text","conversion_output":true,"text":"of sertraline, olanzapine, or both if the participant experiences side effects that are troublesome or otherwise","text_display":" of sertraline, olanzapine, or both if the participant experiences side effects that are troublesome or otherwise","confidence":1,"confidence_rate":1},{"cnt":[[120,2320],[1992,2320],[1992,2370],[120,2370]],"region":{"top_left_x":120,"top_left_y":2320,"width":1872,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8139212a5ef4205a589e7e5d8650c1c","type":"text","conversion_output":true,"text":"clinically significant (e.g., sedation, orthostatic hypertension). In such cases, the titration of both sertraline and","text_display":" clinically significant (e.g., sedation, orthostatic hypertension). In such cases, the titration of both sertraline and","confidence":1,"confidence_rate":1},{"cnt":[[120,2365],[1901,2365],[1901,2413],[120,2413]],"region":{"top_left_x":120,"top_left_y":2365,"width":1782,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3662c7264d524668a2880ad30c208d0f","type":"text","conversion_output":true,"text":"olanzapine will be halted, or if clinically indicated, the dosage of one or both medications can be reduced.","text_display":" olanzapine will be halted, or if clinically indicated, the dosage of one or both medications can be reduced.","confidence":1,"confidence_rate":1},{"cnt":[[120,2411],[1968,2411],[1968,2456],[120,2456]],"region":{"top_left_x":120,"top_left_y":2410,"width":1848,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e961df2d4b224e12bb1898e662ad66ec","type":"text","conversion_output":true,"text":"However, titration to reach the target dose will resume, if and when the side effects resolve. If, after a further","text_display":" However, titration to reach the target dose will resume, if and when the side effects resolve. If, after a further","confidence":1,"confidence_rate":1},{"cnt":[[120,2454],[1974,2454],[1974,2503],[120,2503]],"region":{"top_left_x":120,"top_left_y":2453,"width":1855,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f89862d4d427414eba654d4c8a06d138","type":"text","conversion_output":true,"text":"attempt at titration, a participant is unable to tolerate \\(150 mg /\\) day of sertraline or \\(15 mg /\\) day of olanzapine, the","text_display":" attempt at titration, a participant is unable to tolerate \\(150 mg /\\) day of sertraline or \\(15 mg /\\) day of olanzapine, the","confidence":0.5712557399174367,"confidence_rate":0.9957349359195108},{"cnt":[[1955,2578],[2007,2578],[2007,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":52,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0724a9052ced45b7908850216787aae4","type":"page_info","conversion_output":false,"text":"\\(\\underline{39}\\)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-42","page":42,"lines":[{"cnt":[[120,125],[1927,125],[1927,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1808,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9aacd494987041e7a8e48c0a015fefd9","type":"text","conversion_output":true,"text":"participant may be maintained on a lower dose of these medications, with a minimum allowable dose of 50","text_display":"\nparticipant may be maintained on a lower dose of these medications, with a minimum allowable dose of 50","confidence":1,"confidence_rate":1},{"cnt":[[120,172],[956,172],[956,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":837,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cbab5afaf3f4d12b9452b90aec3ae7d","type":"text","conversion_output":true,"text":"\\(mg /\\) day of sertraline and \\(5 mg /\\) day of olanzapine.","text_display":" \\(mg /\\) day of sertraline and \\(5 mg /\\) day of olanzapine.","confidence":0.5849668659445562,"confidence_rate":0.9913889014633006},{"cnt":[[120,254],[1989,254],[1989,305],[120,305]],"region":{"top_left_x":120,"top_left_y":253,"width":1870,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f82beb01692497fbc2881172d0cd6ad","type":"text","conversion_output":true,"text":"A1.3 Rationale for Dosing: In STOP-PD, by the end of the second week of treatment, the average daily dose","text_display":"\n\nA1.3 Rationale for Dosing: In STOP-PD, by the end of the second week of treatment, the average daily dose","confidence":1,"confidence_rate":1},{"cnt":[[120,301],[1824,301],[1824,350],[120,350]],"region":{"top_left_x":120,"top_left_y":300,"width":1705,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2a7ec5f3c3f47e1b2501a5a9b5c9698","type":"text","conversion_output":true,"text":"of sertraline was \\(150 mg /\\) day, for both younger and older age groups, and the average daily dose of","text_display":" of sertraline was \\(150 mg /\\) day, for both younger and older age groups, and the average daily dose of","confidence":0.572489254293032,"confidence_rate":0.9948959936611382},{"cnt":[[120,346],[1970,346],[1970,393],[120,393]],"region":{"top_left_x":120,"top_left_y":345,"width":1851,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40176ef1f51147ac91176455bf568269","type":"text","conversion_output":true,"text":"olanzapine was 14 mg in the younger group and 13 mg in the older group. These data indicate the feasibility","text_display":" olanzapine was 14 mg in the younger group and 13 mg in the older group. These data indicate the feasibility","confidence":1,"confidence_rate":1},{"cnt":[[120,389],[1996,389],[1996,436],[120,436]],"region":{"top_left_x":120,"top_left_y":388,"width":1876,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58e0a77c632349c6a0b3a50118baf7cb","type":"text","conversion_output":true,"text":"of aiming for target dosages of \\(150 mg /\\) day of sertraline and \\(15 mg /\\) day of olanzapine in both age groups. The","text_display":" of aiming for target dosages of \\(150 mg /\\) day of sertraline and \\(15 mg /\\) day of olanzapine in both age groups. The","confidence":0.9388816473074257,"confidence_rate":0.999495600460849},{"cnt":[[120,434],[1880,434],[1880,483],[120,483]],"region":{"top_left_x":120,"top_left_y":433,"width":1760,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7d921f9780c4df98f9e9e26fc817994","type":"text","conversion_output":true,"text":"target dosages of sertraline and olanzapine are designed to ensure that participants receive therapeutic","text_display":" target dosages of sertraline and olanzapine are designed to ensure that participants receive therapeutic","confidence":1,"confidence_rate":1},{"cnt":[[120,477],[1996,477],[1996,526],[120,526]],"region":{"top_left_x":120,"top_left_y":476,"width":1876,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe901449e0a54860a1b08e3710cf3d53","type":"text","conversion_output":true,"text":"dosages of these medications early in treatment, in an attempt to facilitate improvement as rapidly as possible.","text_display":" dosages of these medications early in treatment, in an attempt to facilitate improvement as rapidly as possible.","confidence":1,"confidence_rate":1},{"cnt":[[120,520],[1921,520],[1921,569],[120,569]],"region":{"top_left_x":120,"top_left_y":519,"width":1801,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52594b2524fa4dedbe34032d42e75319","type":"text","conversion_output":true,"text":"Although sertraline has a flat dose-response curve (Preskorn 1993), meaning that, at a group level, higher","text_display":" Although sertraline has a flat dose-response curve (Preskorn 1993), meaning that, at a group level, higher","confidence":1,"confidence_rate":1},{"cnt":[[120,563],[2000,563],[2000,612],[120,612]],"region":{"top_left_x":120,"top_left_y":562,"width":1881,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d5be0a74731445d83d327bcec29a6f9","type":"text","conversion_output":true,"text":"doses are not necessarily associated with a higher frequency of response, there are individuals who do require","text_display":" doses are not necessarily associated with a higher frequency of response, there are individuals who do require","confidence":1,"confidence_rate":1},{"cnt":[[120,608],[1970,608],[1970,657],[120,657]],"region":{"top_left_x":120,"top_left_y":608,"width":1851,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b25d014b39414f3284681c8883ce3143","type":"text","conversion_output":true,"text":"higher doses in order to respond. Thus, in order to maximize the chance of early response in all participants,","text_display":" higher doses in order to respond. Thus, in order to maximize the chance of early response in all participants,","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[1989,653],[1989,700],[120,700]],"region":{"top_left_x":120,"top_left_y":653,"width":1870,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98b18d4822ea40d7993026e59387ca92","type":"text","conversion_output":true,"text":"we elected to increase the dose of sertraline to \\(150 mg /\\) day early in treatment, rather than maintain the dose at","text_display":" we elected to increase the dose of sertraline to \\(150 mg /\\) day early in treatment, rather than maintain the dose at","confidence":0.9990234375,"confidence_rate":0.9999920566197779},{"cnt":[[120,696],[1450,696],[1450,746],[120,746]],"region":{"top_left_x":120,"top_left_y":696,"width":1331,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16b79404733f4d829cf0ffefec923183","type":"text","conversion_output":true,"text":"a lower level for several weeks, before increasing the dose in non-responders.","text_display":" a lower level for several weeks, before increasing the dose in non-responders.","confidence":1,"confidence_rate":1},{"cnt":[[120,782],[1944,782],[1944,834],[120,834]],"region":{"top_left_x":120,"top_left_y":782,"width":1825,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3af00043faac41ddaec8efd307e68dcc","type":"text","conversion_output":true,"text":"Many persons with PD are hospitalized, they are frequently severely distressed by their delusions, and food","text_display":"\n\nMany persons with PD are hospitalized, they are frequently severely distressed by their delusions, and food","confidence":0.99658203125,"confidence_rate":0.9999694306159178},{"cnt":[[120,829],[1970,829],[1970,879],[120,879]],"region":{"top_left_x":120,"top_left_y":829,"width":1851,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c21bac2774b41b8bf59ced3a050c5dc","type":"text","conversion_output":true,"text":"and fluid intake may be compromised by their psychosis. As a result, it is imperative to treat the psychosis in","text_display":" and fluid intake may be compromised by their psychosis. As a result, it is imperative to treat the psychosis in","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[2007,872],[2007,922],[120,922]],"region":{"top_left_x":120,"top_left_y":872,"width":1887,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd33bee16e6c4f319087df18e8e2fd1e","type":"text","conversion_output":true,"text":"an expeditious manner. Thus, in patients who fail to show significant improvement in psychosis by the end of 7","text_display":" an expeditious manner. Thus, in patients who fail to show significant improvement in psychosis by the end of 7","confidence":1,"confidence_rate":1},{"cnt":[[120,915],[1897,915],[1897,965],[120,965]],"region":{"top_left_x":120,"top_left_y":915,"width":1778,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4f0cea65cd6416289b61ed2a9cb46a8","type":"text","conversion_output":true,"text":"days of treatment with \\(15 mg /\\) day of olanzapine, the dosage will be increased to \\(20 mg /\\) day, as tolerated.","text_display":" days of treatment with \\(15 mg /\\) day of olanzapine, the dosage will be increased to \\(20 mg /\\) day, as tolerated.","confidence":0.8334103445522487,"confidence_rate":0.9984951074748516},{"cnt":[[120,1052],[120,1001],[2005,1003],[2004,1054]],"region":{"top_left_x":120,"top_left_y":1001,"width":1885,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59ebe8c8f86340ec96fc188fab5183fa","type":"text","conversion_output":true,"text":"A1.4 As-Needed Lorazepam: Persons with severe anxiety, restlessness, or insomnia that would prevent them","text_display":"\n\nA1.4 As-Needed Lorazepam: Persons with severe anxiety, restlessness, or insomnia that would prevent them","confidence":1,"confidence_rate":1},{"cnt":[[120,1048],[2000,1048],[2000,1096],[120,1096]],"region":{"top_left_x":120,"top_left_y":1048,"width":1881,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b76f80dfadc4828bf39da7069785f93","type":"text","conversion_output":true,"text":"from continuing in the study can be prescribed lorazepam, starting at 0.5 to \\(2 mg / day\\), as needed. A maximum","text_display":" from continuing in the study can be prescribed lorazepam, starting at 0.5 to \\(2 mg / day\\), as needed. A maximum","confidence":0.9936552047729492,"confidence_rate":0.9999486705997609},{"cnt":[[120,1091],[1861,1091],[1861,1141],[120,1141]],"region":{"top_left_x":120,"top_left_y":1091,"width":1741,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"726fbb00fdf246ebbb97cfc4da381e5d","type":"text","conversion_output":true,"text":"daily dosage of \\(3 mg /\\) day will be allowed during the study, but doses will be kept at a minimum and the","text_display":" daily dosage of \\(3 mg /\\) day will be allowed during the study, but doses will be kept at a minimum and the","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[120,1137],[965,1137],[965,1184],[120,1184]],"region":{"top_left_x":120,"top_left_y":1136,"width":845,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdad1190d3564123a943a1857472cc20","type":"text","conversion_output":true,"text":"lorazepam will be withdrawn as early as possible.","text_display":" lorazepam will be withdrawn as early as possible.","confidence":1,"confidence_rate":1},{"cnt":[[120,1220],[1888,1220],[1888,1274],[120,1274]],"region":{"top_left_x":120,"top_left_y":1220,"width":1769,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"121d4fda0f7d44ba81b94e2114d526d1","type":"text","conversion_output":true,"text":"A1.5 As-Needed Benztropine: Among participants who develop clinically significant EPSE, the dose of","text_display":"\n\nA1.5 As-Needed Benztropine: Among participants who develop clinically significant EPSE, the dose of","confidence":1,"confidence_rate":1},{"cnt":[[120,1268],[1843,1268],[1843,1317],[120,1317]],"region":{"top_left_x":120,"top_left_y":1267,"width":1724,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f1e12d0995444e193bf1354c3d98f17","type":"text","conversion_output":true,"text":"olanzapine will be reduced by 5 mg increments, to a minimum dose of \\(10 mg /\\) day, if needed to lessen","text_display":" olanzapine will be reduced by 5 mg increments, to a minimum dose of \\(10 mg /\\) day, if needed to lessen","confidence":0.71240234375,"confidence_rate":0.9970297494430076},{"cnt":[[120,1311],[1888,1311],[1888,1360],[120,1360]],"region":{"top_left_x":120,"top_left_y":1310,"width":1769,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9be20bd680894e669cb8e2cb1a5d6c16","type":"text","conversion_output":true,"text":"extrapyramidal effects. However, if problematic EPSE persist, despite the dose reduction of olanzapine,","text_display":" extrapyramidal effects. However, if problematic EPSE persist, despite the dose reduction of olanzapine,","confidence":1,"confidence_rate":1},{"cnt":[[120,1354],[1888,1354],[1888,1403],[120,1403]],"region":{"top_left_x":120,"top_left_y":1353,"width":1769,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d81103bc478a414d8c6bc677550bbc73","type":"text","conversion_output":true,"text":"benztropine can be prescribed, to a maximum dose of \\(2 mg / day\\). Lorazepam and benztropine will not be","text_display":" benztropine can be prescribed, to a maximum dose of \\(2 mg / day\\). Lorazepam and benztropine will not be","confidence":0.8833575248718262,"confidence_rate":0.9989030334144292},{"cnt":[[120,1401],[1858,1401],[1858,1446],[120,1446]],"region":{"top_left_x":120,"top_left_y":1400,"width":1739,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63b44368af5f462b9493f2cdd535d120","type":"text","conversion_output":true,"text":"administered within the 12 hours prior to administration of cognitive tests, so as not to disrupt cognitive","text_display":" administered within the 12 hours prior to administration of cognitive tests, so as not to disrupt cognitive","confidence":1,"confidence_rate":1},{"cnt":[[120,1444],[1904,1444],[1904,1491],[120,1491]],"region":{"top_left_x":120,"top_left_y":1443,"width":1784,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f5e473a6e7641bfa2a5e7e0e4135fab","type":"text","conversion_output":true,"text":"function. The prescription of benztropine will be taken into account in the secondary statistical analyses of","text_display":" function. The prescription of benztropine will be taken into account in the secondary statistical analyses of","confidence":0.85986328125,"confidence_rate":0.9986764741982157},{"cnt":[[120,1487],[243,1487],[243,1532],[120,1532]],"region":{"top_left_x":120,"top_left_y":1486,"width":123,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da114da32f464732aa5d9f4c790b5d0f","type":"text","conversion_output":true,"text":"EPSE.","text_display":" EPSE.","confidence":1,"confidence_rate":1},{"cnt":[[116,1568],[638,1568],[638,1622],[116,1622]],"region":{"top_left_x":116,"top_left_y":1568,"width":523,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5218c4a4f1044374ac6b96b35ccc629e","type":"section_header","conversion_output":false,"children_ids":["1b27f45d51a04d48bf8478367b267b27"],"text":"","text_display":""},{"cnt":[[120,1573],[634,1573],[634,1618],[120,1618]],"region":{"top_left_x":120,"top_left_y":1572,"width":514,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b27f45d51a04d48bf8478367b267b27","type":"text","conversion_output":true,"parent_id":"5218c4a4f1044374ac6b96b35ccc629e","text":"A2. STABILIZATION PHASE","text_display":"\n\n\\section*{A2. STABILIZATION PHASE}","confidence":1,"confidence_rate":1},{"cnt":[[120,1663],[1966,1663],[1966,1712],[120,1712]],"region":{"top_left_x":120,"top_left_y":1662,"width":1846,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d43815a447a5401295062afdec39cd77","type":"text","conversion_output":true,"text":"When participants meet remission criteria, they will continue with open-label sertraline and olanzapine during","text_display":"\n\nWhen participants meet remission criteria, they will continue with open-label sertraline and olanzapine during","confidence":1,"confidence_rate":1},{"cnt":[[120,1706],[1983,1706],[1983,1755],[120,1755]],"region":{"top_left_x":120,"top_left_y":1705,"width":1864,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90df5489e4f54c4c8a616c6e7b50c656","type":"text","conversion_output":true,"text":"the 8 -week stabilization phase. Since the goal of this phase is to consolidate stability of remission, adjustment","text_display":" the 8 -week stabilization phase. Since the goal of this phase is to consolidate stability of remission, adjustment","confidence":0.99853515625,"confidence_rate":0.9999879843534795},{"cnt":[[120,1749],[1886,1749],[1886,1798],[120,1798]],"region":{"top_left_x":120,"top_left_y":1748,"width":1767,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"121f6ad7cc684efd8fb36d512ffec582","type":"text","conversion_output":true,"text":"of the doses of study medications will be allowed, if necessitated by clinical worsening or significant side","text_display":" of the doses of study medications will be allowed, if necessitated by clinical worsening or significant side","confidence":0.99853515625,"confidence_rate":0.9999870273612914},{"cnt":[[120,1796],[1996,1796],[1996,1843],[120,1843]],"region":{"top_left_x":120,"top_left_y":1796,"width":1876,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8684dfa9bac84ad68a924fdb40aa996f","type":"text","conversion_output":true,"text":"effects. In the case of exacerbation of depressive symptoms, sertraline can be increased as tolerated by 50 mg","text_display":" effects. In the case of exacerbation of depressive symptoms, sertraline can be increased as tolerated by 50 mg","confidence":1,"confidence_rate":1},{"cnt":[[120,1839],[1914,1839],[1914,1886],[120,1886]],"region":{"top_left_x":120,"top_left_y":1839,"width":1795,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2711df9582eb431e976abdb34e7c3f0e","type":"text","conversion_output":true,"text":"increments every 7 days, to the maximum dose of \\(200 mg /\\) day. Because sustained remission of psychosis","text_display":" increments every 7 days, to the maximum dose of \\(200 mg /\\) day. Because sustained remission of psychosis","confidence":0.9907393455505371,"confidence_rate":0.99991839104166},{"cnt":[[120,1882],[1953,1882],[1953,1931],[120,1931]],"region":{"top_left_x":120,"top_left_y":1882,"width":1833,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"538befb14a6842289cb66e8130a707d5","type":"text","conversion_output":true,"text":"during the stabilization phase will be required for eligibility for the RCT (Section 3.9.2), participants will leave","text_display":" during the stabilization phase will be required for eligibility for the RCT (Section 3.9.2), participants will leave","confidence":1,"confidence_rate":1},{"cnt":[[120,1927],[1893,1927],[1893,1974],[120,1974]],"region":{"top_left_x":120,"top_left_y":1927,"width":1773,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1619aa8b7a0a435390d64729208ece82","type":"text","conversion_output":true,"text":"the stabilization phase if they experience a relapse of delusions or hallucinations as determined by SCID","text_display":" the stabilization phase if they experience a relapse of delusions or hallucinations as determined by SCID","confidence":1,"confidence_rate":1},{"cnt":[[120,1970],[1962,1970],[1962,2017],[120,2017]],"region":{"top_left_x":120,"top_left_y":1970,"width":1842,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c044348d9c349cd8f5e396639cbb64a","type":"text","conversion_output":true,"text":"interview. Nevertheless, in the case of participants who experience worsening of worry that is not delusional,","text_display":" interview. Nevertheless, in the case of participants who experience worsening of worry that is not delusional,","confidence":1,"confidence_rate":1},{"cnt":[[120,2015],[1833,2015],[1833,2065],[120,2065]],"region":{"top_left_x":120,"top_left_y":2015,"width":1713,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0721a685f4a749ec95ffded9c7c7fdec","type":"text","conversion_output":true,"text":"olanzapine can be increased as tolerated by 5 mg increments every 7 days, to the maximum dose of","text_display":" olanzapine can be increased as tolerated by 5 mg increments every 7 days, to the maximum dose of","confidence":1,"confidence_rate":1},{"cnt":[[120,2058],[1871,2058],[1871,2108],[120,2108]],"region":{"top_left_x":120,"top_left_y":2058,"width":1752,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8718243fb4a84a459c2b063787b6bc25","type":"text","conversion_output":true,"text":"\\(20 mg /\\) day. If dosage reductions are necessitated by side effects, sertraline can be decreased by 50 mg","text_display":" \\(20 mg /\\) day. If dosage reductions are necessitated by side effects, sertraline can be decreased by 50 mg","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[120,2101],[1957,2101],[1957,2151],[120,2151]],"region":{"top_left_x":120,"top_left_y":2101,"width":1838,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e9857d715df4d03ab0674908fa57c2f","type":"text","conversion_output":true,"text":"increments every 7 days as needed, to a minimum dose of \\(50 mg /\\) day, and olanzapine can be decreased by","text_display":" increments every 7 days as needed, to a minimum dose of \\(50 mg /\\) day, and olanzapine can be decreased by","confidence":0.97412109375,"confidence_rate":0.9997720289733841},{"cnt":[[120,2144],[1381,2144],[1381,2194],[120,2194]],"region":{"top_left_x":120,"top_left_y":2144,"width":1262,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35f4227789a5451c9860aec48e8937bf","type":"text","conversion_output":true,"text":"5 mg increments every 7 days as needed, to a minimum dose of \\(5 mg /\\) day .","text_display":" 5 mg increments every 7 days as needed, to a minimum dose of \\(5 mg /\\) day .","confidence":0.5687116883927956,"confidence_rate":0.9937487136375028},{"cnt":[[114,2226],[864,2226],[864,2282],[114,2282]],"region":{"top_left_x":113,"top_left_y":2225,"width":751,"height":57},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1804be2d0ee4e6f9e31e6c27bb341e4","type":"section_header","conversion_output":false,"children_ids":["dc310c424da44b1c80fd8212eda5d911"],"text":"","text_display":""},{"cnt":[[120,2230],[857,2230],[857,2277],[120,2277]],"region":{"top_left_x":120,"top_left_y":2230,"width":738,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc310c424da44b1c80fd8212eda5d911","type":"text","conversion_output":true,"parent_id":"c1804be2d0ee4e6f9e31e6c27bb341e4","text":"A3. RANDOMIZED CONTROLLED TRIAL","text_display":"\n\n\\section*{A3. RANDOMIZED CONTROLLED TRIAL}","confidence":1,"confidence_rate":1},{"cnt":[[120,2320],[1931,2320],[1931,2370],[120,2370]],"region":{"top_left_x":120,"top_left_y":2320,"width":1812,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc778be1a50d4690a1592c93e2b05d4c","type":"text","conversion_output":true,"text":"Participants who meet the study's remission criteria, will be randomly allocated, following completion of the","text_display":"\n\nParticipants who meet the study's remission criteria, will be randomly allocated, following completion of the","confidence":1,"confidence_rate":1},{"cnt":[[120,2368],[1916,2368],[1916,2415],[120,2415]],"region":{"top_left_x":120,"top_left_y":2367,"width":1797,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d52aa78113c1415fa0c7ad23371f0ed0","type":"text","conversion_output":true,"text":"stabilization phase, to either continue olanzapine or switch from olanzapine to placebo (see Data Analysis","text_display":" stabilization phase, to either continue olanzapine or switch from olanzapine to placebo (see Data Analysis","confidence":1,"confidence_rate":1},{"cnt":[[120,2411],[1992,2411],[1992,2460],[120,2460]],"region":{"top_left_x":120,"top_left_y":2410,"width":1872,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27adecb2395849ad88e148289f2f18f9","type":"text","conversion_output":true,"text":"section for details of the randomization procedure). Randomization assignments will be generated by Dr. Andy","text_display":" section for details of the randomization procedure). Randomization assignments will be generated by Dr. Andy","confidence":1,"confidence_rate":1},{"cnt":[[120,2454],[1858,2454],[1858,2503],[120,2503]],"region":{"top_left_x":120,"top_left_y":2453,"width":1739,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8614cce8ac2442cdaf26da78b0c2e51e","type":"text","conversion_output":true,"text":"Leon, the study's statistician, and sent to the research pharmacist at each site who will dispense study","text_display":" Leon, the study's statistician, and sent to the research pharmacist at each site who will dispense study","confidence":1,"confidence_rate":1},{"cnt":[[120,2496],[1957,2496],[1957,2546],[120,2546]],"region":{"top_left_x":120,"top_left_y":2496,"width":1838,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dca13cc29524982971220ae29c3e8fe","type":"text","conversion_output":true,"text":"medications. Records of each subject's treatment assignment will be kept at the respective pharmacies and","text_display":" medications. Records of each subject's treatment assignment will be kept at the respective pharmacies and","confidence":1,"confidence_rate":1},{"cnt":[[1955,2578],[2009,2578],[2009,2628],[1955,2628]],"region":{"top_left_x":1955,"top_left_y":2578,"width":54,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d777f6b8962543c08d59d5b07039ca13","type":"page_info","conversion_output":false,"text":"\\(\\underline{40}\\)","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"f8f7abe4-7f5e-43ba-a8e9-d8d2b5ddec93-43","page":43,"lines":[{"cnt":[[120,125],[1970,125],[1970,174],[120,174]],"region":{"top_left_x":120,"top_left_y":124,"width":1851,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2b690611301489789ed5d032837193d","type":"text","conversion_output":true,"text":"made available if a clinical emergency occurs. Site principal investigators and their co-investigators will carry","text_display":"\nmade available if a clinical emergency occurs. Site principal investigators and their co-investigators will carry","confidence":1,"confidence_rate":1},{"cnt":[[120,172],[1910,172],[1910,217],[120,217]],"region":{"top_left_x":120,"top_left_y":171,"width":1790,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3bd2648765047d2bda27e90cae119b2","type":"text","conversion_output":true,"text":"beepers to ensure that 24 -hour/day coverage is provided for medical emergencies that may arise in study","text_display":" beepers to ensure that 24 -hour/day coverage is provided for medical emergencies that may arise in study","confidence":0.599609375,"confidence_rate":0.9954436539487694},{"cnt":[[120,215],[333,215],[333,262],[120,262]],"region":{"top_left_x":120,"top_left_y":214,"width":214,"height":49},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"638fa4ce18d74d34aba4f7c95ab6fe4e","type":"text","conversion_output":true,"text":"participants.","text_display":" participants.","confidence":1,"confidence_rate":1},{"cnt":[[120,301],[1914,301],[1914,348],[120,348]],"region":{"top_left_x":120,"top_left_y":300,"width":1795,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1009816dc6684fc4bec6d901633b5cfa","type":"text","conversion_output":true,"text":"A3.1 Sertraline: Participants will take open-label sertraline for the duration of the RCT. The goal will be to","text_display":"\n\nA3.1 Sertraline: Participants will take open-label sertraline for the duration of the RCT. The goal will be to","confidence":1,"confidence_rate":1},{"cnt":[[120,348],[1966,348],[1966,393],[120,393]],"region":{"top_left_x":120,"top_left_y":348,"width":1846,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f98efedcd3aa49fd870bbea18e6c19a4","type":"text","conversion_output":true,"text":"maintain sertraline at the same acute dose that the participant was prescribed at the time of randomization to","text_display":" maintain sertraline at the same acute dose that the participant was prescribed at the time of randomization to","confidence":1,"confidence_rate":1},{"cnt":[[120,391],[1996,391],[1996,436],[120,436]],"region":{"top_left_x":120,"top_left_y":391,"width":1876,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5a67bf645f941a38e36770d06acb1cf","type":"text","conversion_output":true,"text":"the RCT. Because participants will have been taking sertraline for a minimum of 10 weeks and a maximum of","text_display":" the RCT. Because participants will have been taking sertraline for a minimum of 10 weeks and a maximum of","confidence":1,"confidence_rate":1},{"cnt":[[120,434],[1953,434],[1953,479],[120,479]],"region":{"top_left_x":120,"top_left_y":433,"width":1833,"height":47},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08549dea83924eaaa11c8e895dd79bab","type":"text","conversion_output":true,"text":"20 weeks before entering the RCT, we anticipate that the dose of sertraline will rarely need to be adjusted in","text_display":" 20 weeks before entering the RCT, we anticipate that the dose of sertraline will rarely need to be adjusted in","confidence":1,"confidence_rate":1},{"cnt":[[120,477],[1989,477],[1989,522],[120,522]],"region":{"top_left_x":120,"top_left_y":476,"width":1870,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2c2eba03ccf4fd0a4ac27e510f6675d","type":"text","conversion_output":true,"text":"the RCT because of side effects. However, if for any reason, side effects do necessitate a dose reduction, the","text_display":" the RCT because of side effects. However, if for any reason, side effects do necessitate a dose reduction, the","confidence":1,"confidence_rate":1},{"cnt":[[120,522],[1931,522],[1931,569],[120,569]],"region":{"top_left_x":120,"top_left_y":522,"width":1812,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c97fd01cb9a41b495f345268209e287","type":"text","conversion_output":true,"text":"reason for contemplating a dose reduction will need to be discussed with the site's principal investigator, to","text_display":" reason for contemplating a dose reduction will need to be discussed with the site's principal investigator, to","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[120,567],[1972,567],[1972,612],[120,612]],"region":{"top_left_x":120,"top_left_y":567,"width":1853,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd22e12552f94aab8dd174f81340e969","type":"text","conversion_output":true,"text":"ensure that this is the most appropriate course of action. If a dose reduction is agreed upon, the dose can be","text_display":" ensure that this is the most appropriate course of action. If a dose reduction is agreed upon, the dose can be","confidence":1,"confidence_rate":1},{"cnt":[[120,610],[1880,610],[1880,655],[120,655]],"region":{"top_left_x":120,"top_left_y":610,"width":1760,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae9cf18239db4bd686d19584a6d121bb","type":"text","conversion_output":true,"text":"reduced by 50 mg increments every 7 days, to a minimum dose of \\(50 mg /\\) day, if required. An alternative","text_display":" reduced by 50 mg increments every 7 days, to a minimum dose of \\(50 mg /\\) day, if required. An alternative","confidence":1,"confidence_rate":1},{"cnt":[[120,653],[1979,653],[1979,698],[120,698]],"region":{"top_left_x":120,"top_left_y":653,"width":1859,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc49bf5e144d43698978566ded6e0eb2","type":"text","conversion_output":true,"text":"approach to side effect burden during the RCT would be to disallow any reduction in the dose of sertraline, so","text_display":" approach to side effect burden during the RCT would be to disallow any reduction in the dose of sertraline, so","confidence":1,"confidence_rate":1},{"cnt":[[120,696],[1949,696],[1949,743],[120,743]],"region":{"top_left_x":120,"top_left_y":696,"width":1829,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff7ade4bac8d4429afde954113fe936a","type":"text","conversion_output":true,"text":"as not to confound the analyses of relapse and recurrence. However, forcing a participant to leave the RCT","text_display":" as not to confound the analyses of relapse and recurrence. However, forcing a participant to leave the RCT","confidence":1,"confidence_rate":1},{"cnt":[[120,743],[1983,743],[1983,788],[120,788]],"region":{"top_left_x":120,"top_left_y":743,"width":1864,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e0e97aee83742cdbfda7a3aa44812fc","type":"text","conversion_output":true,"text":"because of intolerable side effects, when a dose reduction may alleviate the problem and allow the participant","text_display":" because of intolerable side effects, when a dose reduction may alleviate the problem and allow the participant","confidence":1,"confidence_rate":1},{"cnt":[[120,786],[1867,786],[1867,831],[120,831]],"region":{"top_left_x":120,"top_left_y":786,"width":1747,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf3f67c75ca840e5aba157881628155c","type":"text","conversion_output":true,"text":"to continue, does not reflect 'real world' clinical practice, and would potentially weaken the power of the","text_display":" to continue, does not reflect 'real world' clinical practice, and would potentially weaken the power of the","confidence":1,"confidence_rate":1},{"cnt":[[120,829],[1927,829],[1927,874],[120,874]],"region":{"top_left_x":120,"top_left_y":829,"width":1808,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4b4e1ba5f074bdb9d15829c7e1296fd","type":"text","conversion_output":true,"text":"statistical models through forced attrition. An increase in dose of sertraline will not be permitted at any time","text_display":" statistical models through forced attrition. An increase in dose of sertraline will not be permitted at any time","confidence":1,"confidence_rate":1},{"cnt":[[120,872],[1946,872],[1946,920],[120,920]],"region":{"top_left_x":120,"top_left_y":872,"width":1827,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0db818b3b0fc471f865ad7c7baa42bc1","type":"text","conversion_output":true,"text":"during the RCT, because it will confound testing of H 1 . Dose changes of sertraline will be carefully recorded","text_display":" during the RCT, because it will confound testing of H 1 . Dose changes of sertraline will be carefully recorded","confidence":0.9455986022949219,"confidence_rate":0.9995378166706614},{"cnt":[[120,917],[1268,917],[1268,965],[120,965]],"region":{"top_left_x":120,"top_left_y":917,"width":1148,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e12334db88084d8fa7c7968b200108ca","type":"text","conversion_output":true,"text":"and will be reported in a descriptive fashion for each treatment arm.","text_display":" and will be reported in a descriptive fashion for each treatment arm.","confidence":1,"confidence_rate":1},{"cnt":[[120,1005],[1876,1005],[1876,1051],[120,1051]],"region":{"top_left_x":120,"top_left_y":1005,"width":1756,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b289ea9c560e4271a2eaf980f2800f1e","type":"text","conversion_output":true,"text":"A3.2 Placebo-Controlled Olanzapine Discontinuation: Eli Lilly has agreed to donate Olanzapine and","text_display":"\n\nA3.2 Placebo-Controlled Olanzapine Discontinuation: Eli Lilly has agreed to donate Olanzapine and","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[120,1048],[1884,1048],[1884,1094],[120,1094]],"region":{"top_left_x":120,"top_left_y":1048,"width":1765,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06b870eb607c4fcaa874df6aea2f3c3c","type":"text","conversion_output":true,"text":"matching placebo to the study. The placebo will be identical in size, weight, and appearance to the 5 mg","text_display":" matching placebo to the study. The placebo will be identical in size, weight, and appearance to the 5 mg","confidence":1,"confidence_rate":1},{"cnt":[[120,1094],[1871,1094],[1871,1139],[120,1139]],"region":{"top_left_x":120,"top_left_y":1093,"width":1752,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bd618154dc14449a3ca5f4e4d41434b","type":"text","conversion_output":true,"text":"olanzapine tablets that participants took during the acute and stabilization phases of the study. With the","text_display":" olanzapine tablets that participants took during the acute and stabilization phases of the study. With the","confidence":1,"confidence_rate":1},{"cnt":[[120,1138],[1974,1136],[1974,1182],[120,1184]],"region":{"top_left_x":120,"top_left_y":1136,"width":1855,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51a9e8b065214a58bfbf6536d5811f72","type":"text","conversion_output":true,"text":"exception of Dr. Leon and research pharmacists at each study site, none of the study's research personnel or","text_display":" exception of Dr. Leon and research pharmacists at each study site, none of the study's research personnel or","confidence":1,"confidence_rate":1},{"cnt":[[120,1182],[1867,1182],[1867,1227],[120,1227]],"region":{"top_left_x":120,"top_left_y":1181,"width":1747,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0f288b28be945ac9f2bed40718afbc8","type":"text","conversion_output":true,"text":"study's participants will be aware of treatment assignment. The following table lists the schedule for the","text_display":" study's participants will be aware of treatment assignment. The following table lists the schedule for the","confidence":1,"confidence_rate":1},{"cnt":[[120,1225],[1841,1225],[1841,1270],[120,1270]],"region":{"top_left_x":120,"top_left_y":1224,"width":1722,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"220ea7f0863f4281bfef718b11243d39","type":"text","conversion_output":true,"text":"substitution of 'blinded' olanzapine or placebo for open-label olanzapine, depending on the number of","text_display":" substitution of 'blinded' olanzapine or placebo for open-label olanzapine, depending on the number of","confidence":1,"confidence_rate":1},{"cnt":[[120,1268],[1300,1268],[1300,1315],[120,1315]],"region":{"top_left_x":120,"top_left_y":1267,"width":1180,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37f303d3d8aa47bea1377f2f0a130a4b","type":"text","conversion_output":true,"text":"olanzapine pills the participant takes at the time of starting the switch.","text_display":" olanzapine pills the participant takes at the time of starting the switch.","confidence":1,"confidence_rate":1},{"cnt":[[116,1349],[1897,1349],[1897,1437],[116,1437]],"region":{"top_left_x":116,"top_left_y":1349,"width":1782,"height":89},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"593ceaa125d84c738d292ec03a7edadc","type":"figure_label","conversion_output":false,"children_ids":["5620dc2ad50c4ca79e13681fde865bdc","e76aeead65634303a21c3ce5f54d9ca4"],"text":"","text_display":""},{"cnt":[[120,1354],[1893,1354],[1893,1399],[120,1399]],"region":{"top_left_x":120,"top_left_y":1353,"width":1773,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5620dc2ad50c4ca79e13681fde865bdc","type":"text","conversion_output":false,"parent_id":"593ceaa125d84c738d292ec03a7edadc","text":"Table: Schedule of Randomized, Double-Blind Switch of Open-Label Olanzapine to 'Blinded' Olanzapine Or","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[120,1396],[260,1396],[260,1433],[120,1433]],"region":{"top_left_x":120,"top_left_y":1396,"width":140,"height":38},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e76aeead65634303a21c3ce5f54d9ca4","type":"text","conversion_output":false,"parent_id":"593ceaa125d84c738d292ec03a7edadc","text":"Placebo","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[120,1431],[2007,1431],[2007,1815],[120,1815]],"region":{"top_left_x":120,"top_left_y":1430,"width":1887,"height":386},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"500ba4e73fcb44a1b0bab3a39420147a","type":"table","conversion_output":true,"children_ids":["02575fc54ad5404d84d90a89a6b30e66","c605cbfdc2fb4e4fb6c9316ed00ee81d","c62d862471294c37b251a1e0c32230f6","4b142c4924054e3fafe58df6df1e93e8","1b1ffba324d448789def3a61eb091e63","229e6d5430514ff4a5621da8184b4143","dee8518195ed4754bdaa58e3edda818e","d7f70fb8bbb24ef4bf469d54465071a3","fd13702d9010437ea4266c0f49a5ddbc","aefb0f1dbc3b49c3bf10dee9833bafa4","bcd54c5bfd574d9aa98d944cdaa2216e","bf6ee3c441174bdd8601a4f3273ba54b","61cff4a865844ad7b568ea1e23a27026","e4065fd144fb44389e4d6eabac389dd3","0aaac7a792ce40c9bb76ff168336a3c1","f7d25b53dc2540c99a20426029b30bb8","225831c2da294e768148c34c69be3fa2","34a8eb8728a74206b45b480e38f5d959","31650e55e501492ca11b4fe1517df2d2","8cb3a958bd9a4c21ab845120e05129bd","5d9b2dd9025a42baadcc843916a7c9ae","dd3ead68191b47e28bd012ddf928943f","1a22d20e0eb0456783bb7b6050e85ce5","c550b895993c414f8b0c021462d673df","40c9dc2baa804569b66c871d2fb9b3bd","288471e8ee32434fb50f3d809524a8f5","e637d6525ffc469b825965ca0c3d5d43","7bc54b3493274b1e9f38b37fae00e68c","d2e6b2403c08419f933926dd8e38d3db","738b0ab55f504e66baa9a332b453741f","8ed72a058e7b445f9135bc254be9c99a","1b50cabb54ce447a8727974a3046ad36","e49c7900925d42b1bd58c57e478567af","55d87ca77dc4476c893ae3fd66305aaa","bccaa35ac05f484188d59c3628c7ef0d","cfc87730d3574445ae94d4d156656ec0","a83da0c358d540afb2b382c80011e2f3","c6b477afbbd6481c8596df2419248404","f3ed04d0f7d24a12802991d1825ac9cb","178530045e7245ec836e89724bb9b059","f7225ba59214458f99b870c36b6751d9","95f573624d4946de842ce6d44984eb2a","4b38cd27ff0b442982b48ca9b03acd05","05ff7c06362c4d1fa88c962d6582dbc2","6f49eff46e0f4a28b88e2c32ee1f650c","3a89a534a394440b88547cf2d0a806e3","0550542dee0b4d5bb35e64aee654db40","88cc4efb3c5a428ea60ef18563d865f1","9a1b121fb76f4867a730e95bfdaa9f20","969c44a2600a4382a4218a427456fc54","5835b45fd7584085b8ca54c2726e6eba","88d4aa8699ee44938abef5ad2e110436","175369866d5c4bee9cb0af087215bcfc","a284fc6af2e74233971f4408c4c95e89","8842255d07f3450dbfc13a7421385951","3337808eb05c40149a95a905c9074044","2f3f09a7a060454c871a12f1a7f0d283","a4e042919a4340a88fafdeb01fc87e47","848faabf2f3a43e7b3cb31acbbf13c6c","804b1c60331c4b7fb2456f2ba5c71c26","a9b6b64e3eef4f989319044d0623bb32","7320446834bb4ee7ae75babb7338f7c9","f7e23c61841e4f1c89eb2b02d4b32f1a","55402d15ccb74cf48126635cda548aae","93c93648fa974457a5fbe8b2c6e6fd3b","14d2e419275842ac906d7b51a1d30132","94a591b4f996457b93433b24428fed6a","5412e711159941fe90176dcde093b6ba","850d04da1ab64675a9c97ff2672d3a24","ccaa8df4f70f4be38af0bee57798d5bc","ca2a135d4b824adb992aaee160fb7684","5ef91c893d534f09a27d8bc01eee80a1","69885a7372284309a5b0f648a5e2cf74"],"selected_labels":["593ceaa125d84c738d292ec03a7edadc"],"text":"\\begin{tabular}{|l|l|l|l|l|l|l|l|l|}\n\\hline 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