Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01302080
• Collaborator: (none)
• Enrollment: 941
• Locations: 44
• Actual Duration (Months): 101.2
• Patients Per Site: 21.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Drug: sertraline; Behavioral: psychotherapy

Detailed Description

Purposive sample: patients are not randomly selected, that is, he or she must meet certain inclusion criteria in order to qualify as a potential study participant.

Study Design

• Study Type: Observational
• Actual Enrollment: 941 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY A NON-INTERVENTIONAL, LONGITUDINAL, COHORT STUDY TO EVALUATE THE EFFECTS OF LONG-TERM SERTRALINE TREATMENT IN CHILDREN AND ADOLESCENTS
• Actual Study Start Date: Apr 4, 2012
• Actual Primary Completion Date: Sep 9, 2020
• Actual Study Completion Date: Sep 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Sertraline-treated enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline	Drug: sertraline; Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
psychotherapy only enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy	Behavioral: psychotherapy; Non-interventional study- as above

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Cognitive Function Using Trails B at Month 3 [Baseline, Month 3]

   Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

2. Change From Baseline in Cognitive Function Using Trails B at Month 6 [Baseline, Month 6]

   Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

3. Change From Baseline in Cognitive Function Using Trails B at Month 12 [Baseline, Month 12]

   Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

4. Change From Baseline in Cognitive Function Using Trails B at Month 18 [Baseline, Month 18]

   Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

5. Change From Baseline in Cognitive Function Using Trails B at Month 24 [Baseline, Month 24]

   Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

6. Change From Baseline in Cognitive Function Using Trails B at Month 30 [Baseline, Month 30]

   Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

7. Change From Baseline in Cognitive Function Using Trails B at Month 36 [Baseline, Month 36]

   Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

8. Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 [Baseline, Month 3]

   BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

9. Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6 [Baseline, Month 6]

   BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

10. Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12 [Baseline, Month 12]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

11. Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18 [Baseline, Month 18]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

12. Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24 [Baseline, Month 24]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

13. Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30 [Baseline, Month 30]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

14. Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36 [Baseline, Month 36]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

15. Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 [Baseline, Month 3]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

16. Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6 [Baseline, Month 6]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

17. Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12 [Baseline, Month 12]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

18. Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18 [Baseline, Month 18]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

19. Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24 [Baseline, Month 24]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

20. Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30 [Baseline, Month 30]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

21. Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36 [Baseline, Month 36]

    BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

22. Change From Baseline in Height at Month 3 [Baseline, Month 3]

    Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.

23. Change From Baseline in Height at Month 6 [Baseline, Month 6]

    Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

24. Change From Baseline in Height at Month 12 [Baseline, Month 12]

    Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

25. Change From Baseline in Height at Month 18 [Baseline, Month 18]

    Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

26. Change From Baseline in Height at Month 24 [Baseline, Month 24]

    Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

27. Change From Baseline in Height at Month 30 [Baseline, Month 30]

    Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

28. Change From Baseline in Height at Month 36 [Baseline, Month 36]

    Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

29. Change From Baseline in Weight at Month 3 [Baseline, Month 3]

    Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

30. Change From Baseline in Weight at Month 6 [Baseline, Month 6]

    Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

31. Change From Baseline in Weight at Month 12 [Baseline, Month 12]

    Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

32. Change From Baseline in Weight at Month 18 [Baseline, Month 18]

    Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

33. Change From Baseline in Weight at Month 24 [Baseline, Month 24]

    Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

34. Change From Baseline in Weight at Month 30 [Baseline, Month 30]

    Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

35. Change From Baseline in Weight at Month 36 [Baseline, Month 36]

    Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

36. Change From Baseline in Body Mass Index (BMI) at Month 3 [Baseline, Month 3]

    BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

37. Change From Baseline in Body Mass Index (BMI) at Month 6 [Baseline, Month 6]

    BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

38. Change From Baseline in Body Mass Index (BMI) at Month 12 [Baseline, Month 12]

    BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

39. Change From Baseline in Body Mass Index (BMI) at Month 18 [Baseline, Month 18]

    BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

40. Change From Baseline in Body Mass Index (BMI) at Month 24 [Baseline, Month 24]

    BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

41. Change From Baseline in Body Mass Index (BMI) at Month 30 [Baseline, Month 30]

    BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

42. Change From Baseline in Body Mass Index (BMI) at Month 36 [Baseline, Month 36]

    BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

43. Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males [Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

44. Number of Participants With Tanner Staging Evaluation at Month 3: All Males [Month 3]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

45. Number of Participants With Tanner Staging Evaluation at Month 6: All Males [Month 6]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

46. Number of Participants With Tanner Staging Evaluation at Month 12: All Males [Month 12]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

47. Number of Participants With Tanner Staging Evaluation at Month 18: All Males [Month 18]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

48. Number of Participants With Tanner Staging Evaluation at Month 24: All Males [Month 24]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

49. Number of Participants With Tanner Staging Evaluation at Month 30: All Males [Month 30]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

50. Number of Participants With Tanner Staging Evaluation at Month 36: All Males [Month 36]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

51. Number of Participants With Tanner Staging Evaluation at Baseline: All Females [Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

52. Number of Participants With Tanner Staging Evaluation at Month 3: All Females [Month 3]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

53. Number of Participants With Tanner Staging Evaluation at Month 6: All Females [Month 6]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

54. Number of Participants With Tanner Staging Evaluation at Month 12: All Females [Month 12]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

55. Number of Participants With Tanner Staging Evaluation at Month 18: All Females [Month 18]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

56. Number of Participants With Tanner Staging Evaluation at Month 24: All Females [Month 24]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

57. Number of Participants With Tanner Staging Evaluation at Month 30: All Females [Month 30]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

58. Number of Participants With Tanner Staging Evaluation at Month 36: All Females [Month 36]

    Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Secondary Outcome Measures

1. Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 [Month 3, 6, 12, 18, 24, 30 and 36]

   CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.

2. Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 [Month 3, 6, 12, 18, 24, 30 and 36]

   CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.

3. Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 [Month 3, 6, 12, 18, 24, 30 and 36]

   The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.

4. Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 [Baseline, Month 3, 6, 12, 18, 24, 30 and 36]

   CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.

5. Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 [Baseline, Month 3, 6, 12, 18, 24, 30 and 36]

   CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well.

6. Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 [Baseline, Month 3, 6, 12, 18, 24, 30 and 36]

   HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.

Exclusion Criteria:

• Psychotic at study entry

• Diagnosis of bipolar disorder

• Diagnosis of schizoaffective or schizophrenia

• Anorexia

• Bulimia or eating disorder not otherwise specified (NOS)

• Autism

• Pervasive developmental disorder

• High risk of suicide within 2 weeks of initiating study treatment

• Significant mental retardation

• Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harmonex Neuroscience Research	Dothan	Alabama	United States	36303
2	Sun Valley Research Center	Imperial	California	United States	92251
3	UCLA Semel institute	Los Angeles	California	United States	90024
4	Institute of Living/Hartford Hospital	Hartford	Connecticut	United States	06106
5	Comprehensive Psychiatric Care	Norwich	Connecticut	United States	06360
6	University of Florida	Gainesville	Florida	United States	32610
7	Nemours Children's Clinic, Dept. of Psychology and Psychiatry	Jacksonville	Florida	United States	32207
8	Medical Research Group of Central Florida	Orange City	Florida	United States	32763
9	Harmonex Neuroscience of Pensacola	Pensacola	Florida	United States	32502
10	University of South Florida - Rothman Center	Saint Petersburg	Florida	United States	33701
11	Georgia Regents University Augusta	Augusta	Georgia	United States	30912
12	Institute for Behavioral Medicine, LLC	Smyrna	Georgia	United States	30080
13	Family Behavioral Health	Plainfield	Illinois	United States	60585
14	University of Kansas School of Medicine/Dept. of Psychiatry	Kansas City	Kansas	United States	66160-7341
15	Family Service and Guidance Center	Topeka	Kansas	United States	66606
16	Kennedy Krieger Institute	Baltimore	Maryland	United States	21205
17	Neuroscientific Insights	Rockville	Maryland	United States	20852
18	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
19	Debora A. LaMonica, MD	South Yarmouth	Massachusetts	United States	02664
20	Baystate Medical Center, Child Behavioral Health Research	Springfield	Massachusetts	United States	01199
21	Mayo Clinic	Rochester	Minnesota	United States	55905
22	Comprehensive Psychiatric Associates	Gladstone	Missouri	United States	64118
23	Saint John's Clinic	Springfield	Missouri	United States	65804
24	Jersey Shore University Medical Center/Meridian Health	Neptune	New Jersey	United States	07753
25	Children's Specialized Hospital	Toms River	New Jersey	United States	08755
26	Finger Lakes Clinical Research	Rochester	New York	United States	14618
27	3-C Family Services, P.A.	Cary	North Carolina	United States	27513
28	Duke University Medical Center, Division of Child & Adolescent Psychiatry	Durham	North Carolina	United States	27705
29	Scott George Crowder, M.D.	Wilmington	North Carolina	United States	28401
30	Family Center by the Falls	Chagrin Falls	Ohio	United States	44023
31	University Of Cincinnati	Cincinnati	Ohio	United States	45219
32	Cincinnati Childrens Hospital and Medical Center	Cincinnati	Ohio	United States	45220
33	Case Western Reserve University, Department of Psychiatry Child/Adolescent	Cleveland	Ohio	United States	44106
34	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73116
35	Child Guidance Resource Center	Havertown	Pennsylvania	United States	19083
36	Tullahoma Pediatrics PLLC	Tullahoma	Tennessee	United States	37388
37	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
38	Bay Pointe Behavioral Health Service, Inc.	Friendswood	Texas	United States	77546
39	Midtown Psychiatry and TMS Center	Houston	Texas	United States	77007
40	Peter Ly MD	Houston	Texas	United States	77058
41	Focus and Balance, LLC	San Antonio	Texas	United States	78229
42	University of Virginia Health System	Charlottesville	Virginia	United States	22903
43	Clinical Research Partners, LLC	Petersburg	Virginia	United States	23805
44	McLean Hospital - Harvard Medical School	Milwaukee	Wisconsin	United States	53227

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Oct 24, 2019
• Statistical Analysis Plan - Oct 20, 2020

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01302080
• Other Study ID Numbers: A0501093; SPRITES
• First Posted: Feb 23, 2011
• Last Update Posted: Oct 14, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: prospective; cohort; sertraline; long-term impact; cognition; emotional and physical development; pubertal maturation
• Additional relevant MeSH terms: Obsessive-Compulsive Disorder; Sertraline

Study Results

Participant Flow

Recruitment Details	This was a non-interventional observational study. Participants to be enrolled were of age 6 to 16 (inclusive), exposed to sertraline (with or without psychotherapy) and exposed to psychotherapy alone under real world conditions. Participants exposed and unexposed to sertraline were followed for a maximum of 3 years.
Pre-assignment Detail	Participants switched from 1 treatment to another throughout the study, irrespective in which arm they were enrolled. Hence, number of participants for reporting arms were different at different visits.

Arm/Group Title	Sertraline	Psychotherapy
Arm/Group Description	Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to United States prescribing information (USPI) provided by their physician. Participants in this group were on sertraline only or sertraline and any other treatment. Treatment here was the one which was planned for the participants at baseline.	Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial/psychotherapy rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a selective serotonin reuptake inhibitor (SSRI) medication. Participants in this group were on psychotherapy only or no treatment at all.
Period Title: Overall Study
STARTED	696	245
COMPLETED	330	102
NOT COMPLETED	366	143

Baseline Characteristics

Arm/Group Title	Sertraline	Other Antidepressant	Psychotherapy	Total
Arm/Group Description	Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.	Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.	Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.	Total of all reporting groups
Overall Participants	695	3	243	941
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.2 (2.9)	14.0 (3.0)	11.0 (2.9)	11.9 (2.9)
Sex: Female, Male (Count of Participants)
Female	405 58.3%	3 100%	130 53.5%	538 57.2%
Male	290 41.7%	0 0%	113 46.5%	403 42.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	73 10.5%	1 33.3%	24 9.9%	98 10.4%
Not Hispanic or Latino	622 89.5%	2 66.7%	219 90.1%	843 89.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	23 3.3%	0 0%	2 0.8%	25 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	66 9.5%	0 0%	15 6.2%	81 8.6%
White	588 84.6%	3 100%	208 85.6%	799 84.9%
More than one race	14 2%	0 0%	13 5.3%	27 2.9%
Unknown or Not Reported	4 0.6%	0 0%	5 2.1%	9 1%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Trails B at Month 3
Description	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	666	3	224
Baseline	1.03 (2.3)	1.23 (1.0)	0.61 (1.8)
Change at Week 3	-0.39 (1.6)	-0.09 (0.5)	-0.03 (2.3)

2. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Trails B at Month 6
Description	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	460	35	159
Mean (Standard Deviation) [Z-score]	-0.64 (2.2)	-0.65 (1.0)	-0.16 (1.9)

3. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Trails B at Month 12
Description	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	367	57	138
Mean (Standard Deviation) [Z-score]	-0.72 (2.3)	-0.22 (1.4)	-0.27 (2.4)

4. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Trails B at Month 18
Description	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame	Baseline, Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	290	70	138
Mean (Standard Deviation) [Z-score]	-0.57 (1.9)	-0.65 (2.2)	-0.22 (2.8)

5. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Trails B at Month 24
Description	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame	Baseline, Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	247	70	134
Mean (Standard Deviation) [Z-score]	-0.44 (2.2)	-1.08 (1.7)	-0.18 (3.4)

6. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Trails B at Month 30
Description	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame	Baseline, Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	209	63	141
Mean (Standard Deviation) [Z-score]	-0.74 (2.1)	-0.61 (2.4)	-0.18 (4.2)

7. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Trails B at Month 36
Description	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame	Baseline, Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	193	56	154
Mean (Standard Deviation) [Z-score]	-0.25 (2.9)	-0.13 (3.6)	-0.59 (2.6)

8. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	686	3	237
Baseline	62.93 (11.3)	57.67 (5.5)	59.27 (13.0)
Change at Week 3	-2.29 (7.8)	4.50 (13.4)	-1.88 (7.3)

9. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	467	35	166
Mean (Standard Deviation) [Z-score]	-2.53 (8.8)	-1.54 (8.8)	-2.74 (8.7)

10. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	370	58	140
Mean (Standard Deviation) [Z-score]	-3.12 (9.1)	-1.97 (8.3)	-2.81 (9.0)

11. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	290	69	140
Mean (Standard Deviation) [Z-score]	-2.40 (9.2)	-1.57 (9.9)	-3.13 (8.3)

12. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	248	66	133
Mean (Standard Deviation) [Z-score]	-3.37 (10.0)	-3.14 (9.0)	-4.16 (9.5)

13. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	200	59	135
Mean (Standard Deviation) [Z-score]	-3.60 (11.2)	-4.39 (8.7)	-4.53 (10.2)

14. Primary Outcome

Title	Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	184	54	141
Mean (Standard Deviation) [Z-score]	-3.96 (12.1)	-3.87 (10.4)	-4.62 (10.9)

15. Primary Outcome

Title	Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	692	3	238
Baseline	65.15 (12.0)	58.67 (4.0)	61.88 (12.6)
Change at Week 3	-3.08 (9.1)	-1.50 (0.7)	-2.39 (7.4)

16. Primary Outcome

Title	Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	472	36	167
Mean (Standard Deviation) [Z-score]	-4.06 (9.4)	-3.14 (9.7)	-3.62 (8.9)

17. Primary Outcome

Title	Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	373	59	140
Mean (Standard Deviation) [Z-score]	-5.42 (10.1)	-2.44 (8.2)	-5.01 (9.5)

18. Primary Outcome

Title	Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	294	71	140
Mean (Standard Deviation) [Z-score]	-5.21 (9.9)	-3.59 (9.9)	-4.48 (9.2)

19. Primary Outcome

Title	Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	252	68	133
Mean (Standard Deviation) [Z-score]	-6.21 (11.2)	-5.78 (8.8)	-6.05 (9.9)

20. Primary Outcome

Title	Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	204	61	136
Mean (Standard Deviation) [Z-score]	-6.92 (10.8)	-5.23 (10.0)	-6.53 (10.4)

21. Primary Outcome

Title	Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36
Description	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame	Baseline, Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	188	55	142
Mean (Standard Deviation) [Z-score]	-7.44 (11.1)	-7.24 (10.6)	-6.22 (11.2)

22. Primary Outcome

Title	Change From Baseline in Height at Month 3
Description	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	693	3	243
Baseline	0.31 (1.1)	0.76 (1.4)	0.32 (1.1)
Change at Month 3	0.00 (0.3)	-0.03 (0.1)	-0.01 (0.3)

23. Primary Outcome

Title	Change From Baseline in Height at Month 6
Description	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	478	36	170
Mean (Standard Deviation) [Z-score]	-0.02 (0.3)	0.07 (0.4)	0.00 (0.4)

24. Primary Outcome

Title	Change From Baseline in Height at Month 12
Description	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	381	59	144
Mean (Standard Deviation) [Z-score]	-0.01 (0.4)	0.06 (0.5)	-0.04 (0.4)

25. Primary Outcome

Title	Change From Baseline in Height at Month 18
Description	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	305	74	145
Mean (Standard Deviation) [Z-score]	-0.03 (0.5)	0.00 (0.5)	-0.02 (0.6)

26. Primary Outcome

Title	Change From Baseline in Height at Month 24
Description	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	263	70	138
Mean (Standard Deviation) [Z-score]	0.01 (0.5)	-0.02 (0.6)	-0.02 (0.5)

27. Primary Outcome

Title	Change From Baseline in Height at Month 30
Description	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	218	66	148
Mean (Standard Deviation) [Z-score]	0.01 (0.7)	-0.10 (0.6)	0.00 (0.6)

28. Primary Outcome

Title	Change From Baseline in Height at Month 36
Description	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	203	62	160
Mean (Standard Deviation) [Z-score]	0.00 (0.7)	-0.04 (0.7)	-0.02 (0.9)

29. Primary Outcome

Title	Change From Baseline in Weight at Month 3
Description	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	693	3	243
Baseline	0.58 (1.2)	0.88 (0.7)	0.42 (1.0)
Change at Month 3	0.02 (0.2)	-0.22 (0.1)	-0.03 (0.2)

30. Primary Outcome

Title	Change From Baseline in Weight at Month 6
Description	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	478	36	170
Mean (Standard Deviation) [Z-score]	0.03 (0.3)	0.01 (0.3)	-0.05 (0.3)

31. Primary Outcome

Title	Change From Baseline in Weight at Month 12
Description	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	382	59	144
Mean (Standard Deviation) [Z-score]	0.10 (0.4)	0.06 (0.5)	0.00 (0.4)

32. Primary Outcome

Title	Change From Baseline in Weight at Month 18
Description	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	305	74	145
Mean (Standard Deviation) [Z-score]	0.14 (0.5)	0.07 (0.6)	-0.01 (0.5)

33. Primary Outcome

Title	Change From Baseline in Weight at Month 24
Description	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	263	70	138
Mean (Standard Deviation) [Z-score]	0.16 (0.5)	0.15 (0.6)	0.00 (0.6)

34. Primary Outcome

Title	Change From Baseline in Weight at Month 30
Description	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	218	66	148
Mean (Standard Deviation) [Z-score]	0.16 (0.6)	0.11 (0.6)	0.04 (0.6)

35. Primary Outcome

Title	Change From Baseline in Weight at Month 36
Description	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	203	62	162
Mean (Standard Deviation) [Z-score]	0.17 (0.6)	0.17 (0.7)	0.02 (0.6)

36. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Month 3
Description	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	693	3	243
Baseline	0.48 (1.3)	0.79 (0.4)	0.27 (1.3)
Change at Month 3	0.02 (0.3)	-0.26 (0.2)	-0.03 (0.3)

37. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Month 6
Description	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	478	36	170
Mean (Standard Deviation) [Z-score]	0.04 (0.4)	-0.03 (0.4)	-0.06 (0.4)

38. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Month 12
Description	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	381	59	144
Mean (Standard Deviation) [Z-score]	0.13 (0.5)	0.06 (0.6)	0.04 (0.6)

39. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Month 18
Description	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	305	74	145
Mean (Standard Deviation) [Z-score]	0.18 (0.6)	0.07 (0.8)	-0.04 (0.6)

40. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Month 24
Description	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	263	70	138
Mean (Standard Deviation) [Z-score]	0.17 (0.7)	0.20 (0.9)	-0.01 (0.7)

41. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Month 30
Description	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	218	66	148
Mean (Standard Deviation) [Z-score]	0.16 (0.8)	0.15 (0.8)	0.03 (0.7)

42. Primary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Month 36
Description	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame	Baseline, Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	203	62	160
Mean (Standard Deviation) [Z-score]	0.17 (0.8)	0.21 (0.9)	0.01 (0.7)

43. Primary Outcome

Title	Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure. There were no male participants in reporting arm "Other Antidepressant" at Baseline, hence no data collected and evaluated.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	288	0	113
Stage 1	122 17.6%	58 1933.3%
Stage 2	53 7.6%	20 666.7%
Stage 3	45 6.5%	17 566.7%
Stage 4	53 7.6%	15 500%
Stage 5	15 2.2%	3 100%

44. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 3: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	230	1	80
Stage 1	94 13.5%	1 33.3%	42 17.3%
Stage 2	40 5.8%	0 0%	10 4.1%
Stage 3	43 6.2%	0 0%	14 5.8%
Stage 4	45 6.5%	0 0%	11 4.5%
Stage 5	8 1.2%	0 0%	3 1.2%

45. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 6: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	203	14	77
Stage 1	75 10.8%	6 200%	36 14.8%
Stage 2	44 6.3%	2 66.7%	11 4.5%
Stage 3	34 4.9%	3 100%	14 5.8%
Stage 4	43 6.2%	2 66.7%	14 5.8%
Stage 5	7 1%	1 33.3%	2 0.8%

46. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 12: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	164	24	69
Stage 1	55 7.9%	7 233.3%	30 12.3%
Stage 2	37 5.3%	2 66.7%	11 4.5%
Stage 3	26 3.7%	5 166.7%	12 4.9%
Stage 4	36 5.2%	8 266.7%	12 4.9%
Stage 5	10 1.4%	2 66.7%	4 1.6%

47. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 18: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	136	33	57
Stage 1	39 5.6%	9 300%	20 8.2%
Stage 2	31 4.5%	5 166.7%	11 4.5%
Stage 3	19 2.7%	6 200%	12 4.9%
Stage 4	33 4.7%	7 233.3%	9 3.7%
Stage 5	14 2%	6 200%	5 2.1%

48. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 24: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	112	34	62
Stage 1	32 4.6%	7 233.3%	13 5.3%
Stage 2	27 3.9%	9 300%	12 4.9%
Stage 3	17 2.4%	6 200%	14 5.8%
Stage 4	22 3.2%	6 200%	16 6.6%
Stage 5	14 2%	6 200%	7 2.9%

49. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 30: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	86	33	64
Stage 1	23 3.3%	5 166.7%	10 4.1%
Stage 2	18 2.6%	7 233.3%	8 3.3%
Stage 3	16 2.3%	5 166.7%	19 7.8%
Stage 4	15 2.2%	6 200%	19 7.8%
Stage 5	14 2%	10 333.3%	8 3.3%

50. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 36: All Males
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	84	34	75
Stage 1	18 2.6%	6 200%	7 2.9%
Stage 2	18 2.6%	4 133.3%	12 4.9%
Stage 3	14 2%	10 333.3%	15 6.2%
Stage 4	22 3.2%	4 133.3%	25 10.3%
Stage 5	12 1.7%	10 333.3%	16 6.6%

51. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Baseline: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	401	3	130
Stage 1	81 11.7%	1 33.3%	39 16%
Stage 2	40 5.8%	0 0%	21 8.6%
Stage 3	61 8.8%	0 0%	25 10.3%
Stage 4	146 21%	1 33.3%	28 11.5%
Stage 5	73 10.5%	1 33.3%	17 7%

52. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 3: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	323	2	94
Stage 1	59 8.5%	1 33.3%	30 12.3%
Stage 2	37 5.3%	0 0%	13 5.3%
Stage 3	47 6.8%	0 0%	14 5.8%
Stage 4	108 15.5%	0 0%	24 9.9%
Stage 5	72 10.4%	1 33.3%	13 5.3%

53. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 6: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	275	22	91
Stage 1	43 6.2%	1 33.3%	22 9.1%
Stage 2	31 4.5%	4 133.3%	13 5.3%
Stage 3	46 6.6%	2 66.7%	18 7.4%
Stage 4	90 12.9%	10 333.3%	18 7.4%
Stage 5	65 9.4%	5 166.7%	20 8.2%

54. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 12: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	218	35	75
Stage 1	27 3.9%	5 166.7%	9 3.7%
Stage 2	27 3.9%	2 66.7%	15 6.2%
Stage 3	31 4.5%	5 166.7%	12 4.9%
Stage 4	71 10.2%	11 366.7%	24 9.9%
Stage 5	62 8.9%	12 400%	15 6.2%

55. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 18: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	169	40	88
Stage 1	17 2.4%	4 133.3%	9 3.7%
Stage 2	14 2%	2 66.7%	14 5.8%
Stage 3	22 3.2%	2 66.7%	13 5.3%
Stage 4	57 8.2%	14 466.7%	31 12.8%
Stage 5	59 8.5%	18 600%	21 8.6%

56. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 24: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	151	37	76
Stage 1	13 1.9%	2 66.7%	8 3.3%
Stage 2	15 2.2%	3 100%	10 4.1%
Stage 3	16 2.3%	1 33.3%	13 5.3%
Stage 4	49 7.1%	11 366.7%	24 9.9%
Stage 5	58 8.3%	20 666.7%	21 8.6%

57. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 30: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 30

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	132	33	84
Stage 1	10 1.4%	1 33.3%	3 1.2%
Stage 2	15 2.2%	2 66.7%	9 3.7%
Stage 3	15 2.2%	1 33.3%	8 3.3%
Stage 4	34 4.9%	8 266.7%	29 11.9%
Stage 5	58 8.3%	21 700%	35 14.4%

58. Primary Outcome

Title	Number of Participants With Tanner Staging Evaluation at Month 36: All Females
Description	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	120	30	88
Stage 1	9 1.3%	0 0%	2 0.8%
Stage 2	9 1.3%	2 66.7%	9 3.7%
Stage 3	9 1.3%	7 233.3%	8 3.3%
Stage 4	32 4.6%	7 233.3%	25 10.3%
Stage 5	61 8.8%	14 466.7%	44 18.1%

59. Secondary Outcome

Title	Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36
Description	CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.
Time Frame	Month 3, 6, 12, 18, 24, 30 and 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	556	73	176
Very Much Improved	77 11.1%	0 0%	17 7%
Much Improved	223 32.1%	0 0%	51 21%
Minimally Improved	151 21.7%	1 33.3%	69 28.4%
Not Changed	63 9.1%	1 33.3%	29 11.9%
Minimally Worse	20 2.9%	0 0%	3 1.2%
Much Worse	21 3%	0 0%	5 2.1%
Very Much Worse	1 0.1%	1 33.3%	2 0.8%
Very Much Improved	96 13.8%	2 66.7%	29 11.9%
Much Improved	220 31.7%	14 466.7%	64 26.3%
Minimally Improved	87 12.5%	7 233.3%	48 19.8%
Not Changed	44 6.3%	8 266.7%	21 8.6%
Minimally Worse	15 2.2%	0 0%	2 0.8%
Much Worse	12 1.7%	3 100%	2 0.8%
Very Much Worse	4 0.6%	0 0%	1 0.4%
Very Much Improved	93 13.4%	9 300%	32 13.2%
Much Improved	174 25%	19 633.3%	55 22.6%
Minimally Improved	80 11.5%	20 666.7%	28 11.5%
Not Changed	16 2.3%	6 200%	18 7.4%
Minimally Worse	7 1%	1 33.3%	2 0.8%
Much Worse	9 1.3%	2 66.7%	6 2.5%
Very Much Worse	3 0.4%	0 0%	0 0%
Very Much Improved	86 12.4%	14 466.7%	32 13.2%
Much Improved	136 19.6%	34 1133.3%	55 22.6%
Minimally Improved	53 7.6%	11 366.7%	34 14%
Not Changed	14 2%	10 333.3%	11 4.5%
Minimally Worse	6 0.9%	1 33.3%	2 0.8%
Much Worse	7 1%	2 66.7%	5 2.1%
Very Much Worse	2 0.3%	1 33.3%	0 0%
Very Much Improved	93 13.4%	10 333.3%	34 14%
Much Improved	113 16.3%	39 1300%	53 21.8%
Minimally Improved	34 4.9%	10 333.3%	27 11.1%
Not Changed	16 2.3%	9 300%	9 3.7%
Minimally Worse	5 0.7%	2 66.7%	2 0.8%
Much Worse	0 0%	0 0%	4 1.6%
Very Much Worse	1 0.1%	0 0%	1 0.4%
Very Much Improved	73 10.5%	12 400%	43 17.7%
Much Improved	102 14.7%	41 1366.7%	63 25.9%
Minimally Improved	21 3%	8 266.7%	23 9.5%
Not Changed	12 1.7%	2 66.7%	12 4.9%
Minimally Worse	4 0.6%	1 33.3%	1 0.4%
Much Worse	1 0.1%	0 0%	1 0.4%
Very Much Worse	1 0.1%	0 0%	0 0%
Very Much Improved	85 12.2%	22 733.3%	53 21.8%
Much Improved	85 12.2%	27 900%	77 31.7%
Minimally Improved	22 3.2%	9 300%	15 6.2%
Not Changed	5 0.7%	3 100%	8 3.3%
Minimally Worse	1 0.1%	1 33.3%	1 0.4%
Much Worse	4 0.6%	2 66.7%	0 0%
Very Much Worse	1 0.1%	0 0%	0 0%

60. Secondary Outcome

Title	Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36
Description	CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.
Time Frame	Month 3, 6, 12, 18, 24, 30 and 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	546	65	96
Very High	274 39.4%	0 0%	25 10.3%
High	123 17.7%	0 0%	18 7.4%
Above Average	40 5.8%	0 0%	18 7.4%
Average	69 9.9%	2 66.7%	30 12.3%
Low	22 3.2%	0 0%	3 1.2%
Very Low	10 1.4%	0 0%	2 0.8%
Extremely Low	8 1.2%	0 0%	0 0%
Very High	245 35.3%	14 466.7%	33 13.6%
High	116 16.7%	4 133.3%	12 4.9%
Above Average	28 4%	1 33.3%	20 8.2%
Average	49 7.1%	6 200%	23 9.5%
Low	19 2.7%	2 66.7%	2 0.8%
Very Low	5 0.7%	1 33.3%	4 1.6%
Extremely Low	6 0.9%	1 33.3%	1 0.4%
Very High	217 31.2%	23 766.7%	30 12.3%
High	84 12.1%	12 400%	14 5.8%
Above Average	19 2.7%	3 100%	12 4.9%
Average	35 5%	10 333.3%	14 5.8%
Low	11 1.6%	4 133.3%	4 1.6%
Very Low	1 0.1%	0 0%	0 0%
Extremely Low	0 0%	0 0%	0 0%
Very High	170 24.5%	32 1066.7%	35 14.4%
High	77 11.1%	15 500%	9 3.7%
Above Average	16 2.3%	3 100%	7 2.9%
Average	26 3.7%	10 333.3%	11 4.5%
Low	5 0.7%	3 100%	6 2.5%
Very Low	2 0.3%	0 0%	0 0%
Extremely Low	2 0.3%	1 33.3%	1 0.4%
Very High	149 21.4%	37 1233.3%	33 13.6%
High	67 9.6%	17 566.7%	12 4.9%
Above Average	9 1.3%	5 166.7%	3 1.2%
Average	19 2.7%	3 100%	8 3.3%
Low	4 0.6%	3 100%	4 1.6%
Very Low	2 0.3%	0 0%	0 0%
Extremely Low	0 0%	0 0%	0 0%
Very High	132 19%	29 966.7%	35 14.4%
High	55 7.9%	18 600%	5 2.1%
Above Average	7 1%	6 200%	6 2.5%
Average	12 1.7%	5 166.7%	9 3.7%
Low	2 0.3%	1 33.3%	1 0.4%
Very Low	1 0.1%	0 0%	1 0.4%
Extremely Low	1 0.1%	0 0%	0 0%
Very High	125 18%	35 1166.7%	32 13.2%
High	51 7.3%	12 400%	10 4.1%
Above Average	11 1.6%	3 100%	6 2.5%
Average	7 1%	5 166.7%	7 2.9%
Low	0 0%	1 33.3%	2 0.8%
Very Low	1 0.1%	0 0%	0 0%
Extremely Low	2 0.3%	0 0%	1 0.4%

61. Secondary Outcome

Title	Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36
Description	The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.
Time Frame	Month 3, 6, 12, 18, 24, 30 and 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	544	67	130
Responders at Month 3	296 42.6%	1 33.3%	55 22.6%
Responders at Month 6	309 44.5%	14 466.7%	72 29.6%
Responders at Month 12	268 38.6%	28 933.3%	52 21.4%
Responders at Month 18	219 31.5%	44 1466.7%	54 22.2%
Responders at Month 24	206 29.6%	47 1566.7%	54 22.2%
Responders at Month 30	173 24.9%	52 1733.3%	66 27.2%
Responders at Month 36	169 24.3%	46 1533.3%	72 29.6%

62. Secondary Outcome

Title	Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Description	CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.
Time Frame	Baseline, Month 3, 6, 12, 18, 24, 30 and 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	692	74	243
Normal, Not Mentally ill	21 3%	0 0%	29 11.9%
Borderline Mentally ill	28 4%	0 0%	17 7%
Mildly Mentally ill	138 19.9%	0 0%	57 23.5%
Moderately Mentally ill	377 54.2%	3 100%	107 44%
Markedly Mentally ill	116 16.7%	0 0%	31 12.8%
Severely Mentally ill	12 1.7%	0 0%	2 0.8%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%
Normal, Not Mentally ill	32 4.6%	0 0%	18 7.4%
Borderline Mentally ill	87 12.5%	0 0%	19 7.8%
Mildly Mentally ill	163 23.5%	1 33.3%	60 24.7%
Moderately Mentally ill	216 31.1%	0 0%	54 22.2%
Markedly Mentally ill	55 7.9%	1 33.3%	23 9.5%
Severely Mentally ill	3 0.4%	1 33.3%	4 1.6%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%
Normal, Not Mentally ill	44 6.3%	1 33.3%	28 11.5%
Borderline Mentally ill	93 13.4%	4 133.3%	33 13.6%
Mildly Mentally ill	139 20%	9 300%	51 21%
Moderately Mentally ill	162 23.3%	15 500%	43 17.7%
Markedly Mentally ill	31 4.5%	6 200%	14 5.8%
Severely Mentally ill	10 1.4%	1 33.3%	3 1.2%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%
Normal, Not Mentally ill	42 6%	2 66.7%	32 13.2%
Borderline Mentally ill	80 11.5%	6 200%	31 12.8%
Mildly Mentally ill	133 19.1%	13 433.3%	39 16%
Moderately Mentally ill	100 14.4%	26 866.7%	29 11.9%
Markedly Mentally ill	22 3.2%	11 366.7%	11 4.5%
Severely Mentally ill	6 0.9%	1 33.3%	4 1.6%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%
Normal, Not Mentally ill	35 5%	1 33.3%	26 10.7%
Borderline Mentally ill	66 9.5%	13 433.3%	29 11.9%
Mildly Mentally ill	106 15.3%	19 633.3%	53 21.8%
Moderately Mentally ill	76 10.9%	33 1100%	34 14%
Markedly Mentally ill	16 2.3%	5 166.7%	7 2.9%
Severely Mentally ill	5 0.7%	3 100%	0 0%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%
Normal, Not Mentally ill	39 5.6%	4 133.3%	25 10.3%
Borderline Mentally ill	61 8.8%	10 333.3%	29 11.9%
Mildly Mentally ill	100 14.4%	17 566.7%	48 19.8%
Moderately Mentally ill	48 6.9%	35 1166.7%	31 12.8%
Markedly Mentally ill	13 1.9%	5 166.7%	5 2.1%
Severely Mentally ill	2 0.3%	0 0%	1 0.4%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%
Normal, Not Mentally ill	30 4.3%	5 166.7%	33 13.6%
Borderline Mentally ill	58 8.3%	13 433.3%	27 11.1%
Mildly Mentally ill	78 11.2%	25 833.3%	55 22.6%
Moderately Mentally ill	45 6.5%	19 633.3%	29 11.9%
Markedly Mentally ill	6 0.9%	3 100%	4 1.6%
Severely Mentally ill	1 0.1%	1 33.3%	0 0%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%
Normal, Not Mentally ill	36 5.2%	10 333.3%	46 18.9%
Borderline Mentally ill	54 7.8%	13 433.3%	31 12.8%
Mildly Mentally ill	72 10.4%	20 666.7%	55 22.6%
Moderately Mentally ill	33 4.7%	16 533.3%	25 10.3%
Markedly Mentally ill	7 1%	4 133.3%	6 2.5%
Severely Mentally ill	2 0.3%	1 33.3%	0 0%
Among the Most Extremely Mentally ill	0 0%	0 0%	0 0%

63. Secondary Outcome

Title	Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36
Description	CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well.
Time Frame	Baseline, Month 3, 6, 12, 18, 24, 30 and 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	691	74	243
Baseline	55.80 (10.0)	56.67 (5.8)	59.86 (10.9)
Change at Month 3	6.58 (10.8)	-7.67 (8.7)	4.61 (9.8)
Change at Month 6	8.24 (11.6)	1.08 (16.5)	8.23 (11.0)
Change at Month 12	10.02 (12.6)	4.48 (9.4)	10.66 (12.7)
Change at Month 18	10.51 (11.7)	6.76 (10.5)	12.46 (12.2)
Change at Month 24	11.29 (12.0)	8.44 (11.3)	11.29 (12.8)
Change at Month 30	12.37 (13.1)	9.94 (11.4)	12.54 (13.0)
Change at Month 36	13.05 (12.9)	8.77 (10.7)	15.28 (13.6)

64. Secondary Outcome

Title	Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36
Description	HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition.
Time Frame	Baseline, Month 3, 6, 12, 18, 24, 30 and 36

Outcome Measure Data

Analysis Population Description

Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	Sertraline	Other Antidepressants	Psychotherapy
Arm/Group Description	At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Measure Participants	685	72	241
Baseline	10.51 (5.4)	8.33 (3.2)	9.19 (4.6)
Change at Month 3	-2.75 (4.8)	4.33 (6.4)	-2.05 (4.2)
Change at Month 6	-3.23 (5.1)	-0.14 (6.0)	-3.21 (4.7)
Change at Month 12	-3.79 (5.5)	-2.46 (5.8)	-3.88 (4.8)
Change at Month 18	-3.98 (5.6)	-3.53 (5.8)	-3.79 (4.6)
Change at Month 24	-3.96 (5.4)	-5.07 (6.0)	-4.57 (4.7)
Change at Month 30	-4.04 (4.8)	-4.75 (4.6)	-4.80 (5.1)
Change at Month 36	-4.33 (5.3)	-4.69 (4.7)	-5.30 (5.1)

Adverse Events

Time Frame	Baseline up to 36 Months
Adverse Event Reporting Description	Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Arm/Group Title	Sertraline (Baseline)		Other Antidepressants (Baseline)		Psychotherapy (Baseline)		Sertraline (Month 3)		Other Antidepressants (Month 3)		Psychotherapy (Month 3)		Sertraline (Month 6)		Other Antidepressants (Month 6)		Psychotherapy (Month 6)		Sertraline (Month 12)		Other Antidepressants (Month 12)		Psychotherapy (Month 12)		Sertraline (Month 18)		Other Antidepressants (Month 18)		Psychotherapy (Month 18)		Sertraline (Month 24)		Other Antidepressants (Month 24)		Psychotherapy (Month 24)		Sertraline (Month 30)		Other Antidepressants (Month 30)		Psychotherapy (Month 30)		Sertraline (Month 36)		Other Antidepressants (Month 36)		Psychotherapy (Month 36)
Arm/Group Description	Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.		Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.		Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.		Participants in this group were on sertraline only or sertraline and any other treatment at Month 3 visit.		Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 3 visit.		Participants in this group were on psychotherapy only or no treatment at all at Month 3 visit.		Participants in this group were on sertraline only or sertraline and any other treatment at Month 6 visit.		Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 6 visit.		Participants in this group were on psychotherapy only or no treatment at all at Month 6 visit.		Participants in this group were on sertraline only or sertraline and any other treatment at Month 12 visit.		Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 12 visit.		Participants in this group were on psychotherapy only or no treatment at all at Month 12 visit.		Participants in this group were on sertraline only or sertraline and any other treatment at Month 18 visit.		Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 18 visit.		Participants in this group were on psychotherapy only or no treatment at all at Month 18 visit.		Participants in this group were on sertraline only or sertraline and any other treatment at Month 24 visit.		Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 24 visit.		Participants in this group were on psychotherapy only or no treatment at all at Month 24 visit.		Participants in this group were on sertraline only or sertraline and any other treatment at Month 30 visit.		Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 30 visit.		Participants in this group were on psychotherapy only or no treatment at all at Month 30 visit.		Participants in this group were on sertraline only or sertraline and any other treatment at Month 36 visit.		Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 36 visit.		Participants in this group were on psychotherapy only or no treatment at all at Month 36 visit.
All Cause Mortality
	Sertraline (Baseline)		Other Antidepressants (Baseline)		Psychotherapy (Baseline)		Sertraline (Month 3)		Other Antidepressants (Month 3)		Psychotherapy (Month 3)		Sertraline (Month 6)		Other Antidepressants (Month 6)		Psychotherapy (Month 6)		Sertraline (Month 12)		Other Antidepressants (Month 12)		Psychotherapy (Month 12)		Sertraline (Month 18)		Other Antidepressants (Month 18)		Psychotherapy (Month 18)		Sertraline (Month 24)		Other Antidepressants (Month 24)		Psychotherapy (Month 24)		Sertraline (Month 30)		Other Antidepressants (Month 30)		Psychotherapy (Month 30)		Sertraline (Month 36)		Other Antidepressants (Month 36)		Psychotherapy (Month 36)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Serious Adverse Events
	Sertraline (Baseline)		Other Antidepressants (Baseline)		Psychotherapy (Baseline)		Sertraline (Month 3)		Other Antidepressants (Month 3)		Psychotherapy (Month 3)		Sertraline (Month 6)		Other Antidepressants (Month 6)		Psychotherapy (Month 6)		Sertraline (Month 12)		Other Antidepressants (Month 12)		Psychotherapy (Month 12)		Sertraline (Month 18)		Other Antidepressants (Month 18)		Psychotherapy (Month 18)		Sertraline (Month 24)		Other Antidepressants (Month 24)		Psychotherapy (Month 24)		Sertraline (Month 30)		Other Antidepressants (Month 30)		Psychotherapy (Month 30)		Sertraline (Month 36)		Other Antidepressants (Month 36)		Psychotherapy (Month 36)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/614 (0.5%)		0/3 (0%)		0/181 (0%)		27/622 (4.3%)		1/19 (5.3%)		9/384 (2.3%)		19/516 (3.7%)		2/48 (4.2%)		2/181 (1.1%)		11/426 (2.6%)		2/80 (2.5%)		7/181 (3.9%)		11/335 (3.3%)		1/84 (1.2%)		4/181 (2.2%)		6/289 (2.1%)		3/83 (3.6%)		3/181 (1.7%)		2/240 (0.8%)		1/85 (1.2%)		2/181 (1.1%)		4/207 (1.9%)		4/73 (5.5%)		2/181 (1.1%)
Blood and lymphatic system disorders
Iron deficiency anaemia	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Anaemia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Gastrointestinal disorders
Abdominal pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Diarrhoea	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Nausea	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Vomiting	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
General disorders
Drug ineffective	3/614 (0.5%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Infections and infestations
Appendicitis	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Pyelonephritis acute	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Pneumonia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		1/73 (1.4%)		0/181 (0%)
Injury, poisoning and procedural complications
Concussion	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Intentional overdose	0/614 (0%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		1/48 (2.1%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Post concussion syndrome	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Overdose	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		1/384 (0.3%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Investigations
Liver function test increased	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Nervous system disorders
Anticholinergic syndrome	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Serotonin syndrome	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Dizziness	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Syncope	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Hypersomnia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Seizure	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		1/181 (0.6%)
Psychiatric disorders
Aggression	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Agitation	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Anger	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Depression	0/614 (0%)		0/3 (0%)		0/181 (0%)		6/622 (1%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		1/80 (1.3%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Emotional disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Homicidal ideation	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Intentional self-injury	0/614 (0%)		0/3 (0%)		0/181 (0%)		7/622 (1.1%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Mental status changes	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Psychotic disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Self-injurious ideation	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Suicidal behaviour	0/614 (0%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		1/19 (5.3%)		3/384 (0.8%)		4/516 (0.8%)		1/48 (2.1%)		0/181 (0%)		2/426 (0.5%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		1/83 (1.2%)		1/181 (0.6%)		1/240 (0.4%)		1/85 (1.2%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Suicidal ideation	0/614 (0%)		0/3 (0%)		0/181 (0%)		10/622 (1.6%)		1/19 (5.3%)		6/384 (1.6%)		9/516 (1.7%)		1/48 (2.1%)		2/181 (1.1%)		5/426 (1.2%)		0/80 (0%)		4/181 (2.2%)		6/335 (1.8%)		1/84 (1.2%)		3/181 (1.7%)		4/289 (1.4%)		3/83 (3.6%)		3/181 (1.7%)		1/240 (0.4%)		1/85 (1.2%)		2/181 (1.1%)		3/207 (1.4%)		3/73 (4.1%)		1/181 (0.6%)
Suicide attempt	0/614 (0%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		0/19 (0%)		1/384 (0.3%)		4/516 (0.8%)		1/48 (2.1%)		0/181 (0%)		2/426 (0.5%)		1/80 (1.3%)		2/181 (1.1%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Depressed mood	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Behaviour disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Conversion disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Anxiety	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Hostility	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Substance-induced psychotic disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Reproductive system and breast disorders
Dysmenorrhoea	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Other (Not Including Serious) Adverse Events
	Sertraline (Baseline)		Other Antidepressants (Baseline)		Psychotherapy (Baseline)		Sertraline (Month 3)		Other Antidepressants (Month 3)		Psychotherapy (Month 3)		Sertraline (Month 6)		Other Antidepressants (Month 6)		Psychotherapy (Month 6)		Sertraline (Month 12)		Other Antidepressants (Month 12)		Psychotherapy (Month 12)		Sertraline (Month 18)		Other Antidepressants (Month 18)		Psychotherapy (Month 18)		Sertraline (Month 24)		Other Antidepressants (Month 24)		Psychotherapy (Month 24)		Sertraline (Month 30)		Other Antidepressants (Month 30)		Psychotherapy (Month 30)		Sertraline (Month 36)		Other Antidepressants (Month 36)		Psychotherapy (Month 36)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/614 (2.1%)		0/3 (0%)		2/181 (1.1%)		201/622 (32.3%)		4/19 (21.1%)		54/384 (14.1%)		153/516 (29.7%)		10/48 (20.8%)		47/181 (26%)		118/426 (27.7%)		18/80 (22.5%)		42/181 (23.2%)		88/335 (26.3%)		20/84 (23.8%)		33/181 (18.2%)		57/289 (19.7%)		19/83 (22.9%)		31/181 (17.1%)		47/240 (19.6%)		12/85 (14.1%)		23/181 (12.7%)		28/207 (13.5%)		6/73 (8.2%)		29/181 (16%)
Blood and lymphatic system disorders
Anaemia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Cardiac disorders
Arrhythmia	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Congenital, familial and genetic disorders
Albright's disease	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Ear and labyrinth disorders
Eustachian tube dysfunction	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Endocrine disorders
Precocious puberty	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Eye disorders
Conjunctivitis allergic	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Vision blurred	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Gastrointestinal disorders
Abdominal pain	0/614 (0%)		0/3 (0%)		1/181 (0.6%)		9/622 (1.4%)		0/19 (0%)		3/384 (0.8%)		11/516 (2.1%)		1/48 (2.1%)		5/181 (2.8%)		5/426 (1.2%)		1/80 (1.3%)		3/181 (1.7%)		3/335 (0.9%)		1/84 (1.2%)		2/181 (1.1%)		4/289 (1.4%)		1/83 (1.2%)		2/181 (1.1%)		3/240 (1.3%)		0/85 (0%)		1/181 (0.6%)		2/207 (1%)		0/73 (0%)		0/181 (0%)
Diarrhoea	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		6/622 (1%)		0/19 (0%)		4/384 (1%)		9/516 (1.7%)		0/48 (0%)		2/181 (1.1%)		3/426 (0.7%)		0/80 (0%)		2/181 (1.1%)		3/335 (0.9%)		0/84 (0%)		0/181 (0%)		2/289 (0.7%)		1/83 (1.2%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Nausea	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		1/19 (5.3%)		5/384 (1.3%)		6/516 (1.2%)		0/48 (0%)		0/181 (0%)		4/426 (0.9%)		0/80 (0%)		2/181 (1.1%)		6/335 (1.8%)		0/84 (0%)		0/181 (0%)		2/289 (0.7%)		2/83 (2.4%)		1/181 (0.6%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		1/207 (0.5%)		1/73 (1.4%)		0/181 (0%)
Vomiting	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		6/622 (1%)		0/19 (0%)		3/384 (0.8%)		3/516 (0.6%)		0/48 (0%)		2/181 (1.1%)		2/426 (0.5%)		1/80 (1.3%)		1/181 (0.6%)		1/335 (0.3%)		1/84 (1.2%)		0/181 (0%)		1/289 (0.3%)		1/83 (1.2%)		1/181 (0.6%)		1/240 (0.4%)		1/85 (1.2%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Abdominal pain upper	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		1/384 (0.3%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Constipation	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Dry mouth	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		2/384 (0.5%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		1/80 (1.3%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		1/289 (0.3%)		1/83 (1.2%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Dyspepsia	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Eructation	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Cheilitis	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Faecaloma	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Toothache	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Dysphagia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Gastritis	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
General disorders
Fatigue	2/614 (0.3%)		0/3 (0%)		0/181 (0%)		11/622 (1.8%)		0/19 (0%)		3/384 (0.8%)		6/516 (1.2%)		1/48 (2.1%)		5/181 (2.8%)		8/426 (1.9%)		0/80 (0%)		1/181 (0.6%)		5/335 (1.5%)		1/84 (1.2%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		1/85 (1.2%)		0/181 (0%)		0/207 (0%)		1/73 (1.4%)		0/181 (0%)
Pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Thirst	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		1/181 (0.6%)
Non-cardiac chest pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		1/48 (2.1%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Pyrexia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Drug ineffective	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		2/335 (0.6%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Treatment noncompliance	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Feeling abnormal	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Feeling jittery	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		1/84 (1.2%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Influenza like illness	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Chest pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Immune system disorders
Food allergy	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Seasonal allergy	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Hypersensitivity	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Infections and infestations
Bronchitis	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Ear infection	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Gastroenteritis	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Gastroenteritis viral	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
H1N1 influenza	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Impetigo	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Influenza	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		1/181 (0.6%)		1/426 (0.2%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		1/181 (0.6%)
Nasopharyngitis	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Pharyngitis streptococcal	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		2/426 (0.5%)		0/80 (0%)		2/181 (1.1%)		1/335 (0.3%)		1/84 (1.2%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Tonsillitis streptococcal	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Upper respiratory tract infection	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		1/73 (1.4%)		0/181 (0%)
Sinusitis	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Croup infectious	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Pharyngitis	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Mononucleosis syndrome	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Pneumonia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Eye infection	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Injury, poisoning and procedural complications
Back injury	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Contusion	0/614 (0%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		0/19 (0%)		1/384 (0.3%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Corneal abrasion	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Intentional product misuse	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Medication error	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Concussion	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		1/84 (1.2%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Foot fracture	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Intentional overdose	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Post-traumatic neck syndrome	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Ankle fracture	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Bone contusion	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Fall	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Hand fracture	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Skin laceration	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Upper limb fracture	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Ligament sprain	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		1/84 (1.2%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Ligament rupture	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Sunburn	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Investigations
Weight increased	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		13/622 (2.1%)		0/19 (0%)		3/384 (0.8%)		12/516 (2.3%)		0/48 (0%)		2/181 (1.1%)		7/426 (1.6%)		3/80 (3.8%)		1/181 (0.6%)		6/335 (1.8%)		2/84 (2.4%)		1/181 (0.6%)		6/289 (2.1%)		0/83 (0%)		2/181 (1.1%)		1/240 (0.4%)		2/85 (2.4%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		2/181 (1.1%)
Weight decreased	0/614 (0%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		0/19 (0%)		4/384 (1%)		1/516 (0.2%)		1/48 (2.1%)		0/181 (0%)		3/426 (0.7%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		1/84 (1.2%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		1/181 (0.6%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/614 (0.3%)		0/3 (0%)		0/181 (0%)		13/622 (2.1%)		0/19 (0%)		8/384 (2.1%)		5/516 (1%)		0/48 (0%)		0/181 (0%)		4/426 (0.9%)		0/80 (0%)		0/181 (0%)		5/335 (1.5%)		0/84 (0%)		1/181 (0.6%)		4/289 (1.4%)		0/83 (0%)		1/181 (0.6%)		2/240 (0.8%)		0/85 (0%)		1/181 (0.6%)		2/207 (1%)		1/73 (1.4%)		2/181 (1.1%)
Increased appetite	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		3/384 (0.8%)		2/516 (0.4%)		0/48 (0%)		2/181 (1.1%)		4/426 (0.9%)		0/80 (0%)		2/181 (1.1%)		3/335 (0.9%)		0/84 (0%)		2/181 (1.1%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Musculoskeletal and connective tissue disorders
Muscular weakness	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Spondylolysis	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		1/80 (1.3%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Tendonitis	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		1/80 (1.3%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Musculoskeletal chest pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		1/83 (1.2%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		1/181 (0.6%)
Musculoskeletal pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Neck pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Nervous system disorders
Dizziness	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		5/622 (0.8%)		0/19 (0%)		1/384 (0.3%)		4/516 (0.8%)		1/48 (2.1%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		1/181 (0.6%)		5/335 (1.5%)		1/84 (1.2%)		1/181 (0.6%)		2/289 (0.7%)		0/83 (0%)		0/181 (0%)		4/240 (1.7%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Akathisia	0/614 (0%)		0/3 (0%)		0/181 (0%)		5/622 (0.8%)		0/19 (0%)		2/384 (0.5%)		3/516 (0.6%)		0/48 (0%)		1/181 (0.6%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		1/83 (1.2%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Disturbance in attention	0/614 (0%)		0/3 (0%)		0/181 (0%)		12/622 (1.9%)		0/19 (0%)		6/384 (1.6%)		7/516 (1.4%)		0/48 (0%)		9/181 (5%)		10/426 (2.3%)		1/80 (1.3%)		3/181 (1.7%)		8/335 (2.4%)		1/84 (1.2%)		1/181 (0.6%)		3/289 (1%)		1/83 (1.2%)		2/181 (1.1%)		3/240 (1.3%)		3/85 (3.5%)		2/181 (1.1%)		3/207 (1.4%)		0/73 (0%)		1/181 (0.6%)
Headache	0/614 (0%)		0/3 (0%)		0/181 (0%)		19/622 (3.1%)		0/19 (0%)		9/384 (2.3%)		16/516 (3.1%)		2/48 (4.2%)		6/181 (3.3%)		6/426 (1.4%)		1/80 (1.3%)		3/181 (1.7%)		4/335 (1.2%)		2/84 (2.4%)		1/181 (0.6%)		7/289 (2.4%)		1/83 (1.2%)		1/181 (0.6%)		2/240 (0.8%)		2/85 (2.4%)		2/181 (1.1%)		2/207 (1%)		0/73 (0%)		3/181 (1.7%)
Hypersomnia	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		3/335 (0.9%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		1/181 (0.6%)
Psychomotor hyperactivity	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		2/384 (0.5%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		1/84 (1.2%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Syncope	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		1/83 (1.2%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Tremor	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Autonomic nervous system imbalance	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Febrile convulsion	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Migraine	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		0/83 (0%)		1/181 (0.6%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Poor quality sleep	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Sedation	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Seizure	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		1/181 (0.6%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Somnolence	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		1/73 (1.4%)		0/181 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Psychiatric disorders
Anxiety	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		26/622 (4.2%)		1/19 (5.3%)		8/384 (2.1%)		33/516 (6.4%)		0/48 (0%)		8/181 (4.4%)		19/426 (4.5%)		1/80 (1.3%)		9/181 (5%)		15/335 (4.5%)		4/84 (4.8%)		5/181 (2.8%)		14/289 (4.8%)		4/83 (4.8%)		8/181 (4.4%)		4/240 (1.7%)		1/85 (1.2%)		1/181 (0.6%)		8/207 (3.9%)		0/73 (0%)		4/181 (2.2%)
Depressed mood	3/614 (0.5%)		0/3 (0%)		1/181 (0.6%)		23/622 (3.7%)		0/19 (0%)		8/384 (2.1%)		11/516 (2.1%)		0/48 (0%)		5/181 (2.8%)		14/426 (3.3%)		0/80 (0%)		4/181 (2.2%)		9/335 (2.7%)		5/84 (6%)		4/181 (2.2%)		4/289 (1.4%)		5/83 (6%)		5/181 (2.8%)		7/240 (2.9%)		0/85 (0%)		5/181 (2.8%)		5/207 (2.4%)		2/73 (2.7%)		4/181 (2.2%)
Hostility	4/614 (0.7%)		0/3 (0%)		1/181 (0.6%)		22/622 (3.5%)		1/19 (5.3%)		9/384 (2.3%)		19/516 (3.7%)		0/48 (0%)		6/181 (3.3%)		17/426 (4%)		3/80 (3.8%)		3/181 (1.7%)		11/335 (3.3%)		0/84 (0%)		5/181 (2.8%)		6/289 (2.1%)		2/83 (2.4%)		3/181 (1.7%)		0/240 (0%)		1/85 (1.2%)		3/181 (1.7%)		0/207 (0%)		1/73 (1.4%)		5/181 (2.8%)
Insomnia	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		10/622 (1.6%)		0/19 (0%)		3/384 (0.8%)		9/516 (1.7%)		1/48 (2.1%)		0/181 (0%)		7/426 (1.6%)		1/80 (1.3%)		1/181 (0.6%)		8/335 (2.4%)		1/84 (1.2%)		0/181 (0%)		3/289 (1%)		0/83 (0%)		1/181 (0.6%)		1/240 (0.4%)		0/85 (0%)		1/181 (0.6%)		1/207 (0.5%)		0/73 (0%)		2/181 (1.1%)
Irritability	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		29/622 (4.7%)		2/19 (10.5%)		7/384 (1.8%)		21/516 (4.1%)		0/48 (0%)		8/181 (4.4%)		9/426 (2.1%)		2/80 (2.5%)		8/181 (4.4%)		7/335 (2.1%)		1/84 (1.2%)		9/181 (5%)		6/289 (2.1%)		4/83 (4.8%)		5/181 (2.8%)		4/240 (1.7%)		3/85 (3.5%)		1/181 (0.6%)		2/207 (1%)		0/73 (0%)		5/181 (2.8%)
Nightmare	1/614 (0.2%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Abnormal dreams	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Affect lability	0/614 (0%)		0/3 (0%)		0/181 (0%)		11/622 (1.8%)		0/19 (0%)		4/384 (1%)		8/516 (1.6%)		0/48 (0%)		5/181 (2.8%)		7/426 (1.6%)		1/80 (1.3%)		4/181 (2.2%)		4/335 (1.2%)		1/84 (1.2%)		3/181 (1.7%)		2/289 (0.7%)		1/83 (1.2%)		1/181 (0.6%)		0/240 (0%)		1/85 (1.2%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Aggression	0/614 (0%)		0/3 (0%)		0/181 (0%)		11/622 (1.8%)		0/19 (0%)		3/384 (0.8%)		10/516 (1.9%)		0/48 (0%)		0/181 (0%)		3/426 (0.7%)		1/80 (1.3%)		0/181 (0%)		3/335 (0.9%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		1/181 (0.6%)		0/240 (0%)		3/85 (3.5%)		0/181 (0%)		0/207 (0%)		1/73 (1.4%)		1/181 (0.6%)
Apathy	0/614 (0%)		0/3 (0%)		0/181 (0%)		6/622 (1%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		3/335 (0.9%)		1/84 (1.2%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		1/181 (0.6%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Blunted affect	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Compulsions	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		1/181 (0.6%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Depression	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		3/516 (0.6%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		1/84 (1.2%)		1/181 (0.6%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		1/181 (0.6%)
Dermatillomania	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Enuresis	0/614 (0%)		0/3 (0%)		0/181 (0%)		3/622 (0.5%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		1/80 (1.3%)		0/181 (0%)		2/335 (0.6%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		1/181 (0.6%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Euphoric mood	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		3/516 (0.6%)		1/48 (2.1%)		0/181 (0%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		1/181 (0.6%)
Frustration tolerance decreased	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		1/48 (2.1%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Hallucination	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		1/181 (0.6%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Impulsive behaviour	0/614 (0%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		0/19 (0%)		2/384 (0.5%)		10/516 (1.9%)		0/48 (0%)		1/181 (0.6%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		1/289 (0.3%)		0/83 (0%)		1/181 (0.6%)		3/240 (1.3%)		1/85 (1.2%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		1/181 (0.6%)
Intentional self-injury	0/614 (0%)		0/3 (0%)		0/181 (0%)		10/622 (1.6%)		0/19 (0%)		0/384 (0%)		15/516 (2.9%)		0/48 (0%)		1/181 (0.6%)		9/426 (2.1%)		0/80 (0%)		2/181 (1.1%)		6/335 (1.8%)		2/84 (2.4%)		0/181 (0%)		4/289 (1.4%)		1/83 (1.2%)		0/181 (0%)		4/240 (1.7%)		0/85 (0%)		2/181 (1.1%)		2/207 (1%)		2/73 (2.7%)		1/181 (0.6%)
Major depression	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Mood altered	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Panic attack	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		1/384 (0.3%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		3/335 (0.9%)		2/84 (2.4%)		0/181 (0%)		0/289 (0%)		1/83 (1.2%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Social avoidant behaviour	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		1/19 (5.3%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Psychotic disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Stress	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Suicidal ideation	0/614 (0%)		0/3 (0%)		0/181 (0%)		10/622 (1.6%)		0/19 (0%)		2/384 (0.5%)		8/516 (1.6%)		2/48 (4.2%)		3/181 (1.7%)		7/426 (1.6%)		1/80 (1.3%)		2/181 (1.1%)		1/335 (0.3%)		2/84 (2.4%)		4/181 (2.2%)		3/289 (1%)		0/83 (0%)		1/181 (0.6%)		2/240 (0.8%)		0/85 (0%)		3/181 (1.7%)		2/207 (1%)		0/73 (0%)		1/181 (0.6%)
Tachyphrenia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		1/19 (5.3%)		2/384 (0.5%)		3/516 (0.6%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		2/335 (0.6%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		1/83 (1.2%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Tic	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		2/335 (0.6%)		0/84 (0%)		1/181 (0.6%)		2/289 (0.7%)		0/83 (0%)		1/181 (0.6%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		1/181 (0.6%)
Trichotillomania	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Violence-related symptom	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Affective disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		1/181 (0.6%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Mood swings	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		1/48 (2.1%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Obsessive-compulsive disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Obsessive-compulsive symptom	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Oppositional defiant disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Paranoia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		1/181 (0.6%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Restlessness	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		2/516 (0.4%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Self-injurious ideation	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Thinking abnormal	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Antisocial behaviour	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		2/207 (1%)		0/73 (0%)		0/181 (0%)
Communication disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Conversion disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Dysphoria	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Emotional distress	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Mental status changes	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Purging	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Defiant behaviour	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Disinhibition	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Emotional disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Learning disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Obsessive thoughts	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Sleep terror	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		1/181 (0.6%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Attention-seeking behaviour	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Behaviour disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		0/181 (0%)
Hallucinations, mixed	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		1/181 (0.6%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Renal and urinary disorders
Pollakiuria	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Incontinence	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Urinary hesitation	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		1/335 (0.3%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Reproductive system and breast disorders
Breast disorder	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Sexual dysfunction	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		1/426 (0.2%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Menstruation irregular	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Dysmenorrhoea	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		1/181 (0.6%)		0/289 (0%)		1/83 (1.2%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Cough	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		1/240 (0.4%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Nasal congestion	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Oropharyngeal pain	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		1/384 (0.3%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Sneezing	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Rhinorrhoea	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Sinus congestion	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Skin and subcutaneous tissue disorders
Acne	0/614 (0%)		0/3 (0%)		0/181 (0%)		4/622 (0.6%)		0/19 (0%)		3/384 (0.8%)		2/516 (0.4%)		0/48 (0%)		1/181 (0.6%)		6/426 (1.4%)		0/80 (0%)		0/181 (0%)		3/335 (0.9%)		0/84 (0%)		2/181 (1.1%)		1/289 (0.3%)		0/83 (0%)		1/181 (0.6%)		4/240 (1.7%)		0/85 (0%)		0/181 (0%)		1/207 (0.5%)		0/73 (0%)		1/181 (0.6%)
Dermatitis contact	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Hyperhidrosis	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		1/48 (2.1%)		0/181 (0%)		0/426 (0%)		1/80 (1.3%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Rash	0/614 (0%)		0/3 (0%)		0/181 (0%)		2/622 (0.3%)		0/19 (0%)		2/384 (0.5%)		2/516 (0.4%)		0/48 (0%)		1/181 (0.6%)		2/426 (0.5%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		1/84 (1.2%)		1/181 (0.6%)		1/289 (0.3%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Urticaria	0/614 (0%)		0/3 (0%)		0/181 (0%)		1/622 (0.2%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Alopecia	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		1/516 (0.2%)		1/48 (2.1%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Night sweats	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		0/181 (0%)		0/335 (0%)		1/84 (1.2%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)
Social circumstances
Fight in school	0/614 (0%)		0/3 (0%)		0/181 (0%)		0/622 (0%)		0/19 (0%)		0/384 (0%)		0/516 (0%)		0/48 (0%)		0/181 (0%)		0/426 (0%)		0/80 (0%)		1/181 (0.6%)		0/335 (0%)		0/84 (0%)		0/181 (0%)		0/289 (0%)		0/83 (0%)		0/181 (0%)		0/240 (0%)		0/85 (0%)		0/181 (0%)		0/207 (0%)		0/73 (0%)		0/181 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.