Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.