Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	oral placebo once daily (QD)
Aripiprazole	oral aripiprazole 2 to 15 mg QD

Participant Flow:   Overall Study

	Placebo	Aripiprazole
STARTED	51	47
COMPLETED	36	39
NOT COMPLETED	15	8
Lack of Efficacy	6	1
Adverse Event	3	5
Withdrawal by Subject	2	1
Lost to Follow-up	4	1

Reporting Groups

	Description
Placebo	oral placebo once daily (QD)
Aripiprazole	oral aripiprazole 2 to 15 mg QD

Baseline Measures

	Placebo	Aripiprazole	Total
Number of Participants   [units: participants]	51	47	98
Age, Customized   [units: participants]
6 to 12 years	46	37	83
13 to 17 years	5	10	15
Gender   [units: participants]
Female	7	5	12
Male	44	42	86
Race/Ethnicity, Customized   [units: participants]
Asian	0	2	2
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	7	11	18
White	41	32	73
Other	3	1	4
Race/Ethnicity, Customized   [units: participants]
Hispanic/Latino	8	6	14
Not Hispanic/Latino	43	41	84
Weight Group   [units: Participants]
<40 kilograms	32	26	58
≥40 kilograms	19	21	40
Body Mass Index   [units: kg/cm2] Mean ± Standard Deviation	19.96 ± 5.392	21.08 ± 5.394	20.50 ± 5.395
Height   [units: centimeters] Mean ± Standard Deviation	138.6 ± 14.7	140.9 ± 18.80	139.7 ± 16.74
Weight   [units: kilograms] Mean ± Standard Deviation	40.6 ± 18.92	43.9 ± 19.15	42.2 ± 19.01

1.  Primary:

Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score   [ Week 8 ]

2.  Secondary:

Mean Clinical Global Impressions Improvement Scale (CGI-I) Score   [ Week 8 ]

3.  Secondary:

Number of Participants With Response at Week 8   [ Week 8 ]

4.  Secondary:

Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)   [ Week 8 ]

5.  Secondary:

Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores   [ Week 8 ]

6.  Secondary:

Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)   [ Week 8 ]

7.  Secondary:

Summary of Safety   [ continuous throughout the study ]

8.  Secondary:

Change From Baseline in Body Weight   [ Week 8 ]