Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
Brief Summary: Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale.

(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.

The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.


Options:
A: Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs (From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs); Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 (Baseline, Week 8, Week 26, Week 52); Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 (Baseline, Week 8, Week 26, Week 52); Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint (Baseline, Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Potentially Clinically Relevant Vital Sign Abnormalities (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline in Patient Weight (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline by Time Period in Body Weight Z-Score (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline in Patient Body Mass Index (BMI) (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline By Time Period in BMI Z-Score (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint))
B: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
C: Clinical Global Impression Improvement (CGI-AD) (Administered weekly, initial and week 8 reported)
D: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)

Answer: C