Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder
Brief Summary: This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).


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 Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
C: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
D: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least Mean Squares Double-blind phase: change from baseline to week 24); Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least mean squares for Open Label: Change between weeks 24-48)

Answer: A