Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Brief Summary: Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or aggression, which can interfere with functioning. The purpose of this pilot study is to test whether transdermal nicotine is effective for irritability and/or aggression in adults with ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in three visits. At the first visit, subjects are screened for eligibility and enrolled. Baseline measures include rating scales and a frustrative computerized task. They will then wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study measures are repeated, vital signs and side effects monitored. Subjects will return for a third and final visit on day 21 to repeat the study measures performed during visit two.


Options:
A: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)
B: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (Baseline and 7 days.)
C: N/A
D: 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))

Answer: B