Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
D: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: C