Figure 1.

Study design, participant randomization, and participant disposition. There were no significant differences in retention between active-varenicline vs. placebo-varenicline groups. Investigator-initiated study discharges were the result of participant noncompliance with study procedures. In instances when >4 participants in a cohort completed the outpatient phase, the investigators (blinded to medication assignment) selected n=4 for move in based on attendance reliability and adherence to outpatient study procedures, including tobacco cessation outcomes.