Varenicline
ADVERSE EVENTS
Varenicline is administered to all study participants during the 12-week treatment phase. Dosing is consistent with the package insert and includes 0.5 mg once per day (q.d.) on Days 1–3, 0.5 mg twice per day (b.i.d.) on Days 4–7, and 1.0 mg b.i.d. starting on Day 8 and lasting until the week 12 EOT visit. If participants experience medication-related adverse events, they meet with a study medical clinician and potentially undergo a temporary or sustained dose reduction. If dose reductions do not improve adverse events, medication may be discontinued, but participants are retained in the study.