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Chunk #18 — Methods — Analytic plan

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A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies.
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yes

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We conducted eleven comparisons for each outcome, which constituted a family of analyses that compared: each active treatment to placebo (five comparisons), each monotherapy with each other (three comparisons), the two combination therapies with one another (two comparisons), and a composite of the monotherapies to the bupropion + lozenge combination and the patch + lozenge combination (two comparisons). To control for the family-wise error when conducting multiple tests, we used a Bonferroni-corrected p-value (p = .0045) for the eleven comparisons for an overall α = .05 (all tests two-sided). We report both adjusted as well as unadjusted p-values. All analyses were conducted using the intent-to-treat principle such that all smokers who were randomized to a treatment were included in the analyses and individuals with missing data were considered to be smoking. Analyses were also conducted controlling for race (white vs. non-white), gender, and site. This study had a priori power = .88 to detect a clinically significant improvement in abstinence rates of 12% at 6-months post-treatment (e.g., 12 vs. 24%), with no correction for multiple comparisons (α = .05) and