Analysis
REGRESSION, SENSITIVITY
Feasibility outcomes are described as proportions or summary statistics with 95% CIs. To estimate the intervention effect on abstinence, lapse incidence, and use of lapse prevention strategies, we used multiple logistic regression, providing ORs with 95% CIs, while adjusting for stratification variables and any prognostic covariates (baseline variables that are known to affect the outcome and may be unbalanced between trial arms), as defined by the prespecified statistical analysis and health economics plan (SHEAP; Between-group analyses of mechanisms of action variables were undertaken with the 2-sample Sensitivity analyses of abstinence at 6 months were conducted excluding withdrawals, as well as a complete case analysis. Although planned, a missing data analysis using the full information maximum likelihood method was not technically possible in commonly available statistical software.