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Each follow-up clinical visit comprised protocol assessments, a check of the participant's diary information, assessment of adverse events, and brief counseling ( 80%) a more than two-fold increase in the odds of achieving smoking reduction at 24 weeks among the snus versus placebo groups, and assuming a smoking reduction rate of 15% in the placebo group versus 28% in the snus group (corresponding to an odds ratio of 2.2), the target sample size was estimated at 156 per treatment group for a total size of 312 study participants

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