While the FDA tightly regulates flavored real tobacco products, these rules do not apply to sugar and gum confections
*Correspondence: Menglu Yuan, [email protected] Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers
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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
