Statistical analysis
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EVALUABLE
The sample size calculation was based on data from a first-generation ENDS study relevant to the primary endpoints for this studyData management and statistical analyses were performed by Celerion with SAS version 9.3 (SAS, Cary, NC). Phoenix® WinNonlin® version 6.3 or higher (Certara, LP, Princeton, NJ) was used to calculate non-compartmental nicotine pharmacokinetics and subjective responses.All data were summarized by descriptive statistics, including arithmetic mean and standard deviation (SD) or median and range for continuous data and frequency counts for categorical data. For comparative analysis, Vuse Vibe and Vuse Ciro were compared with UB cigarettes and nicotine gum, and no comparisons were made between the Vuse products. All participants with at least one post-baseline investigational product assessment and evaluable data were included in the analyses. Evaluable data were defined as having first and last values to calculate changes over time (e.g., AUCPharmacokinetic and subjective measures were analyzed with ANOVA mixed-effects models, except for urge to smoke, for which we used a mixed-effects ANCOVA model. In all models, sequence, period (i.e., order within assigned group of test sessions), and product were included as fixed effects, and participant-nested-within-sequence was included as a random effect. Pharmacokinetic AUC and C