Statistical analyses
The safety population comprised all subjects who had successfully completed eligibility requirements after checking in to the clinic site and used at least one study product. The outcomes population was a subset of the safety population and consisted of subjects who used a study product and had evaluable nicotine pharmacokinetics or subjective effects data. This population was used in the summary and analysis of all data presented in this paper.Due to this being the first study assessing nicotine pharmacokinetics and subjective effects of the Pulze HTS, no sample size calculations could be performed. However, a sample size of 24 subjects was deemed adequate to meet the study objectives and this is in line with similar study designs in the literature