Methods
ICH
This study was a single-center study (ClinicalTrials.gov identifier: NCT03234010, 31/07/ 2017) designed to evaluate plasma nicotine uptake and overall product liking with use of four flavor variants of the Vuse Solo ENDS (Vuse Solo Original, Mint, Tropical and Fusion) in tobacco consumers who were exclusive smokers or dual users of cigarettes and ENDS. The study was completed at a single clinical research site (DaVita Clinical Research, Lakewood, CO) and was reviewed and approved by Chesapeake Institutional Review Board (Columbia, MD).No formal sample size calculations were performed as the study was designed to assess nicotine uptake from flavor variants of Vuse Solo ENDS and no comparisons between flavors was intended. The study was designed to assess nicotine PK from use of flavor variants for the purpose of regulatory submission, rather than comparing a single flavor against other flavor variants. The target number of subjects to be randomized for this study was 35 subjects per flavor variants or total of 140. This allowed for approximately 15% drop out rate (5 subjects per flavor variant) with goal of obtaining 120 study completers or 30 study completers per flavor.Attempts were made to recruit 15–20% African-Americans within each IP group in an effort to balance the study sample for the reported percentage of U.S. smokers who are African AmericanThe study was conducted in accordance with the ethical standards in the Declaration of Helsinki, applicable sections of the United States Code of Federal Regulations, and ICH E6 Good Clinical Practice guidelines.