The objectives and endpoints of this study will be analyzed in the study population of adults
legally authorized to buy tobacco products. The study will describe the patterns of use of
tobacco and nicotine containing products and self-reported health outcomes and health related
events in CC (Cigarette) smokers and IQOS users in Japan.
Note: The initial study record (posted to ClinicalTrials.gov) included a clinical sub-study
designed to estimate population level differences in the biomarkers of exposure and clinical
risk endpoints between iQOS users, CC smokers and never-smokers. However, due to low
recruitment and retention of subjects, the clinical sub-study was terminated in May 2017 and
the main study was terminated in March 2018. The study protocol was updated to remove the
clinical sub-study objectives. This version of the study reflects the latest version of the
updated study protocol.