Study assessments
low dependence
ADVERSE EVENTS
Level of dependence on cigarettes at baseline was assessed with the Fagerström Test for Nicotine Dependence (FTND), in which a score of 0–2 indicates low dependence and 8–10 indicates high dependenceSafety was assessed by monitoring adverse events (AEs), clinical laboratory tests, vital sign measurements, physical examinations, electrocardiography, and, in women, serum pregnancy and serum follicle-stimulating hormone tests. AEs were coded by organ class in accordance with the MedDRA Version 20.0. Severity was classified as mild, moderate, or severe.