Study outcomes measures
ADVERSE EVENTS
The primary efficacy endpoint of the study was the proportion of subjects with continuous abstinence from vaping between week 4 to week 12 (CAR 4–12 weeks). Abstinence from vaping was defined as cotinine-verified (saliva cotinine < 10 ng/ml) self-reported abstinence from EC use since the last study visit. Secondary efficacy endpoints were CAR 4–24 weeks, and 7-day point prevalence of abstinence at weeks 12, and 24.Safety endpoints included information on the number of adverse events (AE), and serious adverse events (SAE) occurring between treatment randomization (V1) and the last week of treatment (V10). Between and within treatment groups changes were reported for blood pressure, heart rate, weight, and BMI.