Study Endpoints
SECONDARY
The primary efficacy endpoint of the study was the continuous abstinence rate (CAR) from week 4 to week 12 (CAR weeks 4-12). Abstinence from smoking was defined as eCO-verified (<10 ppm) self-reported abstinence from cigarette smoking. CAR weeks 4-12 was used to compare quit rates between IQOS-HTP and JustFog-EC.The secondary efficacy endpoints were the 7-day point prevalence of abstinence at week 12 and the continuous reduction rate (CRR) from week 4 to week 12 (CRR weeks 4-12). Smoking reduction was self-reported. A reduction in the number of cigarettes smoked per day of 50% from baseline was considered of importance and excluded those labeled as CAR weeks 4-12. The CRR weeks 4-12 was used to compare reduction rates between IQOS-HTP and JustFog-EC. Participants who could not be classified as CAR weeks 4-12 or CRR weeks 4-12 were considered to have failed. Safety reporting details have been previously published [Product satisfaction was investigated by using the following questionnaires adapted and validated for EC and HTP use: modified Cigarette Evaluation Questionnaire (mCEQ) and modified Smoking Cue Appeal Survey (mSCAS). Risk perception was assessed by using the Perceived Risk Instrument for conventional cigarettes (PRI-P CC) and the Perceived Risk Instrument for reduced risk products (PRI-P RRP). The effect on quality of life was investigated by questionnaires (ie, EQ-5D-5L and EQ VAS) and by measuring changes in body weight and exercise tolerance (ie, V̇O