NCT03887117.

Study name	Effect of switching from cigarette smoking to IQOS on exercise capacity
Methods	Design: RCT Study dates: February 2019 to March 2020 Recruitment: no information Location: Mannheim, Germany Setting: ambulatory setting
Participants	Number randomised: 93 expected  Characteristics: N/A Specialist population: none Inclusion criteria Healthy Currently smoke ≥ 10 cigarettes per day Smoked menthol cigarettes for past ≥ 12 months No plan to quit smoking within next 6 months Exclusion criteria Medical conditions that were a safety concern or would interfere with study BMI < 18.5 or > 32.0 kg/m2 Use of nicotine‐containing products other than menthol cigarettes in 4 weeks prior to screening Performs < 45 minutes of vigorous exercise per week Use drugs likely to interfere with study Current or past alcohol problems Positive urine drug test Pregnant or breastfeeding People of childbearing potential who do not agree to use contraception Current or past employee of tobacco industry (or their close relatives)
Interventions	Randomised to use an electronic HTP (with or without an exercise program), continue smoking cigarettes, or become abstinent Heated tobacco with exercise training arm  Device heating method: electronic Device name: IQOS Device manufacturer: PMI Other instructions and details: asked to buy their own tobacco sticks Behavioural support: exercise training programme Instructions for smoking cessation/switching: switch entirely to IQOS for study period Heated tobacco without exercise training arm  Device heating method: electronic Device name: IQOS Device manufacturer: PMI Other instructions and details: asked to buy their own tobacco sticks Behavioural support: no information Instructions for smoking cessation/switching: switch entirely to IQOS for study period Cigarette smoking arm Behavioural support: no information Instructions for smoking cessation/switching: not advised to stop smoking Abstinence arm Behavioural support: no information Instructions for smoking cessation/switching: do not smoke cigarettes during study period
Outcomes	Follow‐up time points: 1, 6, 10, and 15 weeks Abstinence outcomes: N/A  Safety outcomes: biomarkers of toxicant and carcinogen exposure; biomarkers of harm Prevalence/sales outcomes: N/A
Starting date	February 2019
Contact information	Name: Christelle Haziza, PhD Email: christelle.haziza@pmi.com
Notes	Funding source Assumed to be tobacco industry funded, as PMI is the study sponsor. Author conflicts of interest No conflicts of interest statement available.

HTP: heated tobacco product; N/A: not available/applicable; PMI: Philip Morris International; RCT: randomised controlled trial.