NCT03837704.

Study name	Comparison of abdominal aortic aneurysm growth in adult smoking patients who either switch to IQOS, continue smoking, or quit smoking
Methods	Design: RCT Study dates: October 2018 to April 2025 Recruitment: no information Location: Atsugi, Japan Setting: unclear if confinement in‐clinic or ambulatory setting
Participants	Number randomised: 114 expected  Characteristics: N/A Specialist population: aged ≥ 50 years; diagnosed with abdominal aortic aneurysm Inclusion criteria Currently smoke ≥ 10 cigarettes per day Smoked cigarettes for past ≥ 12 months Aged ≥ 50 years No intention to quit smoking within next 6 months Diagnosed with abdominal aortic aneurysm Exclusion criteria Medical conditions that were a safety concern or would interfere with study Use drugs likely to interfere with study Current or past alcohol or drug problems 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 or continue smoking cigarettes Heated tobacco arm Device heating method: electronic Device name: IQOS Device manufacturer: PMI Other instructions and details: ad libitum use with no flavour restrictions 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
Outcomes	Follow‐up time points: 5 years Abstinence outcomes: N/A  Safety outcomes: biomarkers of toxicant and carcinogen exposure; biomarkers of harm; adverse events; serious adverse events Prevalence/sales outcomes: N/A
Starting date	October 2018
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.