Tricker 2012b.

Study characteristics
Methods	Design: RCT Study dates: not reported Recruitment: no information   Location: Japan Setting: confinement in‐clinic setting
Participants	Number randomised: 128 Characteristics: 30.5% women; mean age 23.5 years; all participants smoked ≥ 10 cigarettes per day; mean FTND score 3.9 Specialist population: aged 19–50 years; Japanese ethnicity Inclusion criteria Currently smoke 10–30 cigarettes per day Aged 20–50 years Japanese ethnicity Only smoked Marlboro non‐menthol cigarettes for 2 weeks prior to study Exclusion criteria Unacceptable medical conditions Use of nicotine or tobacco product other than cigarettes within 3 months prior to screening Alcohol or drug problems BMI ≤ 17.6 and ≥ 26.4 kg/m2 Use of any medication other than hormonal contraceptives Pregnant or lactating People of childbearing potential who did not agree to use contraception
Interventions	Randomised (7:7:7:7:4 ratio) to use a EHCSS‐K6 electronic HTP, EHCSS‐K3 electronic HTP, continue smoking Marlboro cigarettes, switch to Lark1 cigarettes, or become abstinent K6 heated tobacco arm  Device heating method: electronic Device name: EHCSS‐K6, precursor to THS marketed under brand name IQOS Device manufacturer: PMI Other instructions and details: participants were given tobacco sticks Behavioural support: none mentioned Instructions for smoking cessation/switching: switch entirely to heated tobacco use for study period K3 heated tobacco arm  Device heating method: electronic Device name: EHCSS‐K3, precursor to THS marketed under brand name IQOS Device manufacturer: PMI Other instructions and details: participants were given tobacco sticks Behavioural support: none mentioned Instructions for smoking cessation/switching: switch entirely to heated tobacco use for study period Marlboro cigarette smoking arm Other instructions and details: participants were given Marlboro cigarettes Behavioural support: none mentioned Instructions for smoking cessation/switching: continue smoking Marlboro cigarettes for study period Lark1 cigarette smoking arm Other instructions and details: participants were given Lark1 low machine yield cigarettes Behavioural support: none mentioned Instructions for smoking cessation/switching: switch to smoking Lark1 cigarettes for study period Abstinence arm Behavioural support: none mentioned Instructions for smoking cessation/switching: do not smoke cigarettes during study period
Outcomes	Follow‐up time points: 1 week (8 days) Abstinence outcomes: N/A Safety outcomes: biomarkers of exposure to toxins and carcinogens; biomarkers of harm; adverse events; serious adverse events Prevalence/sales outcomes: N/A
Notes	Funding source Tobacco industry funded: quote: "The work reported in all eight parts of this supplement was funded by PMI R&D". Author conflicts of interest Quote: "All authors are or were Philip Morris International (PMI) R&D employees or worked for PMI R&D under contractual agreements".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details on random sequence generation.
Allocation concealment (selection bias)	Unclear risk	No information.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All outcomes were biological.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information on attrition.
Selective reporting (reporting bias)	Unclear risk	No trial registration or analysis plan.