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. 2022 Jan 6;2022(1):CD013790. doi: 10.1002/14651858.CD013790.pub2

Tricker 2012a.

Study characteristics
Methods Design: RCT
Study dates: not reported
Recruitment: no information  
Location: Seoul, South Korea
Setting: confinement in‐clinic setting
Participants Number randomised: 72
Characteristics: 25.0% women; mean age 23.8 years; all participants smoked ≥ 10 cigarettes per day; mean FTND score 3.9 for men and 3.3 for women
Specialist population: aged 20–50 years
Inclusion criteria
  • Currently smoke 10–30 cigarettes per day

  • Aged 20–50 years

  • Only smoked Lark1 cigarettes for 2 weeks prior to study


Exclusion criteria
  • Unacceptable medical conditions

  • Abnormal findings on physical examination

  • Use of nicotine or tobacco product other than cigarettes within 3 months prior to screening

  • Alcohol or drug problems

  • Use of any medication other than hormonal contraceptives

  • Pregnant or lactating

  • People of childbearing potential who did not agree to use contraception

Interventions Randomised (2:2:1 ratio) to use an electronic HTP, continue smoking cigarettes, or become abstinent
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
Cigarette smoking arm
Other instructions and details: participants were given Lark1 low yield cigarettes
Behavioural support: none mentioned
Instructions for smoking cessation/switching: continue 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.