Bullen 2013.

Study characteristics
Methods	Design: 3 parallel groups RCT Recruitment: People who smoke recruited from the community, via newspaper advertisements Setting: Research Unit, New Zealand Study start date: 6 September 2011; Study end date: 5 July 2013
Participants	Total N: 657. 289 nicotine EC (NEC), 295 patch, 73 non‐nicotine EC (PEC) Inclusion criteria: 18 years of age or older; Smoked 10 or more cpd over past year; Wanted to stop smoking Exclusion criteria: Pregnant and breastfeeding Using cessation medicines or using other support to quit Heart attack, Stroke, Severe angina in the last 2 weeks, Poorly‐controlled medical disorder, Allergies, Other chemical dependence 62% women, mean age 42, ⅓ NZ Maori, smoking 18 cpd, mean FTND score 5.5 Motivated to quit E cigarette use at baseline: Not specified
Interventions	EC: Cig‐a‐like Randomized to NEC, PATCH or PEC use for 13 weeks (from 1 week prior to TQD) NEC: Elusion brand 16 mg cartridges; sent product via courier PATCH: 21 mg/24‐hour patch; sent voucher to exchange for NRT at pharmacy (dispensing costs covered) PEC: As per EC, but 0 mg cartridges All participants referred to Quitline and received an invitation to access phone‐ or text‐based support. This was accessed by < 10%
Outcomes	Sustained (≤ 5 cigarettes allowed) validated (exhaled breath CO < 10 ppm) abstinence at 6 months ≥ 50% self‐reported reduction in baseline cigarettes at 6 months Participants reporting any adverse events Proportion of AEs that were serious Proportion of unrelated AEs
Study funding	Health Research Council of New Zealand
Author declarations	"We declare that we have received no support from any companies for the submitted work and have no non‐financial interests that might be relevant to the submitted work. ML, via his company Health New Zealand, previously did research funded by Ruyan (an e‐cigarette manufacturer). CB and HM have done research on Ruyan e‐cigarettes funded by Health New Zealand, independently of Ruyan. HM has received honoraria for speaking at research symposia, has received benefits in kind and travel support from, and has provided consultancy to, the manufacturers of smoking cessation drugs. NW has provided consultancy to the manufacturers of smoking cessation drugs, received honoraria for speaking at a research meeting and received benefits in kind and travel support from a manufacturer of smoking cessation drugs. JW has provided consultancy to the manufacturers of smoking cessation medications."
Notes	Accessed support: NEC: 115/289; PATCH: 106/295; PEC: 26/73
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerized block randomization
Allocation concealment (selection bias)	Low risk	Computerized via study statistician
Blinding of participants and personnel (performance bias) All outcomes	Low risk	NEC and PEC were blind to treatment condition in relation to one another. No blinding for NEC/PEC vs PATCH conditions, but as NEC and PATCH were both active treatments performance bias judged unlikely
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemical validation used
Incomplete outcome data (attrition bias) All outcomes	Low risk	LTFU 22% (all considered to be smoking). Patch group had a higher LTFU and withdrawal than EC (loss to follow‐up 17% NEC, 27% patches, 22% PEC). However, minimal difference in per‐protocol and ITT analyses
Selective reporting (reporting bias)	Low risk	All prespecified outcomes reported