Methods	RCT 52 women randomised
Participants	Age: -intervention group: median 39 years, range 22-56; placebo group: median 44 years, range 31-71 VIN grade: VIN 2 (n=4), VIN 3 (n=47), not reported (n=1) Smoking status: smokers (n=46) and nonsmokers (n=6). HPV status: positive (n=50), negative (n=2)
Interventions	imiquimod vs placebo for 16 weeks (twice weekly)
Outcomes	Response to treatment at 20 weeks (biopsy), 7 months and 12 months (+/− repeat biopsy) Symptoms (pain, pruritus), severe erythema QoL Side effects
Notes	Patients advised to use sulphur precipitate 5% in zinc oxide ointment the day after application to avoid superinfection 4 weekly review with biopsy if suspicion of progression
Risk of bias
Bias	Authors’ judgement	Support for judgement
Adequate sequence generation?	Low risk	“Randomization was carried out by 3M Pharmaceuticals in blocks of four (with a two-by-two design) without stratification”
Allocation concealment?	Low risk	“Except for cases of serious side effects, the randomization code was not broken until all women had been seen at 12 months”
Blinding? All outcomes	Unclear risk	“Double-blind, randomized clinical trial“, but it was unclear as to whether the outcome assessors were blinded
Incomplete outcome data addressed? All outcomes	Low risk	% analysed: 52/52 (100%) at 20 weeks. All but three patients were followed up for 12 months.
Free of selective reporting?	Unclear risk	Insufficient information to permit judgement
Free of other bias?	Unclear risk	Insufficient information to assess whether an important risk of bias exists