Scher 1998.

Methods	Design: parallel group RCT
Participants	Number of participants randomised: 362 Sex: not stated (both sexes included) Mean age: not stated; range 18‐70 years Number included in analysis: 355 ITT Number completing treatment: 313 Inclusion criteria: mycological diagnosis and a positive culture for dermatophytes Type/location/characteristics of infection: 25% involvement of the target nail with at least 2 mm of healthy nail from the nail fold to the proximal onychomycotic border Duration of infection: not stated Exclusion criteria: pregnancy, lactation, hypersensitivity to azoles, significant systemic disease, diabetes mellitus, immunosuppression, renal or hepatic dysfunction, fungal culture positive for non‐dermatophytes, drugs that may interfere with azoles Washout period: 3 months for oral antifungals, 2 weeks for topical antifungals Setting: USA (multicentre) Comorbidities: not stated
Interventions	Placebo once weekly (3 matching placebo tablets) (max 12 months) 150 mg fluconazole once weekly (one 150 mg tablet plus two matching placebo tablets) (max 12 months) 300 mg fluconazole once weekly (two 150 mg tablets plus one matching placebo tablet) (max 12 months) 450 mg fluconazole once weekly (three 150 mg tablets) (max 12 months)
Outcomes	Duration of follow‐up: 6 months after treatment Outcomes measured: clinical (visual; % of nail involved, distance from nail fold, signs/symptoms of onychomycosis) and mycologic (microscopic and microbiologic) evaluations Safety and tolerability: adverse event reporting, blood and urine specimens (haematology, blood chemistry, urinalysis), vital signs, body weight, use of concomitant medications
Source of funding	No information available
Conflict of interest	No conflict of interest identified
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "[t]his study followed a randomised, double‐blind, fixed‐dose, parallel‐group, placebo‐controlled multi‐center design ... Patients were randomly assigned to one of the following four treatment regimens" Comment: not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "[t]his study followed a randomised, double‐blind,fixed‐dose, parallel‐group, placebo‐controlled multi‐center design". Comment: study claims to be double‐blind, no further details
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "[t]his study followed a randomised, double‐blind,fixed‐dose, parallel‐group, placebo‐controlled multi‐center design " Comment: stated multiple times that remained double‐blinded on follow‐up visits, no details given
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis included. All participants are accounted for.
Selective reporting (reporting bias)	Low risk	All results presented as set out in the Methods. All prespecified outcomes appear to be reported.
Other bias	Low risk	No clear other bias seen