Watson 1995.

Methods	Design: RCT
Participants	Number of participants randomised: 118 Sex: 58% male Mean age: not stated Number included in analysis: 118 ITT Number completing treatment: 111 Inclusion criteria: distal or total dermatophyte onychomycosis of at least 1 toenail confirmed by mycological culture Type/location/characteristics of infection: distal or total dermatophyte onychomycosis, at least 1 toenail Duration of infection: not stated Exclusion criteria: renal, hepatic, cardiovascular or gastrointestinal disease, psoriasis, pregnancy, lactation, inadequate contraception, if non‐dermatophyte was considered to be primary pathogen, if participant used topical or oral antifungal agent within 2 or 6 weeks, respectively Washout period: not stated Setting: 13 centres in Australia and New Zealand Comorbidities: not stated
Interventions	Placebo once daily for 12 weeks 250 mg terbinafine once daily for 12 weeks 250 mg terbinafine once daily for 24 weeks (if mycological culture was positive for dermatophyte and unaffected nail length of target toenail had increased by less than 3 mm from baseline at 12 weeks)
Outcomes	Duration of follow‐up: 48 weeks from start of treatment Outcomes measured: clinical assessment (no signs of infection or considerable, minor or no improvement) and mycology (microscopy and mycological culture) Safety and tolerability: adverse event reporting, biochemical, haematologic studies, urinalysis and clinical examination
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 was a randomised, double‐blind, 48‐week study." Comment: method not stated
Allocation concealment (selection bias)	Unclear risk	Quote: "[t]his was a randomised, double‐blind, 48‐week study." Comment: method not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "[t]his was a randomised, double‐blind, 48‐week study." Comment: study claims to be double‐blind, but no method stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "[t]his was a randomised, double‐blind, 48‐week study." Comment: no mention of method
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants 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 other risks of bias identified