Svejgaard 1985.

Methods	Design: double‐blind study
Participants	Number of participants randomised: 20 Sex (M/F): 18/2 Mean age: 40.5 years (range 14‐65) Number included in analysis: 17 Number completing treatment: the study defines 'completing treatment' as treatment till cure, rather than stipulating a timeframe. 9 participants in the ketoconazole group were treated for 8‐12 months (mean 10.6), 5 participants in the griseofulvin group were treated for 12 months Inclusion criteria: culturally proven onychomycosis caused by dermatophytes severe enough to indicate systemic treatment Duration of infection: 1‐30 years (mean 9.3) Exclusion criteria: not specified Washout period: not specified, but 15 participants in the study had received prior treatment with griseofulvin for less than 3 months without side effects Setting: not explicitly stated, but the author is based at Rigshospital, Copenhagen, Denmark, and acknowledges technical assistance from the Dermatological Department of this hospital. Comorbidities: not stated
Interventions	One 200 mg ketoconazole oral tablet, daily at breakfast One 500 mg micro size griseofulvin tablet, daily at breakfast. Dose was doubled if no improvement.
Outcomes	Duration of follow‐up: 12 months Outcomes measured: 'cure' defined as clinical and mycological cure Safety and tolerability assessed by: laboratory tests, including haemoglobin, leucocyte count, platelet estimate, creatinine, cholesterol and alanine‐aminotransferase
Source of funding	Ketoconazle tablets were supplied by Janssen Pharmaceutica, Beerse, Belgium and griseofulvin tablets by Leo, Haelsingborg, Sweden
Conflict of interest	Clear disclosure of pharmaceutical industry funding. No details regarding individual author conflict of interest statements provided
Notes	This a 2‐part study. The first part assesses responsiveness of infection of various body parts to ketoconazole. The details above apply to the second part of the study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "[i]n the double‐blind study ... on a randomised basis" Comment: study claims to be randomised, but does not state method
Allocation concealment (selection bias)	Unclear risk	Quote: "[i]n the double‐blind study ... on a randomised basis" Comment: not stated how allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "[i]n the double‐blind study ... on a randomised basis" Comment: study claims to be double‐blind, but no further details
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "[i]n the double‐blind study ... on a randomised basis" Comment: study claims to be double‐blind, but no further details
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 source of bias seen