Leen 1990.

Methods	Maintenance trial ‐ everyone received Fluconazole initially and only those in whom Rx was successful were included into the maintenance study Location of study: United Kingdom Loss to follow‐up: Fluconazole ‐ 2/9 (22%) Placebo ‐ 0/5 (0%) Analysis: ITT
Participants	Inclusion criteria: HIV+ males; AIDS/ARC; 18‐65 yrs; clinically and mycologically diagnosed severe oral mucosal candidiasis that was not immediately life‐threatening, but needed Rx Exclusion criteria: serum creatinine levels of 110 umol/l or >; patients with moderate to severe liver disease; patients using any other systemic antifungal drug; patients taking drugs that are cleared predominantly by metabolism and that have a low therapeutic ratio i.e. barbiturates, coumarin anticoagulants, oral hypoglycaemic agents; patients taking any other investigational drugs except certain drugs used for other opportunistic diseases Diagnosis confirmed microscopy and culture 24 enrolled, 14 randomised Fluconazole ‐ 9 Placebo ‐ 5
Interventions	Fluconazole 150mg weekly Placebo Duration: 24 weeks
Outcomes	Relapse of candidiasis Adverse events: one patient developed diarrhoea shortly after receiving fluconazole.
Notes	Ethics: informed consent obtained; no mention of ethics approval
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Computer generated randomisation
Allocation concealment?	Unclear risk	Not reported
Blinding? All outcomes	Low risk	Say double blind. Participants blind,but does not state who else is blinded
Incomplete outcome data addressed? All outcomes	Low risk	ITT