Just‐Nubling 1991a.

Methods	Open prevention study in Germany. Patients randomised from May 1989 to January 1990. Loss to follow‐up: Group 1 ‐ 1/22 (5%) Group 2 ‐ 3/21 (14%) Group 3 ‐ 3/22 (14%) Analysis: no ITT
Participants	Inclusion criteria: Patients with advanced stages of HIV infection (stages 2b and 3 according to Frankfurt classification, stages 3‐6 according to Walter Reed); CD4 cells counts <100/mm3; at least 1 episode of candidiasis within previous 3 months Exclusion criteria: candida requiring Rx Diagnosis confirmed looking at culture (colony forming units). 58 participants Group 1 ‐22 Group 2 ‐ 21 Group 3 ‐ 22
Interventions	Group1 ‐ no treatment Group 2 ‐ 50mg fluconazole daily Group 3 ‐ 100mg fluconazole daily
Outcomes	Relapses of OC (lesions) Adverse events: Allergic exanthema in fluconazole group Of the 60 patients enrolled and randomised in the study, 7 were early dropouts. These 7 drop‐outs were replaced by recruiting and randomising 5 new patients into the study.
Notes	Ethics: no mention of ethics approval No demographics reported. Author contacted, no response to date 11/11/2004
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Not specified
Allocation concealment?	Low risk	"Patients were randomised (sealed envelopes) and assigned.."
Blinding? All outcomes	High risk	No blinding
Incomplete outcome data addressed? All outcomes	High risk	No ITT done