Schuman 1997.

Methods	Multi‐centre study. Patients enrolled in the Women's Fungal Study (CPCRA 010) at 14 participating sites in the USA. Patients were enrolled between May 1992 and January 1994. The trial started ended on 30 November 1995, 22 months after the last patient was randomised. Median follow‐up was 29 months. Loss to follow‐up: unclear Analysis: unclear
Participants	Inclusion criteria: Female; HIV positive; >=13 years of age; CD4 count < 300 cells/mm3 or 20% total lymphocyte count Exclusion criteria: history of Candida esophagitis; receiving systemic antifungal agents; known intolerance of azoles; pregnant or breastfeeding Diagnosis confirmed: positive culture and >= 2 signs or symptoms Diagnosis probable: culture and 1 sign / symptom OR KOH positive and >= 2 signs / symptoms OR antifungal response and >= 2 signs / symptoms 323 participants enrolled 162 ‐ Fluconazole 161 ‐ placebo
Interventions	Fluconazole 200mg / week Placebo
Outcomes	First episode mucosal Candidiasis Prophylaxis failure ‐ second episode of confirmed oropharyngeal Candidiasis
Notes	Ethics: ethics approval obtained; informed consent obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Centrally generated at CPCRA statistical centre; stratified by site and using permuted blocks of sizes 2 and 4
Allocation concealment?	Unclear risk	Not reported
Blinding? All outcomes	Low risk	Double‐blind: Patients and committee reviewing candidiasis