MacPhail 1996.

Methods	Study was part of a large multi‐centre trial. Participants volunteers drawn from patients attending the Oral AIDS Clinic at the University of California, San Francisco, Date of enrolment: November 1987 and the multicenter study closed in March 1990. Loss to follow‐up at 20 weeks: Stratum 1 (No history of OC): 20/58 = 34% Stratum 2 (OC history): 14/70 =10% Loss to follow‐up not given separately for the different arms within each stratum. Analysis: no ITT
Participants	Inclusion criteria: HIV infected or AIDS patients; CD4 cells counts < 650 /ul Exclusion criteria: suspected or proven esophageal candidiasis; if required antifungal agent orally or intravenously within 72h of entry; known hypersensitivity to nystatin HIV infected patients stratified by history of oral candidiasis Stratum 1 (no history of oral candidiasis) Stratum 2 ( history of oral candidiasis i.e. presented to the centre with OC and was treated and cured/cleared clinically within 3‐7 days before randomisation) 128 participants Stratum 1 ‐ 58 Stratum 2 ‐ 70 diagnosis confirmed using KOH and culture
Interventions	Within each strata Placebo ‐ 2 placebo pastilles daily One nystatin (200,000 U) and 1 placebo pastille daily Two nystatin pastilles daily Duration: 20 weeks
Outcomes	Delay in onset of oral candidiasis: defined as presence of removable white plaques, erythematous areas, angular cheilitis that were potassium hydroxide positive for fungal hyphae and culture positive for fungal spp Culture positive: defined as growth of one or more colony forming units.
Notes	Ethics: informed consent obtained; no mention of ethics approval
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Random allocation, does not mention method used to generate allocation sequence.
Allocation concealment?	High risk	Not reported
Blinding? All outcomes	Low risk	Double blind. Participant and investigators blinded.
Incomplete outcome data addressed? All outcomes	High risk	34% loss to follow‐up in stratum 1. No ITT,