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. 2016 Jan 16;2016(1):CD004920. doi: 10.1002/14651858.CD004920.pub3

Leon 1990.

Methods Duration of the intervention: 1 July 1987 to 1 August 1989
Patients excluded/patients randomized: 0/51 (0%)
Sample size calculation/method description: No/No
Participants Patients randomized: 51
Age (mean): 62 years
Sex: not reported
Inclusion criteria: patients with severe infections treated with broad spectrum antibiotic therapy
Exclusion criteria: not stated

Percentage post‐surgical: 18%
Percentage colonized with Candida at baseline: 50%
Interventions 1. Amphotericin B orally 2 g daily (n = 24)
2. Placebo (n = 27)
Duration of the intervention: not reported
Outcomes Mortality
Proven IFI
Superficial fungal infection
Follow‐up duration: until ICU discharge
Type of antifungal treatment Empiric
Funding sources Not reported
Declaration of interest among the primary researchers Not reported
Notes Country: France
Setting: single hospital, adult ICU
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: patients randomized according to a randomization table
Allocation concealment (selection bias) Unclear risk Comment: insufficient information to permit a judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: insufficient information to permit a judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient information about blinding of outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no missing data outcome
Selective reporting (reporting bias) Low risk Comment: the study protocol was not available but it is clear that the published report included all expected outcomes
Other bias Low risk Comment: the study appeared free of other sources of bias