[Summary text]
Parallel RCT (n=416)
Inclusion criteria:
N/A
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Eligible patients were randomised according to a central randomisation scheme using permuted blocks of 5 and implemented through an interactive response technology (IRT). Randomisation was stratified by severity of illness (severe or critical) and use of systemic corticosteroids (yes or no).
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Eligible patients were randomised according to a central randomisation scheme using permuted blocks of 5 and implemented through an interactive response technology (IRT).
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Patients and investigators remained blinded to patients' assigned intervention throughout the course of the study. An unblinded pharmacist was responsible for the preparation and dispensation of all study interventions.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Insufficient information provided.
Attrition bias due to amount, nature or handling of incomplete outcome data
All randomised patients provided data for primary ITT and mITT analyses.
Reporting bias due to selective outcome reporting
All relevant prespecified outcomes of interest were reported.
Bias due to problems not covered elsewhere in the table
None identified.