Statistical analyses
REGRESSION, EVENT
Analyses followed a predefined statistical analysis plan according to published guidance.Time to first composite event and time to first of each component of the composite was analysed by Cox proportional hazards modelling, adjusted for the minimisation factors and including γ distributed random frailties. Time varying covariates were used to address any deviation from the proportional hazards assumption. Duration of hospital admission was analysed by linear regression models, adjusted for the minimisation factors with normally distributed random intercepts for hospitals. The analysis model for EQ-5D-5L utility (derived using the crosswalk algorithm) included a fixed effect for baseline EQ-5D-5L utility. Multiple imputation of incomplete or unusable EQ-5D-5L items was performed, with derived utilities overwritten with zero for participants who had died before the 12 month follow-up. All analyses were undertaken using SAS 9.4 (Cary, North Carolina, USA).