Data availability
CRCTU
SECONDARY
The study protocol is provided as Supplementary Note. The Statistical Analysis Plan, including the sample size calculations, interim safety analysis, analysis methods, and Bayesian analysis are available in the “Methods” section. The primary outcomes, secondary outcomes, and exploratory outcomes are available in the figures, supplementary figures, and supplementary tables. The CRCTU is committed to responsible and controlled sharing of anonymized clinical trial data with the wider research community to maximize potential patient benefit while protecting the privacy and confidentiality of trial participants. Data anonymized in compliance with the Information Commissioners Office requirements, using a procedure based on guidelines from the Medical Research Council (MRC) Methodology Hubs, will be available for sharing with researchers outside of the trials team within 12 months of the primary publication. Data Sharing requests can be submitted to the CRCTU and will be reviewed by the CRCTU Directors Committee and relevant Trial Management Group (