Data availability
The trial data are held at MRC CTU at UCL, which encourages optimal use of data by use of a controlled access approach to data sharing. Requests for data can be made at any time and can be initiated by contacting mrcctu.ctuenquiries@ucl.ac.uk or via the MRC CTU website. There is a formal application process, whereby the request will undergo review by the trial team, as well as independent researchers, to ensure that the proposed research is both ethical and has a strong scientific rationale. Data will not be released if it would compromise the ongoing trial. The specific data and associated documents to be shared will be dependent on the nature of the individual request and this will be documented in a formal data-sharing agreement.