Data availability
Participant data and the associated supporting documentation will be available within six months after the publication of this manuscript. Details of our data request process are available on the CRCTU website. Only scientifically sound proposals from appropriately qualified research groups will be considered for data sharing. The decision to release data will be made by the CRCTU Director’s Committee, which will consider the scientific validity of the request, the qualifications and resources of the research group, the views of the Chief Investigator and the trial steering committee, consent arrangements, the practicality of anonymising the requested data and contractual obligations. A data-sharing agreement will cover the terms and conditions of the release of trial data and will include publication requirements, authorship and acknowledgements and obligations for the responsible use of data. An anonymised encrypted dataset will be transferred directly using a secure method and in accordance with the University of Birmingham’s IT guidance on the encryption of datasets.