The trial protocol is available on the study website. The individual participant data that underlie the results reported in this Article, after de-identification, will be available beginning 12 months after publication. A data dictionary defining each field in the set will be made available. Researchers will need to state the aims of any analyses and provide a methodologically sound proposal. Proposals should be directed to [email protected]. Data requestors will need to sign a data access agreement and in keeping with patient consent for secondary use, obtain ethical approval for any new analyses. Following all necessary approvals and mandatory training required for access to UKCTOCS data, the researchers will be given access to the data which is housed within the UCL Data Safe Haven.

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