Availability of data and materials
The datasets containing individual participant data analysed during the VITA trial will be available upon request from the NCTU (ctu@nottingham.ac.uk) a minimum of 6 months after publication of this main results paper. Access to the data will be subject to review of a data sharing and use request by a committee including the Chief Investigator and Sponsor and will only be granted upon receipt of a data sharing and use agreement. Any data shared will be pseudo-anonymised which may impact on the reproducibility of published analyses. The protocol and statistical analysis plan are freely available on the NIHR Journals Library website: 