Anonymised electronic records and paper copies of records will be open to inspection and monitoring from a recognised representative from either the Sponsor, Bournemouth University, the CTU, or the funder (National Institute for Health Research). The trial management group will have access to the full dataset. Other interested parties may make a formal request to access the electronic dataset, which will be approved / declined by the CI in accordance with the Data Management Plan that will detail management of access, sharing, and preservation of the data. Any use of the electronic data set must
comply with the dissemination policy (see below) and be requested via Bournemouth University Library (bordar@bournemouth.ac.uk) who will collaborate with the CI with regards to access. Non-digital data supporting this study
will be stored by the corresponding author at Bournemouth University. Only electronic data will be shared with bona fide researchers intending to use the data for non-commercial research purposes, after an embargo period of approximately 24 months. Access to the following will be restricted to researchers who sign a confidentiality agreement and confirm their intention to use the data is for secondary data analysis for non-commercial research purposes using a Creative Commons licence: statistical analysis plan; where applicable, statistical code (for final analysis of primary outcome measure); and anonymised participant-level dataset and data documentation.