Walker, Jane https://orcid.org/0000-0003-1938-1141
Burke, Katy
Toynbee, Mark
van Niekerk, Maike
Frost, Chris
Magill, Nicholas
Walker, Simon
Sculpher, Mark
White, Ian R.
Sharpe, Michael
Funding for this research was provided by:
Health Services Research Programme (15/11/16)
Article History
Received: 22 November 2018
Accepted: 5 June 2019
First Online: 7 August 2019
Ethics approval and consent to participate
: The trial was reviewed and given ethical approval, which applies to all sites, by the South Central-Oxford C Research Ethics Committee (17/SC/0497). Additional site-level regulatory agreements were also obtained prior to recruitment commencing. The trial will be conducted in accordance with good clinical practice guidelines, the General Data Protection Regulation, the Research Governance Framework and the Mental Capacity Act 2005. All participants (or their consultees) will receive oral and written information about the trial and must give their informed consent (or agreement if a consultee) before enrolment. Participants are free to withdraw at any time. The protocol has been written in accordance with the Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) checklist (Additional file).
: Not applicable.
: The authors declare that they have no competing interests.