Funding for this research was provided by:
Health Technology Assessment Programme (15/10/37)
Received: 10 December 2018
Accepted: 4 January 2019
First Online: 7 February 2019
Ethics approval and consent to participate
: The trial has received a favourable ethical opinion from the Wales 1 National Research Ethics Committee (REC reference: 17/WA/0208, IRAS project ID: 227970) and the Bangor University Research Ethics committee. Specific regard was given to consent procedures to ensure alignment with the Mental Capacity Act 2005 and good practice guidance. Procedures for communicating important protocol modifications to all relevant parties follow NHS Health Research Authority (HRA) guidance [CitationRef removed]. Substantial amendments will be submitted for REC review. For substantial amendments with favourable REC, HRA and Health & Care Research Wales opinion, or for HRA and Health & Care Research Wales-approved non-substantial amendments, the trial manager will communicate the outcome to investigators and R&D offices at all sites. If any amendments are category A or B, sites have 35 days to raise any objections, after which if no objections have been raised, the amendment can be implemented. Category C amendments can be implemented immediately.
: Not applicable.
: The authors declare that they have no competing interests.
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