Rapport, Frances http://orcid.org/0000-0002-4428-2826
Clement, Clare
Seagrove, Anne C.
Alrubaiy, Laith
Hutchings, Hayley A.
Williams, John G.
Funding for this research was provided by:
Health Technology Assessment Programme (HTA 06/78/03)
Article History
Received: 7 April 2019
Accepted: 1 October 2019
First Online: 15 October 2019
Ethics approval and consent to participate
: The Research Ethics Committee for Wales gave ethical approval for the study (08/MRE09/42). This committee had jurisdiction to review multi-site studies and Clinical Trials of Investigational Medical Products (CTIMPs) in patients. In addition, each participating trust or health board gave National Health Service Research and Development approval. The trial has European Union Drug Regulating Authorities Clinical Trials number (2008–001968-36) and clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency. Written consent to participate was obtained from study participants.
: Not applicable.
: The authors declare that they have no competing interests.