Forbes, Rebecca
Ali, Ased
Abouhajar, Alaa
Brennand, Catherine
Brown, Heather
Carnell, Sonya
Chadwick, Thomas
Eardley, Ian
Lecouturier, Jan
Mossop, Helen
Pearce, Ian
Pickard, Robert
Thiruchelvam, Nikesh
Walton, Katherine
Wilkinson, Jennifer
Harding, Chris http://orcid.org/0000-0002-9407-382X
Funding for this research was provided by:
Health Technology Assessment Programme (13/88/21)
Article History
Received: 6 July 2018
Accepted: 16 October 2018
First Online: 9 November 2018
Ethics approval and consent to participate
: The conduct of this trial will be in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. Favourable ethical opinion (REF: 15/NE/0381) from NRES Committee North East – Tyne and Wear South and Clinical Trial Authorisation (MHRA Ref:17136/0279/001–0001) from relevant competent authorities (CAs) was sought prior to commencement of the trial. Local approvals will be sought before recruitment commences. All amendments to the protocol and supporting documents will be submitted to the Research Ethics Committee and/or relevant CAs where necessary for approval. Copies of these approvals (original and all amendments) will be kept in the Trial Master File (TMF) at NCTU and in the ISF at local sites.
: Not applicable.
: The authors declare that they have no competing interests.
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