Funding for this research was provided by:
Health Technology Assessment Programme (14/226/07)
Text and Data Mining valid from 2020-02-13
Received: 6 November 2019
Accepted: 16 January 2020
First Online: 13 February 2020
Ethics approval and consent to participate
: Conduct of the 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. Informed, written consent will be given by all participants prior to any trial screening procedures and participation in the trial.A favourable ethical opinion has been granted from the UK Health Research Authority Research Ethics Committee (North East – Newcastle and North Tyneside 2; study reference approval number 17/NE/0239). As per the UK HRA process, this central REC review is applicable to all trial sites; local ethical review is not required. We will not commence recruitment at sites until local Research and Development confirmation of capacity and capability is received. The trial has also received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA; study reference number 2017–000893-12). The trial has been included in the National Institute for Health Research Clinical Research Network (NIHR CRN) portfolio (NIHR CLRN study ID: 35368).The trial sponsor is the Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Freeman Road, High Heaton, Newcastle upon Tyne, NE7 7DN.The trial sponsor has delegated responsibility for trial management to NCTU, including trial design; review and approval of all localised patient-facing documentation prior to implementation at each site; collection, analysis and interpretation of data; writing of the protocol publication and final clinical report manuscripts. The sponsor did not contribute to this manuscript, but provided review and approval prior to submission for publication.
: Not applicable.
: The authors declare that they have no competing interests.