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Article History

Received: 13 February 2018

Accepted: 18 April 2018

First Online: 4 June 2018

Ethics approval and consent to participate

: The trial will be performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects, adopted by the 18th World Medical Association General Assembly, Helsinki, Finland, 1964, amended by the 48th WMA General Assembly, Somerset West, Republic of South Africa, 1996. The trial will be conducted in accordance with the Research Governance Framework for Health and Social Care and the applicable UK Statutory Instruments (which include the Data Protection Act 1998 and Human Tissue Act 2008 and the Principles of GCP). The protocol was approved by the London City & East Research Ethics Committee (17/LO/0874) before any participants are enrolled into the trial, the trial office will obtain HRA approval and the PI at each site will obtain local R&D approval/assurance. Sites will not be permitted to enrol participants until written confirmation of R&D approval/assurance is received by the BCTU trials team.

: Results of this trial will be submitted for publication in a peer reviewed journal. The manuscript will be prepared by the chief investigator, and authorship will be determined by the trial publication policy. Authors must acknowledge that the trial was performed with the support of BWCNFT and NIHR RfPB.

: The authors declare that they have no competing interests.

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