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Article History

Received: 20 June 2018

Accepted: 10 January 2019

First Online: 18 January 2019

Ethics approval and consent to participate

: Ethical approval was granted by London—Harrow Research Ethics Committee on 23/11/2016. REC reference 16/LO/2135 with the IRAS project ID 215973. The Research Protocol, patient information sheet and informed consent form have been approved by the Hull and East Yorkshire Hospitals NHS Trust Research and Development department (R2034). Informed consent via an information sheet and signed consent form is gained before enrolment into the trial, and the presence of a valid, signed and dated informed consent form is required for participation in the trial. All enrolled participants will have access, should they request it, to the full study protocol, and any publication of the final results.

: The participant information sheet, which has been approved by the Research Ethics Committee, provides information that the results will be submitted for publication in a scientific journal and a final report written. Participants will not be identified in any of the reports or publications. Co-authorship will be assigned according to the *Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, Updated December 2015 of the International Committee of Medical Journal Editors.

: The authors declare that they have no competing interests.

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