Document is current

Article History

Received: 17 June 2020

Accepted: 9 August 2020

First Online: 10 November 2020

Ethics approval and consent to participate

: This trial was approved by the Research Ethics Committee of East Midlands – Leicester Central Research (REC reference number: 17/EM/0175). The ethics approval covers all centres where the study takes place.Written consent must be obtained, utilising the appropriate consent, prior to any study specific procedures being performed, including any study specific screening procedures prior to enrolment (unless already taken as part of routine care e.g. routine bloods). At the time of consent, participants must be informed that they have the right to withdraw their participation in the trial, and also their samples, at any stage and that doing so will not prejudice their future clinical management and care.The original consent forms will be filed in the Site Investigator File; a copy of the consent forms will be given to the participant, and one filed in the hospital notes. The written consent will be taken by either by the PI or by a clinician to whom that the PI has delegated responsibility. The process of obtaining written consent will be clearly documented in the participant’s medical notes.All participants are free to withdraw at any time from the protocol treatment without giving reasons and without prejudicing further treatment.

: Anonymised study results will be presented at relevant conferences and symposiums as a means of early communication. Full reports and papers will then be prepared for publication in high impact medical journals. The reports and papers that are published about the research will not identify patients who participated in this study.

: The authors declare that they have no competing interests.