Funding for this research was provided by:
Wellcome Trust (106939/Z/15/Z)
Health and Social Care Research and Development Division
Received: 12 May 2020
Accepted: 14 May 2020
First Online: 3 June 2020
Ethics approval and consent to participate
: This trial has received ethics approval from the REC (North East York REC). Reference 18/NE/006. Favourable opinion received 6<sup>th</sup> February 2018. REC approval for amended protocol (v4.0 23.03.2020) received 27<sup>th</sup> March 2020.Informed consent will be obtained in accordance with the ethical principles which have their origin in the Declaration of Helsinki. Due to the incapacitating nature of the condition of participants in this trial, consent will be sought from either a Personal Legal Representative (PerLR) or Professional Legal Representative (ProLR). Given visiting restrictions in place during the COVID-19 pandemic provisions are in place to obtain verbal agreement from the PerLR via telephone. When participating patients regain capacity to understand the details of the trial, consent to continue participation in the study will be sought. Patients may withdraw or be withdrawn (by PerLR or ProLR) from the trial at any time without prejudice.
: Not applicable.
: The authors declare that they have no competing interests.