Ethical considerations
Ethical approval was sought for the trial through the Integrated Research Application System (IRAS). This was approved by the Health Research Authority and Health and Care Research Wales (HRA & HCRW) on 23 August 2019. The IRAS project ID was 266235. The trial was registered with York Teaching Hospital NHS Foundation Trust who acted as the sponsor. The trial was registered with ClinicalTrials.gov Protocol Registration and Results system. The Protocol ID is NCT04604262.