Ethics approval and consent to participate
ICH
Ethics approval for the longer-term follow up of trial participants was obtained by South Central - Oxford C Research Ethics Committee (21/SC/0098 and from the South West-Central Bristol Research Ethics Committee for the trial (16/SW/0154). Study procedures were carried out in accordance with the ethical principles of the Declaration of Helsinki and ICH E6 Good Clinical Practice (GCP) Guidelines. All participants received an information leaflet and provided written informed consent to take part in the study.