Ethics and dissemination
The study will be conducted in accordance with the Research Ethics Committee (REC), Health Research Authority (HRA) and local Research and Development department approvals and guidelines (REC reference: 22/EE/0010). The study team will prepare protocol amendments as required and ethics approval will be sought before implementing any changes to the approved protocol. The ISRCTN Trial Registry and the Research Governance Office will be informed of any amendments to the protocol.