Ethics statement
The study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000, and approved by the Wales Research Ethics Committee and the UK Medicines and Healthcare products Regulatory Agency. The study was registered in EudraCT (number 2017-001202-14) on 06/11/2020. Researchers have disclosed to participants any potential conflict and the sponsor name. If the subject was willing to participate in the study, the informed consent form was signed and personally dated by the subject and the study staff member taking consent.