Ethics approval
RECRUITMENT
This study involves human participants, who gave informed consent to participate in the study before taking part. Recruitment to TEMPEST began on 17 February 2021, after approval by the North West-Greater Manchester South Research Ethics Committee (20/NW/0275), the UK Medicines and Healthcare Products Regulatory Agency and the UK Health Research Authority. The study is being conducted in accordance with the principles of Good Clinical Practice and the World Medical Association Declaration of Helsinki.