Conduct and ethics
The study took place from January–June 2019 at the Covance Clinical Research Unit (Leeds, UK) and was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation and Good Clinical Practice. An independent ethics committee reviewed and approved the study protocol and its amendments. All participants freely gave their written informed consent before starting the study. The study was registered with ClinicalTrials.gov (identifier: NCT03809052).