Regulatory aspects
The trial will be conducted in compliance with the approved protocol, UK Policy Framework for Health and Social Care Research 2017, Regulation (EU) No. 536/2014 (Clinical Trial Safety Reporting requirements), the Data Protection Act 2018, and Regulation (EU) 2016/679 (General Data Protection Regulation) and the principles of Good Clinical Practice as defined by the European Good Clinical Practice (GCP) Directive and laid down in UK law by the Medicines for Human Use (Clinical Trials) Regulations (2004) and subsequent amendments thereof. In Austria, the trial will be conducted in compliance with the protocol, the relevant Austrian regulatory bodies’ rules and EU relevant regulations in that member state.The study is sponsored by the University College London (UCL), reference number: 108048.EudraCT number: 2020–001006-39.ISRCTN12552768IRAS reference number: 281209.