Standard protocol approvals, registrations, and patient consent
Independent ethics committees/institutional review boards provided written approval for the study protocol and all amendments. The study was also performed in compliance with the protocol, Good Clinical Practice, Declaration of Helsinki, International Council for Harmonisation, and other applicable regulatory requirements. Written informed consent was obtained from all patients prior to entering the study. The study was registered on 5 March 2019, the first patient was enrolled on 10 July 2019, and the last patient visit was on 21 December 2020.