2.1. Approval
ICH
The Ethics Committee of Northwestern-and central Switzerland (EKNZ): 2019-01111 approved the trial. The trial was conducted in accordance with the current version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued by the International Council on Harmonisation (ICH) and the Swiss law and Swiss regulatory authority’s requirements. All participants gave their informed consent for inclusion before inclusion in the study. The study was registered at ClinicalTrials.gov (NCT04027283).