Ethics approval
MAY
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the independent Ethics Committee “Medisch Ethische Toetsingscommissie van de Stichting Beoordeling Ethiek Biomedisch Onderzoek” (Assen, the Netherlands) on 13 May 2020. This trial is registered in the WHO International Clinical Trials Registry Platform (ICTRP) under study number NL8726. The study was performed in compliance with the Dutch laws on drug research in humans.