Study approval
The study protocol was reviewed and approved by an independent medical ethics committee, the Medische Ethische Toetsingscommissie van de Stichting Beoordeling Ethiek Biomedisch Onderzoek (Assen, the Netherlands). All subjects provided informed consent prior to any study related procedures. The study was conducted at the Centre for Human Drug Research (Leiden, the Netherlands) from July 2018 until October 2018, and registered under clinical trial number NCT03607903. No interim analysis was performed.