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.