Study design
ICH, Nijmegen
This was a randomised, double-blind (both participants and investigators were blinded to the participants’ treatment sequences), placebo-controlled, two-period, crossover intervention study performed at the Radboudumc (Nijmegen, the Netherlands). The study was approved by the local ethics committee and national competent authority and conducted in accordance with the principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act, and applicable ICH Good Clinical Practice guidelines. All participants provided written informed consent.