 12. Agrees to abstain from all medication, including non-prescription and prescription medication including vitamins and natural or herbal remedies, e.g. St. Johns Wort for 28 days prior to each admission to the clinical research center until discharge, except for authorized medications such as hormonal contraceptives for females registered in The Netherlands and paracetamol. On a case-by-case basis, regular co-medication either as defined on the separate medication exception list or as documented by written approval from the Sponsor and the PI as acceptable prior to randomization, will not be considered as a deviation from this criterion. All other situations related to co-medications are considered as deviations 