1. Division of Pharmacovigilance and Medical Devices Danish Medicines Agency Copenhagen Denmark
2. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science Utrecht University Utrecht The Netherlands
3. Copenhagen Centre for Regulatory Science, Department of Pharmacy, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark
4. Department of Clinical Pharmacy, Division Laboratories, Pharmacy and Biomedical Genetics University Medical Center Utrecht Utrecht the Netherlands
5. Department of Pharmaceutical Sciences, School of Health Sciences University of Iceland Reykjavik Iceland