Ethics
The trial was approved by the relevant authorities (Danish Medicines Agency and the Danish Scientific Ethics Committees) and was registered in the European Clinical Trials Database (EudraCT no.: 2017-000776-29) and on ClinicalTrials.gov (NCT03188445). The trial complied with Good Clinical Practice guidelines. Participation was voluntary and written informed consent was obtained by the trial investigators from all participants, with personal data protected in accordance with the General Data Protection Regulation.