Materials and methods
The protocol was approved by the Regional Health Research Ethics Committee of the Capital Region of Denmark (identifier: H-19073983), the Danish Data Protection Agency (P-2020-652) and the Danish Medicines Agency (identifier: 2020033418). We obtained a signed consent form at the time of screening before any protocol-related procedures or assessments. All study-related procedures complied with the Declaration of Helsinki, with later revisions. The study is registered in ClinicalTrials.gov (identifier: NCT04452929).