Ethics approval and consent to participate
The trial was conducted in accordance with the Helsinki Declaration and approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark (H-18017307) and the Danish Data Protection Agency (VD-2018–299, I-suite nr: 6543). The study protocol is registered at clinicialtrial.gov (Record NCT 03963245). Participants’ data were collected, stored, and processed following General Data Protection Regulation (GPDR). All participants gave informed written consent for their data to be used in the study.