Ethics approval and consent to participate
The trial was approved by the Committees on Health Research Ethics for the Capital Region of Denmark (reference number: H-18043987), the Danish Medicines Agency (reference number: 2018040088) and the Capital Region on behalf of the Danish Data Protection Agency (reference number: P-2022-85). The study was conducted in accordance with the Declaration of Helsinki and all study participants parents provided written informed parental consent while study participants equally gave their verbal consent to study participation. The study was monitored according to good clinical practice (GCP) quality standard by the GCP units at Aarhus, Odense and Copenhagen University Hospitals.