Data availability
The dataset generated from this study will not be made publicly available because of data protection regulations, but investigators (whose proposed use of the data has been approved by an independent review committee identified for this purpose) can request access to de-identified participant data or anonymised clinical study reports 24 months after publication by contacting the corresponding author. The trial investigators will review the request and, if accepted, data will be shared upon approval from relevant bodies in the Capital Region of Denmark governing sharing of trial data. The study protocol will be made available on 