Material and Methods
This is a randomized controlled trial (RCT). The study was approved by the data protector officer at Oslo University Hospital and the Norwegian National Research Ethics Committees (REK 23380). It is registered at ClinicalTrials.gov (ref. NCT02116478). The inclusion period was between June 2014 and December 2015. The 6-year follow-up was conducted between November 2020 and March 2022. A written informed consent was obtained for every participant.