Methods
The study protocol and informed consent following the Helsinki Declaration of 1975 (version 2008) was approved by the Medical Research Ethics Committee (2019/30233), University of Bergen, Norway. The clinical trial was prospectively registered in ClinicalTrials.gov with registration NCT04152668 (05/11/2019). The study was conducted as a single-masked RCT. Prior to inclusion, participating patients read and signed the informed consent after the investigators had provided a thorough explanation of the study procedure and its associated risks and benefits. All methods were carried out in accordance with relevant guidelines and regulations. The CONSORT guidelines for reporting RCTs were followed.