Ethics approval and consent to participate
Ethics approval for the LongSTEP trial was granted by The Regional Committees for Medical and Health Research Ethics (2018/994/REK Nord, 03 July 2018). Each site also obtained ethics approvals in accordance with local and national procedures for clinical research. Informed consent from participants was obtained after written and oral explanation of project’s aims, duration of involvement, expected benefits to participants and others, nature of the interventions, procedures involved in participation, and any potential risks. It was emphasized that participation in the study was voluntary and that participants could withdraw at any time from all or part of the study.