Ethical approval and consent to participate
ICH, der Medizinsche Universität Innsbruck
The regional ethics committee in Norway, the Norwegian Medicines Agency, the Etikkommission der Medizinsche Universität Innsbruck and the Austrian Federal Office for Safety in Health Care (BASG) in Austria approved the study (ClinicalTrials.gov identifier: NCT01446328). All methods were performed in accordance with the Declaration of Helsinki and the ICH guidelines for good clinical practice. All participants gave informed written consent to participate before baseline data collection. The participants were reimbursed for travel expenses at each assessment point. The clinical monitoring was undertaken by the Department of Research and Development, Haukeland University Hospital for sites in Norway and in Austria by the Clinical Trial Centre at the Medical University Innsbruck.