2.5. Ethical considerations
The study was approved by the regional ethics committee (2015/209 REK) and the Norwegian Medicines Agency (SLV) (15/01581-13) and was registered at ClinicalTrials.gov (NCT02604446). All authors from the main study approved the ethical protocol for the sub-study. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from all subjects. This study was monitored by The Norwegian University of Science and Technology, Unit for Applied Clinical Research. This study conforms to all CONSORT guidelines and reports the required information accordingly.