Study conduct
The study was conducted in accordance with the principles of the Declaration of Helsinki (2013), the International Council for Harmonization Guidance for Good Clinical Practice and was approved by the independent ethics committees at Linköping University, Linköping, Sweden, and Maastricht University Medical Centre, Maastricht, the Netherlands. The national regulatory authorities in each country were notified and approved the study. Written informed consent forms and any other written information and materials to be provided to participants were approved by the independent ethics committees. Written informed consent from all participants was obtained before enrolment into the trial. The study is registered at ClinicalTrials.gov (