Ethical considerations The patient physical and mental integrity will be safeguarded. The participants will be protected by the law on personal data and the Danish health legislation act. The study will be conducted in compliance with the principles set forth in the declaration of Helsinki and the guidelines for god clinical practise (GCP). The Study will be conducted in compliance with this protocol as well as according to national legislation. The study will be approved by the regional committee on medical health ethics, the Danish data protection agency and the Danish Health and Medicines Authority. The study will be submitted at ClinicalTrial.gov.