Confidentiality {27}
The patient is protected under the GDPR rules including the processing of personal data (data protection law) and the Danish Health Act, ensuring patient confidentiality throughout the study. All data is kept in an encrypted database, REDCap, and can only the assessed by personnel who have been granted access by the principal investigator. Following completion of the trial, all data including the biobank material analyses will be stored pseudo-anonymously in a secured server.