DATA MANAGEMENT AND QUALITY ASSURANCE Handling and storage of data and documents. In accordance with the Dutch law 'Wet Bescherming Persoonsgegevens' (WBP; Personal Data Protection Act) and GCP all patient data will be handled confidentially and anonymously. Therefore, all participants will get a study code ('RED-xxx'). The code list, with both identifier data and study number, will be stored securely on the server of the VUMC, protected by passwords only known by the responsible research physicians and principal investigator.