Confidentiality {27}
In the trial database and forms, participants will only be identified by a participant identification number, consisting of six figures, which represent the respective site and the enrollment number of the participant. The corresponding participant identification log will be kept in a securely locked separate trial site file, that only delegated staff will have access to. All participants´ records and laboratory specimen displaying names or addresses will be kept confidential in a secure storage area at the sites. The trial database will be encrypted, stored on secure servers with regular back-up, and access control.