Procedure for unblinding if needed {17b}
EMERGENCY
An allocation list is kept in a locked safety cabinet at Rigshospitalet in case of emergency unblinding. Emergency unblinding may occur when ever judged by the investigators. Sponsor and investigators are responsible for the unblinding procedure. Investigators can unblind the study medication allocation without prior contact to the sponsor. According to the ICH-Good Clinical Practice (GCP) guideline 4.3.1, the investigators are responsible for all trial-related medical decisions and can unblind immediately without restrictions.