Blinding is essential in order to maintain the integrity of the study. Should, however, an emergency develop in which knowledge of the substance administered is necessary, then the blinding can be broken by the attending physician. If unblinding takes place, the responsible study directors must be contacted. All cases of unblinding will be recorded in the study record sheets. The study directors may be contacted in emergencies at any time by the telephone hotline (+ 49-30 8445 2305). Reports on serious adverse events should be made within 24 hours. These reports of serious adverse events must be sent to the study directors (Prof. Dr. med. M. Tepel or Dr. med. van der Giet, Freie Universität Berlin, Universitätsklinikum Benjamin Franklin, Medizinische Klinik IV, Hindenburgdamm 30, 12200 Berlin, Tel/Fax: +49-30 8445 2305). Other side-effects will be recorded by the attending physician, documented and registered at the control visits.