It is the responsibility of the Investigator at each site that all pts, considered as candidates for the study, are listed in the "Screening and Enrolment log". Pts will receive a consecutive screening number when signing the informed consent and are thereafter considered to be study patients. Once they have been randomized, they will also get a patient-specific randomization number and they are considered as enrolled in the study. It is the responsibility of the investigator to keep a patient identification list, identifying each individual study patient.