6. Data Management: All data for the study will be entered in the Clinical Record Forms and submitted for central analysis of the data (study directors). One copy of the Clinical Record Form will be retained by the attending physician. The study directors will ensure that the data are analyzed and statistically evaluated. Current Data Protection Regulations will be observed. The data will be analyzed in an anonymised form. The patient must consent to the data being recorded in the context of the clinical trial, being analyzed and being submitted at the request of the pertinent supervisory authorities. Each patient will be assigned a number on enrolment in the study and his /her initials will be recorded. Unequivocal patient identification will be possible via a patient identification list consisting of the patient number, initials, date of birth, name and first name. All data will be archived for a period of 10 years.