 - Selection visit: Before initiating any study specific procedure, the investigator must obtain the written informed consent from the patient, Screening evaluations include laboratory tests, a physical examination, a pregnancy test for women of childbearing potential. In case results should be available for such exams which were performed within one month previously they do not have to be repeated. Evaluations will be recorded in the CRF at the Visit 1 page only if the patient is eligible. 