CL Item
Revocation of Consent by patient (1)
CL Item
Early ending of the entire study (2)
CL Item
Lack of patient compliance (3)
CL Item
Fall in hemoglobin of more than 2 units [g / dL] from initial value and source of bleeding can not be stopped (4)
CL Item
Decision of the investigator that further participation of the patient in the study is not justifiable (5)
CL Item
Violation of inclusion or exclusion criteria after 1st dose study medication (6)