 Standard Operating Procedures: Before starting the clinical trial all centers will have a telephoneweb-based start meeting with presentation of the study, study procedures and documentation. The first visit at site will be when the center has included some patients into the study. During the study period, monitors will have regular contact with the participating departments to ensure that the trial is conducted in compliance with the protocol and applicable regulatory requirements. The monitors will also provide information and support to the investigators. The number of monitoring visits will be limited and unless no specific problems occur the main part of the monitoring will be centralized by regular checks of the data quality in the database. Moreover logs of signed informed consents and AE forms will be faxed to the sponsor for follow-up. The monitors will review source documents for verification of consistency with the study data recorded in CRF according to risk based monitoring. Investigators and other responsible personnel must be available during the monitoring visits, possible audits and inspections and should devote sufficient time to these processes. Patient recruitment status is continuous updated every 24 hours on weekdays and will be available on the trial website. 