 To ensure that the study is conducted in accordance with ethical principles, internal monitoring will be carried out regularly throughout the study. At the screening the internal monitor will review the protocol, and the database and all other aspects of the study with the investigator and other staff. Monitoring will be carried out early in the study and again after the last subject has completed the study. During monitoring, the monitor will verify compliance with the protocol and amendments, review the signed informed consent forms, diverse logs and all other source data. Direct access to all study-related site and source datadocuments is mandatory for the monitoring review. Study team staff must be made available to answer any queries during the monitoring process. 