2.12. Monitoring
RECRUITMENT
The monitor (Dr. Egmont Zieseniß, Inpharm Consulting, Germany) reviewed the case report forms with the investigator and his staff at regular intervals:First monitoring visit after 30% recruitment.Second monitoring visit after 12 months.Third monitoring visit at study close-out.During the study, the monitor reviewed the case report forms at the above intervals to verify completeness, plausibility and consistency of the data, protocol adherence, and the progress of enrolment, and to ensure that study supplies are being stored, dispensed, and accounted for according to specifications.