A study initiation meeting was held at each investigative site before enrollment of the first subject to review study design, study procedures, data collection, and investigator responsibilities. During interim field monitoring visits, the monitor verified CRF entries against available source documents and ensured that appropriate data were collected and documented. Independent GCP audits of selected study sites were performed. Prior to data entry, CRFs were checked for completeness and consistency by a monitor and verified against source documentation that was maintained at each study site. Data from CRF were reviewed and queries to the study sites were generated by the clinical and data management staff of the CRO. Discrepancies were reconciled with the study site and the respective laboratory.