Prior to data lock a final audit report and memo was generated summarizing the audit findings and given to the Data Manager Data analyses were performed primarily with Statistical Analysis System (SAS®) software, version 9.2. SAS analysis datasets were crosschecked against the locked database and/or CRF. Data summary tables were crosschecked against SAS analysis datasets. All identified inconsistencies were reported to the lead statistician and resolved prior to production of this report. This clinical study report was checked for accuracy and consistency before sign-off.