The Health Decisions biostatistical group develops the statistical analysis plan early in each study. This identifies issues of interest and key variables in the data, focuses priorities in the collection, review, validation, and updating of study data, and defines any planned interim analyses. Early completion of the statistical analysis plan allows the data-management team to focus data checks throughout the study on areas that defend the statistical analysis. For the analysis, the statistical team creates and validates required programs and displays and the project statistician develops the analysis databases, produces data displays for subject characteristics, treatment exposure, compliance and primary study objectives, and validates CRF listings and data displays of secondary study objectives. An independent quality assurance group audits statistical tables while the statistical team completes the statistical methods section of the Clinical Study Report.