Biostatistics is responsible for support with respect to data management and analysis of results. With regard to data management, we will be responsible for creating an "environment", and for providing training that will ensure that data are collected and managed using methods that result in a high-quality database. The basis of the approach is the now widely accepted "distributed data management" approach where the staff manage the data arising from their activities using systems created by Biostatics. This approach has been shown to result in higher-quality data, and not result in an increased workload. The data management "environment" is created by meeting responsibilities that include the creation of documentation, training materials, study databases, and archival structures for the processing of data. In addition, we will work with project and core staff to ensure that they are appropriately training in the use of these systems. Finally, Biostatistics will be responsible for providing secure backup and security measures for efforts. Biostatistics will also work with the project in the analysis and reporting of study results. The faculty has worked closely with the project faculty in the development of approaches that appropriately address hypotheses. Biostatistics will be responsible for performing the appropriate analyses, working with the staff in the interpretation of results, participating in the development of manuscripts and other reports summarizing the results.