Core C – Biostatistics and Data Management The Biostatistics and Data Management Core provides a broad array of statistical services in support of the three Projects. The Core will provide advice on experimental design - such as selection of end points and possible stratification, consideration and calculation of sample size and statistical power. The Core is responsible for all aspects of data management in a secure central database with strong emphasis of data integrity and quality. The Core will form plans and perform expert statistical analyses in a format consistent between Projects using techniques that are state of the art in practice. The Core will also facilitate data sharing between projects in the Program as well as the general scientific community following NIH guidelines. The Core is staffed by one biostatistician serving as Protocol Manager (Data Manager) and three highly experienced biostatisticians who have daily working relationships with the Project investigators. The Core biostatisticians have been an integral part in the development of the proposed Program and have participated with this group of investigators the last 4-5 years of this current CENIC grant. The primary objective of the Biostatistics and Data Management Core is to contribute to the science and operation of the center by participating fully in its activities. Core Statisticians have broad long-standing expertise in experimental design, data collection, data storage, data analysis, and interpretation of results incorporating novel and complex statistical procedures as needed. By providing expertise research methodology and logistical support to data analytic activities with each Project, this Core will enhance data interpretation and scientific productivity.