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Study Safety

The TODAY study has been developed by a team of endocrinologists, pediatricians, statisticians, psychologists and dietitians. It has been thoroughly reviewed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Food and Drug Administration, and Institutional Review Boards at the 12 study sites. Each reviewing institution is independent of the TODAY staff and the studys participating pharmaceutical companies.

In addition, a Data Safety Monitoring Board, consisting of independent investigators appointed by NIDDK, oversees the progress and safety of TODAY throughout the entire study period. The Board includes experts in endocrinology, pediatrics, statistics, and clinical trials. Its purpose is to assure independent review in order to properly assess whether study patients are exposed to unreasonable risk due to their study participation. It will also monitor the studys progress and integrity.