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GARVEY ASSOCIATES, INC. 10215 Gary Road Potomac, MD 20854 Phone: 301-299-3431 Fax: 301- 299-5931 Web: http://www.garveyassociates.com Garvey Associates, Inc. (GAI), founded by Thomas Q. Garvey III, M.D., is a medical/scientific consulting firm that has worked with pharmaceutical, medical device, and biologics firms worldwide for nearly 25 years. The firm designs clinical trials and programs of clinical trials for prescription and over-the-counter drugs and devices. GAI also analyzes, organizes, and presents data derived from clinical trials and composes New Drug Applications. GAI has had a great deal of experience with a variety of practical and theoretical problems related to all aspects of drug development, including data analysis and interpretation and submissions to and interactions with FDA.