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present to please silence your cell phones, Blackberries and other devices if you have not

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already done so. I would also like to identify the FDA press contact, Ms. Karen Reilly,

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who is standing on my left. Thank you very much. I would like now to have

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introductions by members and consultants around the table. Dr. Parks, would you mind

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starting?

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everyone again that even though this is a public meeting, for the public and everyone in

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the audience, please do not cross over the rope to approach the panel members at any

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time during the meeting today including the breaks. Thank you.

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DR. BURMAN: Good morning. I would like first to remind everyone

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DR. KONSTAM: Mark Konstam, Tufts Medical Center, Cardiology.

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DR. HENDERSON: Jessica Henderson, Consumer Representative.

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MR PROSCHAN: Michael Proschan, Statistician at the National Institute

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CALL TO ORDER AND INTRODUCTIONS

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KENNETH BURMAN, M.D.

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Endocrinology Products.

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DR. TRAN: Good morning. Before we start, I just want to remind

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DR. PARKS: Mary Parks, Director of Division of Metabolism and

Endocrinology, FDA.

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DR. JOFFE: Hylton Joffe, Lead Medical Officer for the diabetes drug

group in FDA.

DR. LOWY: Naomi Lowy, Medical Officer, Division of Metabolism and

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of Allergy and Infectious Diseases.

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DR. FLEGAL: Kathrine Flegal, Epidemiologist at the Centers for Disease

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Control and Prevention.

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