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just wanted to raise another quick issue, does anyone have any further discussion

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regarding other events? We focused on cardiovascular to a large extent, anybody have

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any questions for the Sponsor or the FDA regarding other safety signals besides

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cardiovascular?

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versus placebo and for all control groups. The point estimate is to the left of unity; the

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confidence intervals go past unity. Our interpretation of these data would be that we have

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not seen evidence for cardiovascular harm, for other members of the class, for where

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there are published data I just want to mention that the Vildagliptin data were also

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recently made available, and I think they were presented at the EASD in 2008, thank you.

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Question, if everyone agrees. We will be using the new electronic voting system for this

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meeting. Each voting member has three voting buttons on your microphone, yes, no and

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abstain. Once we begin the vote, please press the button that corresponds to your vote.

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You will have approximately 20 seconds to vote. After everyone has completed their

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vote, the vote will be locked in, the vote will then be displayed on the screen, I will read

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DR. BURMAN: Thank you. Dr. Savage, any further follow-up? Then I

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censored, I guess I was wrong. I would just like to call your attention to - so this is

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from a manuscript that was published just recently by Merck. The slide summarizes the

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cardiac disorder SAEs, Ischemia Related AEs, Ischemia Related SAEs and fatal Ischemia

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related outcomes. The Sponsor interpreted these data as not showing a signal; that was

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their assessment. If I could show slide 3-88, these are data for Vildagliptin, Vildagliptin

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is not approved in the United States. It is approved in Europe.

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(No response.)

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DR. BURMAN: No. All right. Then let’s move on to the Voting

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This slide represents odds ratios for Cardiovascular SAEs for Vildagliptin

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