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DR. WOLF: I’m sorry. I don’t know the answer to that question.

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DR. BURMAN: Thank you. Any other comments or questions by the

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DR. WYNE: Can I clarify? What he is asking is, of those 40 events,

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what’s the duration of disease in those people? Is it possible to see a breakdown with

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those 40 events? What we want to know is, Are those events enriched in people who

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DR. BURMAN: Does the Sponsor want to respond to that?

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DR. WOLF: Could you repeat?

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DR. BURMAN: Sure. Please repeat the question.

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DR. LESAR: Sure, my question has to do with the use of concurrent

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know, this is in the diabetes literature, the risk begins actually increasing at the ten-year

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point. It’s continuous but it goes up more then. So if you have it for the ten-year, I

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would love to see that.

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have longer duration of disease? He is specifically using ten years as a break point

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because that’s what the recent studies seem to indicate. Where I am disagreeing with him

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is I think it’s a continuum where that increase in risk definitely picks up after five years,

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probably around seven, but absolutely beyond ten years. So that’s what he is wondering.

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Is it possible those events are all in people of more than ten years or is it evenly split?

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DR. LESAR: Yes there was a discussion related to how many patients

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were on Statins but I am also curious if there was balance and some measurement of

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medications that might alter the frequency of cardiovascular events outside of Statins,

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Committee? Yes, Dr. Lesar.

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other medications that might alter rates of cardiovascular events, either positive or

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negative, such as Aspirin, Beta blockers, nonsteroidal anti-inflammatory drugs?

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DR. TEERLINK: No, because I mean the cardiovascular events, you

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