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DR. TEERLINK: Okay, and related to that, what would be very useful is

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obviously one of the things that's in the recommendations from the diabetes guidelines is

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that it says specifically that program should include patients at high risk of cardiovascular

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recent cardiovascular event from our clinical trial experience. We did look carefully at

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the incidents of cardiovascular events in subsets of patients who were at increased risk;

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even in those subsets of patients we did not see a signal for cardiovascular harm for

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Saxagliptin.

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of patients were above 65 years of age, and the majority of patients had duration of

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diabetes much less than five years. I would appreciate if you could preset more detail on

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the breakdown of the renal insufficiency experience where a breakdown of 80 millimeters

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per minute is not all that informative as well as a breakdown of the details that micro-

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intent of your inclusion and exclusion criteria in the data set that we have before us,

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that's the first question.

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approval we would - and we are planning a comprehensive set of studies including,

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pharmacoepidemiologic studies and additional randomized clinical trial studies as Dr.

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Daniels described in higher risk patients.

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events such as, patients with relatively advanced disease, elderly patients and patients

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with some lesser degree of - some degree of renal impairment, granted that it's for new

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clinical programs and so you don't technically fall under that requirement although, I

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guess that's part of what this committee meeting is about.

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DR. WOLF: I agree with you that we did exclude patients who had had a

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Nonetheless, it's still probably useful to see. I saw that you had only 15%

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DR. TEERLINK: Based on 40 events?

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DR. WOLF: Based on 40 events. As part of our plan going forward post

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