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Any additions or modifications to that brief summary?

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(No response.)

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Okay, then let’s go to Question No. 3

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Question No. 3:

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The Saxagliptin trials included a 24-week, short-term, double-blind period

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are uncomfortable with the post-hoc adjudication, which really is, the company is caught

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in between the regulation. So both the FDA and the company have done a fantastic job

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of trying to work out a system that helps determine whether there is an increased

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cardiovascular risk and all of us are uncomfortable with the data as it is. I think given the

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circumstances we agree that it’s the best way it can be done and that there are some

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suggestions, as John had mentioned and Mike had mentioned, for future trials. There

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seem to me to be minor modifications because the data in most of these trials have

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already been collected.

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followed by a long-term, double-blind period. Patients entered the long-term period if

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they completed the short-term period or if they were discontinued from the short-term

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period due to inadequate glycemic control. Patients who had entered the long-term

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period because of inadequate glycemic control during the short-term period were

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administered open-label rescue medications. Please discuss whether this trial design

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affects interpretation of cardiovascular results for the short-term period and for the

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combined short-term and long-term periods.

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DR. BURMAN: Any other comments on this particular issue?

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(No response.)

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Then let me try to summarize this issue from part two and that is, all of us

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