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know, there aren’t that many events and there are a lot of different analyses done. That I

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see is actually an advantage. The first one is not an advantage; not having too many

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events is not an advantage. Analyzing it in many different ways is an advantage and I

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think it showed that the results don’t change very much as you change your methodology,

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which is important. Of course, you know, it’s true that there are not a lot of events. In

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particular, that causes problems, you know, when you are looking at the more specific

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cardiovascular outcome because some trials have no events and, you know, how do you

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include them? I mean the traditional method of analyzing that kind of data when you

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have a small number of events is too conditioned on the total number of events you have

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in a given trial.

3

clinical trials permits a reliable assessment of cardiovascular safety. We have had some

4

discussion of this but I would like to open it up for further clarification and discussion.

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probability that they would be as lopsided as they are, in terms of treatment - the control

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versus the treatment? If you do that type of analysis the natural thing to use is the odds

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ratio. It just so happens that when you look at the distribution of that kind of statistic,

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what comes out naturally is that it depends on the odds ratio. Here we have relatively

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small event rates so the odds ratio and the relative risk are about the same thing. So, you

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know, I found it reassuring that the different analyses came out with similar conclusions

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by and large.

5

DR. PROSCHAN: Yeah. You know, as mentioned earlier about, you

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Say, okay, given that we have had five of these events, what’s the

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Question No. 1:

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Please discuss whether the low cardiovascular event rate in the Saxagliptin

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DR. BURMAN: Thank you. Dr. Konstam?

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