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The only other definition of MACE that we used was the definition that counted all

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deaths, not just cardiovascular deaths, and the reason for doing that is that we were

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concerned about any possible bias that might have been introduced by our assessment of

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cause of death. So when we included all deaths, not just CV related deaths, we

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essentially arrived at the same answer.

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filed the NDA and before there was a lot of the discussion surrounding the people who

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are gamma agonists, we had to find an endpoint of acute CV events and that endpoint

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was defined by a list of preferred terms. When we began to engage with the FDA on

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focusing on MACE like events, what we did is we selected a subset of the preferred terms

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and defined acute CV events and these were preferred terms that focused on acute

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myocardial infarction, stroke, and cardiovascular causes of mortality. We did not do

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iterative definitions of events.

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understand the data and maybe the statistical folks in the room can help me with this

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because we are being asked to look at upper boundaries of confidence limits and I'm

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trying to reconcile, and I know we are going to have an FDA presentation, but I am trying

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We selected that particular definition of MACE as our primary definition.

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list of preferred terms that defined acute CV events, we subsetted those events to really

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focus on the events that were more consequential like MI and stroke.

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DR. WOLF: The way that we arrived at that definition is before we

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DR. KONSTAM: All right. My last question relates to just making sure I

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DR. KONSTAM: So the primary MACE definition is something you

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constructed and that was your first shot at it without any preconception about how the

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data was going to come out, is that what I hear?

DR. WOLF: That’s right. Again, the method was based upon our original

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