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expect that the hazard or odds ratio will be different in different populations? Is there a

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reason to expect that in this population that is a somewhat lower risk, although I would

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challenge that it’s really a truly low risk population, but certainly a lower risk population

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than one that was enriched with a lot of non-cardiovascular disease. I guess it becomes a

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biologic question. Will those two different populations differ in their response to the

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drug or in the impact that the drug has on cardiovascular safety?

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that needs to come out from this question because in listening to the questions and

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comments around the table, I think it is important. Because I think there are two different

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issues here; one is how many events do we have? When we have a low number of

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events, what degree of confidence can we build, you know, about the point estimate in

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the various boundaries. So that’s a purely statistical question and a critical one.

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separate those two out. The first one we can deal with, you know, just by looking at the

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statistics as best we can and getting our own estimate of it. I think it really helps me that

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the point estimate, a lot of the point estimates, is to the better side of unity. So that’s

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something that I think will come out. The other issues we can’t deal with, although I

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must sort of challenge myself to ask, you know, do I know of another drug that has two

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directional effects that actually drives the point estimates in a good direction in a low risk

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population and a bad direction in a high risk population?

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DR. KONSTAM: Yeah. You know, I think there is a really key point

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The other question is a population related question; Is there a reason to

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So I think it’s, in our discussion and deliberations, really important that we

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another issue. I think when you are going to expose these drugs, you know, to patients

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who have high cardiovascular risk, as others have pointed out, as John has pointed out, I

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Now I don’t know of such a drug, I can’t think of one. I think that is

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