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address, basically. The upper limit of the confidence interval, you know, tells you how

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bad it could be and so I think, you know, these results do rule out significant harm at

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least, you know, if you look at the, the more specific the cardiovascular event, I think

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these confidence intervals do rule out, you know, much harm at all. If there is any harm

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it would have to be very small in this population.

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impossible question to answer, but from a statistical standpoint what’s the likelihood,

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given the data that we have, that we are missing a significant event of higher cardiac

6

events at a larger population, even if it’s the same population?

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CAS study, which was brought up before with the 1C antiarrhythmic agents, there is

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actually molecular basis for the harm that we have seen there and it’s not Torsade, which

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is class 1A sodium blockage. It’s 1C, where in an ischemic population where you

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provide potent sodium blockade and conduction block, when the ischemia occurs you

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shorten refractory periods, therefore you engage re-entrance cycle in the circuit.

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even in that case will be very difficult to figure out whether the treatment effect is

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different in that group than in the group without cardiac disease.

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DR. BURMAN: From a statistical standpoint, correct.

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DR. PROSCHAN: Well, I mean that’s what the confidence intervals

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DR. BURMAN: Thank you. Dr. Veltri.

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DR. VELTRI: I just want to make a short comment and that is, with the

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So in CAS, I think in the ischemic population as opposed to non-ischemic

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population, there is a molecular basis for that. I think in this particular arena, I don’t see

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137

DR. BURMAN: Thank you. Let me ask you, I know this is probably an

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DR. PROSCHAN: So you are saying, what, how likely is it that what we

are seeing is misleading?