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mean there are various ways that MIs are adjudicated, if you really do it up front and care

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about pre-specifying. One typical approach would be to say that you need two out of

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three of CPK elevation, ECG abnormality, and clinical symptoms. That’s a typical

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approach, there are others, but you certainly could not say that, with only a CPK, it is not

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an MI. What you could say is that, as has been discussed and I think well, it’s not

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specific for an MI and there are other things that could cause it.

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Alexander from Duke had brought it up, and being a pediatric endocrinologist, I don’t see

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CPK too often or MIs for that matter. Is it safe to say or agreed upon that if you have an

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elevation in your CPK, but you have no EKG findings, that that is not a cardiac event, is

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that a -- can you say that?

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a concern and it’s a possible MI. I don’t know, how and where to titrate it. I think the

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discussion was very good, there are a number of other possible reasons for a CPK and

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without the other documentation you are left with a great deal of uncertainty.

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DR. KONSTAM: No, you can’t say that. What you can say is that, I

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DR. KONSTAM: Well you just said it a little bit differently, I mean…

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DR. FELNER: Well, that was to say, after you made your comment, that

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DR. FELNER: Yeah. Just because the cardiologists, I think Dr.

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Please.

DR. BURMAN: Thank you. Any other questions from the Committee?

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DR. FELNER: Without clinical symptoms and without EKG findings, an

elevated CPK, it means very little, correct?

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was what I want to add on because…

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DR. KONSTAM: I wouldn’t say it means very little, I would say that it’s

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