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small MI for sure, let's say I was convinced the patient did in fact have an MI, I am not

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sure I would discontinue the patient either from the study. In other words, the fact, I am

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not sure how well that speaks to whether the clinician really thought or whether this

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really was an MI the fact that it was discontinued, because I don’t think that there was a

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high level of concern by the investigators that the experimental drug was likely to cause

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MIs. So I am not sure they would discontinue, I don’t know how much that helps me.

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DR. BURMAN: Well, why don’t we move on? Thank you very much. I

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think Dr. Teerlink, did you have a comment before - a question. Please identify yourself

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what you would expect. I agree with all of the comments that we have heard about the

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relatively low risk and small numbers of events in the population making it difficult to be

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certain that there is not an excess risk.

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DR. KONSTAM: That’s not surprising; I don’t find it that surprising.

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DR. MELE: I mean, no other event is recorded for them, is what I am

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DR. TEERLINK: You probably would have admitted them, you probably

would have admitted the patient, these are mostly out patient.

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DR. KONSTAM: I think we’re on the same wavelength, this is a very

non-specific finding, I agree with that, I just I don’t, you know.

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for the record when you speak. Dr. Savage.

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DR. MELE: Can I just point out one thing about the CPKs, that most of

these CPKs, these patients did not discontinue. So they continue on the trial.

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saying.

DR. KONSTAM: Right, but I am not sure, if I thought a patient had a

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DR. SAVAGE: I guess, I’m sort of trying to put in perspective the

problem we are facing here. If you really want to look at the effect of a new drug, you

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