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sorts of stuff, which might not happen to someone else out there in the community, so

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they are already a special set. From the pediatric point of view, I understand it’s hard to

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find anybody over the age of 17 who dies in an auto accident in this county, who doesn’t

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have large vessel beginning disease. So what is coronary artery disease? Is it when you

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come in complaining that you are out of breath and your chest hurts? Or is it, I mean,

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how are you going to define this? Are you going to cath everybody before you are

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allowed in the study? I don’t understand how you would define that. So my attitude

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toward this is similar to yours, which is that the biology suggests that there are not going

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to be adverse outcomes of this drug but I don’t think we have the data right now to say

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that.

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things, I am hearing several things here. I am hearing an attempt to create stratification

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of who could use this medication. Yet we are dealing with the standard problem that you

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have in any trial, which is that these people because of the study but because of also the

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doctors who were working in this study were very well cared for.

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so far, to say that this drug needs a 20-year study before it can be released out on the

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market. I think it’s just, it’s a complicated decision governed by the meeting which

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discussed cardiovascular risks. I think that it also is a model for other drugs to follow, so

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we have to be very careful of what we do is fair to other drugs where the biology might

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be somewhat different.

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They were on ACE inhibitors, they were on beta-blockers, they are on all

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On the other hand, I don’t think that it’s reasonable, given what we know

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DR. BURMAN: Thank you, let’s see Mike you had a, oh I am sorry;

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you were indeed, thank you very much. Dr. Levitsky.

DR. LEVITSKY: So once again, coming at it from the youth end of

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