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DR. PARKS: No, all the analyses are of first events.

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DR. WYNE: So there…

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DR. PARKS: There weren’t really multiple events in these studies.

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DR. WYNE: Okay.

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DR. PARKS: I don’t know if the company wants to confirm them, but

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measuring the sensitivity, and I think we agree that they are reasonably sensitive,

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there could be a slight chance that they are wrong and over the longer term there will be a

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higher rate of adverse events, but that likelihood seems low. Okay. Everyone agree with

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that? Also I think we have time to, number one, go back and does anyone have any

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further comments on questions one through four that they want to bring up or for their

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discussion. Yes.

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criterion. I think it would be helpful to sort of reframe that instead of - because it doesn’t

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sound good, it doesn’t sound good to say oh we ruled out a harm of a relative risk of 1.8.

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That still allows a possibility of a very harmful drug. So, I think it would be good to sort

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of rephrase that by, first of all, thinking in terms of one sided confidence interval instead

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of two sided, since you are really only concerned about one direction, and then may be

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earlier. All of these events in the custom MACE those were not first events, they were

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total events, correct?

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DR. WYNE: We just had a quick question we were trying to clarify

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DR. BURMAN: Thank you. Mike.

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DR. PROSCHAN: I just want to make one more point about the 1.8

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that’s what I observed.

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DR. WOLF: We agree with that, I believe - I recall there were two

subjects who had more than one event, but it was really a minority of them.

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