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these endpoints in the post-hoc analysis permit a reliable assessment of cardiovascular

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safety and given the limitations of the data, it seems like they might. Actually it’s

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unknown because there is no real adjudication. All of us have participated in clinical

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trials where you may comment on an individual patient but adjudication, which is more

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strict, may or may not be accurate. So the real question is, how accurate is this post-hoc

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adjudication? Is it enough to then have these custom MACE and broad MACE to base

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the decision on at this point in time? Any comments? Dr. Veltri?

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suggestions on how to analyze the data. There is one more way to handle data that has a

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small number of events and that is, instead of conditioning on the number of events, the

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total number of events across both groups, you don’t do that. You say, is there any

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common event probabilities? Suppose the event probability is the same in the two

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groups. Is there any probability that would be consistent with the data shown? So there

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is just one more test, Statistic Bernard’s test, which might be done in addition.

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done a wonderful job in looking at this custom MACE concept. If you have a database

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where these CV death and mild stroke have been adjudicated, then you have that same

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database where you have investigative reports looking at specific MedDRA preferred

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terms, you can actually possibly compare the actual CEC adjudicated in these clinical

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trials versus the customized approach. I suspect that is going to be very close. I think

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that’s one way of trying to validate this when you don’t have the CEC adjudication.

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DR. PROSCHAN: Yes, there is just one more thing in terms of

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DR. BURMAN: Thank you. One statement is, please discuss whether

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DR. VELTRI: It’s the same comment I had before. I think the FDA has

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DR. BURMAN: Thank you. Other comments?

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