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we were trying to do was make a statement where we lowered the confidence level,

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instead of being 95% confident maybe 80% and then translating that into, so we have to

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be 80% confident, but now we are ruling out 1.4, something like that. So I think this idea

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of ruling out a 1.8 and feeling somehow confident about that is really not saying a whole

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lot. On the other hand, I don't know, whether I, this is not really a question. So maybe I

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should shut up now.

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beyond a reasonable doubt and the judge always says, well it's, if you don’t have a

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reasonable doubt or something, it's hard to pin it down, and I think the guidelines, the 1.8,

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my recollection of that advisory committee meeting was that the statisticians, myself and

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Tom Fleming were trying to get it more instead of saying, ruling out 1.8 which isn't

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ruling out much. I mean that’s, ruling out something as harmful as 1.8 is not saying a

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whole lot.

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see in the custom MACE and, I am interested because you always yell about how you can

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never do subgroup analyses on small numbers and here we are doing multiple subgroup

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analysis on 40 events at an event rate that's barely 1%, but that being said, the one

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analysis where you finally get to what is potentially a high-risk group, which is the

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That still allows something that’s very harmful to get in. So I think what

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DR. JOFFE: Right.

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DR. FLEGAL: Thanks.

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DR. PROSCHAN: Yeah, I think this is sort of like trying to define what's

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discussion. Anything you like to say of course. Dr. Teerlink, you had a question and

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then we will go to Dr. Veltri.

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DR. BURMAN: We will have much more time in the afternoon for

DR. TEERLINK: Yes, the question was in regards to, it's interesting to

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