we were trying to do was make a statement where we lowered the confidence level,
instead of being 95% confident maybe 80% and then translating that into, so we have to
be 80% confident, but now we are ruling out 1.4, something like that. So I think this idea
of ruling out a 1.8 and feeling somehow confident about that is really not saying a whole
lot. On the other hand, I don't know, whether I, this is not really a question. So maybe I
should shut up now.
beyond a reasonable doubt and the judge always says, well it's, if you don’t have a
reasonable doubt or something, it's hard to pin it down, and I think the guidelines, the 1.8,
my recollection of that advisory committee meeting was that the statisticians, myself and
Tom Fleming were trying to get it more instead of saying, ruling out 1.8 which isn't
ruling out much. I mean that’s, ruling out something as harmful as 1.8 is not saying a
see in the custom MACE and, I am interested because you always yell about how you can
never do subgroup analyses on small numbers and here we are doing multiple subgroup
analysis on 40 events at an event rate that's barely 1%, but that being said, the one
analysis where you finally get to what is potentially a high-risk group, which is the
That still allows something that’s very harmful to get in. So I think what
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DR. JOFFE: Right.
DR. FLEGAL: Thanks.
DR. PROSCHAN: Yeah, I think this is sort of like trying to define what's
discussion. Anything you like to say of course. Dr. Teerlink, you had a question and
then we will go to Dr. Veltri.
DR. BURMAN: We will have much more time in the afternoon for