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make any good statistical point, but we don’t want to keep setting the bar higher and

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higher, we started out with 1.8 as encompassing the range and then we say, well, we want

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to have below 1.8 in all the subgroups or now we want to say, well, 1.8 if we had had

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more events, but I think we need to be careful about what we are - our goal is here is

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again not to show that this drug has a cardiovascular benefit, but to try to rule out major

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harm. So I think we need to be cautious about trying to impose too many conditions and

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really actually ending up making it more difficult than the guidance suggests to meet this

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criteria.

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issue on question number four, and in my summary to see if this is accurate. Multiple

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statistical methods were used, please discuss the adequacy of these methods for

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sensitivity analyses per se, to say oh does it matter on, is the result sensitive to the

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different type of statistical test you implement, but rather how sensitive is it to possible

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random changes in patients from one group to the other, because it’s so small, the

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number.

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DR. ALXEXANDER: Thank you.

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DR. FLEGAL: I’m not a statistician either, but I may not be going to

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(No response.)

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All right. Then, let me, since we have time, let me open to just review the

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groups.

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DR. BURMAN: John, excuse me. What was the trial you just quoted, I

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DR. BURMAN: Thank you. Other comments on this statistical question?

Question No. 4?

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didn’t understand you?

DR. TEERLINK: The Vesnarinone trials is one of them in terms of the

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