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DR. TRAN: Just a quick reminder; even though this is a public meeting,

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please do not cross the rope and approach the panel members during breaks or anytime

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rescue medication. It seems that the consensus to the panel is that this, given the

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issues that we have discussed before, is an appropriate summary, and does give us

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significant information regarding the risks of cardiovascular and other events in this

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group. We further discussed and wondered whether there was a relationship between

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rescue and a higher rate of events and it didn’t seem that that was so, and that also it

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seemed the longer a patient was studied the greater the chance of risk over time. Does

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that sound reasonable to the group? Then I would like to break, if the FDA has any

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announcements or anything. Then we will break from 2:30 p.m. to 2:45 p.m. and

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reconvene at 2:45 for the next question.

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outcomes. Please discuss the adequacy of these methods for measuring sensitivity of the

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results to analytical method.

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(Afternoon recess.)

150

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No. 4 and after discussion of Question No. 4, we will move on to the voting questions.

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With regard to Question No. 4, it states

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like to open it up for discussion and may be ask Mike as a statistician if he would be glad

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to answer part of the question.

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This of course is a technical question that focuses on statistics. I would

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Question No. 4

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Multiple statistical methods were used to analyze cardiovascular

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during the meeting, thank you.

DR. BURMAN: Thank you Paul, I would like to move now to Question

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