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DISCUSSION AND QUESTIONS

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TO THE COMMITTEE

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inhibitor use, angiotensin receptor blocker use, beta-blockers, and calcium channel

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blocker is presented on this slide. We, at the present time, don’t have information on

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nonsteroidals but we can address the questions about ACE inhibitors and beta-blockers.

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meeting. Although this portion is open to public observers, public attendees may not

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participate except at the specific request of the panel. In terms of overall agenda it’s

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approximately 1:30, that will give us 30-35 minutes or so for each of the four questions

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and I know that there is some overlap between each of the questions. Then we will end

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that and then go to specific discussion of the voting issues and then vote. Let me read the

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first questions and open it up for discussion.

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which had been discussed. I am particularly interested in things like potentially

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chronic Non-steroidal anti-inflammatory use, which may obviously increase, or such

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things as, what was the percent of patients in groups that took Aspirin, Beta blockers,

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ACE inhibitors, etc. that might alter cardiovascular events rates.

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on that slide? Let me open further any comments by the committee to the FDA or the

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Sponsor before we move on to discussion of the specific questions.

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Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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DR. BURMAN: We will now begin the panel discussion portion of the

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DR. WOLF: Could you please project slide 3-99. The frequency of ACE

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DR. BURMAN: Thank you. Does anybody have any specific questions

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(No response.)

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Seeing none, then we shall move on.

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