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information we had regarding the increased CPKs and the most information we could

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find in connection was those subjects who were discontinued because of increased CPKs.

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Those were subjects that had narratives. From those narratives that we reviewed, these

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did not appear to be cardiac events. I don't have a full listing of them, but in general,

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again they were random CPK elevations associated with exercise, associated with

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possible Statin use, but again, there was no suggestion that these were cardiac events.

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events of increased CPK, the information was fairly limited. Another thing to point

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out was these CPK elevations in general were not serious adverse events; again, giving us

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limited information. In general, these were elevated CPKs found on study visits in which

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blood was drawn and the increased CPKs were found and reported to be an adverse event

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by these individual investigators.

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question that was asked before regarding how many of the subjects in general in this

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development program were on Statins, I'm not sure if the Sponsor yet has that

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information, but for instance, in the monotherapy studies, I can say at least study 11, I

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believe about a third of patients were on cholesterol medications with the use of Statins

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was about 8%, anywhere from 7% to 10%. So again overall, fairly low, but I don’t have

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that exact information about how many of those increased CPKs were associated with

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Statin use. They were certainly not all of them.

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Given all those constraints, we did recently take a look at whatever

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DR. BURMAN: Thank you. The Sponsor had a comment?

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DR. LOWRY: I don’t have the exact information. In regards to the

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DR. BURMAN: One more question on that if I might, do you have any

idea what percentage of these people who had elevated CPKs were on Statins?

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