with regards to the sub-groups. Due to the small number of events within the sub-groups,
one would not expect, there to be power to observe interactions that might be clinically
relevant and we did not see any.
DR. WOLF: We will have to look at that during the break.
DR. WYNE: Okay, thank you.
DR. BURMAN: Thank you. One more question Mike.
DR. PROSCHAN: With respect to all those different cardiovascular
questions that we had earlier, I wanted the committee to be aware that the Sponsors are
currently conducting a randomized clinical trial in patients with moderate and severe
renal sufficiency. Those data, I mean that study is still ongoing at this time.
DR. BURMAN: Thank you very much.
DR. WOLF: If I could, I just wanted to finish a response to one of the
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outcomes you have had, were any of the tests for heterogeneity of the risk ratios, did any
of those come out significant? I think I know the answer to this.
DR. WOLF: We will get the data for you on the percent use of Statin
and the second question?
address that question.
DR. HENRY: David Henry, Biostatistics, Bristol-Myers Squibb. This is
DR. BURMAN: Thank you. We will now proceed with our presentation
from the FDA. I would like to remind public observers at this meeting that while this
DR. WOLF: I think I will ask Dr. Dave Henry to come to the podium to
DR. WYNE: Just if there was any specific Statins, I guess to go with it is
actually the Statin-fibrate combination also.