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claim and the mean.

So what approaches are there to assuring an alpha of .05?  Dr. Hauck, I believe, is also going to speak to that issue.

I'd like to finish up then with two questions to the advisory committee.  We will come back to these after hearing the presentations by Dr. Olsson and Dr. Hauck.  The first question for the advisory committee ‑‑ I think we'll be putting this up on the screen later ‑‑ is, does the ACPS agree that a parametric tolerance interval test is conceptually acceptable as a replacement for the agency's non-parametric DCU and DCU through container life tests for OINDPs?  And to help the committee answer this question, as I say, we've asked Dr. Bo Olsson, representing IPAC-RS, to describe their approach to us.

I'd also emphasize that the IPAC-RS approach is claimed to be based upon the current FDA/DCU acceptance rule, but certainly as we'll see, the operating characteristic curves for the FDA's test and the IPAC-RS test are not superimposable.

Then following Dr. Olsson's presentation, OPS

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