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FOOD AND DRUG ADMINISTRATION - page 245 / 263

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It tends to be under 10 percent per individual in the individual, and when you compare taking intensive sampling over 24 hours and compared that against the mean of three pre-dose samples, it's not very much different.  I think it's 7.77 versus 7.75 percent CV.  So we didn't feel that it would be necessary to do that.

The other thing in that study, it was a point-by-point subtraction method, and the fact of the matter is we still don't know exactly what happens to baseline on treatment, and it doesn't make sense to increase your noise because the point estimates switch and the confidence intervals change.

DR. MEYER:  I guess I was just looking at the AUC 96 hours.  For a 1.125 difference in dose, the point estimate is 1.08 for the correction method 3 and 1.03.  So there was a 5 percent improvement, if you will, by using the overall correction.

DR. JOHNSON:  Right, and we attribute some of that improvement to the fact that when we're comparing the 400 and 450 microgram doses, you are getting closer to baseline and that noise from the baseline is going to interfere with that evaluation.  That was the point that I

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