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Wednesday, August 06, 2008 6:43:33 PM
Worst-case: no efficacy, no analgesia.
I think there's a decent chance that efficacy will be there, because they got significance with n=7. This is consistent with a robust effect, so I expect there to be some effect at 1500. Further, in this second study, efficacy is a bonus, since it's established that there's good efficacy at 2100 mg. The only thing that matters is analgesia, and even partial preservation of analgesia will warrant further development, given the dearth of alternatives.
They showed nothing pertaining to the lower dosages. This may be because the data were terrrible, but it is also possible that there were problems with the fentanyl administration, or with the rebreathing protocol.
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