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gfp927z

08/17/08 8:34 AM

#19962 RE: Aiming4 #19958

Aiming, No, for the maintenance of analgesia data to be useful, it has to be concurrent with at least reasonably good RD prevention. So there are two ways for us to wind up with useless analgesia data -

1) The procedural problems that occurred in RD-2 (anxiety, loose masks, etc), occurred again in RD-1.

or -

2) There were no procedural problems, but 1500 mg produced little/no RD efficacy.





















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zebra4o1

08/17/08 10:46 AM

#19966 RE: Aiming4 #19958

Aiming, Gfp has a mental block on this issue. If the 2100 mg dose gives p = 0.03, it is not such a stretch to guess that there is some efficacy at 1500mg. Conversly, if there is no measurable loss of analgesia at 1500 mg, is it such a stretch to guess that analgesia might be substatiantially maintained at 2100 mg?

Obviously there would be no certainty in these conclusions - but this is a PII, proof of concept trial. We are looking for a trend, not absolute verification. PIII is where you go for certainty (well p = 0.05 anyway).