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Gold/Mining/Energy : Nuvo Research Inc

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To: jef saunders who wrote (6720)	2/9/2001 10:50:31 PM
From: Mark Bartlett	Read Replies (1) of 14101

Jef, The phase IV studies involved 3700 people. This was not a blinded/controlled study - nor was it ever intended to be. Its intention was NOT to measure statistical significance as far as efficacy is concerned. The purpose of the study was to look at any side-effects that may creep in, that may not be seen when smaller studies are done. I believe that is where the 5% came from, but I am going by memory - and it may have also been reflected in the Phase III studies too - I would have to check. Bottom line - if 5% skin irritation was the only problem in the study population, we are in pretty good shape. As far as statistical significance goes, you can have a very statistically significant sample with just a few hundred people, assuming they are chosen correctly and there is not a lot of attrition during the study. Of course the closer "n" approaches the population, the better your data should be. I hope that answers your question - I am real tired and heading for ZZZZZZ land<G> MB

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