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could be done.

But 5 percent has been a traditional level of consumer protection.  It's thought approving something unacceptable 5 percent of the time, I suppose, is rare enough that it's not a concern but not so very rare that in order to assure it, you have to do arduous testing, but certainly that number is at the discretion of the regulators.  It doesn't come from the statisticians.

DR. SWADENER:  The 5 percent also has not only been tradition in FDA or those kind of circles.  It's other fields as well.  I'm from education and it's very common in that field.

DR. DeLUCA:  Yes.  I noticed when Wally had some questions, Dr. Adams, you also listed as one of the options 90 percent of the doses within 80 to 120 percent.  Walter, in your treatment, that option wasn't included.  The other three were.  I guess that's one question.  What would the treatment look like if you included that?

And then, I guess the rationale for not maintaining the sample mean of 85 to 115 percent ‑‑ that was part of, I guess, the FDA draft and the PTI, and I'm

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