DR. KIBBE: Thank you.
DR. HAUCK: If acceptable, I wanted to go back briefly to the question raised about the empty canister and the zero tolerance criterion.
DR. KIBBE: Sure. Enjoy yourself.
DR. HAUCK: The problem with the zero tolerance criterion in the FDA draft proposal is it really impinges on normal variability. That's what makes it sort of a guaranteed to fail sort of thing eventually. You can imagine setting -- I should put a different name on it. You can imagine setting some sort of, say, clinically acceptable limits or some much wider than that, saying if there really was a canister that had 10 percent in it or 300 percent in it, that we don't want that to be in a consumer's hands, and if by some stroke of luck that should show up in a sample, that would be a problem. It would be a much wider type of zero tolerance and that sort of thing would probably not impinge on the producer risk in terms of normal variability.
DR. KIBBE: Anybody else? Gary?
DR. HOLLENBECK: Is there a concern when the distribution is not normal? Whoever would like to respond.