JRoon, I don't think you are missing my point. I don't think I'm explaining it well. If FDA doesn't except the Japanese study, bioavailability and safety could be addressed in a single 12 week study. As obtuse as FDA tends to be, I think the safety of the active ingredient has been well established. The reason I made reference to the 4g dose is because that isn't a dosage that Mochida uses. At least not that I'm aware of. Sleven,