Tom and Dottie, I hope we soon know the changes they are making for phase III. If they can't use the changes without first testing it in a clinical trial, could they keep you out of the statistics and do it all during phase III?

I'm thinking that you couldn't be fully in phase III, because it would be open label for you. It seems logical [this is all speculation] to keep you separate but give you the newer version being used in phase III. Does this leave more to actually observe and work with? 3 groups, two blnded- one placebo and one with new treatment- and one group open label with new treatment?

But then sometimes procedures defy logic from our perspective.

hope that makes sense,
paula