I’ve been involved in double blind and randomized studies. In the randomized study, we actually ran into an issue where the trial was cancelled. For this study, active ingredient material was administered to some patients and placebo to others. The problem was that the placebo had a very minor difference to the active material and when patients compared medication, they were able to identify who was in the control group and who was in the experimental group, creating a bias. The study ended up being repeated, with different placebo material, but not before a great deal of money was lost and paperwork was completed to amend the changes.