It is a procedure for a clinical indication. Not a drug therefore it is hard to design a placebo procedure.

The disease is a bad feeling, such as headache that cannot be quantified.

The hypothesis is complicated to explain. We have worked on it for more than 10 years and finally have a one time, non-stressful procedure to reduce the bad feeling in a long run. The retention of the effectiveness will be studied in one year's followup and my few subjects studied are still good after two years.

Yes, phase II is generally for multicenter phase III. The goal is the clinical application for the indication. The near goal is to survive ourselves:)

I might have to go back to research only if this time is not good either.