In Italy, we are now carrying out a randomized control study with the following characteristics. It's blinded so that you may take away any doubt about the placebo effect, because the untreated arm will have the same surgery, and the treated arm conventional angioplasty. We also need independent assessors measuring the clinical outcome as well as conventional MRI measures.
I want to underline that until now there are no treatments capable of having a real and serious primary end point for treatment regarding a neurodegenerative disease, because until now, the viable treatment can simply reach an MRI and radiological end point and not a clinical end point, because disability cannot be prevented at all by the actual treatment. The challenge with this supervised randomized control double-blind study is to try to investigate if the additional benefits of the angioplasty and the eventually associated treatment of a major vascular problem may also lead to the prevention of disability.