Why did you report on patient results of Phase 2 when, by your own admission, you didn't improve CCSVI, your endpoint was not met, and the venoplasty treatment was a failure?
How can you report on any of the EDSS data, relapse data, or new lesions data if the treatment did not correct CCSVI?
According to your study outline, the end point for venoplasty "success" was >75% restoration of the venous outflow compared to baseline.
And you achieved this in the unblinded phase 1 part of the study!
Here is the PREMiSe trial booklet for participating patients, where you list the endpoints.
However, you did not achieve greater than 75% restoration of venous outflow in phase 2.