Bullish - Simplified Treatment / Based on Info Gathered The protocol amendments were recommended by clinical investigators and key medical advisors assisting with the study and were based on information gathered to date from the first 45 patients recruited into the Phase II trial.
The amendments approved by Health Canada include the lowering of the minimum age of patients admissible into the trial to 18 years from 45 and a simplified treatment regimen including the reduction in daily blood draws based on the safety profile observed in prior patients.