Results
RECRUITMENT
Thirty-six patients (A1 = 16; A2 = 20) were recruited between December 2018 and March 2022. The A1 component stopped short of its original recruitment target of 20 patients due to conclusion of planned recruitment period. At that point, the A1 cohort was one patient away from hitting an early stopping rule for the success of recruiting 10 on a schedule (Schedule 6). Although 20 patients were recruited to A2, two patients withdrew before any trial treatment was delivered.