In line with the absence of randomized trials in the
literature, we found conducting of the current trial challenging,
with accrual lasting for 10 years. We estimate that
80% of the eligible patients did not enter the study in the
participating centers, creating a possibility for selection
bias (6). We did our best to improve accrual, but the accrual
rate remained low. We persisted with the study because we
believe that a randomized trial, even a slowly accruing trial,
allows more reliable evaluation of the treatments than
nonrandomized cohort studies.