Our study had several strengths. We included
safeguards against potential bias (concealed randomization
and concealment of study-group assignments
from patients, end-point adjudicators,
and data analysts) and safeguards against interpretation
bias.31 The study also had broad inclusion
criteria with a large number of centers in
countries with diverse health care systems, as
well as a focus on an end point (i.e., reoperation)
that is of unequivocal importance to both patients
and the health care system.