The criteria for including patients in the intention-
to-treat analysis included randomization
and the possibility of applying each of the study
antiseptic preparations (which required performance
of surgery). Inclusion in the per-protocol
analysis required the application of the study
preparation before clean-contaminated surgery
and completion of the 30-day follow-up. An independent
data and safety monitoring board composed
of an infectious-disease physician, a surgeon,
and a statistician met annually to review
the conduct of the study. No formal criteria were
set for stopping the study.