Who will be blinded {17a}
Trial participants, care providers, research coordinators involved in data collection and monitoring, outcome assessors, and the study statisticians are masked. The only members of the study team with access to the masking key are the two study nurses that prepare the active and placebo solutions and two senior research staff members at the coordinator center. To assess for unmasking, the surgeons are asked to guess whether the solution is active or placebo at the time of administration, and these data are monitored at DSMC meetings.