Treatment allocation
Patients were randomly assigned to receive either FX06 or its vehicle (phosphate-buffered saline) as the placebo. The randomization list was computer-generated with a 1:1 ratio and undisclosed block sizes, stratified by center. Concealment of the study-group assignments used a centralized, secure, interactive, web-based response system (CleanWeb, Telemedicine Technologies S.A.S., Boulogne-Billancourt, France) accessible from each study center. All investigators, statisticians, and data analysts were blinded to arm assignments until the study and analysis were completed.