Study design
This was a global, multi-center, randomized, double-blinded, placebo-controlled clinical study that occurred at 16 sites in the USA, Ukraine, Russia, and Hungary. Subjects were randomized 2:1 to either efbemalenograstim alfa group or placebo group using a central randomization system. Randomization was stratified by country/region to reduce regional bias. The study comprised a 14-day screening period and an 84-day treatment period.