2.11. Statistical analysis
The primary analysis is performed in the per-protocol (PP) set, considering the non-inferiority design. The per-protocol group is defined as patients who do not have any of these following significant deviations from the clinical trial protocol: Failure to administer the study drug (pegteograstim) within the scheduled period (same-day arm: within 4 hours, Next-day arm: 24–36 hours); Discontinuation of CBCs before < 50% of tests (on 3 or fewer days) or until ANC reaches > 500/μL, and; development of FN and treatment with additional filgrastim at the discretion of the investigator.Demographics, clinical presentation, perioperative clinical findings, and laboratory values are summarized using descriptive statistics. Continuous variables are described by median values, and categorical variables are described by absolute numbers and percentages. 