Statistical analysis
PD
Safety and demographic analysis data populations and outputs were produced by the Biostatistics Department of Resolutum Global using the SAS system Version 9.4 (SAS Institute, Cary, NC, USA). The statistical methods for the safety analyses were descriptive in nature, and no formal statistical comparisons were made.Noncompartmental analysis of PK parameters was performed using the validated software, Phoenix WinNonlin v 8.3 (Certara L.P. (Pharsight), St. Louis, MO, USA). Dose-normalized PK parameters were calculated by dividing the PK parameter by the actual administered individual dose (i.e., the assigned dose in milligrams per kilogram multiplied by baseline body weight).The ADA data were summarized by Certara, and the impacts of ADA on PK and PD were evaluated graphically using Phoenix WinNonlin v 8.3. Results from the confirmatory assay were summarized at each time point as either confirmed ADA positive or confirmed ADA negative. The overall incidence of treatment-emergent ADA was reported for each cohort as the proportion of evaluable participants found to have seroconverted during the study period.