Statistical analysis
All statistical analyses were performed using SAS® 9.4 (SAS Institute, Inc., Cary, NC, USA) except for the calculation of PK parameters using Phoenix® WinNonlin 8.1 (Pharsight Corp., Certara, Princeton, NJ, USA). Exploratory biomarker analyses were performed by a two-tailed paired t test using GraphPad Prism 9.3 (GraphPad Software, Inc., CA, USA).