Extract to table

Female subjects of childbearing potential must have a negative pregnancy test at screening and must agree to use highly effective contraception throughout the study and for the protocol-specified period following the last dose of study treatment

Site-level principal investigators must meet the qualifications set forth in 21 C

53 and must be listed on the Form FDA 1572 for their respective sites

The schedule of tumor assessments is as follows: • Baseline: Tumor assessment must be performed within twenty-eight (28) days prior to randomization as part of the screening procedures

The End-of-Treatment Visit must be completed within thirty (30) days of the last dose of study treatment for each subject

Data entry must be performed by qualified and trained site personnel who have been granted user access to the EDC system