CL Item
Yes - Please telephone the Central Randomization Center to enroll the patient. Record the assigned (1)
CL Item
Randomization Number and check the appropriate box to indicate the assigned Cohort in the (Randomization Number and check the appropriate box to indicate the assigned Cohort in the)
CL Item
section below. (section below.)
CL Item
No - Record the reason for Screen Failure on the "Patient Screening/Enrollment Log." (2)