Fig. 1

Study Flow Chart. ^aThis visit should occur on the same day as the last visit of the previous treatment cycle. Re-treatment was expected to occur approximately 12–16 weeks after the last treatment; however, the exact timing of treatment was determined by the investigator based on clinical need. ^bPatients who withdrew from the study early (ie, before week 12 of cycle 3) underwent all procedures required for the week 36 visit