Table 1: Phase I dose escalation.

CohortTv g/dayDose escalation timing (using escalation decision rule in next box)

13Starting dose (dose used in clinical practice)
26Begin after a minimum of 3 subjects in group 1 who have completed 2 weeks of product with no dose limiting toxicity (DLT—defined as any treatment related toxicity > grade 1)
39Begin after a minimum of 3 subjects in group 2 who have completed 2 weeks of product with no DLT