Table 1.

Phase I dose escalation.

Cohort	Tv g/day	Dose escalation timing (using escalation decision rule in next box)
1	3	Starting dose (dose used in clinical practice)
2	6	Begin 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)
3	9	Begin after a minimum of 3 subjects in group 2 who have completed 2 weeks of product with no DLT