Fig. 1.

Patient flow throughout the course of the trial. Patients are presented in chronological order from left to right. Open circles indicate patients treated without reaching a primary safety outcome. Crosses indicate patients who reached primary safety outcomes. Note that dose de-escalation occurred after 2 patients reached primary safety outcomes at the 6-mg/kg dose tier. The second patient in this pair was enrolled before the first patient was noted to reach a primary safety outcome.