Patients were assessed according to a schedule of assessments through study Day 28, with daily monitoring through Day 5. Study drug was held if QTc was >500 ms, if the patient declined a dose, or if enteral access became unavailable. Concomitant medications were not restricted but were recorded both before and through 5 days after randomization. Although both study drugs are considered generally safe, a priority in the trial was optimization of safety. We employed the following four parallel mechanisms for safety monitoring: 1) exclusion of patients at increased risk of arrhythmia or other side effects, 2) an electrocardiogram performed 24–48 h after enrollment, 3) daily review of medications to assure no contraindicated or potentially contraindicated medications were initiated, and 4) daily review for potential adverse events. Further details of safety monitoring are available in the protocol.

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