ECG Recording and Analysis

2

• 12-lead electrocardiograms (> 10,000 tracings)

• Timepoint recording

  • Phase III: baseline, first dose (2 h), Months 1 and 3 (2 h)
  • Long-term: baseline; Months 2, 6, and 12

• Analysis:

  • Central analysis by independent cardiologist
  • Intervals evaluated by SigmaScan technique

• No effects on ECG (QTc intervals or arrhythmias)

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