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Figure 1 Schematic Illustration of Study Design and Assessments
Timing and hourly intervals for assessments are described in the text. *Inpatient stays until 4 h after second and seventh dose and 32 h after tenth dose.
Also collected on day 16.
Assessment hourly intervals at baseline: 0 to 4, 4 to 8, 8 to 12, and 12 to 24; on days 1, 6, 10, and 16: 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24.
Collection hourly intervals at baseline: 0 to 4, 4 to 8, 8 to 12, and 12 to 24; on days 1, 6, 10: 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24; on day 11: 28 h to 32 h after last dose. ||Collection hourly intervals at baseline: 0, 4, 8, 12, and 24; on days 1, 6, and 10: 2, 4, 8, and 12; on days 4 and 8: 0; on day 11: 4 and 8. NYHA = New York Heart Association; PGA = Physicians Global Assessment; PO = per os (by mouth).