Report - TITLE PAGEDay -1 Pre-Dose 0 h 0.5 h 1 h 1.5 h 2 h 3 h 4 h 6 h 8 h 10 h 12 h 24 h 36 h 48 h Follow-up 2 Informed Consent X Inclusion & Exclusion Criteria X X Demography X Full physical

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