• Days free of mechanical ventilation (ventilator free days, VFD) within 28 days • Drug-related adverse events (through day 14) • All adverse events through day 28 • All-cause deaths through day 28 • Vital signs daily through day 14 (heart rate, systolic and diastolic blood pressure, and body temperature) • ECG parameters (if available) including heart rate PQ, QRS, QT and QTc intervals through day 7 • Clinical laboratory assessments (haematology, clinical chemistry, blood gases and urine analysis) daily through day 14 • 24-hour fluid balance through day 7 • Hemodynamic parameters: mean arterial pressure, pulmonary blood volume (PBV), cardiac index and cardiac output assessed at screening and daily until end of treatment • Need for vasoactive drugs assessed at screening and daily until end of treatment

• Days free of mechanical ventilation (ventilator free days, VFD) within 28 days • Drug-related adverse events (through day 14) • All adverse events through day 28 • All-cause deaths through day 28 • Vital signs daily through day 14 (heart rate, systolic and diastolic blood pressure, and body temperature) • ECG parameters (if available) including heart rate PQ, QRS, QT and QTc intervals through day 7 • Clinical laboratory assessments (haematology, clinical chemistry, blood gases and urine analysis) daily through day 14 • 24-hour fluid balance through day 7 • Hemodynamic parameters: mean arterial pressure, pulmonary blood volume (PBV), cardiac index and cardiac output assessed at screening and daily until end of treatment • Need for vasoactive drugs assessed at screening and daily until end of treatment