25% albumin solution diluted to 4.4%

An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product.

Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product. As per the study statistical analysis plan (SAP), descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is a medically significant event.

SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically significant event. As per the study SAP, descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin, direct bilirubin, indirect bilirubin and estimated glomerular filtration rate [eGFR]). The number of participants with a shift from the Baseline value to the worst post-treatment value (low, normal, or high) was reported. The worst criterion for the parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low, ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR - severe impairment.

Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (ALP, ALT, AST, bilirubin, direct bilirubin, indirect bilirubin and eGFR). Percentage of participants with a shift from the Baseline value to the worst post-treatment value (low, normal, or high) was reported. The worst criterion for the parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low, ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR - severe impairment. As per the study SAP, descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets.

Hepatic parameters included ALT, ALP and AST.