Safety was assessed by clinical observation and spontaneous reporting of adverse events (AEs) during the study. Clinical laboratory tests (blood chemistry, hematology, coagulation and urinalysis), 12-lead ECG, physical examination and vital signs were also assessed at the end of the study. All AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA®) (version 20.0), and the seriousness and severity of AEs were recorded in term of the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.03).

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