The solicited administration site events are pain, redness and swelling.

The solicited administration site events are pain, redness and swelling.

The solicited systemic events are fatigue, fever, nausea, vomiting, diarrhea, abdominal pain, headache, myalgia and arthralgia.

The solicited systemic events are fatigue, fever, nausea, vomiting, diarrhea, abdominal pain, headache, myalgia and arthralgia.

An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs.

An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs.

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Hematology and biochemistry results below or above the laboratory normal ranges were evaluated for the following parameters: Hematology: platelet count, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count with differential neutrophils, lymphocytes and eosinophils. Biochemistry: blood urea nitrogen (BUN), creatinine, liver function tests - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin.

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Hematology and biochemistry results below or above the laboratory normal ranges were evaluated for the following parameters: Hematology: platelet count, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count with differential neutrophils, lymphocytes and eosinophils. Biochemistry: blood urea nitrogen (BUN), creatinine, liver function tests - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin.

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Hematology and biochemistry results below or above the laboratory normal ranges were evaluated for the following parameters: Hematology: platelet count, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count with differential neutrophils, lymphocytes and eosinophils. Biochemistry: blood urea nitrogen (BUN), creatinine, liver function tests - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin.

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Hematology and biochemistry results below or above the laboratory normal ranges were evaluated for the following parameters: Hematology: platelet count, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count with differential neutrophils, lymphocytes and eosinophils. Biochemistry: blood urea nitrogen (BUN), creatinine, liver function tests - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin.

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Hematology and biochemistry results below or above the laboratory normal ranges were evaluated for the following parameters: Hematology: platelet count, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count with differential neutrophils, lymphocytes and eosinophils. Biochemistry: blood urea nitrogen (BUN), creatinine, liver function tests - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin.

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Hematology and biochemistry results below or above the laboratory normal ranges were evaluated for the following parameters: Hematology: platelet count, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count with differential neutrophils, lymphocytes and eosinophils. Biochemistry: blood urea nitrogen (BUN), creatinine, liver function tests - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin.

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Hematology and biochemistry results below or above the laboratory normal ranges were evaluated for the following parameters: Hematology: platelet count, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count with differential neutrophils, lymphocytes and eosinophils. Biochemistry: blood urea nitrogen (BUN), creatinine, liver function tests - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin.

A MAE is an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.

Potential immune-mediated diseases (pIMDs) are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Other AESIs are COVID-19 cases (any suspected, probable or confirmed case of COVID-19 should be reported by the principal investigator as AESI, as defined by World Health Organization).