An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-Vi antigen (Ag) total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The lower limit of quantification (LLOQ) for antibody concentrations was >=2.2 microgram per milliliter (µg/mL). In case the measured antibody concentration fell below 2.2 µg/mL, a value of half the LLOQ value was imputed.

The analysis was performed on the Per Protocol Set (PPS), that included all eligible participants who received all doses as per protocol, had immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA).

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Blood samples were collected at specified timepoint for each component as measured by ELISA.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-Vi Ag total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-S. Typhimurium OAg total IgG and Anti-S. Enteritidis OAg total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

Blood samples were collected at specified timepoint for each component as measured by ELISA.

The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited administration site events included redness (erythema), pain, and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (>=) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the unsolicited safety set, which included all participants who received the first dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints.

An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the unsolicited safety set, which included all participants who received the second dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.

An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the unsolicited safety set, which included all participants who received the third dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set, which included all participants who received at least 1 dose of the study intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.

An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention.

AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included alanine aminotransferase [ALT] and aspartate aminotransferase [AST], and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature >=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature >=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature >=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.

An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the unsolicited safety set, which included all participants who received the first dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.

An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the unsolicited safety set, which included all participants who received the second dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.

An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the unsolicited safety set, which included all participants who received the third dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.

Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: <range> (at baseline) - <range> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.