An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.

Safety population included all participants who received at least 1 dose of IMP.

An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.

Safety population included all participants who received at least 1 dose of IMP.

Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP.

No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the Pharmacokinetic (PK) population.

Pharmacokinetic (PK) population included all participants who received IMP and had at least 1 post-dose PK concentration measurement.

No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement.

No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 due to insufficient number of quantifiable sisunatovir concentrations.

T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate t1/2 and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate AUC(0 to inf) and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate AUC(0 to inf) and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate clearance and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate clearance and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate volume of distribution and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate volume of distribution and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.

Accumulation ratio was calculated as ratio of the area under the curve (AUC) during a single dosing interval under steady state conditions to the AUC during a dosing interval after one singe dose. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Accumulation ratio could not be calculated as it was depended on AUC which was not calculable due to insufficient number of quantifiable concentrations.

Percentage fluctuation was calculated as 100*(Cmax-Cmin)/Cavg, where Cmin=minimum plasma concentration and Cmax measured over dosing interval.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

AUC(0 to tau) was determined using the linear trapezoidal method.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Cavg was estimated as AUC(0 to tau)/tau, where tau=dosing interval (12 hours).

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects analysis of covariance (ANCOVA) model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group >=1 month to <6 months.

Modified Intent to Treat (mITT) population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoints. Data for Cohorts 4 and 5 were combined as pre-specified in statistical analysis plan.

Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects ANCOVA model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group >=1 month to <6 months.

mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoints. Data for Cohorts 4 and 5 were combined as pre-specified in statistical analysis plan.

Time to resolution was calculated for RSV-related signs and symptoms that were present at study start and was defined as the time of randomization to the time that RSV-related signs and symptoms were absent.

mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time to improvement was calculated for RSV-related signs and symptoms that were classified as moderate or severe during the course of the study and was defined as the time from randomization to the time that RSV-related signs and symptoms were mild or absent.

mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

RSV clinical score was a composite score for infants with RSV infection >= 1 month of age based on 4 items (respiratory rate, wheezing, retraction of respiratory muscles and general condition). Score for each item ranged from 0 to 3 where 0=none/normal and 3=severe. Total score was calculated as sum of individual items and ranged from 0 to 12, where higher score indicated severe disease. RSV symptoms were graded as mild: score <=5, moderate: score > 5 but < 9 and severe: score >=9.

mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified timepoints.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 2= assessment prior to receiving dose 2 of IMP on Day 1.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 3= assessment prior to receiving dose 3 of IMP on Day 2.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 4= assessment prior to receiving dose 4 of IMP on Day 2.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 5= assessment prior to receiving dose 5 of IMP on Day 3.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 6= assessment prior to receiving dose 6 of IMP on Day 3.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 7= assessment prior to receiving dose 7 of IMP on Day 4.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 8= assessment prior to receiving dose 8 of IMP on Day 4.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 9= assessment prior to receiving dose 9 of IMP on Day 5.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 10= assessment prior to receiving dose 10 of IMP on Day 5.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Hematology parameters included basophils, eosinophils, mean cell hemoglobin concentration (MCHC), mean cell hemoglobin (MCH), mean cell volume (MCV), red blood cell count (RBC), hematocrit (HCT), hemoglobin (Hb), white blood cell count (WBC), lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per high power field [hpf]), erythrocytes (0 to 2 per hpf), granular casts (0 per low power field [lpf]), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and potential of hydrogen (pH) (5 to 8).

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QT interval corrected by Bazzett's formula (QTcB) interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.