Trial Outcomes & Findings for A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn (NCT NCT01720524)

NCT ID: NCT01720524

Last Updated: 2021-08-16

Results Overview

Time in days, on iNO treatment, for participants without iNO treatment failure, was calculated 14 days from the initiation of IV study drug or hospital discharge, whichever occurred first. iNO treatment failure was defined as need for additional treatment targeting PPHN, need for extra corporeal membrane oxygenation (ECMO), or death during the study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 59 participants
• Primary outcome timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)
• Results posted on: 2021-08-16

Participant Flow

This study was planned in two parts Part A (double-blind phase) and Part B (long-term, non-intervention phase).

Neonates with persistent pulmonary hypertension of the newborn (PPHN) or hypoxic respiratory failure (HRF) and at risk of PPHN who were receiving inhaled nitric oxide (iNO) treatment were evaluated in this study.

Participant milestones

Measure	IV Sildenafil Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part A STARTED	29	30
Part A COMPLETED	22	18
Part A NOT COMPLETED	7	12
Part B STARTED	27	26
Part B COMPLETED	22	17
Part B NOT COMPLETED	5	9

Reasons for withdrawal

Measure	IV Sildenafil Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part A Insufficient Clinical Response	2	4
Part A Adverse Event	2	2
Part A Death	2	1
Part A Lost to Follow-up	0	1
Part A Missed 28 day follow-up visit	1	1
Part A Withdrawal by Subject	0	1
Part A Other	0	1
Part B No longer willing to participate in study	1	4
Part B Other	2	0
Part B Lost to Follow-up	2	3
Part B Death	0	2

Baseline Characteristics

A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

Baseline characteristics by cohort

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Total n=59 Participants Total of all reporting groups
Age, Continuous	1.7 days STANDARD_DEVIATION 0.90 • n=5 Participants	1.9 days STANDARD_DEVIATION 0.75 • n=7 Participants	1.8 days STANDARD_DEVIATION 0.83 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	29 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Population: The intent-to-treat population (ITT) included all randomized participants treated with study treatment. Here "Overall number of participants analyzed" signifies number of participants without iNO treatment failure.

Time in days, on iNO treatment, for participants without iNO treatment failure, was calculated 14 days from the initiation of IV study drug or hospital discharge, whichever occurred first. iNO treatment failure was defined as need for additional treatment targeting PPHN, need for extra corporeal membrane oxygenation (ECMO), or death during the study.

Outcome measures

Measure	IV Sildenafil n=21 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=24 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure	4.1 days Interval 2.58 to 5.58	4.1 days Interval 2.7 to 5.5

PRIMARY outcome

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Population: The ITT population included all randomized participants treated with study treatment.

Treatment failure rate was defined as percentage of participants who needed additional treatment targeting PPHN, needed ECMO, or died during the study.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Treatment Failure Rate	27.6 percentage of participants Interval 11.3 to 43.9	20.0 percentage of participants Interval 5.7 to 34.3

SECONDARY outcome

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Population: The ITT population included all randomized participants treated with study treatment.

Time in days, from initiation of IV study drug to final weaning of mechanical ventilation among participants achieving final weaning of mechanical ventilation for PPHN was evaluated. Kaplan-Meier method was used for estimation. For participants with mechanical ventilation beyond 336 hours (14 days) from initiation of IV study drug, data was censored at 14 days.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Time From Initiation of Intravenous (IV) Study Drug to Final Weaning of Mechanical Ventilation	8.3 days Interval 5.46 to 11.75	7.3 days Interval 5.46 to 10.78

SECONDARY outcome

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Population: The ITT population included all randomized participants treated with study treatment.

Time in days, from initiation of IV study drug to first treatment failure (defined as need for additional treatment targeting PPHN, need for ECMO, or death) for participants with treatment failure was evaluated. Kaplan-Meier method was used for estimation. For participants without treatment failure by the endpoint assessment date, data was censored at the endpoint assessment date.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Time From Initiation of Intravenous (IV) Study Drug to First Treatment Failure	NA days Due to low number of participants with events, Kaplan-Meier estimates of median, upper and lower limit of CI could not be estimated/calculated.	NA days Due to low number of participants with events, Kaplan-Meier estimates of median, upper and lower limit of CI could not be estimated/calculated.

SECONDARY outcome

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Population: The ITT population included all randomized participants treated with study treatment.

Percentage of participants with individual components of treatment failure (need to start additional treatment targeting PPHN, need to start ECMO, or death) were evaluated. Some participants could have had multiple qualifying events for treatment failure.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Percentage of Participants With Individual Components of Treatment Failure Additional Treatment Targeting PPHN	13.8 percentage of participants Interval 3.9 to 31.7	10.0 percentage of participants Interval 2.1 to 26.5
Percentage of Participants With Individual Components of Treatment Failure ECMO	10.3 percentage of participants Interval 2.2 to 27.4	10.0 percentage of participants Interval 2.1 to 26.5
Percentage of Participants With Individual Components of Treatment Failure Death	6.9 percentage of participants Interval 0.8 to 22.8	0.0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: Baseline, Hours 6, 12 and 24 after start of infusion

Population: The ITT population included all randomized participants treated with study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

Oxygenation index was calculated as the product of fraction of inspired oxygen (FiO2) and mean airway pressure divided by partial pressure of oxygen dissolved in arterial blood (PaO2) [(FiO2*mean airway pressure)/PaO2] measured in centimeter of water per millimeter of mercury (cmH2O/mmHg). FiO2 is the measure of oxygen concentration that is breathed. Mean airway pressure is defined as an average of the airway pressure throughout the respiratory cycle. PaO2 is the measure of oxygen level dissolved in the arterial blood.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Change From Baseline in Oxygenation Index (OI) at Hours 6, 12 and 24 Post-Infusion Change at Hour 6	-4.2 cmH2O/mmHg Interval -11.64 to 3.34	-8.0 cmH2O/mmHg Interval -16.63 to 0.57
Change From Baseline in Oxygenation Index (OI) at Hours 6, 12 and 24 Post-Infusion Change at Hour 12	-4.1 cmH2O/mmHg Interval -10.51 to 2.23	-8.2 cmH2O/mmHg Interval -15.42 to -1.04
Change From Baseline in Oxygenation Index (OI) at Hours 6, 12 and 24 Post-Infusion Change at Hour 24	-11.6 cmH2O/mmHg Interval -15.4 to -7.83	-9.5 cmH2O/mmHg Interval -13.36 to -5.57

SECONDARY outcome

Timeframe: Baseline, Hours 6, 12 and 24 after start of infusion

Population: The ITT population included all randomized participants treated with study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

Differential oxygenation saturation is a simple way to detect the right-to left shunting at ductus arteriosus using 2 pulse oximeters. It is the difference between pre-ductal and post-ductal sites pulse oxygen saturation (SpO2). Where, pre-duct refers to right upper extremity and post-duct refers to lower limb. Oxygenation saturation is measured as percentage of hemoglobin binding sites occupied by oxygen in the blood.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Change From Baseline in Differential Saturation at Hours 6, 12 and 24 Post-Infusion Change at Hour 6	1.5 percentage of hemoglobin Interval -1.79 to 4.8	0.8 percentage of hemoglobin Interval -3.1 to 4.62
Change From Baseline in Differential Saturation at Hours 6, 12 and 24 Post-Infusion Change at Hour 12	-1.2 percentage of hemoglobin Interval -7.65 to 5.21	6.7 percentage of hemoglobin Interval -0.65 to 14.12
Change From Baseline in Differential Saturation at Hours 6, 12 and 24 Post-Infusion Change at Hour 24	1.2 percentage of hemoglobin Interval -7.15 to 9.49	9.3 percentage of hemoglobin Interval -0.4 to 19.08

SECONDARY outcome

Timeframe: Baseline, Hours 6, 12 and 24 after start of infusion

Population: The ITT population included all randomized participants treated with study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

The ratio of partial pressure of arterial oxygen to fraction of inspired oxygen is a ratio between the oxygen level in the arterial blood and the oxygen concentration that is breathed. It helps to determine the degree of any problems with how the lungs transfer oxygen to the blood.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to Fraction of Inspired Oxygen (P/F) at Hours 6, 12 and 24 Change at Hour 6	45.3 ratio Interval 17.21 to 73.37	8.1 ratio Interval -23.48 to 39.6
Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to Fraction of Inspired Oxygen (P/F) at Hours 6, 12 and 24 Change at Hour 12	43.4 ratio Interval 16.76 to 70.13	16.9 ratio Interval -11.97 to 45.68
Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to Fraction of Inspired Oxygen (P/F) at Hours 6, 12 and 24 Change at Hour 24	94.6 ratio Interval 18.52 to 170.69	14.7 ratio Interval -67.83 to 97.25

SECONDARY outcome

Timeframe: Loading dose, Day 1: prior to the start of infusion, 5, 30 minutes after end of loading infusion; Maintenance dose: 48 to 72, 96 to 120 hours during infusion and immediately prior to end of maintenance infusion (up to maximum on Day 14)

Population: Pharmacokinetic (PK) analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period.

Cmax was obtained for Sildenafil and its major metabolite UK-103,320.

Outcome measures

Measure	IV Sildenafil n=25 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Maximum Plasma Concentration (Cmax) of Sildenafil and Its Metabolite Loading dose: Sildenafil	52.64 nanogram per milliliter Standard Deviation 27.91	—
Maximum Plasma Concentration (Cmax) of Sildenafil and Its Metabolite Loading dose: UK-103320	1.04 nanogram per milliliter Standard Deviation 1.68	—
Maximum Plasma Concentration (Cmax) of Sildenafil and Its Metabolite Maintenance dose: Sildenafil	78.12 nanogram per milliliter Standard Deviation 48.63	—
Maximum Plasma Concentration (Cmax) of Sildenafil and Its Metabolite Maintenance dose: UK-103320	21.65 nanogram per milliliter Standard Deviation 11.57	—

SECONDARY outcome

Timeframe: Loading dose: prior to the start of infusion, 5, 30 minutes after end of loading infusion on Day 1; Maintenance dose: between 48 to 72, 96 to 120 hours during infusion and immediately prior to end of infusion on Day 1

Population: PK analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period.

CL is volume of the body fluid/ plasma from which the drug or the metabolite is completely removed per unit time. CL was obtained for Sildenafil and its major metabolite UK-103,320.

Outcome measures

Measure	IV Sildenafil n=25 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Total Plasma Clearance (CL) of Sildenafil and Its Metabolite Sildenafil	1.78 Liters/hour Standard Deviation 0.89	—
Total Plasma Clearance (CL) of Sildenafil and Its Metabolite UK-103,320	5.05 Liters/hour Standard Deviation 2.25	—

SECONDARY outcome

Timeframe: Loading dose: prior to the start of infusion, 5, 30 minutes after end of loading infusion on Day 1; Maintenance dose: between 48 to 72, 96 to 120 hours during infusion and immediately prior to end of infusion on Day 1

Population: PK analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period.

Vc is the hypothetical volume into which a drug or a metabolite initially distributes upon administration. It was determined by using a population-based analysis, non-linear mixed-effects modeling (NONMEM), version 7.4.0. Vc was calculated for Sildenafil and its major metabolite, UK-103,320.

Outcome measures

Measure	IV Sildenafil n=25 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Central Volume of Distribution (Vc) of Sildenafil and Its Metabolite Sildenafil	8.76 Liters Standard Deviation 1.8	—
Central Volume of Distribution (Vc) of Sildenafil and Its Metabolite UK-103,320	15.96 Liters Standard Deviation 11.20	—

SECONDARY outcome

Timeframe: Baseline up to 31 days after end of study drug infusion (up to 45 days)

Population: The safety population included all participants treated with study treatment.

An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent are events between first infusion of study drug and up to 31 days after end of study drug infusion (up to 45 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	22 Participants	19 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	7 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to 31 days after end of study drug infusion (up to 45 days)

Population: The safety population included all participants treated with study treatment.

AE: untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent are events between first infusion of study drug and up to 31 days after end of study drug infusion (up to 45 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Severity criteria: mild=did not interfere with subject's usual function; moderate=interfered to some extent with participant's usual function and severe=interfered significantly with participant's usual function. Missing baseline severities were imputed as mild.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=30 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Number of Treatment-Emergent Adverse Events (AEs) According to Severity Mild	49 events	42 events
Number of Treatment-Emergent Adverse Events (AEs) According to Severity Moderate	29 events	24 events
Number of Treatment-Emergent Adverse Events (AEs) According to Severity Severe	12 events	17 events

SECONDARY outcome

Timeframe: Up to 14 days from initiation of study drug infusion

Population: The safety population included all participants treated with study treatment. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Criteria for laboratory values: Hematology: hemoglobin, hematocrit, red blood cell count <0.8*lower limit of normal (LLN), platelets<0.5*LLN, >1.75*upper limit of normal (ULN), white blood cells count <0.6*LLN, >1.5*ULN; Liver function: total and direct bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, total protein <0.8*LLN, >1.2*ULN; Renal function: blood urea nitrogen, creatinine >1.3*ULN; Electrolytes: sodium <0.95*LLN, >1.05*ULN, potassium, chloride, calcium, bicarbonate (venous) <0.9*LLN, >1.1*ULN.

Outcome measures

Measure	IV Sildenafil n=29 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=28 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Number of Participants With Laboratory Abnormalities	27 Participants	22 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Bayley-III assesses infant and toddler development across five domains: cognitive, language, motor, social-emotional (SE), and adaptive behavior (AB). Assessments of the cognitive, language, and motor domains conducted using items administered to the child; assessments of the SE and AB domains conducted using the primary caregiver's responses to a questionnaire. Score ranges: cognitive scale 0-91, language scale 0-97 and motor scale 0-132, where higher scores indicated better cognitive function, communication and motor skills respectively. Raw scores of cognitive, language and motor domains were converted to composite scores. Composite scores of cognitive, language and motor developmental scales ranged from a scale of 40 to 160, where higher score indicated stronger skills and abilities. In this outcome measure composite scores for infants and toddlers were reported at month 12 and 24.

Outcome measures

Measure	IV Sildenafil n=19 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=13 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Composite Scores of Cognitive, Language, and Motor Developmental Progress of Participants as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Cognitive Development: Month 12	97.5 units on a scale Standard Deviation 16.14	94.5 units on a scale Standard Deviation 14.18
Part B: Composite Scores of Cognitive, Language, and Motor Developmental Progress of Participants as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Cognitive Development: Month 24	97.4 units on a scale Standard Deviation 18.12	97.3 units on a scale Standard Deviation 14.95
Part B: Composite Scores of Cognitive, Language, and Motor Developmental Progress of Participants as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Language Development: Month 12	99.5 units on a scale Standard Deviation 16.86	94.7 units on a scale Standard Deviation 10.25
Part B: Composite Scores of Cognitive, Language, and Motor Developmental Progress of Participants as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Language Development: Month 24	96.7 units on a scale Standard Deviation 21.91	95.8 units on a scale Standard Deviation 17.70
Part B: Composite Scores of Cognitive, Language, and Motor Developmental Progress of Participants as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Motor Development: Month 12	93.1 units on a scale Standard Deviation 16.10	88.2 units on a scale Standard Deviation 14.61
Part B: Composite Scores of Cognitive, Language, and Motor Developmental Progress of Participants as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Motor Development: Month 24	99.0 units on a scale Standard Deviation 19.59	105.3 units on a scale Standard Deviation 24.00

SECONDARY outcome

Timeframe: Month 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

The Bayley-III assesses infant and toddler development across five domains: cognitive, language, motor, social-emotional (SE), and adaptive behavior (AB). Assessments of the cognitive, language, and motor domains conducted using items administered to the child; assessments of the SE and AB domains conducted using the primary caregiver's responses to a questionnaire. The questionnaire comprises the SE scale (35 items) and the AB scale (241 items). Raw scores of SE and AB were converted to composite scores. Composite scores for SE and AB scale ranged from 40 to 160, where higher scores indicated better social-emotional skills and adaptive behavior in child. In this outcome measure composite scores for parent/caregiver were reported at month 24.

Outcome measures

Measure	IV Sildenafil n=15 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=8 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Composite Scores of Social-Emotional and Adaptive Behavior Questionnaire as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Social-Emotional Development	104.5 units on a scale Standard Deviation 21.40	112.5 units on a scale Standard Deviation 18.13
Part B: Composite Scores of Social-Emotional and Adaptive Behavior Questionnaire as Assessed by Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) Adaptive Behavior Development	91.6 units on a scale Standard Deviation 15.66	98.3 units on a scale Standard Deviation 12.44

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Standard age-appropriate ophthalmological examinations were used to assess eye movement disorders (presence of amblyopia, strabismus, and nystagmus) at month 12 and 24. In this outcome measure, data have been reported for right and left eye separately. Rows according to eye movement disorder categories at specified time points are reported in this outcome measure, only when there was a non-zero data for at least 1 reporting arm.

Outcome measures

Measure	IV Sildenafil n=16 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=14 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Number of Participants With Eye Movement Disorders as Assessed by Eye Examination Strabismus Present, Right Eye: Month 12	0 Participants	1 Participants
Part B: Number of Participants With Eye Movement Disorders as Assessed by Eye Examination Strabismus Present, Left Eye: Month 12	0 Participants	1 Participants
Part B: Number of Participants With Eye Movement Disorders as Assessed by Eye Examination Strabismus Present, Right Eye: Month 24	1 Participants	0 Participants
Part B: Number of Participants With Eye Movement Disorders as Assessed by Eye Examination Strabismus Present, Left Eye: Month 24	1 Participants	0 Participants
Part B: Number of Participants With Eye Movement Disorders as Assessed by Eye Examination Nystagmus Present, Left Eye: Month 24	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Standard age-appropriate ophthalmological examinations were used to assess visual acuity (performed differently for children able of verbal interaction) through visual acuity chart (VAC) quantitative, counting finger (CF), hand motion (HM), light perception (LP), no light perception (NLP) and missing at month 12 and 24. In this outcome measure, data have been reported for right and left eye separately. Rows according to visual acuity categories at specified time points are reported in this outcome measure, only when there was a non-zero data for at least 1 reporting arm.

Outcome measures

Measure	IV Sildenafil n=16 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=14 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment VAC Quantitative, Right Eye: Month 12	2 Participants	1 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment HM, Right Eye: Month 12	0 Participants	2 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment LP, Right Eye: Month 12	1 Participants	0 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment Missing, Right Eye: Month 12	13 Participants	11 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment VAC Quantitative, Left Eye: Month 12	2 Participants	1 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment HM, Left Eye: Month 12	0 Participants	2 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment LP, Left Eye: Month 12	1 Participants	0 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment Missing, Left Eye: Month 12	13 Participants	11 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment VAC Quantitative, Right Eye: Month 24	6 Participants	5 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment HM, Right Eye: Month 24	1 Participants	0 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment Missing, Right Eye: Month 24	5 Participants	7 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment VAC Quantitative, Left Eye: Month 24	6 Participants	5 Participants
Part B: Visual Acuity of Verbal Participants as Assessed by Ophthalmological Assessment Missing, Left Eye: Month 24	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Standard age-appropriate ophthalmological examinations were used to assess visual acuity (performed differently for children unable of verbal interaction) through fixates and follows (included central, steady and maintained), light perception (wince to light), no light perception, and missing at month 12 and 24. In this outcome measure, data have been reported for right and left eye separately. Rows according to visual acuity categories at specified time points are reported in this outcome measure, only when there was a non-zero data for at least 1 reporting arm.

Outcome measures

Measure	IV Sildenafil n=16 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=14 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Fixates and Follows, Right Eye: Month 12	15 Participants	13 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Light Perception, Right Eye: Month 12	0 Participants	1 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Missing, Right Eye: Month 12	1 Participants	0 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Fixates and Follows, Left Eye: Month 12	15 Participants	13 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Light Perception, Left Eye: Month 12	0 Participants	1 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Missing, Left Eye: Month 12	1 Participants	0 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Fixates and Follows, Right Eye: Month 24	5 Participants	9 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Missing, Right Eye: Month 24	7 Participants	3 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Fixates and Follows, Left Eye: Month 24	5 Participants	9 Participants
Part B: Visual Acuity of Non-Verbal Participants as Assessed by Ophthalmological Assessment Missing, Left Eye: Month 24	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Standard age-appropriate ophthalmological examinations were used to assess visual acuity (performed differently for children able of verbal interaction) at month 12 and 24. Visual acuity (VA) of verbal children was assessed for each eye using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal, logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately.

Outcome measures

Measure	IV Sildenafil n=6 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=6 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Visual Acuity of Verbal Participants as Assessed by LogMAR Through Visual Acuity Chart Right Eye: Month 12	0.45 LogMAR Standard Deviation 0.394	0.57 LogMAR Standard Deviation 0.513
Part B: Visual Acuity of Verbal Participants as Assessed by LogMAR Through Visual Acuity Chart Left Eye: Month 12	0.47 LogMAR Standard Deviation 0.372	0.57 LogMAR Standard Deviation 0.513
Part B: Visual Acuity of Verbal Participants as Assessed by LogMAR Through Visual Acuity Chart Right Eye: Month 24	0.20 LogMAR Standard Deviation 0.155	0.28 LogMAR Standard Deviation 0.299
Part B: Visual Acuity of Verbal Participants as Assessed by LogMAR Through Visual Acuity Chart Left Eye: Month 24	0.20 LogMAR Standard Deviation 0.155	0.35 LogMAR Standard Deviation 0.409

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Standard age-appropriate ophthalmological examinations were used to assess examination of anterior and posterior chamber for abnormality in lids, conjunctiva, cornea, anterior chamber, lens, iris, pupil, extraocular muscle movement and eye movements at month 12 and 24. In this outcome measure, data have been reported for right and left eye separately. Rows according to visual status categories at specified time points are reported in this outcome measure, only when there was a non-zero data for at least 1 reporting arm.

Outcome measures

Measure	IV Sildenafil n=17 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=15 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Visual Status of Participants With Abnormality as Assessed by Eye Examination of the Anterior and Posterior Segments Anterior Segment (Lids), Right Eye: Month 12	0 Participants	1 Participants
Part B: Visual Status of Participants With Abnormality as Assessed by Eye Examination of the Anterior and Posterior Segments Anterior Segment (Lids), Left Eye: Month 12	0 Participants	1 Participants
Part B: Visual Status of Participants With Abnormality as Assessed by Eye Examination of the Anterior and Posterior Segments Anterior Segment (Extraocular muscle movements), Right Eye: Month 24	1 Participants	0 Participants
Part B: Visual Status of Participants With Abnormality as Assessed by Eye Examination of the Anterior and Posterior Segments Anterior Segment (Extraocular muscle movements), Left Eye: Month 24	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Audiological evaluations of participants were recorded and reported using behavior hearing assessment through pure tone audiometry test which includes participants with normal, abnormal, incomplete/inconclusive behavior at month 12 and 24.

Outcome measures

Measure	IV Sildenafil n=16 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=12 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Behavior Hearing Assessment Through Pure Tone Audiometry Test Abnormal Behavioral Assessment: Month 24	0 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Behavior Hearing Assessment Through Pure Tone Audiometry Test Normal Behavioral Assessment: Month 12	11 Participants	8 Participants
Part B: Audiological Status of Participants as Assessed by Behavior Hearing Assessment Through Pure Tone Audiometry Test Abnormal Behavioral Assessment: Month 12	1 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Behavior Hearing Assessment Through Pure Tone Audiometry Test Incomplete/Inconclusive Behavioral Assessment: Month 12	4 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Behavior Hearing Assessment Through Pure Tone Audiometry Test Normal Behavioral Assessment: Month 24	13 Participants	8 Participants
Part B: Audiological Status of Participants as Assessed by Behavior Hearing Assessment Through Pure Tone Audiometry Test Incomplete/Inconclusive Behavioral Assessment: Month 24	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Audiological evaluations of participants were recorded and reported by bone conduction assessment through pure tone audiometry test which included participants with sensorineural hearing loss, conductive hearing loss, mixed hearing loss, neural, and unspecified at month 12 and 24. Rows according to bone conduction categories at specified time points are reported in this outcome measure, only when there was a non-zero data for at least 1 reporting arm.

Outcome measures

Measure	IV Sildenafil n=1 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=2 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Bone Conduction Through Pure Tone Audiometry Test Conductive Hearing Loss: Month 12	0 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Bone Conduction Through Pure Tone Audiometry Test Unspecified: Month 12	1 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Bone Conduction Through Pure Tone Audiometry Test Conductive Hearing Loss: Month 24	—	1 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Audiological evaluations of participants were recorded and reported by air conduction via phones/headphones through pure tone audiometry test which included participants with hearing loss ranged from less than or equal to (<=) 20 decibel hearing loss (DB HL), 21-40 DB HL, 41-70 DB HL, 71-90 DB HL, greater than (>) 90 DB HL or no response, and missing at frequencies ranged from 500 Hertz (Hz) to 8000 Hz at month 12 and 24. In this outcome measure, data have been reported for right and left ear separately. Rows according to air conduction categories at specified time points are reported in this outcome measure, only when there was a non-zero data for at least 1 reporting arm.

Outcome measures

Measure	IV Sildenafil n=8 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=5 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 500 Hz, <=20 DB HL: Month 12	3 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 500 Hz, 21 - 40 DB HL: Month 12	2 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 1000 Hz, <=20 DB HL: Month 12	4 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 1000 Hz, 21 - 40 DB HL: Month 12	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 2000 Hz, <=20 DB HL: Month 12	3 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 2000 Hz, 21 - 40 DB HL: Month 12	2 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 4000 Hz, <=20 DB HL: Month 12	4 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 4000 Hz, 21 - 40 DB HL: Month 12	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 8000 Hz, <=20 DB HL: Month 12	3 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 8000 Hz, Missing: Month 12	2 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 500 Hz, <=20 DB HL: Month 12	3 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 500 Hz, 21 - 40 DB HL: Month 12	2 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 1000 Hz, <=20 DB HL: Month 12	3 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 1000 Hz, 21 - 40 DB HL: Month 12	2 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 2000 Hz, <=20 DB HL: Month 12	3 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 2000 Hz, 21 - 40 DB HL: Month 12	2 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 4000 Hz, <=20 DB HL: Month 12	4 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 4000 Hz, 21 - 40 DB HL: Month 12	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 8000 Hz, <=20 DB HL: Month 12	3 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 8000 Hz, Missing: Month 12	2 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 500 Hz, <=20 DB HL: Month 24	5 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 500 Hz, 21-40 DB HL: Month 24	2 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 1000 Hz, <=20 DB HL: Month 24	5 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 8000 Hz, <=20 DB HL: Month 24	4 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 1000 Hz, 21-40 DB HL: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 2000 Hz, <=20 DB HL: Month 24	6 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 2000 Hz, 21-40 DB HL: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 4000 Hz, <=20 DB HL: Month 24	7 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 8000 Hz, 21-40 DB HL: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Right Ear, 8000 Hz, Missing: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 500 Hz, <=20 DB HL: Month 24	6 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 500 Hz, 21-40 DB HL: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 1000 Hz, <=20 DB HL: Month 24	4 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 1000 Hz, 21-40 DB HL: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 2000 Hz, <=20 DB HL: Month 24	6 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 2000 Hz, 21-40 DB HL: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 4000 Hz, <=20 DB HL: Month 24	7 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 8000 Hz, <=20 DB HL: Month 24	3 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 8000 Hz, 21-40 DB HL: Month 24	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Phones/Headphones Through Pure Tone Audiometry Test Left Ear, 8000 Hz, Missing: Month 24	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Audiological evaluations of participants were recorded and reported by air conduction via soundfield through pure tone audiometry test which included participants with hearing loss ranged from <=20 DB HL, 21-40 DB HL, 41-70 DB HL, 71-90 DB HL, >90 DB HL or no response, and missing at frequencies ranged from 500 Hz to 4000 Hz at month 12 and 24. Rows according to air conduction categories at specified time points are reported in this outcome measure, only when there was a non-zero data for at least 1 reporting arm.

Outcome measures

Measure	IV Sildenafil n=13 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=9 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 500 Hz, 71-90 DB HL: Month 12	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 500 Hz, <=20 DB HL: Month 12	6 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 500 Hz, 21-40 DB HL: Month 12	5 Participants	6 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 1000 Hz, <=20 DB HL: Month 12	9 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 1000 Hz, 21-40 DB HL: Month 12	1 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 1000 Hz, 71-90 DB HL: Month 12	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 2000 Hz, <=20 DB HL: Month 12	7 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 2000 Hz, 21-40 DB HL: Month 12	3 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 2000 Hz, Missing: Month 12	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 4000 Hz, <=20 DB HL: Month 12	6 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 4000 Hz, 21-40 DB HL: Month 12	4 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 4000 Hz, 71-90 DB HL: Month 12	1 Participants	0 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 500 Hz, <=20 DB HL: Month 24	6 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 500 Hz, 21-40 DB HL: Month 24	2 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 1000 Hz, <=20 DB HL: Month 24	6 Participants	6 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 1000 Hz, 21-40 DB HL: Month 24	4 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 2000 Hz, <=20 DB HL: Month 24	6 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 2000 Hz, 21-40 DB HL: Month 24	2 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 4000 Hz, <=20 DB HL: Month 24	5 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Air Conduction Via Soundfield Through Pure Tone Audiometry Test 4000 Hz, 21-40 DB HL: Month 24	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Audiological evaluations of participants were recorded and reported by tympanometry assessment through immittance audiometry test which included participants with peak pressure signs (+) and (-) at month 12 and 24. In this outcome measure, data have been reported for right and left ear separately.

Outcome measures

Measure	IV Sildenafil n=9 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=8 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (+), Right Ear: Month 12	51.89 decapascals Standard Deviation 63.024	27.33 decapascals Standard Deviation 26.539
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (+), Left Ear: Month 12	5.07 decapascals Standard Deviation 4.900	73.75 decapascals Standard Deviation 28.987
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (+), Right Ear: Month 24	44.00 decapascals Standard Deviation 46.130	33.50 decapascals Standard Deviation 44.125
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (+), Left Ear: Month 24	42.71 decapascals Standard Deviation 50.112	35.00 decapascals Standard Deviation 46.578
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (-), Right Ear: Month 12	149.3 decapascals Standard Deviation 144.34	67.75 decapascals Standard Deviation 57.350
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (-), Left Ear: Month 12	79.89 decapascals Standard Deviation 64.367	46.80 decapascals Standard Deviation 46.912
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (-), Right Ear: Month 24	98.00 decapascals Standard Deviation 55.685	83.67 decapascals Standard Deviation 107.38
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Peak Pressure) Through Immittance Audiometry Test Peak Pressure for Sign (-), Left Ear: Month 24	102.2 decapascals Standard Deviation 84.781	135.0 decapascals Standard Deviation 70.711

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Audiological evaluations of participants were recorded and reported by tympanometry assessment through immittance audiometry test which included participants with static acoustic admittance at month 12 and 24. In this outcome measure, data have been reported for right and left ear separately.

Outcome measures

Measure	IV Sildenafil n=9 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=11 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Static Acoustic Admittance) Through Immittance Audiometry Test Right Ear: Month 12	0.241 millimho Standard Deviation 0.1403	0.403 millimho Standard Deviation 0.1691
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Static Acoustic Admittance) Through Immittance Audiometry Test Left Ear: Month 12	0.364 millimho Standard Deviation 0.1513	0.330 millimho Standard Deviation 0.1595
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Static Acoustic Admittance) Through Immittance Audiometry Test Right Ear: Month 24	0.273 millimho Standard Deviation 0.0784	0.400 millimho Standard Deviation 0.1321
Part B: Audiological Status of Participants as Assessed by Tympanometry Assessment (Static Acoustic Admittance) Through Immittance Audiometry Test Left Ear: Month 24	0.295 millimho Standard Deviation 0.0691	0.585 millimho Standard Deviation 0.5558

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Audiological evaluations of participants were recorded and reported by ipsilateral stapedial reflex through immittance audiometry test which included participants with presence of ipsilateral stapedial reflex at frequencies ranged from 500 Hz to 2000 Hz at month 12 and 24. Ipsilateral stapedial reflex measures are used to assess the neural pathway surrounding the stapedial reflex, which occurs in response to a loud sound (70 to 90 decibel above threshold). In this outcome measure, data have been reported for right and left ear separately.

Outcome measures

Measure	IV Sildenafil n=14 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=12 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 500 Hz, Right Ear: Month 12	5 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 500 Hz, Left Ear: Month 12	6 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 1000 Hz, Right Ear: Month 12	5 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 1000 Hz, Left Ear: Month 12	6 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 2000 Hz, Right Ear: Month 12	5 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 2000 Hz, Left Ear: Month 12	6 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 500 Hz, Right Ear: Month 24	4 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 500 Hz, Left Ear: Month 24	4 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 1000 Hz, Right Ear: Month 24	4 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 1000 Hz, Left Ear: Month 24	5 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 2000 Hz, Right Ear: Month 24	4 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Ipsilateral Stapedial Reflex Through Immittance Audiometry Test 2000 Hz, Left Ear: Month 24	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Audiological evaluations of participants were recorded and reported by transient evoked emission through otoacoustic emissions assessment which included participants with presence of transient evoked emissions from frequencies 1000 Hz to 4000 Hz at month 12 and 24. In this outcome measure, data have been reported for right and left ear separately.

Outcome measures

Measure	IV Sildenafil n=7 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=3 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 4000 Hz, Left Ear: Month 12	5 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1000 Hz, Right Ear: Month 24	3 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1000 Hz, Right Ear: Month 12	3 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1000 Hz, Left Ear: Month 12	2 Participants	1 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1500 Hz, Right Ear: Month 12	3 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1500 Hz, Left Ear: Month 12	2 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 2000 Hz, Right Ear: Month 12	5 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 2000 Hz, Left Ear: Month 12	5 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 3000 Hz, Right Ear: Month 12	4 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 3000 Hz, Left Ear: Month 12	4 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 4000 Hz, Right Ear: Month 12	6 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1000 Hz, Left Ear: Month 24	2 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1500 Hz, Right Ear: Month 24	2 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 1500 Hz, Left Ear: Month 24	2 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 2000 Hz, Right Ear: Month 24	7 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 2000 Hz, Left Ear: Month 24	6 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 3000 Hz, Right Ear: Month 24	6 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 3000 Hz, Left Ear: Month 24	4 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 4000 Hz, Right Ear: Month 24	7 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Transient Evoked Emission Through Otoacoustic Emissions Assessment 4000 Hz, Left Ear: Month 24	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

Audiological evaluations of participants were recorded and reported by distort product through otoacoustic emissions assessment which included participants with presence of distort product at frequencies ranged from 2000 Hz to 8000 Hz at month 12 and 24. Distortion-product otoacoustic emissions (DPOAEs) are generated in the cochlea in response to two tones of a given frequency and sound pressure level presented in the ear canal. Distort product otoacoustic emissions are an objective indicator of normally functioning cochlea outer hair cells. In this outcome measure, data have been reported for right and left ear separately.

Outcome measures

Measure	IV Sildenafil n=7 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=7 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 2000 Hz, Right Ear: Month 12	4 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 2000 Hz, Left Ear: Month 12	5 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 3000 Hz, Right Ear: Month 12	5 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 3000 Hz, Left Ear: Month 12	5 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 4000 Hz, Right Ear: Month 12	5 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 4000 Hz, Left Ear: Month 12	5 Participants	3 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 6000 Hz, Right Ear: Month 12	4 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 6000 Hz, Left Ear: Month 12	5 Participants	4 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 8000 Hz, Right Ear: Month 12	4 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 8000 Hz, Left Ear: Month 12	5 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 2000 Hz, Right Ear: Month 24	4 Participants	7 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 2000 Hz, Left Ear: Month 24	4 Participants	6 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 3000 Hz, Right Ear: Month 24	7 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 3000 Hz, Left Ear: Month 24	6 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 4000 Hz, Right Ear: Month 24	6 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 4000 Hz, Left Ear: Month 24	6 Participants	5 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 6000 Hz, Right Ear: Month 24	4 Participants	6 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 6000 Hz, Left Ear: Month 24	5 Participants	6 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 8000 Hz, Right Ear: Month 24	3 Participants	2 Participants
Part B: Audiological Status of Participants as Assessed by Distort Product Through Otoacoustic Emissions Assessment 8000 Hz, Left Ear: Month 24	4 Participants	2 Participants

SECONDARY outcome

Timeframe: up to 24 months after end of study treatment in Part A (maximum up to 26 months)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety.

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.

Outcome measures

Measure	IV Sildenafil n=27 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=26 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Deaths AEs	17 Participants	17 Participants
Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Deaths SAEs	9 Participants	6 Participants
Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Deaths Deaths	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Month 12 and 24 after end of study treatment in Part A (Day 1 to 14)

Population: Part B safety analysis set included all participants enrolled in Part B of the study for data analyses on developmental progress, audiological, neurological and ophthalmological assessment, and safety. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.

The Hammersmith Infant Neurological Examination (HINE) was a standard scoring examination to assess development of cranial nerve; posture; movement; tone; and reflexes and reaction. HINE exam global score is a sum of subset (cranial nerve, posture, movement, tone, reflexes and reactions) scores, ranged from 0 to 78, where higher score represents better outcome. Here, the HINE global scores were reported at month 12 and 24.

Outcome measures

Measure	IV Sildenafil n=21 Participants Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Placebo n=12 Participants Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Part B: Neurological Progress of Participants as Assessed by the Neurology Optimality Score Neurological Exam Global Score: Month 12	69.9 units on a scale Standard Deviation 14.97	75.6 units on a scale Standard Deviation 3.45
Part B: Neurological Progress of Participants as Assessed by the Neurology Optimality Score Neurological Exam Global Score: Month 24	65.6 units on a scale Standard Deviation 19.71	76.5 units on a scale Standard Deviation 2.42

Adverse Events

Part A: IV Sildenafil

Serious events: 7 serious events

Other events: 20 other events

Deaths: 2 deaths

Part A: Placebo

Serious events: 2 serious events

Other events: 19 other events

Deaths: 1 deaths

Part B: IV Sildenafil

Serious events: 9 serious events

Other events: 14 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 6 serious events

Other events: 15 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part A: IV Sildenafil n=29 participants at risk Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Part A: Placebo n=30 participants at risk Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Part B: IV Sildenafil n=27 participants at risk Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Part B: Placebo n=26 participants at risk Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Respiratory, thoracic and mediastinal disorders Viral upper respiratory tract infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Cardiomyopathy	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Congenital, familial and genetic disorders Pulmonary malformation	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Drug withdrawal syndrome	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urosepsis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyponatraemia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Myoclonus	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Seizure	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hypertensive crisis	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hypotension	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Gastroenteritis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Gastroesophageal Reflux	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bronchiolitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pneumonia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.4% 2/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bronchopneumonia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.4% 2/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	11.5% 3/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Upper respiratory tract infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Immune system disorders Food allergy	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension crisis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Oxygen saturation decreased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Congenital, familial and genetic disorders Congenital heart disease	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Measure	Part A: IV Sildenafil n=29 participants at risk Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Part A: Placebo n=30 participants at risk Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Part B: IV Sildenafil n=27 participants at risk Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.	Part B: Placebo n=26 participants at risk Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
Eye disorders Periorbital oedema	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Pupil fixed	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal distension	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Diarrhoea	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.4% 2/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Intestinal perforation	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Vomiting	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Disease progression	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Drug withdrawal syndrome	13.8% 4/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Drug withdrawal syndrome neonatal	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Generalised oedema	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Infusion site extravasation	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Malaise	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Oedema	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Secretion discharge	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Withdrawal syndrome	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Cholestasis	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Hyperbilirubinaemia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Conjunctivitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Lung infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Nosocomial infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pneumonia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Sepsis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Tracheitis	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Underdose	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Alanine aminotransferase increased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood albumin decreased	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood calcium decreased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood magnesium decreased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood methaemoglobin present	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood urea increased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 2/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations C-reactive protein increased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Haematocrit decreased	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Hepatic enzyme increased	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Oxygen saturation decreased	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations PCO2 decreased	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Platelet count decreased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Staphylococcus test positive	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Thyroid function test abnormal	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Acidosis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Alkalosis hypochloraemic	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Feeding intolerance	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Fluid overload	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Fluid retention	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperchloraemia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypoalbuminaemia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypocalcaemia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypochloraemia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypokalaemia	24.1% 7/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypoproteinaemia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Metabolic acidosis	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Brain injury	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Cerebral ischaemia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Hypertonia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Motor dysfunction	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Seizure	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Vocal cord paralysis	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Selective eating disorder	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Oliguria	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Renal failure	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Reproductive system and breast disorders Oedema genital	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Choking	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Hiccups	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	13.3% 4/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary interstitial emphysema syndrome	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Stridor	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Tachypnoea	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Skin irritation	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Haemodynamic instability	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hypertension	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 2/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hypotension	24.1% 7/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.7% 2/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Cardiomyopathy	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Congenital, familial and genetic disorders Plagiocephaly	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Ear and labyrinth disorders Conductive deafness	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Hypermetropia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Strabismus	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Constipation	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Acute sinusitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bronchiolitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.4% 2/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bronchitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 2/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Ear infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	14.8% 4/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Gastroenteritis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Herpangina	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Nasopharyngitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	14.8% 4/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	11.5% 3/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Oral candidiasis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Otitis media	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	11.5% 3/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Otitis media acute	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Parainfluenzae virus infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pharyngitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.4% 2/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Roseola	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Sinusitis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Upper respiratory tract infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.4% 2/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Post procedural hypotension	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Adenovirus test positive	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood creatinine increased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood pyruvic acid increased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Gastric residual assessment	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Haemoglobin abnormal	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Heart rate decreased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Heart rate increased	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Prothrombin time prolonged	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Weight gain poor	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intra-abdominal haemangioma	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Phrenic nerve paralysis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Psychomotor skills impaired	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Drug dependence	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Thrombosis	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.8% 1/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Anaemia	13.8% 4/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	10.0% 3/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.7% 2/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Leukocytosis	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Bradycardia	10.3% 3/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Bradycardia neonatal	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.7% 1/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Junctional ectopic tachycardia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Myocardial ischaemia	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Sinus bradycardia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Supraventricular tachycardia	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Congenital, familial and genetic disorders Persistent foetal circulation	3.4% 1/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Endocrine disorders Hypothyroidism	0.00% 0/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	3.3% 1/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Eye oedema	6.9% 2/29 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/30 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/27 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/26 • Part A: Baseline up to 31 days after end of study drug infusion (up to 45 days); Part B: up to 24 months after end of study treatment in Part A (maximum up to 26 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER