Trial Outcomes & Findings for Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants (NCT NCT03169881)

NCT ID: NCT03169881

Last Updated: 2025-11-17

Results Overview

Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score \< 85); 2 standard deviations below the mean, moderate delay (score \< 70); and 3 standard deviations below the mean, severe delay (score \< 55). This self-standing scale comprises the primary outcome for the Darbe study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 650 participants
• Primary outcome timeframe: 22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier
• Results posted on: 2025-11-17

Participant Flow

Participant milestones

Measure	Darbepoetin Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks' PMA, intravenously when the infant had intravenous access, otherwise subcutaneously	Placebo Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks' postmenstrual age as a sham subcutaneous dose
Overall Study STARTED	322	328
Overall Study Completed Assessment for Bayley Cognitive Score at Two-Year Follow-Up	239	239
Overall Study Died After Hospital Discharge	2	3
Overall Study Died Before Hospital Discharge	50	50
Overall Study Started Study Drug and Data Not Withdrawn Prior to Hospital Discharge	316	325
Overall Study Survived to Hospital Discharge (a Median of 94 Days)	269	277
Overall Study COMPLETED	291	292
Overall Study NOT COMPLETED	31	36

Reasons for withdrawal

Measure	Darbepoetin Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks' PMA, intravenously when the infant had intravenous access, otherwise subcutaneously	Placebo Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks' postmenstrual age as a sham subcutaneous dose
Overall Study Incomplete Follow-up	10	15
Overall Study Lost to Follow-up	18	20
Overall Study Data withdrawn prior to hospital discharge	3	1

Baseline Characteristics

Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Baseline characteristics by cohort

Measure	Darbepoetin n=322 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=328 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose	Total n=650 Participants Total of all reporting groups
Age, Continuous	26.2 weeks STANDARD_DEVIATION 1.7 • n=202 Participants	26.2 weeks STANDARD_DEVIATION 1.6 • n=283 Participants	26.2 weeks STANDARD_DEVIATION 1.7 • n=120 Participants
Sex/Gender, Customized Female	166 Participants n=202 Participants	162 Participants n=283 Participants	328 Participants n=120 Participants
Sex/Gender, Customized Male	156 Participants n=202 Participants	166 Participants n=283 Participants	322 Participants n=120 Participants
Race/Ethnicity, Customized Hispanic or Latino	54 Participants n=202 Participants	56 Participants n=283 Participants	110 Participants n=120 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	263 Participants n=202 Participants	265 Participants n=283 Participants	528 Participants n=120 Participants
Race/Ethnicity, Customized Unknown or Not Reported	5 Participants n=202 Participants	7 Participants n=283 Participants	12 Participants n=120 Participants
Birth weight, Continuous	838.2 grams STANDARD_DEVIATION 252.9 • n=202 Participants	822.1 grams STANDARD_DEVIATION 238.5 • n=283 Participants	830.1 grams STANDARD_DEVIATION 245.7 • n=120 Participants
Race, Customized American Indian or Alaska Native	7 Participants n=202 Participants	11 Participants n=283 Participants	18 Participants n=120 Participants
Race, Customized Asian, Native Hawaiian, or Other Pacific Islander	15 Participants n=202 Participants	7 Participants n=283 Participants	22 Participants n=120 Participants
Race, Customized Black or African American	96 Participants n=202 Participants	102 Participants n=283 Participants	198 Participants n=120 Participants
Race, Customized More Than One Race	7 Participants n=202 Participants	2 Participants n=283 Participants	9 Participants n=120 Participants
Race, Customized Unknown or Not Reported	7 Participants n=202 Participants	9 Participants n=283 Participants	16 Participants n=120 Participants
Race, Customized White	190 Participants n=202 Participants	197 Participants n=283 Participants	387 Participants n=120 Participants

PRIMARY outcome

Timeframe: 22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier

Population: The analysis population includes all randomized infants with available data up to the two-year followup.

Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score < 85); 2 standard deviations below the mean, moderate delay (score < 70); and 3 standard deviations below the mean, severe delay (score < 55). This self-standing scale comprises the primary outcome for the Darbe study.

Outcome measures

Measure	Darbepoetin n=291 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=292 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Bayley III Composite Cognitive Score	80.7 score on a scale Standard Deviation 19.5	80.1 score on a scale Standard Deviation 18.7

SECONDARY outcome

Timeframe: Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

The number of transfusions recorded during the study, up to 35 completed weeks gestational age

Outcome measures

Measure	Darbepoetin n=319 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=327 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Number of Transfusions Per Infant	2.3 Transfusions Standard Deviation 3.1	3.3 Transfusions Standard Deviation 3.5

SECONDARY outcome

Timeframe: Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)

Population: The analysis population includes all randomized infants that were ever transfused.

The total volume of transfusions for the infant if ever transfused

Outcome measures

Measure	Darbepoetin n=192 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=257 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Total Volume of Transfusions Per Infant	54.5 mL Standard Deviation 51.9	69.0 mL Standard Deviation 51.0

SECONDARY outcome

Timeframe: Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

The number of donor exposures recorded during the study, up to 35 completed weeks gestational age

Outcome measures

Measure	Darbepoetin n=319 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=327 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Number of Donor Exposures Per Infant	1.6 Donors Standard Deviation 2.3	2.2 Donors Standard Deviation 2.3

SECONDARY outcome

Timeframe: at 2 and at 7 weeks in the study

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

Hematocrit adjusted for center, gestational age group, and familial clustering

Outcome measures

Measure	Darbepoetin n=314 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=319 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Hematocrit week 2	36.84 Percent of blood volume made up of RBCs Interval 36.35 to 37.33	33.88 Percent of blood volume made up of RBCs Interval 33.4 to 34.36
Hematocrit week 7	37.02 Percent of blood volume made up of RBCs Interval 36.45 to 37.59	31.78 Percent of blood volume made up of RBCs Interval 31.24 to 32.32

SECONDARY outcome

Timeframe: at 2 and at 7 weeks in the study

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

Red Cell Mass (Circulating Erythrocyte Volume), adjusted for center, gestational age group, and familial clustering

Outcome measures

Measure	Darbepoetin n=319 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=327 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Red Cell Mass week 7	42.78 mL Interval 41.65 to 43.92	36.01 mL Interval 34.9 to 37.12
Red Cell Mass week 2	28.35 mL Interval 27.26 to 29.43	24.74 mL Interval 23.67 to 25.82

SECONDARY outcome

Timeframe: Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

This is measured as Yes if experienced necrotizing enterocolitis, Bells stage >=2 with surgery; Otherwise, No.

Outcome measures

Measure	Darbepoetin n=319 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=327 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Necrotizing Enterocolitis, Bells Stage >=2 With Surgery Necrotizing Enterocolitis with Surgery	14 Participants	13 Participants
Necrotizing Enterocolitis, Bells Stage >=2 With Surgery No Necrotizing Enterocolitis with Surgery	305 Participants	314 Participants

SECONDARY outcome

Timeframe: At 36 weeks postmenstrual age

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

This is measured as Yes if infant is on invasive mechanical ventilation, nasal cannula >2 L/min or noninvasive positive airway pressure at 36 weeks of postmenstrual age; Otherwise, No.

Outcome measures

Measure	Darbepoetin n=261 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=277 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Bronchopulmonary Dysplasia Grades 2 or 3 No Bronchopulmonary Dysplasia at 36 Weeks Postmenstrual Age	170 Participants	149 Participants
Bronchopulmonary Dysplasia Grades 2 or 3 Bronchopulmonary Dysplasia at 36 Weeks Postmenstrual Age	91 Participants	128 Participants

SECONDARY outcome

Timeframe: Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

This is measured as Yes if experienced Retinopathy of prematurity stage >=3 or treatment for that condition received; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.

Outcome measures

Measure	Darbepoetin n=273 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=279 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received No Retinopathy of Prematurity Stage At least stage 3 or Treatment for That Condition Received	238 Participants	234 Participants
Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received Retinopathy of Prematurity At least stage 3 or Treatment for That Condition Received	35 Participants	45 Participants

SECONDARY outcome

Timeframe: Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

This is measured as Yes if experienced Grade I+ Intraventricular Hemorrhage; Otherwise, No.

Outcome measures

Measure	Darbepoetin n=315 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=318 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Intraventricular Hemorrhage Grade I+ Grade 1+ Intraventricular Hemorrhage	108 Participants	98 Participants
Intraventricular Hemorrhage Grade I+ No Intraventricular Hemorrhage	207 Participants	220 Participants

SECONDARY outcome

Timeframe: At initial hospital discharge or at death if it occurs earlier (a median of 94 days), assessed up to one year of life.

Population: The analysis population includes all randomized infants with available data during the initial hospitalization.

This is measured as the length of stay up to hospital discharge or death, whichever occurred first.

Outcome measures

Measure	Darbepoetin n=304 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=318 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Length of Hospital Stay	96.2 Days Standard Deviation 58.5	104.8 Days Standard Deviation 67.3

SECONDARY outcome

Timeframe: Birth, through the 22-26 months corrected age follow-up window, which corresponds to a median of 29 months calendar age in the analysis population

Population: The analysis population includes all randomized infants with available data up to the two-year followup.

This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No.

Outcome measures

Measure	Darbepoetin n=319 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=327 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Death Death	52 Participants	53 Participants
Death No Death	267 Participants	274 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age (a median of 25 months corrected age)

Population: The analysis population includes all randomized infants with available data at the two-year followup.

This is a 4-level outcome, where Severe NDI denotes a BSID III cognitive score less than 70, a Gross Motor Functional (GMF) level of 3-5 (where higher scores indicate worse outcomes), blindness (less than 20/200 vision), and/or profound hearing loss, Moderate NDI denotes a BSID III cognitive score from 70-84 and either a GMF level of 2 or limited blindness / moderate hearing loss, Mild NDI denotes a BSID III cognitive score from 70-84, or a cognitive score >=85 with a GMF level of 1 and/or mild hearing loss, and No NDI denotes a cognitive score >= 85 and an absence of neurosensory deficits.

Outcome measures

Measure	Darbepoetin n=231 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=237 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Neurodevelopmental Impairment Mild	72 Participants	68 Participants
Neurodevelopmental Impairment Moderate	1 Participants	3 Participants
Neurodevelopmental Impairment None	121 Participants	124 Participants
Neurodevelopmental Impairment Severe/profound	37 Participants	42 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age (a median of 25 months corrected age)

Population: The analysis population includes all randomized infants with available data at the two-year followup.

This is measured as Yes if the child has been deemed by the medical examiner as having Cerebral Palsy; Otherwise, No.

Outcome measures

Measure	Darbepoetin n=244 Participants Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou	Placebo n=247 Participants Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Any Cerebral Palsy Any Cerebral Palsy	40 Participants	38 Participants
Any Cerebral Palsy No Cerebral Palsy	204 Participants	209 Participants

Adverse Events

Darbepoetin

Serious events: 85 serious events

Other events: 16 other events

Deaths: 52 deaths

Placebo

Serious events: 92 serious events

Other events: 21 other events

Deaths: 53 deaths

Serious adverse events

Measure	Darbepoetin n=316 participants at risk Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age, intravenously when the infant had intravenous access, otherwise subcutaneously	Placebo n=325 participants at risk Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Blood and lymphatic system disorders Acute anemia	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Blood and lymphatic system disorders DIC	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Blood and lymphatic system disorders Neutropenia	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Blood and lymphatic system disorders Twin-twin transfusion syndrome	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Cardiac disorders Cardiac arrest	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Cardiac disorders Cardiopulmonary arrest	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Cardiac disorders Cardiopulmonary failure	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Cardiac disorders Ventricular dysfunction	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Congenital, familial and genetic disorders Congenital anomaly	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Congenital, familial and genetic disorders Newborn persistent pulmonary hypertension	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Endocrine disorders Adrenal insufficiency	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Abdominal distension	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Esophageal perforation	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Gastric perforation	0.63% 2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Ileal perforation	0.63% 2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Necrotizing enterocolitis neonatal	2.2% 7/316 • Number of events 7 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	4.0% 13/325 • Number of events 13 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Neonatal intestinal perforation	3.5% 11/316 • Number of events 11 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	3.7% 12/325 • Number of events 12 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Gastrointestinal disorders Pneumoperitoneum	0.63% 2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
General disorders Multi-organ failure	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Hepatobiliary disorders Direct hyperbilirubinemia	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 3 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Hepatobiliary disorders Failure liver	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Aspergillosis	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Cytomegalovirus infection	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Enterovirus infection	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Fungal infection	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Infection	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Klebsiella infection	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Klebsiella sepsis	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Neonatal sepsis	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Pneumonia	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Pseudomonal sepsis	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Sepsis neonatal	10.1% 32/316 • Number of events 34 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	8.0% 26/325 • Number of events 27 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Staphylococcus aureus pneumonia	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Urinary tract infection	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Infections and infestations Urosepsis	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Injury, poisoning and procedural complications Stoma site bleeding	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Investigations Cerebrospinal fluid volume increased	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Metabolism and nutrition disorders Hyperkalemia	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Nervous system disorders Cerebral haemorrhage	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Nervous system disorders Hydrocephalus	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Nervous system disorders Intraventricular hemorrhage neonatal	1.9% 6/316 • Number of events 6 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	1.2% 4/325 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Nervous system disorders Posthaemorrhagic hydrocephalus	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Nervous system disorders Seizure	0.95% 3/316 • Number of events 3 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Pregnancy, puerperium and perinatal conditions Extreme immaturity	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Renal and urinary disorders Anuria	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Renal and urinary disorders Oliguria	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Vascular disorders Hemorrhage	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Renal and urinary disorders Renal failure	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Acute lung injury	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Acute respiratory decompensation	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.63% 2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory failure	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.00% 0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.95% 3/316 • Number of events 3 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	1.5% 5/325 • Number of events 5 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	2.8% 9/316 • Number of events 9 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	2.5% 8/325 • Number of events 8 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Respiratory, thoracic and mediastinal disorders Syndrome respiratory distress newborn	0.00% 0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.31% 1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Vascular disorders Hypertension neonatal	1.3% 4/316 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Vascular disorders Hypotension	0.32% 1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	1.2% 4/325 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
Vascular disorders Thrombosis	1.3% 4/316 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	0.62% 2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.

Other adverse events

Measure	Darbepoetin n=316 participants at risk Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age, intravenously when the infant had intravenous access, otherwise subcutaneously	Placebo n=325 participants at risk Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
Infections and infestations Sepsis neonatal	5.1% 16/316 • Number of events 18 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.	6.5% 21/325 • Number of events 22 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age. Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.

Additional Information

Robin K Ohls, MD

University of Utah

Phone: 801-581-7052

Email: robin.ohls@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place