Trial Outcomes & Findings for Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia (NCT NCT02059135)

NCT ID: NCT02059135

Last Updated: 2017-08-09

Results Overview

Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.

Results posted on

2017-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Recombinant Human Antithrombin (ATryn) ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Normal Saline 0.9% Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%
Maternal Follow-up (ITT Population) STARTED	62	58
Maternal Follow-up (ITT Population) COMPLETED	59	51
Maternal Follow-up (ITT Population) NOT COMPLETED	3	7
Neonatal Follow-up (Safety Population) STARTED	60	54
Neonatal Follow-up (Safety Population) COMPLETED	56	50
Neonatal Follow-up (Safety Population) NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Recombinant Human Antithrombin (ATryn) ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Normal Saline 0.9% Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%
Maternal Follow-up (ITT Population) Withdrawal by Subject	3	2
Maternal Follow-up (ITT Population) Lost to Follow-up	0	3
Maternal Follow-up (ITT Population) declined to see site staff	0	1
Maternal Follow-up (ITT Population) didn't return to site (f/u elsewhere)	0	1
Neonatal Follow-up (Safety Population) Lost to Follow-up	1	0
Neonatal Follow-up (Safety Population) Death	3	2
Neonatal Follow-up (Safety Population) delivered at another hospital	0	1
Neonatal Follow-up (Safety Population) Withdrawal by Subject	0	1

Baseline Characteristics

Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recombinant Human Antithrombin (ATryn) n=62 Participants ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Normal Saline 0.9% n=58 Participants Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%	Total n=120 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	48 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.0 years STANDARD_DEVIATION 6.1 • n=5 Participants	29.3 years STANDARD_DEVIATION 6.7 • n=7 Participants	29.2 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	58 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	58 participants n=7 Participants	120 participants n=5 Participants
Gestational Age at Randomization	27.18 weeks STANDARD_DEVIATION 1.96 • n=5 Participants	27.34 weeks STANDARD_DEVIATION 2.06 • n=7 Participants	27.25 weeks STANDARD_DEVIATION 2.00 • n=5 Participants
Type of Preeclampsia Preeclampsia	39 Participants n=5 Participants	32 Participants n=7 Participants	71 Participants n=5 Participants
Type of Preeclampsia Superimposed Preeclampsia	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Parity (number of previous live births) 0	37 Participants n=5 Participants	16 Participants n=7 Participants	53 Participants n=5 Participants
Parity (number of previous live births) 1	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Parity (number of previous live births) 2	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Parity (number of previous live births) 3	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Parity (number of previous live births) 4	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Parity (number of previous live births) 5	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Parity (number of previous live births) >5	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.

Population: ITT

Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.

Outcome measures

Outcome measures
Measure	Recombinant Human Antithrombin (ATryn) n=62 Participants ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Normal Saline 0.9% n=58 Participants Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%
Increase in Gestational Age in Days	5.0 days Interval 0.0 to 75.0	6.0 days Interval 0.0 to 85.0

SECONDARY outcome

Timeframe: Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)

Population: ITT

Composite score was calculated based on the following fetal and neonatal events: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), cystic periventricular leucomalacia (PVL), retinopathy of prematurity (ROP), late Sepsis, necrotizing enterocolitis (NEC) and mortality (fetal and neonatal). The endpoint is measured on a 5 point scale where 0 represents no outcomes experienced and no mortality, and 4 represents death, as shown below. Should the same outcome occur more than once, it will only be counted once. Score Outcome 0 No events, no mortality 1. One event, no mortality 2. Two events, no mortality 3. Three or more events, no mortality 4. Death

Outcome measures

Outcome measures
Measure	Recombinant Human Antithrombin (ATryn) n=60 Participants ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Normal Saline 0.9% n=56 Participants Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%
Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)	0.7 scores on a scale of 0 to 4 Standard Deviation 1.0	0.6 scores on a scale of 0 to 4 Standard Deviation 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery).

Population: ITT

Maternal and fetal/neonatal outcomes of specific interest were defined in the protocol. Maternal subjects were assessed through 4-6 weeks post delivery to determine if outcomes had occurred. Neonatal outcomes were assessed from birth until 36 weeks post menstrual age, or through the 4-6 week post delivery visit (if 36 weeks PMA occurs \<28 days following delivery). A second fetal/neonatal composite outcome was the avoidance of fetal/neonatal mortality and neonatal morbidity \[BPD, IVH grade ≥ 3, cystic PVL, ROP stage ≥ 3, late sepsis, and NEC (Bell's stage ≥ 2)\].

Outcome measures

Outcome measures
Measure	Recombinant Human Antithrombin (ATryn) n=62 Participants ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Normal Saline 0.9% n=58 Participants Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Death	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Eclamptic Seizure	0 participants	1 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Myocardial Infarction	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Cerebrovascular Accident	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Transient Ischemic Attack	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Progressive Renal Insufficiency	2 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Thrombocytopenia (without HELLP)	8 participants	2 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal HELLP	2 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal DIC	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Pulmonary Edema	2 participants	4 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Placental Abruption	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal Severe Intra and Post-Partum Hemorrhage	2 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Maternal VTE Including DVT and Pulmonary Embolism	1 participants	2 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Fetal Death (including stillbirth)	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Death	3 participants	2 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Fetal and neonatal death	3 participants	2 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Small for Gestational Age (SGA) <10%	12 participants	9 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Respiratory Distress Syndrom (RDS)	59 participants	51 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Bronchopulmonary Dysplasia (BPD)	22 participants	20 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Retinopathy of Prematurity stage >= 3	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Necrotizing Enterocolitis-Bell's gr >= 2	1 participants	2 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Intraventricular Hemorrhage gr >= 3	3 participants	1 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Cystic Periventricular Leucomalacia	2 participants	1 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Early Sepsis	0 participants	0 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Late Sepsis	2 participants	4 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Neonatal Meningitis	0 participants	1 participants
Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality Avoidance of neonatal morbidity and mortality	36 participants	33 participants

Adverse Events

Maternal/Fetal Safety Population: ATryn

Serious events: 10 serious events

Other events: 60 other events

Deaths: 0 deaths

Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%)

Serious events: 11 serious events

Other events: 53 other events

Deaths: 0 deaths

Neonatal Safety Population: ATryn

Serious events: 32 serious events

Other events: 0 other events

Deaths: 3 deaths

Neonatal Safety Population: Placebo

Serious events: 24 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Laura Massey, Sr. Clinical Project Manager

LFB USA

Phone: 508-370-5157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The site may publish the results of the study after the multi-center publication or 18 months after the sponsor's final evaluation of all study data from all sites, whichever occurs first. Up to 90 days prior to submitting a manuscript or prior to any public presentation, a copy of the abstract, manuscript, or presentation will be provided to Sponsor by the Site for review and comment. Sponsor shall have said 90 day period to respond to the Site with comments.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Maternal/Fetal Safety Population: ATryn n=60 participants at risk Subjects treated with Recombinant human antithrombin (ATryn): ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) n=54 participants at risk Subjects treated with Placebo; Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.	Neonatal Safety Population: ATryn n=60 participants at risk Neonates born to mothers treated with Recombinant Human Antithrombin (ATryn)	Neonatal Safety Population: Placebo n=54 participants at risk Neonates born to mothers treated with placebo (Normal Saline 0.9%)
Blood and lymphatic system disorders Thrombocytopenia	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Abdominal Pain	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Abdominal Wall haematoma	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Ileus	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
General disorders Pyrexia	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Infections and infestations Lobar pneumonia	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Infections and infestations Postoperative wound infection	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions HELLP syndrome	3.3% 2/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Intrapartum haemorrhage	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	3.7% 2/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	3.3% 2/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	7.4% 4/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Vascular disorders Hypertension	5.0% 3/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Vascular disorders Venous thrombosis	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Congenital, familial and genetic disorders Hypospadias	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Congenital, familial and genetic disorders Persistent foetal circulation	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Necrotising enterocolitis neonatal	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	3.7% 2/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Neonatal intestinal perforation	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Infections and infestations Meningitis neonatal	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Infections and infestations Sepsis neonatal	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.0% 3/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Nervous system disorders Intraventricular haemorrhage neonatal	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.0% 3/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Nervous system disorders Periventricular leukomalacia	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	3.3% 2/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	8.3% 5/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	15.0% 9/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	16.7% 9/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	43.3% 26/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	38.9% 21/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory failure	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage neonatal	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Cardiac disorders Nonreassuring foetal heart rate pattern	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.

Other adverse events
Measure	Maternal/Fetal Safety Population: ATryn n=60 participants at risk Subjects treated with Recombinant human antithrombin (ATryn): ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days	Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) n=54 participants at risk Subjects treated with Placebo; Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.	Neonatal Safety Population: ATryn n=60 participants at risk Neonates born to mothers treated with Recombinant Human Antithrombin (ATryn)	Neonatal Safety Population: Placebo n=54 participants at risk Neonates born to mothers treated with placebo (Normal Saline 0.9%)
Vascular disorders Hypertension	53.3% 32/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	46.3% 25/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Nervous system disorders Headache	40.0% 24/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	35.2% 19/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	33.3% 20/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	22.2% 12/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Musculoskeletal and connective tissue disorders Back pain	15.0% 9/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	9.3% 5/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Investigations Aspartate aminotransferase increased	15.0% 9/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	7.4% 4/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Blood and lymphatic system disorders Thrombocytopenia	13.3% 8/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	3.7% 2/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Investigations Alanine aminotransferase increased	11.7% 7/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	3.7% 2/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Psychiatric disorders Insomnia	10.0% 6/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	7.4% 4/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Constipation	10.0% 6/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	0.00% 0/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Abdominal pain upper	8.3% 5/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	13.0% 7/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	8.3% 5/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	11.1% 6/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Abdominal pain	8.3% 5/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	9.3% 5/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Nervous system disorders Dizziness	8.3% 5/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
General disorders Infusion site extravasation	6.7% 4/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	27.8% 15/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Nausea	6.7% 4/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	7.4% 4/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Gastrointestinal disorders Vomiting	6.7% 4/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
General disorders Oedema peripheral	6.7% 4/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	3.7% 2/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Musculoskeletal and connective tissue disorders Neck pain	6.7% 4/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	3.7% 2/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Investigations Blood lactate dehydrogenase increased	6.7% 4/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Investigations Hepatic enzyme increased	6.7% 4/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	1.9% 1/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Psychiatric disorders Anxiety	5.0% 3/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 3/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
General disorders Pyrexia	3.3% 2/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	7.4% 4/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	9.3% 5/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Eye disorders Vision blurred	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Investigations Platelet count decreased	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Psychiatric disorders Postpartum depression	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Skin and subcutaneous tissue disorders Pruritus	1.7% 1/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	5.6% 3/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/60 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	7.4% 4/54 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.	— 0/0 • Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery). Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.