Trial Outcomes & Findings for A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour (NCT NCT02292771)

Last Updated: 2020-07-29

Results Overview

Time to delivery is the number of days from the first dose of study treatment until delivery. The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The adjusted mean number of days to delivery along with standard error has been presented. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

97 participants

Primary outcome timeframe

Up to 17 weeks

Results posted on

2020-07-29

Participant Flow

ZINN was a randomized, double-blind, double-dummy multicenter study to compare efficacy and safety of retosiban versus atosiban in female participants aged 12 to 45 years with an uncomplicated singleton pregnancy in preterm labor with intact membranes between 24 0/7 and 33 6/7 weeks gestation.

From 330 planned participants 97 were randomized to receive either retosiban or atosiban intravenous (IV) infusion in a ratio of 1:1. The study was terminated early due to feasibility.

Participant milestones

Participant milestones
Measure	Retosiban Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Study STARTED	47	50
Overall Study COMPLETED	43	48
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Retosiban Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.	Total n=97 Participants Total of all reporting groups
Age, Continuous	27.7 Years STANDARD_DEVIATION 6.15 • n=93 Participants • Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.	27.1 Years STANDARD_DEVIATION 5.66 • n=4 Participants • Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.	27.4 Years STANDARD_DEVIATION 5.88 • n=27 Participants • Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
Sex: Female, Male Female	47 Participants n=93 Participants • Maternal ITT Population	50 Participants n=4 Participants • Maternal ITT Population	97 Participants n=27 Participants • Maternal ITT Population
Sex: Female, Male Male	0 Participants n=93 Participants • Maternal ITT Population	0 Participants n=4 Participants • Maternal ITT Population	0 Participants n=27 Participants • Maternal ITT Population
Race/Ethnicity, Customized White/Caucasian/European Heritage	21 Count of Participants n=93 Participants • Maternal ITT Population	31 Count of Participants n=4 Participants • Maternal ITT Population	52 Count of Participants n=27 Participants • Maternal ITT Population
Race/Ethnicity, Customized American Indian or Alaskan Native	7 Count of Participants n=93 Participants • Maternal ITT Population	4 Count of Participants n=4 Participants • Maternal ITT Population	11 Count of Participants n=27 Participants • Maternal ITT Population
Race/Ethnicity, Customized East Asian Heritage	9 Count of Participants n=93 Participants • Maternal ITT Population	4 Count of Participants n=4 Participants • Maternal ITT Population	13 Count of Participants n=27 Participants • Maternal ITT Population
Race/Ethnicity, Customized Arabic/North African Heritage	11 Count of Participants n=93 Participants • Maternal ITT Population	10 Count of Participants n=4 Participants • Maternal ITT Population	21 Count of Participants n=27 Participants • Maternal ITT Population
Race/Ethnicity, Customized African American/African Heritage	0 Count of Participants n=93 Participants • Maternal ITT Population	3 Count of Participants n=4 Participants • Maternal ITT Population	3 Count of Participants n=27 Participants • Maternal ITT Population

PRIMARY outcome

Timeframe: Up to 17 weeks

Population: Maternal ITT Population

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Time to Delivery From the Start of Investigational Product (IP) Administration	32.51 Days Standard Error 2.990	33.71 Days Standard Error 2.531

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: Maternal ITT Population

Gestational age (GA) at birth (weeks) is defined as the GA when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm , if the GA at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births Prior to 37 0/7 Weeks Gestation	25 Participants	28 Participants

SECONDARY outcome

Timeframe: Up to 17 weeks

Population: Maternal ITT Population

Participants were considered to have delivered at term if the gestational age was \>=37 0/7. The number of participants who delivered at term, that is, 37 0/7 to 41 6/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births at Term	21 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to 28 days post estimated date of delivery (EDD) of 40 0/7 weeks gestation

Population: Neonatal ITT Population

The length of stay was collected from medical records and was calculated as the days between the delivery date and time and discharge date and time. Log of length of stay was calculated as treatment plus GA at randomization plus established progesterone use based on Analysis of covariance (ANCOVA) model. The p-value was calculated using t-test method. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Length of Neonatal Hospital Stay	4.98 Days Interval 3.54 to 6.99	4.38 Days Interval 3.15 to 6.09

SECONDARY outcome

Timeframe: Up to 28 weeks after EDD (40 weeks gestation)

Population: Neonatal ITT Population

The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, Respiratory Distress Syndrome (RDS), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity (ROP), Intraventricular Hemorrhage (IVH), white matter injury and cerebellar hemorrhage.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Neonates With Composite Neonatal Morbidity and Mortality	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 28 weeks after EDD (40 weeks gestation)

Population: Neonatal ITT Population

The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, white matter injury and cerebellar hemorrhage. Number of neonates with any composite neonatal morbidity and mortality component, excluding RDS has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Neonates With Any Composite Neonatal Morbidity and Mortality, Excluding RDS	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 28 weeks after EDD (40 weeks gestation)

Population: Neonatal ITT Population

The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, cerebellar hemorrhage and white matter injury included Periventricular Leukomalacia PVL), porencephalic cyst, and persistent ventriculomegaly. Number of neonates with with each individual component of the composite neonatal morbidity and mortality has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality BPD	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality ROP	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality IVH	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality Persistent Ventriculomegaly	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality Cerebellar Hemorrhage	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality Fetal death	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality Neonatal death	0 Participants	1 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality RDS	3 Participants	1 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality NEC or isolated perforation	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality Sepsis	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality Meningitis	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality PVL	0 Participants	0 Participants
Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality Porencephalic Cyst	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days post EDD (40 0/7 weeks gestation)

Population: Neonatal Safety Population

Length of neonatal stay in specialized care unit like Intensive Care Unit (ICU) or Neonatal Intensive Care Unit (NICU) are reported.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Length of Stay in Specialized Care Unit	13.65 Days Interval 3.5 to 57.5	12.49 Days Interval 7.6 to 21.8

SECONDARY outcome

Timeframe: Up to 28 days of EDD (40 0/7 weeks gestation)

Population: Neonatal Safety Population

Newborn hospital readmission following hospitalization for birth was obtained from the newborn's medical records. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Retosiban n=46 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Newborn Participants With Hospital Readmission	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: Maternal ITT Population

The number of participants who delivered prior to 28 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 28 0/7 week's gestation and delivered were included.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births Prior to 28 0/7 Weeks Gestation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Maternal ITT Population

Number of participants who delivered prior to 32 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 32 0/7 week's gestation and delivered were included.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births Prior to 32 0/7 Weeks Gestation	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 11 weeks

Population: Maternal ITT Population

Number of participants who delivered prior to 35 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 35 0/7 week's gestation and delivered were included.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births Prior to 35 0/7 Weeks Gestation	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 7 days

Population: Maternal ITT Population

Number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births <=7 Days From the First Study Treatment	10 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 48 hours

Population: Maternal ITT Population

Number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births <=48 Hours From the First Study Treatment	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

Population: Maternal ITT Population

Number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Births <=24 Hours From the First Study Treatment	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks after delivery

Population: Maternal Safety Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one non-serious AE and one SAE has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Maternal Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	7 Participants	9 Participants
Number of Maternal Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) Non-serious AE	34 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

SBP and DBP were measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants DBP; Day 1: 15 to 30 minutes, n=42,45	-3.6 Millimeter of mercury (mmHg) Standard Deviation 10.96	-0.7 Millimeter of mercury (mmHg) Standard Deviation 8.95
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants DBP; Day 1: 4 to 8 hours, n=42,43	-4.3 Millimeter of mercury (mmHg) Standard Deviation 11.07	-3.7 Millimeter of mercury (mmHg) Standard Deviation 10.28
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants DBP; Day 1: 20 to 24 hours, n=38,41	-5.7 Millimeter of mercury (mmHg) Standard Deviation 9.31	-4.1 Millimeter of mercury (mmHg) Standard Deviation 9.90
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants DBP; Day 2, n=40,42	-4.4 Millimeter of mercury (mmHg) Standard Deviation 9.57	-2.6 Millimeter of mercury (mmHg) Standard Deviation 9.93
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants DBP; Post-infusion assessment, n=35,41	-1.6 Millimeter of mercury (mmHg) Standard Deviation 8.63	1.3 Millimeter of mercury (mmHg) Standard Deviation 10.12
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants SBP; Day 1: 15 to 30 minutes, n=42,45	-2.5 Millimeter of mercury (mmHg) Standard Deviation 9.53	-0.4 Millimeter of mercury (mmHg) Standard Deviation 11.02
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants SBP; Day 1: 4 to 8 hours, n=42,43	-4.3 Millimeter of mercury (mmHg) Standard Deviation 9.05	-3.3 Millimeter of mercury (mmHg) Standard Deviation 12.21
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants SBP; Day 1: 20 to 24 hours, n=38,41	-4.1 Millimeter of mercury (mmHg) Standard Deviation 10.16	-5.2 Millimeter of mercury (mmHg) Standard Deviation 13.03
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants SBP; Day 2, n=40,42	-3.9 Millimeter of mercury (mmHg) Standard Deviation 11.53	-3.0 Millimeter of mercury (mmHg) Standard Deviation 11.35
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants SBP; Post-infusion assessment, n=35,41	-1.5 Millimeter of mercury (mmHg) Standard Deviation 11.04	-2.1 Millimeter of mercury (mmHg) Standard Deviation 11.37

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Heart rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Heart Rate in Maternal Participants Day 2, n=39, 41	-2.2 Beats per minute Standard Deviation 11.81	-2.3 Beats per minute Standard Deviation 13.44
Change From Baseline in Heart Rate in Maternal Participants Day 1: 15 to 30 minutes, n=42,46	-3.0 Beats per minute Standard Deviation 12.65	-0.8 Beats per minute Standard Deviation 10.45
Change From Baseline in Heart Rate in Maternal Participants Day 1: 4 to 8 hours, n=42, 43	-5.0 Beats per minute Standard Deviation 13.69	-3.0 Beats per minute Standard Deviation 13.65
Change From Baseline in Heart Rate in Maternal Participants Day 1: 20 to 24 hours, n=38, 41	-1.2 Beats per minute Standard Deviation 14.44	-3.1 Beats per minute Standard Deviation 13.82
Change From Baseline in Heart Rate in Maternal Participants Post-infusion assessment, n=35, 41	-2.7 Beats per minute Standard Deviation 12.90	-1.8 Beats per minute Standard Deviation 13.83

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Respiratory rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Respiratory Rate in Maternal Participants Day 1: 15 to 30 minutes, n=25, 28	0.3 breaths per minute Standard Deviation 2.82	-0.6 breaths per minute Standard Deviation 1.93
Change From Baseline in Respiratory Rate in Maternal Participants Day 1: 4 to 8 hours, n=23, 24	0.0 breaths per minute Standard Deviation 1.65	-0.8 breaths per minute Standard Deviation 2.33
Change From Baseline in Respiratory Rate in Maternal Participants Day 1: 20 to 24 hours, n=21, 21	0.2 breaths per minute Standard Deviation 1.87	-0.6 breaths per minute Standard Deviation 2.40
Change From Baseline in Respiratory Rate in Maternal Participants Day 2, n=23, 24	-0.3 breaths per minute Standard Deviation 1.64	0.2 breaths per minute Standard Deviation 3.45
Change From Baseline in Respiratory Rate in Maternal Participants Post-infusion assessment, n=22, 23	-0.3 breaths per minute Standard Deviation 2.15	-1.3 breaths per minute Standard Deviation 2.70

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Temperature was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Temperature in Maternal Participants Day 2, n=40, 42	-0.07 degree Celsius Standard Deviation 0.467	-0.06 degree Celsius Standard Deviation 0.353
Change From Baseline in Temperature in Maternal Participants Day 1: 15 to 30 minutes, n=41, 43	-0.02 degree Celsius Standard Deviation 0.379	0.02 degree Celsius Standard Deviation 0.467
Change From Baseline in Temperature in Maternal Participants Day 1: 4 to 8 hours, n=40, 42	-0.06 degree Celsius Standard Deviation 0.359	0.00 degree Celsius Standard Deviation 0.507
Change From Baseline in Temperature in Maternal Participants Day 1: 20 to 24 hours, n=37, 41	-0.07 degree Celsius Standard Deviation 0.366	-0.03 degree Celsius Standard Deviation 0.486
Change From Baseline in Temperature in Maternal Participants Post-infusion assessment, n=35, 41	-0.18 degree Celsius Standard Deviation 0.334	-0.20 degree Celsius Standard Deviation 0.422

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.

Outcome measures

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change in erythrocytes from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Erythrocytes in Maternal Participants Early withdrawal, n =1, 1	-0.20 Trillion cells per liter Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-0.70 Trillion cells per liter Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Erythrocytes in Maternal Participants Post-infusion assessment, n=25, 31	0.06 Trillion cells per liter Standard Deviation 0.257	0.05 Trillion cells per liter Standard Deviation 0.236
Change From Baseline in Erythrocytes in Maternal Participants Day 2, n=23, 27	-0.22 Trillion cells per liter Standard Deviation 0.284	-0.29 Trillion cells per liter Standard Deviation 0.261

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus. NA indicates standard deviation was not calculable for a single data point.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants Hemoglobin; Day2, n=23, 27	-5.4 grams per liter (g/L) Standard Deviation 7.81	-8.4 grams per liter (g/L) Standard Deviation 6.86
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants MCHC; Post-infusion assessment, n=25, 31	1.0 grams per liter (g/L) Standard Deviation 7.36	0.4 grams per liter (g/L) Standard Deviation 8.98
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants Hemoglobin; Post-infusion assessment, n=25, 31	0.8 grams per liter (g/L) Standard Deviation 7.55	0.5 grams per liter (g/L) Standard Deviation 5.37
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants Hemoglobin; early withdrawal, n=1, 1	-8.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-19.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants MCHC; Day 2, n=23, 27	1.0 grams per liter (g/L) Standard Deviation 9.41	0.9 grams per liter (g/L) Standard Deviation 6.85
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants MCHC; early withdrawal, n=1, 1	-3.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	24.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants MCV; Day 2, n=23, 27	0.3 femtoliter (fL) Standard Deviation 2.67	-0.4 femtoliter (fL) Standard Deviation 1.82
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants MCV; Post-infusion assessment, n=25, 31	-1.2 femtoliter (fL) Standard Deviation 2.17	-1.0 femtoliter (fL) Standard Deviation 2.22
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants MCV; early withdrawal, n=1, 1	-1.0 femtoliter (fL) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-5.0 femtoliter (fL) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants MPV; Day 2, n=22, 25	0.05 femtoliter (fL) Standard Deviation 0.607	0.06 femtoliter (fL) Standard Deviation 0.553
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants MPV, Post-infusion assessment, n=24, 31	-0.10 femtoliter (fL) Standard Deviation 0.639	-0.03 femtoliter (fL) Standard Deviation 0.803
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants MPV, early withdrawal, n=1, 1	0.00 femtoliter (fL) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-1.40 femtoliter (fL) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.

Outcome measures

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Albumin and Protein Levels in Maternal Participants Albumin; Day 2, n=35, 35	-1.9 grams per liter (g/L) Standard Deviation 2.28	-2.0 grams per liter (g/L) Standard Deviation 1.95
Change From Baseline in Albumin and Protein Levels in Maternal Participants Albumin; Post-infusion assessment, n=30, 35	0.3 grams per liter (g/L) Standard Deviation 2.39	-0.2 grams per liter (g/L) Standard Deviation 2.26
Change From Baseline in Albumin and Protein Levels in Maternal Participants Albumin; early withdrawal, n=1, 1	-4.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-8.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Albumin and Protein Levels in Maternal Participants Protein; Day 2, n=35, 35	-3.7 grams per liter (g/L) Standard Deviation 4.18	-3.3 grams per liter (g/L) Standard Deviation 3.69
Change From Baseline in Albumin and Protein Levels in Maternal Participants Protein; Post-infusion assessment, n=30, 35	0.5 grams per liter (g/L) Standard Deviation 4.73	0.0 grams per liter (g/L) Standard Deviation 4.05
Change From Baseline in Albumin and Protein Levels in Maternal Participants Protein; early withdrawal, n=1, 1	-5.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-12.0 grams per liter (g/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change from Baseline in levels of calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.

Outcome measures

SECONDARY outcome

Timeframe: Baseline and up to 1 week

Population: Maternal Safety Population

Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Direct Bilirubin; Day2, n=35,35	-0.3 micromoles per liter (µmol/L) Standard Deviation 0.85	-0.3 micromoles per liter (µmol/L) Standard Deviation 0.66
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Post-infusion assessment, n=30,35	-0.5 micromoles per liter (µmol/L) Standard Deviation 3.41	-0.1 micromoles per liter (µmol/L) Standard Deviation 0.73
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Direct Bilirubin;early withdrawal, n=1,1	0.0 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	0.0 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Bilirubin;Day2, n= 35,35	-0.7 micromoles per liter (µmol/L) Standard Deviation 2.52	-1.3 micromoles per liter (µmol/L) Standard Deviation 2.03
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Bilirubin; Post-infusion assessment, n= 30, 35	-1.1 micromoles per liter (µmol/L) Standard Deviation 8.24	-0.5 micromoles per liter (µmol/L) Standard Deviation 2.01
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Bilirubin; early withdrawal, n= 1,1	-2.0 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-3.0 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Indirect Bilirubin; Day2, n=35,35	-0.4 micromoles per liter (µmol/L) Standard Deviation 2.35	-1.1 micromoles per liter (µmol/L) Standard Deviation 1.98
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Indirect Bilirubin;Postinfusion assessment,n=30,35	-0.6 micromoles per liter (µmol/L) Standard Deviation 5.06	-0.4 micromoles per liter (µmol/L) Standard Deviation 2.03
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Indirect Bilirubin; early withdrawal, n=1,1	-2.0 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-3.0 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Creatinine; Day2, n=35,34	1.75 micromoles per liter (µmol/L) Standard Deviation 6.765	0.04 micromoles per liter (µmol/L) Standard Deviation 5.336
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Creatinine; Post-infusion assessment, n=30,33	2.19 micromoles per liter (µmol/L) Standard Deviation 4.437	0.72 micromoles per liter (µmol/L) Standard Deviation 4.680
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants Creatinine; early withdrawal, n=1,1	-0.90 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-6.10 micromoles per liter (µmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.

SECONDARY outcome

Timeframe: Up to 6 weeks post-delivery

Population: Maternal Safety Population

Maternal AESI included: maternal death; chorioamnionitis and its complications (clinical chorioamnionitis, preterm premature rupture of membranes, endomyometritis, wound infection, pelvic abscess, bacteremia, septic shock, disseminated intravascular coagulation, and adult RDS); placental abruption; postpartum hemorrhage - postpartum hemorrhage and/or retained placenta and pulmonary edema. The number of participants with at least one AESI has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Maternal Participants With AEs of Special Interest (AESI)	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks post-delivery

Population: Maternal Safety Population

Maternal DREs included: signs and symptoms of labor discomfort (example, cramping, backache, muscle aches, nausea); subsequent episodes of preterm labor and hospitalization for delivery. The number of participants with at least one DRE has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Maternal Participants With Disease Related AEs (DRE)	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 17 weeks

Population: Maternal Safety Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one non-serious AE and one SAE has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Fetal Non-serious AEs and SAEs Non-serious AE	6 Participants	6 Participants
Number of Participants With Fetal Non-serious AEs and SAEs SAE	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 17 weeks

Population: Maternal Safety Population

Fetal AESI included: intrauterine fetal demise; category II or III fetal heart rate tracing; and fetal inflammatory response syndrome characterized by cord blood interleukin-6 \>11 picogram per milliliter (pg/mL), funisitis, or chorionic vasculitis. The number of participants who experienced at least one AESI has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants With Fetal AESI	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 5 minutes after birth

Population: Neonatal ITT Population

APGAR is a quick test to assess the health of new born children. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two, then summing up the five values obtained. APGAR score ranges from 0 to 10 where a score of 7 and above is normal. The mean and standard deviation of APGAR scores at one minute and at five minutes of birth has been presented.Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Neonatal APGAR Scores five minutes, n=46, 50	9.1 Score on APGAR scale Standard Deviation 0.96	9.4 Score on APGAR scale Standard Deviation 0.67
Neonatal APGAR Scores one minute, n=46, 50	8.2 Score on APGAR scale Standard Deviation 1.35	8.4 Score on APGAR scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Up to 17 weeks

Population: Neonatal ITT Population

The weight of neonates was obtained from the neonate birth record. The mean weight of neonates and standard deviation has been presented. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Retosiban n=46 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=49 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Weight of Neonates	2761.9 grams (g) Standard Deviation 567.84	2844.4 grams (g) Standard Deviation 664.80

SECONDARY outcome

Timeframe: Up to 17 weeks

Population: Neonatal ITT Population

The head circumference was determined from the neonate birth record. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Retosiban n=43 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=42 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Head Circumference of Neonates	32.95 centimeters (cm) Standard Deviation 2.179	33.00 centimeters (cm) Standard Deviation 1.892

SECONDARY outcome

Timeframe: Up to 28 days after the EDD of 40 weeks gestation

Population: Neonatal Safety Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one non-serious AE and one SAE has been presented. Neonatal Safety Population consisted of neonates whose mothers received randomized treatment.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Neonatal Participants With Non-serious AEs and SAEs Non-serious AEs	23 Participants	17 Participants
Number of Neonatal Participants With Non-serious AEs and SAEs SAEs	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to 28 days after EDD of 40 weeks gestation

Population: Neonatal Safety Population

Neonatal AESI included: Neonatal death; Asphyxia; Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis); RDS; Hypotension; IVH/periventricular leukomalacia; Bronchopulmonary dysplasia; Neonatal acidosis; Hyperbilirubinemia; Necrotizing enterocolitis; and Hypoxic ischemic encephalopathy. The number of neonatal participants who experienced at least one AESI has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Neonatal Participants With AESI	19 Participants	16 Participants

SECONDARY outcome

Timeframe: Up to 28 days after EDD of 40 weeks gestation

Population: Neonatal Safety Population

The disease related neonatal events occurring in Infants born prior to 37 completed weeks included: apnea (severe), respiratory failure due to fatigue, hypoxia, or air leak from alveolar injury, patent ductus arteriosus, bradycardia, ventriculomegaly, cerebellar hemorrhage, hydrocephalus other than congenital, gastroesophageal reflux, aspiration pneumonia, anemia, retinopathy of prematurity (all stages), hearing disorder, temperature instability and hypoglycemia. The number of participants with at least one DRE has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Neonatal Participants With DRE	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 28 days post EDD (40 0/7 weeks gestation)

Population: Maternal Safety Population

The length of hospital stay associated with hospital admission for preterm labor and term labor/term delivery was collected from review of medical records. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Maternal Length of Stay in Hospital Preterm labor, n=13, 10	5.549 Days Interval 1.32 to 72.0	7.487 Days Interval 0.87 to 37.82
Maternal Length of Stay in Hospital Term labor, n=25, 28	3.146 Days Interval 0.17 to 62.71	3.398 Days Interval 0.41 to 36.74

SECONDARY outcome

Timeframe: Up to 28 days post EDD (40 0/7 weeks gestation)

Population: Maternal Safety Population

Maternal healthcare resource utilization associated with an episode of preterm labor and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit like general ward, private/semi-private room, recovery, and other has been presented.

Outcome measures

Outcome measures
Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Number of Participants Admitted to Particular Hospital Unit Preterm labor, private/semi-private room	1 Participants	0 Participants
Number of Participants Admitted to Particular Hospital Unit Normal term labor, recovery	1 Participants	2 Participants
Number of Participants Admitted to Particular Hospital Unit Normal term labor, Other	5 Participants	7 Participants
Number of Participants Admitted to Particular Hospital Unit Preterm labor, general ward	9 Participants	7 Participants
Number of Participants Admitted to Particular Hospital Unit Preterm, Other	3 Participants	4 Participants
Number of Participants Admitted to Particular Hospital Unit Normal term labor, general ward	16 Participants	12 Participants
Number of Participants Admitted to Particular Hospital Unit Normal term labor, ward-not specified	2 Participants	0 Participants
Number of Participants Admitted to Particular Hospital Unit Normal term labor,private/semi-private room	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

Population: Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).

Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).

Outcome measures

Outcome measures
Measure	Retosiban n=53 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Retosiban Clearance	83.4 Liters per hour Geometric Coefficient of Variation 5.25	—

SECONDARY outcome

Timeframe: Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

Outcome measures

Outcome measures
Measure	Retosiban n=53 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Volume of Distribution of Retosiban	68.6 Liters Geometric Coefficient of Variation 109	—

Adverse Events

Retosiban (Maternal)

Serious events: 7 serious events

Other events: 34 other events

Deaths: 0 deaths

Atosiban (Maternal)

Serious events: 9 serious events

Other events: 25 other events

Deaths: 0 deaths

Retosiban (Fetal)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Atosiban (Fetal)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Retosiban (Neonatal)

Serious events: 10 serious events

Other events: 23 other events

Deaths: 0 deaths

Atosiban (Neonatal)

Serious events: 11 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Retosiban (Maternal) n=47 participants at risk Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban (Maternal) n=50 participants at risk Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.	Retosiban (Fetal) n=47 participants at risk Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban (Fetal) n=50 participants at risk Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.	Retosiban (Neonatal) n=46 participants at risk Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban (Neonatal) n=50 participants at risk Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Congenital, familial and genetic disorders Cataract congenital	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.0% 3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Normal labour	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Hydrops foetalis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Amniotic cavity infection	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Appendicitis	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Haematoma infection	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Postoperative wound infection	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Urinary tract infection	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Bacterial disease carrier	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Gastroenteritis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Abdominal pain	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Pancreatitis	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Retroperitoneal haematoma	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Gastric perforation	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Eye disorders Visual impairment	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Hepatobiliary disorders Cholelithiasis	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	8.7% 4/46 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.0% 3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Injury, poisoning and procedural complications Abdominal wound dehiscence	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations Foetal monitoring abnormal	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations Blood bilirubin increased	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Cardiac disorders Foetal heart rate disorder	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Cardiac disorders Foetal heart rate deceleration abnormality	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Congenital, familial and genetic disorders Congenital hydronephrosis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Congenital, familial and genetic disorders Ankyloglossia congenital	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Congenital, familial and genetic disorders Pyloric stenosis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Meconium aspiration syndrome	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Sudden infant death syndrome	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Immune system disorders Milk allergy	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.

Other adverse events

Other adverse events
Measure	Retosiban (Maternal) n=47 participants at risk Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban (Maternal) n=50 participants at risk Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.	Retosiban (Fetal) n=47 participants at risk Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban (Fetal) n=50 participants at risk Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.	Retosiban (Neonatal) n=46 participants at risk Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban (Neonatal) n=50 participants at risk Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Cardiac disorders Foetal heart rate disorder	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	8.0% 4/50 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Cardiac disorders Foetal heart rate deceleration abnormality	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.4% 3/47 • Number of events 15 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Cardiac disorders Bradycardia foetal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Cardiac disorders Tachycardia	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Cardiac disorders Bradycardia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Cardiac disorders Tachycardia foetal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.1% 1/47 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Polyhydramnios	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Premature labour	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	21.7% 10/46 • Number of events 10 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	16.0% 8/50 • Number of events 8 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Hepatobiliary disorders Jaundice	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.3% 2/46 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Hepatobiliary disorders Hepatic steatosis	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	8.5% 4/47 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Candida infection	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Respiratory disorder neonatal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Respiratory, thoracic and mediastinal disorders Use of accessory respiratory muscles	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Infantile colic	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Constipation	21.3% 10/47 • Number of events 12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	10.0% 5/50 • Number of events 5 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Flatulence	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Inguinal hernia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Regurgitation	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Umbilical hernia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Vomiting	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Abdominal pain upper	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Dental caries	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Gingival bleeding	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Gastrointestinal disorders Toothache	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Urinary tract infection	8.5% 4/47 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.0% 3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Bacterial vaginosis	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Cervicitis	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Gastroenteritis	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.0% 3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Vaginitis gardnerella	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Escherichia urinary tract infection	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Genital candidiasis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Herpes zoster	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Influenza	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Pulpitis dental	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Pyuria	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Nasopharyngitis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Skin candida	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Ureaplasma infection	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Infections and infestations Vaginal infection	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Reproductive system and breast disorders Testicular retraction	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Reproductive system and breast disorders Vaginal haemorrhage	4.3% 2/47 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Reproductive system and breast disorders Breast engorgement	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Reproductive system and breast disorders Uterine atony	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Reproductive system and breast disorders Vulval oedema	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Reproductive system and breast disorders Vulvovaginal pruritus	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Blood and lymphatic system disorders Polycythaemia neonatorum	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Blood and lymphatic system disorders Anaemia	8.5% 4/47 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Blood and lymphatic system disorders Anaemia of pregnancy	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Ear and labyrinth disorders Auditory disorder	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Eye disorders Eyelid oedema	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Generalised oedema	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Pyrexia	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.0% 3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Asthenia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Chest pain	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Non-cardiac chest pain	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Oedema peripheral	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Peripheral swelling	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
General disorders Suprapubic pain	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Eyelid haemangioma	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Nervous system disorders Cerebral haemorrhage	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Nervous system disorders Headache	17.0% 8/47 • Number of events 8 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.0% 3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Nervous system disorders Dizziness	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	6.0% 3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Nervous system disorders Burning sensation	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Nervous system disorders Syncope	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Vascular disorders Haematoma	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Vascular disorders Hypotension	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations Escherichia test positive	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations Psychiatric evaluation abnormal	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations Candida test positive	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations Haemoglobin decreased	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations Klebsiella test positive	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Investigations White blood cell count increased	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	4.0% 2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Musculoskeletal and connective tissue disorders Flank pain	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Musculoskeletal and connective tissue disorders Neck pain	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Musculoskeletal and connective tissue disorders Pain in extremity	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Psychiatric disorders Insomnia	4.3% 2/47 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Psychiatric disorders Agitation	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Psychiatric disorders Depression	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Psychiatric disorders Mood swings	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Injury, poisoning and procedural complications Procedural pain	6.4% 3/47 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Injury, poisoning and procedural complications Abdominal wound dehiscence	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Metabolism and nutrition disorders Hypoglycaemia	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Skin and subcutaneous tissue disorders Acne infantile	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Skin and subcutaneous tissue disorders Blister	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Skin and subcutaneous tissue disorders Macule	2.1% 1/47 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Congenital, familial and genetic disorders Congenital hydronephrosis	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.2% 1/46 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
Renal and urinary disorders Renal pain	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	2.0% 1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/46 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.	0.00% 0/50 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894. SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Platelets;early withdrawal,n=1,1	-33.0 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-58.0 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Basophils;Day2,n=21,23	0.003 Billion cells per liter (L) Standard Deviation 0.0362	0.010 Billion cells per liter (L) Standard Deviation 0.0304
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Basophils;Post-infusion assessment,n=24,28	0.001 Billion cells per liter (L) Standard Deviation 0.0315	0.007 Billion cells per liter (L) Standard Deviation 0.0181
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Basophils;early withdrawal,n=1,1	-0.020 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	0.030 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Eosinophils;Day2,n=21,23	-0.010 Billion cells per liter (L) Standard Deviation 0.0626	-0.037 Billion cells per liter (L) Standard Deviation 0.1181
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Eosinophils;Post-infusion assessment,n=24,28	0.023 Billion cells per liter (L) Standard Deviation 0.0442	0.066 Billion cells per liter (L) Standard Deviation 0.1535
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Eosinophils;early withdrawal,n=1,1	0.030 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	0.050 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Lymphocytes;Day2,n=21,23	0.186 Billion cells per liter (L) Standard Deviation 0.9115	0.067 Billion cells per liter (L) Standard Deviation 0.6017
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Lymphocytes;Post-infusion assessment,n=24,28	0.348 Billion cells per liter (L) Standard Deviation 0.8611	0.233 Billion cells per liter (L) Standard Deviation 0.8047
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Lymphocytes;early withdrawal,n=1,1	0.270 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-1.770 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Monocytes;Day2,n=21,23	0.082 Billion cells per liter (L) Standard Deviation 0.2222	0.044 Billion cells per liter (L) Standard Deviation 0.2702
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Monocytes;Post-infusion assessment,n=24,28	0.222 Billion cells per liter (L) Standard Deviation 0.1904	0.133 Billion cells per liter (L) Standard Deviation 0.3467
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Monocytes;early withdrawal,n=1,1	-0.160 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	0.410 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Neutrophils;Day2,n=21,23	0.102 Billion cells per liter (L) Standard Deviation 2.6712	0.559 Billion cells per liter (L) Standard Deviation 3.3890
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Neutrophils;Post-infusion assessment,n=24,28	-1.865 Billion cells per liter (L) Standard Deviation 2.9246	-0.670 Billion cells per liter (L) Standard Deviation 2.7063
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Neutrophils;early withdrawal,n=1,1	-0.710 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-3.550 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Platelets;Day2,n=22,25	0.0 Billion cells per liter (L) Standard Deviation 25.95	-2.4 Billion cells per liter (L) Standard Deviation 36.59
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Platelets;Post-infusion assessment,n=24,31	21.5 Billion cells per liter (L) Standard Deviation 63.14	20.6 Billion cells per liter (L) Standard Deviation 43.74
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Leukocytes;Day2,n=23,25	0.17 Billion cells per liter (L) Standard Deviation 2.785	0.72 Billion cells per liter (L) Standard Deviation 2.905
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Leukocytes;Post-infusion assessment,n=25,30	-1.18 Billion cells per liter (L) Standard Deviation 2.492	-0.05 Billion cells per liter (L) Standard Deviation 2.756
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants Leukocytes;early withdrawal,n=1,1	-0.60 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-4.80 Billion cells per liter (L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.

Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants AST; Day 2, n=34, 35	-0.9 International Units per liter (IU/L) Standard Deviation 4.82	-1.7 International Units per liter (IU/L) Standard Deviation 3.07
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants AST; Post-infusion assessmet, n=29, 35	-1.3 International Units per liter (IU/L) Standard Deviation 4.87	-1.3 International Units per liter (IU/L) Standard Deviation 4.09
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants ALT; Post-infusion assessment, n= 30, 35	0.0 International Units per liter (IU/L) Standard Deviation 6.34	0.8 International Units per liter (IU/L) Standard Deviation 6.19
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants GGT; eearly withdrawal, n=1, 1	0.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	0.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants LDH; Day 2, n=34, 35	-9.7 International Units per liter (IU/L) Standard Deviation 50.58	-20.0 International Units per liter (IU/L) Standard Deviation 29.18
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants LDH; Post-infusion assessment, n=29, 35	-2.4 International Units per liter (IU/L) Standard Deviation 22.08	-5.4 International Units per liter (IU/L) Standard Deviation 30.93
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants LDH; early withdrawal, n=1, 1	-18.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-59.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants ALP; Day 2, n=35, 35	-10.1 International Units per liter (IU/L) Standard Deviation 12.12	-12.6 International Units per liter (IU/L) Standard Deviation 13.07
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants ALP; Post-infusion assessment, n=30, 35	14.1 International Units per liter (IU/L) Standard Deviation 39.85	5.9 International Units per liter (IU/L) Standard Deviation 15.87
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants ALP; early withdrawal, n=1, 1	-6.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-19.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants AST; early withdrawal, n=1, 1	-3.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	1.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants ALT; Day 2, n= 35, 35	-0.2 International Units per liter (IU/L) Standard Deviation 2.53	0.0 International Units per liter (IU/L) Standard Deviation 2.40
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants ALT; early withdrawal, n= 1, 1	-2.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	5.0 International Units per liter (IU/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants GGT; Day 2, n= 35, 35	-0.4 International Units per liter (IU/L) Standard Deviation 2.44	-0.9 International Units per liter (IU/L) Standard Deviation 3.08
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants GGT; Post-infusion assessment, n=30, 35	17.6 International Units per liter (IU/L) Standard Deviation 79.05	2.3 International Units per liter (IU/L) Standard Deviation 4.39

Measure	Retosiban n=47 Participants Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Atosiban n=50 Participants Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Calcium; Day 2, n=34, 35	-0.097 millimoles per liter (mmol/L) Standard Deviation 0.1125	-0.078 millimoles per liter (mmol/L) Standard Deviation 0.0884
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Calcium; Post-infusion assessment, n=29, 35	0.018 millimoles per liter (mmol/L) Standard Deviation 0.0953	0.023 millimoles per liter (mmol/L) Standard Deviation 0.0861
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Calcium; early withdrawal, n=1, 1	-0.120 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-0.230 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Chloride; Day 2, n=35, 35	1.5 millimoles per liter (mmol/L) Standard Deviation 2.02	1.4 millimoles per liter (mmol/L) Standard Deviation 2.03
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Chloride; Post-infusion assessment, n=30, 35	-1.5 millimoles per liter (mmol/L) Standard Deviation 1.83	-1.3 millimoles per liter (mmol/L) Standard Deviation 2.63
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Carbon dioxide, Post-infusion assessment, n=29,35	1.9 millimoles per liter (mmol/L) Standard Deviation 2.06	1.9 millimoles per liter (mmol/L) Standard Deviation 2.67
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Carbon dioxide, early withdrawal, n=1, 1	-2.0 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	6.0 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Glucose; Day 2, n=35,35	0.13 millimoles per liter (mmol/L) Standard Deviation 2.013	1.51 millimoles per liter (mmol/L) Standard Deviation 2.156
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Glucose; Post-infusion assessment, n=30, 35	-0.70 millimoles per liter (mmol/L) Standard Deviation 1.994	-0.35 millimoles per liter (mmol/L) Standard Deviation 2.283
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Glucose; early withdrawal, n= 1, 1	0.70 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-5.20 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Potassium; Day 2, n= 34, 35	0.06 millimoles per liter (mmol/L) Standard Deviation 0.392	-0.06 millimoles per liter (mmol/L) Standard Deviation 0.346
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Potassium; Post-infusion assessment, n= 29, 35	0.21 millimoles per liter (mmol/L) Standard Deviation 0.362	0.18 millimoles per liter (mmol/L) Standard Deviation 0.355
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Potassium; early withdrawal, n= 1,1	-0.10 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	0.50 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Magnesium; Day 2, n= 35,35	0.073 millimoles per liter (mmol/L) Standard Deviation 0.2098	-0.003 millimoles per liter (mmol/L) Standard Deviation 0.0657
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Magnesium, Post-infusion assessment, n= 30,35	0.026 millimoles per liter (mmol/L) Standard Deviation 0.0760	0.009 millimoles per liter (mmol/L) Standard Deviation 0.0772
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Magnesium; early withdrawal, n= 1,1	-0.060 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	0.030 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Phosphate; Day 2, n= 35,35	-0.101 millimoles per liter (mmol/L) Standard Deviation 0.2684	-0.170 millimoles per liter (mmol/L) Standard Deviation 0.2357
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Phosphate; Post-infusion assessment, n= 30,35	0.041 millimoles per liter (mmol/L) Standard Deviation 0.2267	0.094 millimoles per liter (mmol/L) Standard Deviation 0.2864
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Phosphate; early withdrawal, n= 1,1	0.100 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	-0.120 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Sodium; Day 2, n= 35,35	0.7 millimoles per liter (mmol/L) Standard Deviation 2.13	0.1 millimoles per liter (mmol/L) Standard Deviation 1.69
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Sodium; Post-infusion assessment, n= 30,35	-1.1 millimoles per liter (mmol/L) Standard Deviation 2.05	-0.2 millimoles per liter (mmol/L) Standard Deviation 2.11
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Sodium; early withdrawal, n= 1,1	-1.0 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	3.0 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Chloride; early withdrawal, n=1, 1	2.0 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.	8.0 millimoles per liter (mmol/L) Standard Deviation NA NA indicates standard deviation was not calculable for a single data point.
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants Carbon dioxide; Day 2, n=34, 35	0.7 millimoles per liter (mmol/L) Standard Deviation 2.34	0.3 millimoles per liter (mmol/L) Standard Deviation 2.63